Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics
Import Alert 17-04
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 17-04
Published Date: 10/02/2009
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Bulk Shipments of High-Risk Bovine Tissue from BSE-Countries--Bovine Spongiform Encephalopathy"
Reason for Alert:
BSE has been identified in more than 100,000 cattle in the United Kingdom and, to a much lesser extent, in several other countries. This neurological disease is a transmissible spongiform encephalopathy (TSE) and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. The spongiform encephalopathies are uniformly fatal and no rapid diagnostic test for infection in living animals or humans is presently available. Current scientific information indicates that the causative agent is extremely resistant to activation by normal disinfection or sterilization procedures. A range of research projects into the exact nature of both the BSE agent and other TSE agents, host range, patterns of pathogenicity, and development of rapid ante mortem diagnostic tests is ongoing.
Since 1991, USDA has prohibited the importation into the U.S. of certain tissues and organs from ruminants from countries where BSE exists. (refer to 9 CFR 94.18). On January 6, 1998, USDA issued an interim rule listing other countries because of import requirements less restrictive than those that would be acceptable for importation into the U.S. and/or because of inadequate surveillance, which would present a significant risk. USDA's regulations are intended to protect livestock in the United States from contracting TSEs and address known or strongly suspected modes of transmission. The USDA regulations permit, under certain conditions, the importation of some cosmetic ingredients (i.e., collagen, collagen products, amniotic liquids or extracts, placental liquids or extracts, serum albumin, and serocolostrum) derived from ruminants from BSE-countries (see 9 CFR 95.4).
The USDA regulations do not apply to imports of:
cosmetic products that are packaged and ready for sale;
bovine-derived materials intended for human consumption as either finished dietary supplement products or for use as ingredients in dietary supplements; or
human food (except meat, i.e., skeletal muscle).
In March 1996, the Spongiform Encephalopathy Advisory Committee of the UK reported that 10 cases of CJD in the UK are likely linked to exposure BSE before the UK ban in 1989.
The FDA has recommended that manufacturers who use bovine by-products voluntarily investigate the geographic source(s) of any bovine or bovine material used in their products (generally neural or glandular tissue or tissue extracts). The Agency also suggested that each manufacturer develop a plan "to assure, with a high degree of certainty," that such materials are not from BSE-countries, as identified by USDA's APHIS, or from scrapie-infected sheep flocks, either foreign or domestic.
FDA considers further protective steps to be reasonable and, in an August 17, 1994, letter (Attachment B), recommended that manufacturers and importers of dietary supplements, cosmetic products, and raw materials for these finished product develop plans for ensuring, with a high degree of certainty, that specific bovine-derived materials from BSE-countries are not being used.
Attachment A is an expanded list of those tissues presenting the highest known risk of infectivity, e.g., high-risk tissue, which are the subject of this import alert. Additional tissues may be added to this list as studies warrant and this import alert will be revised accordingly.
FDA will be gathering information on the development of BSE plans for all bovine - derived tissues and documenting the use of high-risk tissue from BSE-countries during domestic inspections under both the cosmetics and dietary supplements compliance programs. Due to the difficulty in verifying the presence of high-risk tissues in finished dietary supplements or cosmetic products, this import alert is limited to bulk lots of these tissues from BSE-affected or at risk countries listed above. However, if during wharf examinations or label reviews high-risk bovine tissues are noted in the ingredients statement, districts should follow the procedure in the Guidance section of this alert to notify CFSAN.
The United States Department of Agriculture issued an interim rule on January 6, 1998. The interim rule restricts the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts not only from countries and other regions in which BSE is known to exist, but also from countries and other regions which, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present a significant risk.
Guidance:
Districts may detain the shipment without physical examination, if the high-risk bovine tissue or ingredient, as listed in Attachment A, originated from one of the following Countries: Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, the Czech Republic, Denmark, the Federal Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Republic of, Italy, Japan, Leichtenstein, Luxembourg, the Former Yugoslav Republic of Macedonia, Monaco, Netherlands, Norway, Oman, Poland, Portugal, Romania, San Marino, the Slovak Republic (Slovakia), Slovenia, Spain, Sweden, Switzerland and United Kingdom. If an entry is detained and the importer or manufacturer has not provided within sixty (60) days documentation that establishes that the bovine derived tissue used in the product came from BSE-free cattle or from a non BSE affected or at risk country, districts should attempt to determine the status of the entry and, where possible, reach a final determination as to the entry. Sixty (60) days should be ample time for an importer or manufacturer to provide such documentation.
Districts may provide a copy of the Agency's August 17, 1994, letter (Attachment B) to importer's for their use in developing plans to assure that future shipments of bovine tissues are obtained from non-BSE countries.
Districts should be alert to entries of finished products from BSE affected countries which contain high-risk bovine tissues listed in the ingredients. When conducting field examinations and/or label reviews of finished products, such as dietary supplements or cosmetics that contain high-risk bovine tissues, contact CFSAN/Import Branch with product identity, high-risk bovine tissue used as ingredient, manufacturer/shipper, country of origin, and importer of record and for further guidance.
For any issues and/or questions regarding science, science policy, sample collection, analyses, preparation, analytical methodology or confirmation tests, districts should contact the Division of Field Science.
ATTACHMENTS
ATTACHMENT A
HIGH-RISK BOVINE TISSUE AND TISSUE-DERIVED INGREDIENTS
Adrenal gland
Bone marrow
Brain
Brain extract
Cerebellum
Cerebrospinal fluid
Cranial nerves
Colon (proximal and distal)
Dura mater
Eye
Hypothalamus
Ileum
Lymph nodes
Nasal mucosa
Olfactory bulb or gland
Pineal gland
Pituitary gland
Placenta
Spinal cord
Spleen
Suprarenal gland
Tonsil Attachment B
August 17, 1994
Food and Drug Administration Rockville, MD 20857
To Manufacturers and Importers of Dietary Supplements:
To Manufacturers and Importers of Cosmetics:
The Food and Drug Administration (FDA) is recommending that firms that manufacture or import dietary supplements and cosmetics containing specific bovine tissues (see Appendix A) ensure that such tissues do not come from cattle born, raised, or slaughtered in countries where bovine spongiform encephalopathy (BSE) exists (BSE-countries). Extracts of these tissues and ingredients derived from these tissues are also of concern. The recommended actions are precautionary measures to reduce potential risk of human exposure to, or transmission of, the agent which causes BSE in cattle.
At this time, FDA is not extending the recommendation in this letter to dairy products or gelatin, because available evidence does not suggest transmission via these foods. Furthermore, meat (i.e., skeletal muscle) is not covered by this letter. For guidance on importation of meat and other products regulated by the United States Department of Agriculture (USDA), refer to Title 9 of the Code of Federal Regulations.
The Agency is providing the following information to explain why it believes that BSE may potentially be a concern with certain dietary supplements and cosmetic products. BSE has been identified in more than 100,000 cattle in the United Kingdom and, to a much lesser extent, in several other countries. This neurological disease is a transmissible spongiform encephalopathy (TSE) and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. The spongiform encephalopathies are uniformly fatal and no rapid diagnostic test for infection in living animals or humans is presently available. Current scientific information indicates that the causative agent is extremely resistant to inactivation by normal disinfection or sterilization procedures. A range of research projects into the exact nature of both the BSE agent and other TSE agents, host range, patterns of pathogenicity, and development of rapid ante mortem diagnostic tests is ongoing.
Since 1991, USDA has prohibited the importation into the U.S. of certain tissues and organs from ruminants from countries where BSE exists (BSE-countries; see 9 CFR 94.18). USDA's regulations are intended to protect livestock in the United States from contracting TSEs and address known or strongly suspected modes of transmission. For the up-to-date listing of BSE-countries please contact USDA, Animal and Plant Health Inspection Service (APHIS) at (301) 436-7830.
The USDA regulations permit, under certain conditions, the importation of some cosmetic ingredients (i.e., collagen, collagen products, amniotic liquids or extracts, placental liquids or extracts, serum albumin, and serocolostrum) derived from ruminants from BSE-countries; see 9 CFR 95.4.
The USDA regulations do not apply to imports of:
cosmetic products that are packaged and ready for sale;
bovine-derived materials intended for human consumption as either finished dietary supplement products or for use as ingredients in dietary supplements; or
human food (except meat, i.e., skeletal muscle).
While documented transmission of the causative agents of BSE or scrapie to humans has not been reported to date, the FDA wrote to manufacturers of dietary supplements in November 1992, alerting them to the developing concern about TSEs in animals and CJD in man. That letter recommended that manufacturers voluntarily investigate the geographic source(s) of any bovine or ovine material used in their products (generally neural or glandular tissue or tissue extracts). The Agency also suggested that each manufacturer develop a plan "to assure, with a high degree of certainty," that such materials are not from BSE-countries, as identified by USDA's APHIS, or from scrapie-infected sheep flocks, either foreign or domestic.
FDA now considers further protective steps to be reasonable and is restating and expanding its recommendation to manufacturers and importers of dietary supplements and their ingredients, to develop plans for ensuring, with a high degree of certainty, that specific bovine-derived materials (see Appendix A) from BSE-countries are not being used. The Agency is also recommending that manufacturers and importers of cosmetic products and their ingredients develop the same type of plans. FDA is not, at this time, recommending restrictions on the use of ovine-derived materials in the manufacture of dietary supplement and cosmetic products and ingredients, as the epidemiological evidence now appears convincing that scrapie is not related to TSEs in humans.
FDA believes it is prudent to expand its recommendation to cosmetics and cosmetic ingredients because extracts of listed tissues, e.g. sphingolipids isolated from brain tissue and extracts of bovine placenta, are used in cosmetics. Additionally, FDA is unaware of data demonstrating that processing techniques used in the manufacture of cosmetics will inactivate TSE agents. Further, little is known about the potential human risk of transmission from topical application of cosmetics containing TSE agents to intact, broken or abraded skin.
To assist manufacturers and importers whose products are within the scope of this recommendation in developing their plans, the following guidance is provided:
. To ensure that bovine-derived materials (listed in appendix A) used in the product(s) are from non BSE-countries, identify all countries where the animals used were born, raised or slaughtered. The supplier of the bovine-derived materials should provide the necessary records.
b. Maintain traceable records for each lot of bovine-derived material and records of products containing the materials.
. Maintain records for those products manufactured at foreign sites or by foreign manufacturers which contain bovine-derived materials.
The Agency recommends that manufacturers and importers of dietary supplements and cosmetic products and ingredients used in the manufacture of these products develop their plans within the next two months and notify the Agency, in writing, that their plans have been developed. The designated contact is Dr. Elisa Elliot, Science Policy Analyst, Executive Operations Staff, HFS-22, Center for Food Safety and Applied Nutrition, FDA, 200 C Street, S.W., Washington, DC, 20204 or FAX (202) 205-5025. FDA recommends that the plans be implemented as soon after development as possible, and be available for review by the Agency during inspections.
The Agency is continuing to examine all available information about TSEs and will provide additional guidance as necessary. If you need more information please contact Dr. Elliot by telephone at (202) 205-5140.
We appreciate your attention to and cooperation in this matter.
Sincerely,
/s/
Linda A. Suydam
Interim Deputy Commissioner for
Operations
May 9, 1996
TO MANUFACTURERS AND IMPORTERS OF DIETARY SUPPLEMENTS:
TO MANUFACTURERS AND IMPORTERS OF COSMETICS:
As the media have widely reported, the British government announced on March 20, 1996, that new information had been gathered about bovine spongiform encephalopathy (BSE) in cattle that suggests a possible relationship between BSE and ten cases of a newly identified form of Creutzfeldt-Jakob disease (CJD), a similar fatal transmissible spongiform encephalopathy (TSE) in humans. To serve our mutual interest in protecting public health, the Food and Drug Administration (FDA) believes it is prudent to reiterate concerns we have previously expressed on this issue.
BSE is a transmissible neurologic disorder of cattle and is prevalent in certain parts of the world. This neurological disease is one of a number of transmissible spongiform encephalopathies (TSE) known and is similar to other TSEs such as scrapie in sheep and CJD in humans. It is believed that the spread of BSE in cattle in some countries, particularly Great Britain, was caused by the feeding of infected cattle and sheep tissues to cattle. While transmission of the causative agent of BSE to humans has not been definitively documented to date, inter-species transfer has been demonstrated (e.g., mice can be infected by exposure to infected bovine tissues). Recent developments in Great Britain raise serious questions regarding potential hazards of the consumption of animal tissues containing the causative agent of BSE.
Although there is still no definitive evidence that the consumption of bovine tissues that contain the transmissible agent for BSE cause CJD in humans, FDA is concerned that appropriate measures to eliminate the use of bovine tissues from BSE-countries be instituted industry-wide.
We strongly recommend that firms manufacturing or importing dietary supplements which contain specific bovine tissues (see appendix A), including extracts or substances derived from such tissues, take whatever steps are necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists.
FDA believes that immediate and concrete steps should be taken by manufacturers to reduce the potential risk of human exposure to the infectious agent which causes BSE in cattle.
The list of countries where BSE is known to exist is maintained by the U.S. Department of Agriculture (USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18. The following is the current list:
USDA LIST OF COUNTRIES WHERE BSE EXISTS
(Current as of May 1996)
Great Britain (including Northern Ireland and the Falklands)
Switzerland
France
Republic of Ireland
Oman
Portugal
A range of research projects into the exact nature of both the BSE agent and other TSE agents is ongoing. Available scientific information indicates that these agents are extremely resistant to inactivation by normal disinfection or sterilization procedures. A number of dietary supplement products use bovine-derived tissues or extracts of such tissues as ingredients. These ingredients include, for example, specific tissues and organs or their extracts (e.g., liver powder, "orchic" extracts, ovaries, eye tissue, mammary tissue), glandular powders or extracts (e.g., adrenal gland, thyroid gland), or specific substances extracted from glands or tissues (e.g., melatonin extracted from the pineal gland).
At a future date, we will contact you with guidance on how best to provide assurance that your products do not contain potentially BSE-infected materials.
We appreciate your attention to and cooperation in this matter. If you need more information, please contact Dr. Elisa Elliot by telephone at (202) 205-5140.
Sincerely yours,
/s/
Michael A. Friedman, M.D.
Deputy Commissioner for Operations
Enclosure Appendix A
List of Tissues With Suspected Infectivity
Category I (High infectivity)
brain
spinal cord
Category II (Medium infectivity)
ileum
lymph nodes
proximal colon
spleen
tonsil
dura mater
pineal gland
placenta
cerebrospinal fluid
pituitary gland
adrenal gland
Category III (Low infectivity)
distal colon
nasal mucosa
sciatic nerve
bone marrow
liver
lung
pancreas
thymus gland
List taken from Report of a WHO Consultation on Public Health
Issues Related to Animal and Human Spongiform Encephalopathies,
World Health Organization, Office of International Epizootics,
Geneva, Switzerland, November 12-14, 1991.
Product Description:
Bulk shipments of high-risk bovine tissues and tissue-derived ingredients (see Attachment A for a list of affected products).
Adrenal gland; Bone marrow; Brain; Brain extract; Cerebellum; Cerebrospinal fluid; Cranial nerves; Colon (proximal and distal); Dura mater; Eye; Hypothalamus; Ileum; Lymph nodes; Nasal mucosa; Olfactory bulb or gland;;Pineal gland; Pituitary gland; Placenta; Spinal cord; Spleen; Suprarenal gland; Tonsil
Charge:
As ingredients in dietary supplements, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food [Adulteration, Section 402(a)(3)]." "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and may have been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 402(a)(4)]." As ingredients in cosmetics, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a cosmetic product and appears to have or may have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 601(c)." If final disposition of the bulk lot is undetermined, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be unfit for food [Adulteration, Section 402(a)(3)]." AND "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health [Adulteration, 402(a)(4)]".
Countries (AL) ALBANIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(AD) ANDORRA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(AT) AUSTRIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(BE) BELGIUM
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(BA) BOSNIA-HERCEGOVINA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(BG) BULGARIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(CA) CANADA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(HR) CROATIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(CS) CZECHOSLOVAKIA (DO NOT USE)
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(DK) DENMARK
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(FK) FALKLAND ISLANDS
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(FI) FINLAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(FR) FRANCE
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(DE) GERMANY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(GR) GREECE
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(HU) HUNGARY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(IE) IRELAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(IL) ISRAEL
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(IT) ITALY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(JP) JAPAN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(LI) LIECHTENSTEIN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(LU) LUXEMBOURG
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(MK) MACEDONIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(MC) MONACO
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(NL) NETHERLANDS
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(NO) NORWAY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(OM) OMAN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(PL) POLAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(PT) PORTUGAL
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(RO) ROMANIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SM) SAN MARINO
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SK) SLOVAKIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SI) SLOVENIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(ES) SPAIN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SE) SWEDEN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(CH) SWITZERLAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(GB) UNITED KINGDOM
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(YU) YUGOSLAVIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
-
http://www.accessdata.fda.gov/cms_ia/importalert_53.html
Date: Sun, 12 Jan 2003 12:56:44 -0600
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ???
With these known facts about nutritional supplements, I think it imperative to include this potential route and source of TSE and warning in this article.
Why was it not included? I lost my mother to hvCJD DOD 12/14/97, and I probably will not live long enough to know the route and source of her TSE. Exactly one year previously, to the day 12/14/96, my neighbor also lost his mother to sporadic CJD. Both of these cases were confirmed. but my neighbor's mother had been taking a nutritional supplement called IPLEX, made by Standard Process Co.
Here is a listing of potentially TSE-tainted tissues:
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
The CDC came and took the pills, a few years later, I spoke with the late Dr. Gibbs and NIH/CDC and he told me that those particular pills did not show any infectivity with the testing techniques to date, but he also told me -
1. That the testing techniques at that time may not be sufficient to pick up any 'low-level' infectivity. (so, if accumulation plays into this, this could play a big part).
2. She had been taking these type pills for years, could have been another batch.
There have been other people die of CJD that were taking these type nutritional supplements.
So, my point being, I believe this to warrant a potential risk factor, one not to be ignored, especially in the USA where there are many known TSEs, and where there are many unknowns due to the lack of sufficient TSE testing in USA cattle, and especially since the new findings of Collinge et al, where BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc, the commonest sporadic CJD.
I believe these findings to be of substantial importance:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
Friday, January 19, 2001
Holiday Inn Bethesda Versailles I and II 8120 Wisconsin Avenue Bethesda, Maryland
2 PARTICIPANTS Paul W. Brown, M.D., Chairperson William Freas, Ph.D., Executive Secretary
VOTING MEMBERS Ermias D. Belay, M.D. David C. Bolton, Ph.D. Donald S. Burke, M.D. Dean O. Cliver, Ph.D. Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D. Pedro Piccardo, M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D. Elizabeth S. Williams, D.V.M., Ph.D.
VOTING CONSULTANTS Linda A. Detwiler, D.V.M. David Gaylor, Ph.D.
Paul R. McCurdy, M.D. Kenrad E. Nelson, M.D.
NONVOTING CONSULTANT Susan Leitman, M.D.
GUESTS Richard Davey, M.D. Louis Katz, M.D.
snip...
page 501
253
1 DR. BOLTON: I have an additional question about 2 that. What is the assurance that additional locally sourced 3 tracheas are not added into that manufacturing process, thus 4 boosting the yield, if you will, but being returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected brain are likely to infect 8 an organism, either animal or man, when taken orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a gram is enough in a cow, orally; 11 in other words, one good dietary-supplement pill. 12 DR. McCURDY: What I am driving at is the question 13 we are asked is really not do we wish to regulate these 14 things coming in. I think the statements about difficulties 15 in regulating things in the future or near future for new 16 regulations were probably accurate. 17 But I think that we could exhibit some quite 18 reasonable concern about blood donors who are taking dietary 19 supplements that contain a certain amount of unspecified- 20 origin brain, brain-related, brain and pituitary material. 21 If they have done this for more than a sniff or something 22 like that, then, perhaps, they should be deferred as blood 23 donors. 24 That is probably worse than spending six months in 25 the U.K.
1/19/01 3681t2.rtf(845) page 501
http://www.fda.gov/ohrms/dockets/ac/cber01.htm
There has been a Nutritional Supplement mad cow warning letter circulating around since about 1990. Every year they issue the same letter to the manufactures asking them to please be sure they source their products from BSE-FREE countries. but we all know, the statement BSE-FREE, is a joke, especially in the USA. I sat in on the 50 state emergency BSE conference call, (uninvited guest) and I know for a fact the so-called 'pharmaceutical grade' bovine source herds, bovines that were to never be fed ruminant materials, the USA cannot for certain say that indeed these cattle have never ingested ruminant feed, in fact, some probably had.
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
Bovine Spongiform Encephalopathy
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
And I would have been doing just fine, until I asked my question. I was surprised my time to ask a question came so quickly.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns] And now a question from Terry S. Singeltary of CJD Watch.
[TSS] Yes, Thank You. U.S. cattle - what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the background, mumbling and "We can't. Have him ask the question again."]
[host Richard] Could you repeat the question?
[TSS] U.S. cattle..what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this] What group are you with?
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking] Could you please disconnect Mr. Singeltary
[TSS] You are not going to answer my question?
[not sure whom speaking] NO
From this point, I was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
[unknown woman] What group are you with?
[TSS] CJD Watch and my Mom died from hvCJD We are trying to tract down CJD and other human TSE's world wide. I was invited to sit in on this from someone inside the USDA/APHIS and that is why I am here. Do you intend on banning me from this conference now?
At this point the conference was turned back up, and I got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, I will try and give you a run-down for now, of the conference.
IF O were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from:
RBARNS@ORA.FDA.GOV 301-827-6906
He would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.
FULL TEXT MY TRANSCRIPT ARCHIVED HERE;
Friday, January 29, 2010 14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)
http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html
now to explore more on this issue of TSEs and Nutritional Supplements. please read further;
Suit Filed Over Mad Cow Disclaimer By Jason Hoppin The Recorder March 23, 2001
A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.
The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.
"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.
The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.
"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies the disease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."
No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.
The case was filed in San Francisco Superior Court.
The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.
Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bones and brains, where BSE is most highly concentrated.
Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S. government-inspected facilities.
"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.
The human manifestation of BSE -- variant Creutzfeld-Jakob disease -- has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.
U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.
"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."
However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.
© 2001 law.com Inc. © 1999-2001 NLP IP Company,
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http://vm.cfsan.fda.gov/~dms/qa-sup5.html
[ Q: ] What is a dietary supplement and how is it regulated?
[ A: ] A dietary supplement is any product taken by mouth that contains a so-called "dietary ingredient" and its label clearly states that it is a dietary supplement.
The "dietary ingredients" in dietary supplements may include vitamins, minerals, herbs, and amino acids as well as substances such as enzymes, organ tissues, metabolites, extracts or concentrates. Dietary supplements can be found in many forms such as pills, tablets, capsules, liquids or powders. They must be identified on the label as a dietary supplement.
How are Dietary Supplements regulated?
The label of a dietary supplement must contain enough information about the composition of the product so that consumers can make informed choices. (The information must be presented in FDA-specified format.) The manufacturer must make sure the label information is truthful and not misleading. The manufacturer is also responsible for making sure that all the dietary ingredients in the supplements are safe. Manufactures and distributors do not need to register with FDA or get FDA approval before producing or selling dietary supplements.
Are advertisements for Dietary Supplements regulated by FDA?
No. The Federal Trade Commission (FTC) handles advertising for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but their work is directed by different laws.
============================================================
U. S. Food and Drug Administration Email this Page To a Friend [email a friend] Center for Food Safety and Applied Nutrition January 3, 2001 [ ]
Overview of Dietary Supplements
What is a dietary supplement?
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
What is a "new dietary ingredient" in a dietary supplement?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
* a vitamin,
* a mineral,
* an herb or other botanical,
* an amino acid,
* a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
* a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.
What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.
Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.
Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. However, FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.
When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.
There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information on new dietary ingredients, go to: http://www.cfsan.fda.gov/~dms/ds-ingrd.html.
What information must the manufacturer disclose on the label of a dietary supplement?
FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.
In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a
"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.
Must all ingredients be declared on the label of a dietary supplement?
Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: http://www.cfsan.fda.gov/~lrd/fr97923a.html. Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.
Where can I get information about a specific dietary supplement?
Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.
Who has the responsibility for ensuring that a dietary supplement is safe?
By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?
No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information on claims that can be made for dietary supplements, see (http://www.cfsan.fda.gov/~dms/hclaims.html). How can consumers inform themselves about safety and other issues related to dietary supplements?
It is important to be well informed about products before purchasing them. Because it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase (see previous question "Where can I get information about a specific dietary supplement?"). In addition, to help consumers in their search to be better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information -- http://www.cfsan.fda.gov/~dms/ds-savvy.html (includes information on how to evaluate research findings and health information on-line) and Claims That Can Be Made for Conventional Foods and Dietary Supplements -- http://www.cfsan.fda.gov/~dms/hclaims.html, (provides information on what types of claims can be made for dietary supplements).
What is FDA's oversight responsibility for dietary supplements?
Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occaisional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency. Does FDA routinely analyze the content of dietary supplements?
In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.
Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product. Who validates claims and what kinds of claims can be made on dietary supplement labels?
FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.
By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail at the following site: (http://www.cfsan.fda.gov/~dms/hclaims.html). Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
How are advertisements for dietary supplements regulated?
The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www.ftc.gov/bcp/menu-health.htm . Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service. How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?
If you think you have suffered a serious harmful effect or illness from a product FDA regulates, including dietary supplements, the first thing you should do is contact or see your healthcare provider immediately. Then, you and your health care provider are encouraged to report this problem to FDA.
Your health care provider can call FDA's MedWatch hotline at 1-800-FDA-1088, submit a report by fax to 1-800-FDA-0178 or on-line at: http://www.fda.gov/medwatch/report/hcp.htm. The MedWatch program provides a way for health care providers to report problems believed to be caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements.
You, or anyone, may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any of the above-mentioned products, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or reporting on-line at: http://www.fda.gov/medwatch/report/consumer/consumer.htm . FDA would like to know when you think a product caused you a serious problem, even if you are not sure that the product was the cause, or even if you do not visit a doctor or clinic. In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site.
NOTE: The identity of the reporter and/or patient is kept confidential.
For a general, not serious, complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number: http://www.fda.gov/opacom/backgrounders/complain.html.
For more recent information on Dietary Supplements See http://www.cfsan.fda.gov/~dms/supplmnt.html
http://vm.cfsan.fda.gov/~dms/ds-oview.html
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. T01-09 Print Media: 202-205-4144 February 5, 2001 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA FDA ISSUES LETTER TO INDUSTRY ON FOODS CONTAINING BOTANICAL AND OTHER NOVEL INGREDIENTS
The Food and Drug Administration (FDA) recently issued a letter to the food industry restating the requirements of the Federal Food, Drug, and Cosmetic Act regarding the marketing of conventional foods containing novel ingredients, including botanicals. FDA is issuing this letter because of the significant growth in the marketing of foods containing these ingredients.
FDA is concerned that some botanical and other novel ingredients that are being added to conventional foods are neither approved food additives, nor generally recognized as being safe for these uses. This letter serves as a reminder to the industry of the longstanding legal requirements governing conventional food products.
In issuing this letter, FDA is also reminding manufacturers about the legal requirements regarding claims on conventional foods. The Food Drug and Cosmetic Act allows for certain claims such as:
* health claims -- a claim characterizing the relationship between a food substance and a disease or health related condition;
* nutrient content claims -- a claim characterizing the level of a nutrient in a food; and
* structure/function claims -- a claim characterizing the effect of a food on the structure or function of the body.
FDA must review health claims and nutrient content claims prior to marketing, unless the claim has been authorized by regulation or by statute under the authoritative statement notification procedure.
Manufacturers are encouraged to contact the agency regarding the regulatory status of ingredients and claims they intend to use for foods.
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01070.html
more listings of potential TSE carrying nutritional supplements, only a few of hundreds out there;
IPLEX; (listing only potentially TSE tainted tissues) vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
also this is another;
Immuplex Ingredients;
Bovine Liver PMG Extract, zinc-iron-copper liver chelate, bovine liver powder, veal bone PMG Extract, ascorbic acid, nutritional yeast, bovine spleen PMG Extract, high selenium yeast, vaccum dried bovine and ovine spleen, bovine thymus PMG Extract, bovine thymus Cytosol Extract, mixed tocopherois, high chromium yeast, pyridoxal 5-phosphate, vitamin A esters, calcium lactate, folic asid and cyanocabalamin.
Two capsules supple 165 mg Bovine Liver PMG Extract, 45 mg Bovine spleen PMG Extract, 40 mg Vacuum Dried Bovine and Ovine Spleen, 35 mg. Bovine Thymus PMG Extract and 35 mg Bovine Thymus Cytosol Extract.
METABOLIFE; Bovine Complex; Glandular system; Ovaries, Prostate, Scrotum and Adrenal (usda cattle) [big deal...tss]
12,500 cattle ever checked for a TSE in the U.S.A. in the 12 year program (to aug. 2001)
in that 12 years, the U.S. has raised 1.5 BILLION head of cattle including calf crop. 100 million in the USA in any given year.
37 MILLION slaughtered annually
190,000 DOWNERS annually
=========================================
Subject: Metabolife
Date: Mon, 7, Dec 1998 14:21:35 -0800
From: Rand Smith
To: "'flounder@wt.net'"
Dear Sir,
We are looking at reformulation. I agree that slow virus diseases present a problem in some areas of the world.
Our product uses healthy USDA inspected cattle for the glandular extract.
If you have any links to more information on this subject I would like to examine them.
Thank you for your interest and concern.
Dr. Smith
============================
here is the famous yearly token letter from FDA to supplements manufacturer;
Letter to Manufacturers of Biological Products - Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)
Department of Health and Human Services Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448
April 19, 2000
To Manufacturers of Biological Products
The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.
CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:
1.Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.
2.Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.
3.Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities.
It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephone number 301-734-8364, website address http://www.aphis.usda.gov/ncie, and codified at 9 CFR 94.18 (see attached).
Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:
Dr. David Asher, Office of Blood Research and Review 301-827-3524 Dr. Paul Richman, Office of Vaccines Research and Review 301-827-3070 James Crim, Office of Therapeutics Research and Review 301-827-5101
Thank you for your attention to this matter.
Sincerely,
---- signature ---
Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And Research
Attachment
http://www.fda.gov/cber/ltr/bse041900.htm
also, you can go to this FDA dockets page, and skroll down until you see EMC 597 'Terry S. Singeltary Sr.' highlighted in blue. this also has some very interesting information. It is a PDF file;
http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/030100.htm
another thing most disturbing, the USA imports supplements with SRMs from known BSE countries. and if you don't think scrapie or CWD can transmit to man as easily or as difficult as BSE (depends whom you have watched suffer and die from this horrible disease) well, i would like to see this proof of this (transmission studies only). but let us not forget the potential threat of BSE in sheep.
another fine example;
snip...
In fact, the salesman now tells us he doesn't sell the machines anymore. But the quest for youth goes beyond facial creams and exotic contraptions, anti-agers are also ingesting some pretty wild-sounding dietary supplements. "Live proteins from sheep and pig from France, processed," says a representative.
Life-Cell Technologies touts the benefits of supplements that contain processed pig and sheep organs. "I have a lot of body builders and professional athletes that use these products because they strengthen and stimulate the different glands and organs," says one woman. The idea, she implied, often is that ingesting ground up animal organs will strengthen human organs or even cure thyroid and adrenal diseases. "To my knowledge you can't just take pulverzied organs and feed them to somebody and think they're not going to have thyroid disease anymore or hypo-adrenalism," says Dr. Wexler. It would be kind of a medical miracle, wouldn't it? "It would be amazing, truly amazing," says Dr. Wexler. "Dateline" attended another anti-aging conference and expo in Chicago - this time with our cameras in plain view.
Remember the exhibitor selling processed pig and sheep organs? We pressed her for scientific documentation. We asked, what is the science behind the idea? The woman tells us, "You would have to go on the Internet and get information, scientific studies." But this is her company, isn't it? "Yes it is," she says. "And if you don't mind, I don't want to be interviewed. I don't."
"Dateline" tells her, "They are simple questions that any consumer would ask." Everywhere "Dateline" went at the anti-aging expo we heard a lot about so-called "scientific studies." "Well, it comes from 3,000 studies," a man at the expo tells us.
At one booth the product is called transfer factor, and the active ingredient is colostrum - the potent pre-milk fluid in a lactating mother's breast.
"We actually filtrate the transfer factor out of the colostrum," says one man. From where, mothers? "No," the man tells us. "From bovine colostrum, from cows."
http://www.msnbc.com/news/550100.asp?cp1=1
----- Original Message -----
From: "TERRY SINGELTARY"
To:
Sent: Thursday, March 19, 2009 8:47 PM
Subject: [CJD-L] Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)
10.3201/eid1505.081458 Suggested citation for this article: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of print]
Chronic Wasting Disease Prions in Elk Antler Velvet
Rachel C. Angers,1 Tanya S. Seward, Dana Napier, Michael Green, Edward Hoover, Terry Spraker, Katherine O'Rourke, Aru Balachandran, and Glenn C. Telling Author affiliations: University of Kentucky Medical Center, Lexington, Kentucky, USA (R.C. Angers, T.S. Seward, D. Napier, M. Green, G.C. Telling); Colorado State University, Fort Collins, Colorado, USA (E. Hoover, T. Spraker); US Department of Agriculture, Pullman, Washington, USA (K. O'Rourke); and Canadian Food Inspection Agency, Ottawa, Ontario, Canada (A. Balachandran) 1Current affiliation: MRC Laboratory of Molecular Biology, Cambridge, UK.
Chronic wasting disease (CWD) is a contagious, fatal prion disease of deer and elk that continues to emerge in new locations. To explore the means by which prions are transmitted with high efficiency among cervids, we examined prion infectivity in the apical skin layer covering the growing antler (antler velvet) by using CWD-susceptible transgenic mice and protein misfolding cyclic amplification. Our finding of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among cervids. Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions. The fact that CWD prion incubation times in transgenic mice expressing elk prion protein are consistently more rapid raises the possibility that residue 226, the sole primary structural difference between deer and elk prion protein, may be a major determinant of CWD pathogenesis.
snip...
Discussion
The transmission of CWD prions in antler velvet from 2 naturally affected elk to mice in 2 Tg models demonstrates that this tissue contains low, but detectable, amounts of CWD prions. In addition, serial PMCA amplified otherwise undetectable levels of PrPSc in antler velvet. We characterized CWD prion infectivity by end-point titration. The .6 log i.c.ID50/g CWD prion titer estimated by this method contrasts with .9 log i.c.ID50/g titers of mouse-adapted scrapie prions in rodent brains (9) and .7.7.7 log i.c.ID50/g titers of BSE prions estimated by bioassay in transgenic mice (10,11). The linear relationship between dose and incubation time (12) provides an opportunity to estimate the level of prions in materials containing an unknown amount of infectivity. The attack rates of <100%>30 months (28). Prion strain properties are also critical when considering the potential for interspecies transmission. The existence of multiple CWD strains has been suggested by several studies (4,25,29,30), but strain isolation and host range characterization have not been reported. Finally, it is worth considering that if CWD were to cross the species barrier into humans, this transmission source might not be recognized if the disease profile overlapped with one of the forms of sporadic CJD reported in North America.
Possible Role for Residue 226 in CWD Pathogenesis
Previous studies that demonstrated more rapid CWD prion incubation times in Tg mice expressing elk PrP (24,29) than in Tg(CerPrP)1536+/. mice (4) raised the possibility that the single amino acid difference at residue 226 between elk and deer PrP (5) may influence CWD pathogenesis (29). However, when the transmission characteristics of CWD isolates were directly compared in Tg mice expressing differing levels of deer or elk PrP, Tamguney et al.
Page 8 of 17
concluded that CWD incubation times were related solely to the level of PrP transgene expression (25). We compared CWD transmission in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice, which express PrP at levels .5-fold higher than PrP in wild type mouse brain (Figure 1A), and found that CWD transmission was consistently and substantially more rapid in Tg(CerPrP-E226)5037+/. mice. Our results appear compatible with more efficient CWD prion propagation by elk cellular prion protein (CerPrPC) containing E at residue 226 than by deer CerPrPC containing Q at this position. Consistent with this interpretation, despite 5-fold lower levels of transgene expression in Tg(CerPrP-E226)5029+/. than in Tg(CerPrP)1536+/. mice, mean incubation times of the D92 isolate were equivalent in these 2 lines (Table). Nonetheless, undetected differences in CerPrPC expression, for example in particular cell types, might result in more rapid disease and/or altered pathologic changes. The generation of transgenic mice expressing elk and deer coding sequences using gene replacement strategies would seem to be an excellent approach for resolving this issue. The different responses to CWD in Tg mice also appear to recapitulate aspects of CWD pathogenesis in the natural hosts. Previous limited comparative transmission studies indicated that CWD developed .25% more rapidly in orally challenged elk than deer (31). Although plaques were not detected in brains of CWD-affected elk, florid plaques have been observed in the brains of diseased deer (32,33). Similar differences in pathologic changes were observed in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice (Figure 4). Structural analyses suggest that residue 226 is located within a region of PrPC proposed to interact with a factor (34), possibly equivalent to the postulated protein X (35). Although mutation of the equivalent residue from Q to lysine (K) in epitope-tagged mouse PrP had no effect on PrPSc formation in transfected chronically infected ScN2A cells, the effects of the Q-to-E substitution were not assessed (36).
Acknowledgments We thank Dongyue Zhuang for excellent technical assistance. This work was supported by grants 2RO1NS040334-04 from the National Institute
http://www.cdc.gov/eid/content/15/5/pdfs/08-1458.pdf
snip...
1998 MY SUBMISSION TO THE BSE INQUIRY ENGLAND
Sender: "Patricia Cantos"
To: "Terry S Singeltary Sr. (E-mail)"
Subject: Your submission to the Inquiry
Date: Fri, 3 Jul 1998 10:10:05 +0100
3 July 1998 Mr Terry S Singeltary Sr. E-Mail: Flounder at wt.net Ref: E2979
Dear Mr Singeltary,
Thank you for your E-mail message of the 30th of June 1998 providing the Inquiry with your further comments. Thank you for offering to provide the Inquiry with any test results on the nutritional supplements your mother was taking before she died.
As requested I am sending you our general Information Pack and a copy of the Chairman's letter. Please contact me if your system cannot read the attachments.
Regarding your question, the Inquiry is looking into many aspects of the scientific evidence on BSE and nvCJD. I would refer you to the transcripts of evidence we have already heard which are found on our internet site at http://www.bse.org.uk. Could you please provide the Inquiry with a copy of the press article you refer to in your e-mail? If not an approximate date for the article so that we can locate it? In the meantime, thank you for you comments. Please do not hesitate to contact me on 0171 261 8332 should you have any queries.
Yours sincerely Patricia Cantos Families Team Leader Attachments TSS
==============
My neighbors Mom also died from CJD. She had been taking a nutritional supplement which contained the following; vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. As I said, this woman taking these nutritional supplements, died from CJD. The particular batch of pills that was located, in which she was taking, was tested. From what I have heard, they came up negative, for the prion protein. But, in the same breath, they said their testing, may not have been strong enough to pick up the infectivity. Plus, she had been taking these type pills for years, so, could it have come from another batch?
http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406
IPLEX, mad by standard process;
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
also;
i will only list animal ingredients of the following Nutritional Supplements by only ONE company;
Standard Process Co.
IPLEX; bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder, vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal, vacuum dried veal bone.
A-FBetafood R vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine kidney, bovine orchic glandular extract, bovine liver fat extract.
Arginex R bovine liver powder.
Adrenal, Desiccated TM Vacuum dried bovine adrenal.
Albaplex R bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney PMF Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal, vacuum dried bovine kidney, veal bone meal.
Allerplex TM bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried veal bone.
Immuplex R Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract, bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine thymus PMF Extract, bovine thymus Cytosol Extract.
Vasculin R Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder, vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum dried bovine and ovine spleen.
Zypan R bovine pancreas Cytosol Extract, vacuum dried bovine and ovine spleen.
last i heard, they were getting sued;
Suit Filed Over Mad Cow Disclaimer
By Jason Hoppin The Recorder March 23, 2001
A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.
The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.
"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.
The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.
"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies thedisease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."
No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.
The case was filed in San Francisco Superior Court.
The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.
Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bonesand brains, where BSE is most highly concentrated.
Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S.government-inspected facilities.
"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.
The human manifestation of BSE -- variant Creutzfeld-Jakob disease --has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.
U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.
"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."
However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.
© 2001 law.com Inc. =======================
Supplements Association Moves to Eliminate Bovine Parts From Products
WASHINGTON (Reuters Health) Mar 16 - The nation's largest dietary supplements industry group has issued new guidance to manufacturers amid concerns that some alternative health products containing bovine materials pose a risk of transmitting bovine spongiform encephalopathy (BSE) to humans.
The guidance, published by the National Nutritional Foods Association (NNFA), encourages manufacturers to eliminate all neurological bovine materials from their products. Consumption of brains and spinal cords from cows infected with BSE are widely believed to be the source of new variant Creutzfeldt-Jakob disease (vCJD) in humans........
snip... full text at;
http://id.medscape.com/
see ;
http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html
-------- Original Message --------
Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
Date: Thu, 01 May 2003 16:04:35 -0400
From: "Marcia G Crosse" To:
CC: "Charles W Davenport" , "Carolyn Feis Korman" , "Martin Gahart"
Mr. Singletary,
We were informed by representatives of Metabolife, Inc. that Metabolife 356 was reformulated to remove bovine complex as an ingredient in the product, approximately September 2001. We did not independently verify the contents of the product.
Sincerely, Marcia Crosse Acting Director Health CarePublic Health and Science Issues U.S. General Accounting Office 441 G Street, N.W. Washington, D.C. 20548
===================
-------- Original Message --------
Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
Date: Thu, 01 May 2003 15:48:52 -0500
From: "Terry S. Singeltary Sr."
To: Marcia G Crosse
CC: Charles W Davenport , Carolyn Feis Korman , Martin Gahart References:
THANK YOU!
MIRACLES DO HAPPEN! ;-)
now all we need to do is;
snip......
one small step for man, one giant leap for mankind ;-)
however;
''We did not independently verify the contents of the product''
???
TSS
####### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ########
see history of mad cow in a pill ;
Thursday, March 19, 2009
Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)
http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html
####### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ########
http://www.wellsphere.com/cjd-article/chronic-wasting-disease-prions-in-elk-antler-velvet-nutritional-supplements-and-cjd/628645
'Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from 3 US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated. (neighbors Mom, whom also died from CJD, had been taking bovine based supplement, which contained brain, eye, and many other bovine/ovine tissues for years, 'IPLEX'). What is
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47
Posted Apr 09 2009 7:13pm
http://stanford.wellsphere.com/cjd-article/use-of-materials-derived-from-cattle-in-human-food-and-cosmetics-docket-no-2004n-0081-rin-0910-af47/641209
http://cjdmadcowbaseoct2007.blogspot.com/2008/04/use-of-materials-derived-from-cattle-in.html
http://www.epa.gov/EPA-IMPACT/2008/April/Day-17/i1142.htm
http://lists.iatp.org/listarchive/archive.cfm?id=123840
http://cjdmadcowbaseoct2007.blogspot.com/2008/04/use-of-materials-derived-from-cattle-in.html
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian v CJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfillment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
It is clear that the designing scientists must also have shared Mr Bradley’s surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley’s surprise at the results because all the
dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts
[BBC radio 4 FARM news]
http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
2) Infectious dose:
To cattle: 1 gram of infected brain material (by oral ingestion)
http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml
Tuesday, January 19, 2010
CVM's OR Develops New PCR-Based Method for Testing Animal Feed
http://madcowfeed.blogspot.com/2010/01/cvms-or-develops-new-pcr-based-method.html
NOW that we have established that this infamous part of the USA BSE MAD COW TRIPLE FIRE WALL was a farce, let's look further into the historical myth of no mad cows in the USA (well, they estimate at 1 in a million slip by into the food system), but i dispute that by many more. The BSE surveillance program was/is terribly flawed as well.
bottom line, and i say this with full confidence, with the present and past surveillance of BSE/TSE in the USA, and the continued feed violations, in the TONS, no one will ever know the true extent of any strain of mad cow disease in the USA. you don't have to just take my word on it, read the facts. blunder, after blunder, after blunder. they have all been posted here, i would be glad to go over any and or all of them one by one for any that doubts me. i can sum it all up real quick, Canada is looking to find, and the USA has never, EVER, done that. it's been just the opposite for the USA. don't believe me, or the facts, here is what Dr. Paul Brown of the cdc/nih et al ;
PAUL BROWN COMMENT TO ME ON THIS ISSUE
Tuesday, September 12, 2006 11:10 AM
"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."
PAUL BROWN CDC ET AL COMMENT TO THE MEDIA ON THIS ISSUE ;
"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end
http://www.upi.com/
http://usdameatexport.blogspot.com/2009/09/japans-new-leaders-seen-tougher-on-us.html
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
Statement on Texas cow with central nervous system symptoms
Main Category: Public Health Article
Date: 05 May 2004 - 0:00 PDT
The Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.
FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.
Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).
FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.
Source: FDA http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm092863.htm
Monday, October 19, 2009
Atypical BSE, BSE, and other human and animal TSE in North America Update October 19, 2009
http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html
full text please see ;
Tuesday, January 26, 2010
Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity Draft 09/24/09
http://fdafailedus.blogspot.com/2010/01/establishing-fully-integrated-national.html
PLEASE BE AWARE ;
The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
http://www.oie.int/boutique/extrait/06heim937950.pdf
Saturday, January 2, 2010
Human Prion Diseases in the United States January 1, 2010 ***FINAL***
http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html
my comments to PLosone here ;
http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd
Thursday, January 28, 2010
Multiorgan Detection and Characterization of Protease-Resistant Prion Protein in a Case of Variant CJD Examined in the United States
http://creutzfeldt-jakob-disease.blogspot.com/2010/01/multiorgan-detection-and.html
Friday, January 29, 2010
14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)
18.173 page 189
Experimental Challenge of Cattle with H-type and L-type Atypical BSE
A. Buschmann1, U. Ziegler1, M. Keller1, R. Rogers2, B. Hills3, M.H. Groschup1. 1Friedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany, 2Health Canada, Bureau of Microbial Hazards, Health Products & Food Branch, Ottawa, Canada, 3Health Canada, Transmissible Spongiform Encephalopathy Secretariat, Ottawa, Canada
Background: After the detection of two novel BSE forms designated H-type and L-type atypical BSE the question of the pathogenesis and the agent distribution of these two types in cattle was fully open. From initial studies of the brain pathology, it was already known that the anatomical distribution of L-type BSE differs from that of the classical type where the obex region in the brainstem always displays the highest PrPSc concentrations. In contrast in L-type BSE cases, the thalamus and frontal cortex regions showed the highest levels of the pathological prion protein, while the obex region was only weakly involved.
Methods:We performed intracranial inoculations of cattle (five and six per group) using 10%brainstemhomogenates of the two German H- and L-type atypical BSE isolates. The animals were inoculated under narcosis and then kept in a free-ranging stable under appropriate biosafety conditions.At least one animal per group was killed and sectioned in the preclinical stage and the remaining animals were kept until they developed clinical symptoms. The animals were examined for behavioural changes every four weeks throughout the experiment following a protocol that had been established during earlier BSE pathogenesis studies with classical BSE.
Results and Discussion: All animals of both groups developed clinical symptoms and had to be euthanized within 16 months. The clinical picture differed from that of classical BSE, as the earliest signs of illness were loss of body weight and depression. However, the animals later developed hind limb ataxia and hyperesthesia predominantly and the head. Analysis of brain samples from these animals confirmed the BSE infection and the atypical Western blot profile was maintained in all animals. Samples from these animals are now being examined in order to be able to describe the pathogenesis and agent distribution for these novel BSE types. Conclusions: A pilot study using a commercially avaialble BSE rapid test ELISA revealed an essential restriction of PrPSc to the central nervous system for both atypical BSE forms. A much more detailed analysis for PrPSc and infectivity is still ongoing.
http://www.isid.org/14th_icid/
http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf
http://www.isid.org/publications/ICID_Archive.shtml
From: xxxx
To: Terry Singeltary
Sent: Saturday, December 05, 2009 9:09 AM
Subject: 14th ICID - abstract accepted for 'International Scientific Exchange'
Your preliminary abstract number: 670
Dear Mr. Singeltary,
On behalf of the Scientific Committee, I am pleased to inform you that your abstract
'Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009'
WAS accepted for inclusion in the INTERNATIONAL SCIENTIFIC EXCHANGE (ISE) section of the 14th International Congress on Infectious Diseases. Accordingly, your abstract will be included in the "Intl. Scientific Exchange abstract CD-rom" of the Congress which will be distributed to all participants.
Abstracts accepted for INTERNATIONAL SCIENTIFIC EXCHANGE are NOT PRESENTED in the oral OR poster sessions.
Your abstract below was accepted for: INTERNATIONAL SCIENTIFIC EXCHANGE
#0670: Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009
Author: T. Singeltary; Bacliff, TX/US
Topic: Emerging Infectious Diseases Preferred type of presentation: International Scientific Exchange
This abstract has been ACCEPTED.
#0670: Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009
Authors: T. Singeltary; Bacliff, TX/US
Title: Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009
Body: Background
An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and feed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.
Methods
12 years independent research of available data
Results
I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.
Conclusion
I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries.
I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.
Keywords: Transmissible Spongiform Encephalopathy Creutzfeldt Jakob Disease Prion
http://www.isid.org/14th_icid/
http://www.isid.org/publications/ICID_Archive.shtml
http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf
full text ;
http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html
Wednesday, February 11, 2009
Atypical BSE North America Update February 2009
Both of the BSE cases ascertained in the US native-born cattle were atypical cases (H-type), which contributed to the initial ambiguity of the diagnosis. 174, 185 In Canada, there have been 2 atypical BSE cases in addition to the 14 cases of the classic UK strain of BSE2: one was the H-type, and the other was of the L-type.198
snip...end
source : Enhanced Abstract Journal of the American Veterinary Medical Association January 1, 2009, Vol. 234, No. 1, Pages 59-72 Bovine spongiform encephalopathy Jane L. Harman, DVM, PhD; Christopher J. Silva, PhD
http://avmajournals.avma.org/doi/ref/10.2460/javma.234.1.59
http://bse-atypical.blogspot.com/2009/06/l-type-bse-h-type-bse-c-type-bse-ibnc.html
Wednesday, October 08, 2008
Idiopathic Brainstem Neuronal Chromatolysis (IBNC): a novel prion protein related disorder of cattle?
http://bse-atypical.blogspot.com/2008/10/idiopathic-brainstem-neuronal.html
Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle to a Primate
Emmanuel E. Comoy1*, Cristina Casalone2, Nathalie Lescoutra-Etchegaray1, Gianluigi Zanusso3, Sophie Freire1, Dominique Marcé1, Frédéric Auvré1, Marie-Magdeleine Ruchoux1, Sergio Ferrari3, Salvatore Monaco3, Nicole Salès4, Maria Caramelli2, Philippe Leboulch1,5, Paul Brown1, Corinne I. Lasmézas4, Jean-Philippe Deslys1
1 Institute of Emerging Diseases and Innovative Therapies, CEA, Fontenay-aux-Roses, France, 2 Istituto Zooprofilattico Sperimentale del Piemonte, Turin, Italy, 3 Policlinico G.B. Rossi, Verona, Italy, 4 Scripps Florida, Jupiter, Florida, United States of America, 5 Genetics Division, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America
Abstract Top Background Human variant Creutzfeldt-Jakob Disease (vCJD) results from foodborne transmission of prions from slaughtered cattle with classical Bovine Spongiform Encephalopathy (cBSE). Atypical forms of BSE, which remain mostly asymptomatic in aging cattle, were recently identified at slaughterhouses throughout Europe and North America, raising a question about human susceptibility to these new prion strains.
Methodology/Principal Findings Brain homogenates from cattle with classical BSE and atypical (BASE) infections were inoculated intracerebrally into cynomolgus monkeys (Macacca fascicularis), a non-human primate model previously demonstrated to be susceptible to the original strain of cBSE. The resulting diseases were compared in terms of clinical signs, histology and biochemistry of the abnormal prion protein (PrPres). The single monkey infected with BASE had a shorter survival, and a different clinical evolution, histopathology, and prion protein (PrPres) pattern than was observed for either classical BSE or vCJD-inoculated animals. Also, the biochemical signature of PrPres in the BASE-inoculated animal was found to have a higher proteinase K sensitivity of the octa-repeat region. We found the same biochemical signature in three of four human patients with sporadic CJD and an MM type 2 PrP genotype who lived in the same country as the infected bovine.
Conclusion/Significance Our results point to a possibly higher degree of pathogenicity of BASE than classical BSE in primates and also raise a question about a possible link to one uncommon subset of cases of apparently sporadic CJD. Thus, despite the waning epidemic of classical BSE, the occurrence of atypical strains should temper the urge to relax measures currently in place to protect public health from accidental contamination by BSE-contaminated products.
snip...
In summary, we have transmitted one atypical form of BSE (BASE) to a cynomolgus macaque monkey that had a shorter incubation period than monkeys infected with classical BSE, with distinctive clinical, neuropathological, and biochemical features; and have shown that the molecular biological signature resembled that seen in a comparatively uncommon subtype of sporadic CJD. We cannot yet say whether BASE is more pathogenic for primates (including humans) than cBSE, nor can we predict whether its molecular biological features represent a clue to one cause of apparently sporadic human CJD. However, the evidence presented here and by others justifies concern about a potential human health hazard from undetected atypical forms of BSE, and despite the waning epizoonosis of classical BSE, it would be premature to abandon the precautionary measures that have been so successful in reversing the impact of cBSE. We would instead urge a gradual, staged reduction that takes into account the evolving knowledge about atypical ruminant diseases, and both a permanent ban on the use of bovine central nervous system tissue for either animal or human use, and its destruction so as to eliminate any risk of environmental contamination.
Citation: Comoy EE, Casalone C, Lescoutra-Etchegaray N, Zanusso G, Freire S, et al. (2008) Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle to a Primate. PLoS ONE 3(8): e3017. doi:10.1371/journal.pone.0003017
Editor: Neil Mabbott, University of Edinburgh, United Kingdom
Received: April 24, 2008; Accepted: August 1, 2008; Published: August 20, 2008
Copyright: © 2008 Comoy et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This work has been supported by the Network of Excellence NeuroPrion.
Competing interests: CEA owns a patent covering the BSE diagnostic tests commercialized by the company Bio-Rad.
* E-mail: emmanuel.comoy@cea.fr
http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0003017
http://www.chsc.or.kr/xe/?mid=reference&listStyle=webzine&sort_index=readed_count&order_type=asc&page=9&document_srl=3656&cpage=
P2-110 TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY TO MICROCEBUS MURINUS, A NON-HUMAN PRIMATE. DEVELOPMENT OF CLINICAL SYMPTOMS AND TISSUE DISTRIBUTION OF PRPRES
Nadine Mestre-Frances1, Anne-Gaelle Biacabe2, Sylvie Rouland1, Thierry Baron2, Jean-Michel Verdier1, 1INSERM U710, Montpellier, France; 2AFSSA, Lyon, France. Contact e-mail: nfrances@univmontp2. fr
Background: Atypical BSE cases have been observed in Europe, Japan and North America. They differ in their PrPres profiles from those found in classical BSE. These atypical cases fall into 2 types, depending on the molecular mass of the unglycosylated PrPres band observed by Western blot: the L-type (lower molecular mass than the typical BSE cases) and H-type (higher molecular mass than the typical BSE cases).
Methods: Height animals (4 males and 4 females) were intracerebrally inoculated with 50 l of a 10% brain homogenates of atypical (L and H-type) French BSE cases.
Results: Only one of the four lemurs challenge with H-type BSE died without clinical signs after 19 months post inoculation (mpi), the 4 animals inoculated with L-type BSE died at 19 mpi (2 males) and 22 mpi (2 females). Three months before their sacrifice, they developed blindness, tremor, abnormal posture, incoordinated movements, balance loss. Symptoms get worse according to the disease progression, until severe ataxia. The brain tissue were biochemically and immunocytochemically investigated for PrPres. For the H-types, spongiform changes without PrPres accumulation were observed in the brainstem. Western blot analysis confirmed that no PrPres was detected into the brain. For the L-types, severe spongiosis was evidenced into the thalamus, the striatum, the mesencephalon, and the brainstem, whereas into the cortex the spongiosis was evidenced, but the vacuolisation was weaker. Strong deposits of PrPres was detected by western blot, PET-blot and immunocytochemistry in the CNS: dense accumulation was observed into the thalamus, the striatum, and the hippocampus whereas in the cerebral cortex, PrPres was prominently accumulated in plaques. Western blot analysis confirmed the presence of protease-resistant prion protein.
Conclusions: L-type infected lemurs showed survival times considerably shorter than for classical BSE strain, indicating that the disease is caused by a very virulent distinct prion strain.
http://download.journals.elsevierhealth.com/pdfs/journals/1552-5260/PIIS1552526008013447.pdf
Journal of Virology, April 2008, p. 3697-3701, Vol. 82, No. 7 0022-538X/08/$08.00+0 doi:10.1128/JVI.02561-07 Copyright © 2008, American Society for Microbiology. All Rights Reserved.
Evaluation of the Human Transmission Risk of an Atypical Bovine Spongiform Encephalopathy Prion Strain
Qingzhong Kong,1* Mengjie Zheng,1 Cristina Casalone,2 Liuting Qing,1 Shenghai Huang,1, Bikram Chakraborty,1 Ping Wang,1 Fusong Chen,1 Ignazio Cali,1 Cristiano Corona,2 Francesca Martucci,2 Barbara Iulini,2 Pierluigi Acutis,2 Lan Wang,1 Jingjing Liang,1 Meiling Wang,1 Xinyi Li,1 Salvatore Monaco,3 Gianluigi Zanusso,3 Wen-Quan Zou,1 Maria Caramelli,2 and Pierluigi Gambetti1* Department of Pathology, Case Western Reserve University, Cleveland, Ohio 44106,1 CEA, Istituto Zooprofilattico Sperimentale, 10154 Torino, Italy,2 Department of Neurological and Visual Sciences, University of Verona, 37134 Verona, Italy3
Received 30 November 2007/ Accepted 16 January 2008
Bovine spongiform encephalopathy (BSE), the prion disease in cattle, was widely believed to be caused by only one strain, BSE-C. BSE-C causes the fatal prion disease named new variant Creutzfeldt-Jacob disease in humans. Two atypical BSE strains, bovine amyloidotic spongiform encephalopathy (BASE, also named BSE-L) and BSE-H, have been discovered in several countries since 2004; their transmissibility and phenotypes in humans are unknown. We investigated the infectivity and human phenotype of BASE strains by inoculating transgenic (Tg) mice expressing the human prion protein with brain homogenates from two BASE strain-infected cattle. Sixty percent of the inoculated Tg mice became infected after 20 to 22 months of incubation, a transmission rate higher than those reported for BSE-C. A quarter of BASE strain-infected Tg mice, but none of the Tg mice infected with prions causing a sporadic human prion disease, showed the presence of pathogenic prion protein isoforms in the spleen, indicating that the BASE prion is intrinsically lymphotropic. The pathological prion protein isoforms in BASE strain-infected humanized Tg mouse brains are different from those from the original cattle BASE or sporadic human prion disease. Minimal brain spongiosis and long incubation times are observed for the BASE strain-infected Tg mice. These results suggest that in humans, the BASE strain is a more virulent BSE strain and likely lymphotropic.
-------------------------------------------------------------------------------- * Corresponding author. Mailing address: Department of Pathology, Case Western Reserve University, Cleveland, OH 44106. Phone for Pierluigi Gambetti: (216) 368-0586. Fax: (216) 368-2546. E-mail: pxg13@case.edu. Phone for Qingzhong Kong: (216) 368-1756. Fax: (216) 368-2546. E-mail: qxk2@case.edu
Published ahead of print on 30 January 2008.
Present address: Department of Patient Education and Health Information, Cleveland Clinic Foundation, Cleveland, OH 44195.
-------------------------------------------------------------------------------- Journal of Virology, April 2008, p. 3697-3701, Vol. 82, No. 7 0022-538X/08/$08.00+0 doi:10.1128/JVI.02561-07 Copyright © 2008, American Society for Microbiology. All Rights Reserved.
http://jvi.asm.org/cgi/content/abstract/82/7/3697?etoc.
Atypical BSE in Cattle
BSE has been linked to the human disease variant Creutzfeldt Jakob Disease (vCJD). The known exposure pathways for humans contracting vCJD are through the consumption of beef and beef products contaminated by the BSE agent and through blood transfusions. However, recent scientific evidence suggests that the BSE agent may play a role in the development of other forms of human prion diseases as well. These studies suggest that classical type of BSE may cause type 2 sporadic CJD and that H-type atypical BSE is connected with a familial form of CJD.
http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2=
Monday, December 14, 2009 R.I.P. MOM DOD
Similarities between Forms of Sheep Scrapie and Creutzfeldt-Jakob Disease Are Encoded by Distinct Prion Types
> Sporadic CJD type 1 and atypical/ Nor98 scrapie are characterized by fine (reticular) deposits,
http://nor-98.blogspot.com/2009/12/similarities-between-forms-of-sheep.html
see also ;
> All of the Heidenhain variants were of the methionine/ methionine type 1 molecular subtype.
http://cjdusa.blogspot.com/2009/09/co-existence-of-scrapie-prion-protein.html
Thursday, January 07, 2010
Scrapie and Nor-98 Scrapie November 2009 Monthly Report Fiscal Year 2010 and FISCAL YEAR 2008
http://scrapie-usa.blogspot.com/2010/01/scrapie-and-nor-98-scrapie-november.html
BSE prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein
Emmanuel A. Asante, Jacqueline M. Linehan, Melanie Desbruslais, Susan Joiner, Ian Gowland, Andrew L. Wood, Julie Welch, Andrew F. Hill, Sarah E. Lloyd, Jonathan D.F. Wadsworth, and John Collinge1 MRC Prion Unit and Department of Neurodegenerative Disease, Institute of Neurology, University College, Queen Square, London WC1N 3BG, UK 1Corresponding author e-mail: j.collinge@prion.ucl.ac.ukReceived August 1, 2002; Revised September 24, 2002; Accepted October 17, 2002.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC136957/?tool=pubmed
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
*** CJD USA RISING, with UNKNOWN PHENOTYPE ;
5 Includes 41 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 46 cases with type determination pending in which the diagnosis of vCJD has been excluded.
http://www.cjdsurveillance.com/pdf/case-table.pdf
Monday, February 01, 2010
Import Alert 57-20 and 84-03 Human Dura Mater and risk factors there from due to Creutzfeldt Jakob Disease (CJD)
http://creutzfeldt-jakob-disease.blogspot.com/2010/02/import-alert-57-20-and-84-03-human-dura.html
TERRY S. SINGELTARY SR.
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 17-04
Published Date: 10/02/2009
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Bulk Shipments of High-Risk Bovine Tissue from BSE-Countries--Bovine Spongiform Encephalopathy"
Reason for Alert:
BSE has been identified in more than 100,000 cattle in the United Kingdom and, to a much lesser extent, in several other countries. This neurological disease is a transmissible spongiform encephalopathy (TSE) and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. The spongiform encephalopathies are uniformly fatal and no rapid diagnostic test for infection in living animals or humans is presently available. Current scientific information indicates that the causative agent is extremely resistant to activation by normal disinfection or sterilization procedures. A range of research projects into the exact nature of both the BSE agent and other TSE agents, host range, patterns of pathogenicity, and development of rapid ante mortem diagnostic tests is ongoing.
Since 1991, USDA has prohibited the importation into the U.S. of certain tissues and organs from ruminants from countries where BSE exists. (refer to 9 CFR 94.18). On January 6, 1998, USDA issued an interim rule listing other countries because of import requirements less restrictive than those that would be acceptable for importation into the U.S. and/or because of inadequate surveillance, which would present a significant risk. USDA's regulations are intended to protect livestock in the United States from contracting TSEs and address known or strongly suspected modes of transmission. The USDA regulations permit, under certain conditions, the importation of some cosmetic ingredients (i.e., collagen, collagen products, amniotic liquids or extracts, placental liquids or extracts, serum albumin, and serocolostrum) derived from ruminants from BSE-countries (see 9 CFR 95.4).
The USDA regulations do not apply to imports of:
cosmetic products that are packaged and ready for sale;
bovine-derived materials intended for human consumption as either finished dietary supplement products or for use as ingredients in dietary supplements; or
human food (except meat, i.e., skeletal muscle).
In March 1996, the Spongiform Encephalopathy Advisory Committee of the UK reported that 10 cases of CJD in the UK are likely linked to exposure BSE before the UK ban in 1989.
The FDA has recommended that manufacturers who use bovine by-products voluntarily investigate the geographic source(s) of any bovine or bovine material used in their products (generally neural or glandular tissue or tissue extracts). The Agency also suggested that each manufacturer develop a plan "to assure, with a high degree of certainty," that such materials are not from BSE-countries, as identified by USDA's APHIS, or from scrapie-infected sheep flocks, either foreign or domestic.
FDA considers further protective steps to be reasonable and, in an August 17, 1994, letter (Attachment B), recommended that manufacturers and importers of dietary supplements, cosmetic products, and raw materials for these finished product develop plans for ensuring, with a high degree of certainty, that specific bovine-derived materials from BSE-countries are not being used.
Attachment A is an expanded list of those tissues presenting the highest known risk of infectivity, e.g., high-risk tissue, which are the subject of this import alert. Additional tissues may be added to this list as studies warrant and this import alert will be revised accordingly.
FDA will be gathering information on the development of BSE plans for all bovine - derived tissues and documenting the use of high-risk tissue from BSE-countries during domestic inspections under both the cosmetics and dietary supplements compliance programs. Due to the difficulty in verifying the presence of high-risk tissues in finished dietary supplements or cosmetic products, this import alert is limited to bulk lots of these tissues from BSE-affected or at risk countries listed above. However, if during wharf examinations or label reviews high-risk bovine tissues are noted in the ingredients statement, districts should follow the procedure in the Guidance section of this alert to notify CFSAN.
The United States Department of Agriculture issued an interim rule on January 6, 1998. The interim rule restricts the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts not only from countries and other regions in which BSE is known to exist, but also from countries and other regions which, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present a significant risk.
Guidance:
Districts may detain the shipment without physical examination, if the high-risk bovine tissue or ingredient, as listed in Attachment A, originated from one of the following Countries: Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, the Czech Republic, Denmark, the Federal Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Republic of, Italy, Japan, Leichtenstein, Luxembourg, the Former Yugoslav Republic of Macedonia, Monaco, Netherlands, Norway, Oman, Poland, Portugal, Romania, San Marino, the Slovak Republic (Slovakia), Slovenia, Spain, Sweden, Switzerland and United Kingdom. If an entry is detained and the importer or manufacturer has not provided within sixty (60) days documentation that establishes that the bovine derived tissue used in the product came from BSE-free cattle or from a non BSE affected or at risk country, districts should attempt to determine the status of the entry and, where possible, reach a final determination as to the entry. Sixty (60) days should be ample time for an importer or manufacturer to provide such documentation.
Districts may provide a copy of the Agency's August 17, 1994, letter (Attachment B) to importer's for their use in developing plans to assure that future shipments of bovine tissues are obtained from non-BSE countries.
Districts should be alert to entries of finished products from BSE affected countries which contain high-risk bovine tissues listed in the ingredients. When conducting field examinations and/or label reviews of finished products, such as dietary supplements or cosmetics that contain high-risk bovine tissues, contact CFSAN/Import Branch with product identity, high-risk bovine tissue used as ingredient, manufacturer/shipper, country of origin, and importer of record and for further guidance.
For any issues and/or questions regarding science, science policy, sample collection, analyses, preparation, analytical methodology or confirmation tests, districts should contact the Division of Field Science.
ATTACHMENTS
ATTACHMENT A
HIGH-RISK BOVINE TISSUE AND TISSUE-DERIVED INGREDIENTS
Adrenal gland
Bone marrow
Brain
Brain extract
Cerebellum
Cerebrospinal fluid
Cranial nerves
Colon (proximal and distal)
Dura mater
Eye
Hypothalamus
Ileum
Lymph nodes
Nasal mucosa
Olfactory bulb or gland
Pineal gland
Pituitary gland
Placenta
Spinal cord
Spleen
Suprarenal gland
Tonsil Attachment B
August 17, 1994
Food and Drug Administration Rockville, MD 20857
To Manufacturers and Importers of Dietary Supplements:
To Manufacturers and Importers of Cosmetics:
The Food and Drug Administration (FDA) is recommending that firms that manufacture or import dietary supplements and cosmetics containing specific bovine tissues (see Appendix A) ensure that such tissues do not come from cattle born, raised, or slaughtered in countries where bovine spongiform encephalopathy (BSE) exists (BSE-countries). Extracts of these tissues and ingredients derived from these tissues are also of concern. The recommended actions are precautionary measures to reduce potential risk of human exposure to, or transmission of, the agent which causes BSE in cattle.
At this time, FDA is not extending the recommendation in this letter to dairy products or gelatin, because available evidence does not suggest transmission via these foods. Furthermore, meat (i.e., skeletal muscle) is not covered by this letter. For guidance on importation of meat and other products regulated by the United States Department of Agriculture (USDA), refer to Title 9 of the Code of Federal Regulations.
The Agency is providing the following information to explain why it believes that BSE may potentially be a concern with certain dietary supplements and cosmetic products. BSE has been identified in more than 100,000 cattle in the United Kingdom and, to a much lesser extent, in several other countries. This neurological disease is a transmissible spongiform encephalopathy (TSE) and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. The spongiform encephalopathies are uniformly fatal and no rapid diagnostic test for infection in living animals or humans is presently available. Current scientific information indicates that the causative agent is extremely resistant to inactivation by normal disinfection or sterilization procedures. A range of research projects into the exact nature of both the BSE agent and other TSE agents, host range, patterns of pathogenicity, and development of rapid ante mortem diagnostic tests is ongoing.
Since 1991, USDA has prohibited the importation into the U.S. of certain tissues and organs from ruminants from countries where BSE exists (BSE-countries; see 9 CFR 94.18). USDA's regulations are intended to protect livestock in the United States from contracting TSEs and address known or strongly suspected modes of transmission. For the up-to-date listing of BSE-countries please contact USDA, Animal and Plant Health Inspection Service (APHIS) at (301) 436-7830.
The USDA regulations permit, under certain conditions, the importation of some cosmetic ingredients (i.e., collagen, collagen products, amniotic liquids or extracts, placental liquids or extracts, serum albumin, and serocolostrum) derived from ruminants from BSE-countries; see 9 CFR 95.4.
The USDA regulations do not apply to imports of:
cosmetic products that are packaged and ready for sale;
bovine-derived materials intended for human consumption as either finished dietary supplement products or for use as ingredients in dietary supplements; or
human food (except meat, i.e., skeletal muscle).
While documented transmission of the causative agents of BSE or scrapie to humans has not been reported to date, the FDA wrote to manufacturers of dietary supplements in November 1992, alerting them to the developing concern about TSEs in animals and CJD in man. That letter recommended that manufacturers voluntarily investigate the geographic source(s) of any bovine or ovine material used in their products (generally neural or glandular tissue or tissue extracts). The Agency also suggested that each manufacturer develop a plan "to assure, with a high degree of certainty," that such materials are not from BSE-countries, as identified by USDA's APHIS, or from scrapie-infected sheep flocks, either foreign or domestic.
FDA now considers further protective steps to be reasonable and is restating and expanding its recommendation to manufacturers and importers of dietary supplements and their ingredients, to develop plans for ensuring, with a high degree of certainty, that specific bovine-derived materials (see Appendix A) from BSE-countries are not being used. The Agency is also recommending that manufacturers and importers of cosmetic products and their ingredients develop the same type of plans. FDA is not, at this time, recommending restrictions on the use of ovine-derived materials in the manufacture of dietary supplement and cosmetic products and ingredients, as the epidemiological evidence now appears convincing that scrapie is not related to TSEs in humans.
FDA believes it is prudent to expand its recommendation to cosmetics and cosmetic ingredients because extracts of listed tissues, e.g. sphingolipids isolated from brain tissue and extracts of bovine placenta, are used in cosmetics. Additionally, FDA is unaware of data demonstrating that processing techniques used in the manufacture of cosmetics will inactivate TSE agents. Further, little is known about the potential human risk of transmission from topical application of cosmetics containing TSE agents to intact, broken or abraded skin.
To assist manufacturers and importers whose products are within the scope of this recommendation in developing their plans, the following guidance is provided:
. To ensure that bovine-derived materials (listed in appendix A) used in the product(s) are from non BSE-countries, identify all countries where the animals used were born, raised or slaughtered. The supplier of the bovine-derived materials should provide the necessary records.
b. Maintain traceable records for each lot of bovine-derived material and records of products containing the materials.
. Maintain records for those products manufactured at foreign sites or by foreign manufacturers which contain bovine-derived materials.
The Agency recommends that manufacturers and importers of dietary supplements and cosmetic products and ingredients used in the manufacture of these products develop their plans within the next two months and notify the Agency, in writing, that their plans have been developed. The designated contact is Dr. Elisa Elliot, Science Policy Analyst, Executive Operations Staff, HFS-22, Center for Food Safety and Applied Nutrition, FDA, 200 C Street, S.W., Washington, DC, 20204 or FAX (202) 205-5025. FDA recommends that the plans be implemented as soon after development as possible, and be available for review by the Agency during inspections.
The Agency is continuing to examine all available information about TSEs and will provide additional guidance as necessary. If you need more information please contact Dr. Elliot by telephone at (202) 205-5140.
We appreciate your attention to and cooperation in this matter.
Sincerely,
/s/
Linda A. Suydam
Interim Deputy Commissioner for
Operations
May 9, 1996
TO MANUFACTURERS AND IMPORTERS OF DIETARY SUPPLEMENTS:
TO MANUFACTURERS AND IMPORTERS OF COSMETICS:
As the media have widely reported, the British government announced on March 20, 1996, that new information had been gathered about bovine spongiform encephalopathy (BSE) in cattle that suggests a possible relationship between BSE and ten cases of a newly identified form of Creutzfeldt-Jakob disease (CJD), a similar fatal transmissible spongiform encephalopathy (TSE) in humans. To serve our mutual interest in protecting public health, the Food and Drug Administration (FDA) believes it is prudent to reiterate concerns we have previously expressed on this issue.
BSE is a transmissible neurologic disorder of cattle and is prevalent in certain parts of the world. This neurological disease is one of a number of transmissible spongiform encephalopathies (TSE) known and is similar to other TSEs such as scrapie in sheep and CJD in humans. It is believed that the spread of BSE in cattle in some countries, particularly Great Britain, was caused by the feeding of infected cattle and sheep tissues to cattle. While transmission of the causative agent of BSE to humans has not been definitively documented to date, inter-species transfer has been demonstrated (e.g., mice can be infected by exposure to infected bovine tissues). Recent developments in Great Britain raise serious questions regarding potential hazards of the consumption of animal tissues containing the causative agent of BSE.
Although there is still no definitive evidence that the consumption of bovine tissues that contain the transmissible agent for BSE cause CJD in humans, FDA is concerned that appropriate measures to eliminate the use of bovine tissues from BSE-countries be instituted industry-wide.
We strongly recommend that firms manufacturing or importing dietary supplements which contain specific bovine tissues (see appendix A), including extracts or substances derived from such tissues, take whatever steps are necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists.
FDA believes that immediate and concrete steps should be taken by manufacturers to reduce the potential risk of human exposure to the infectious agent which causes BSE in cattle.
The list of countries where BSE is known to exist is maintained by the U.S. Department of Agriculture (USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18. The following is the current list:
USDA LIST OF COUNTRIES WHERE BSE EXISTS
(Current as of May 1996)
Great Britain (including Northern Ireland and the Falklands)
Switzerland
France
Republic of Ireland
Oman
Portugal
A range of research projects into the exact nature of both the BSE agent and other TSE agents is ongoing. Available scientific information indicates that these agents are extremely resistant to inactivation by normal disinfection or sterilization procedures. A number of dietary supplement products use bovine-derived tissues or extracts of such tissues as ingredients. These ingredients include, for example, specific tissues and organs or their extracts (e.g., liver powder, "orchic" extracts, ovaries, eye tissue, mammary tissue), glandular powders or extracts (e.g., adrenal gland, thyroid gland), or specific substances extracted from glands or tissues (e.g., melatonin extracted from the pineal gland).
At a future date, we will contact you with guidance on how best to provide assurance that your products do not contain potentially BSE-infected materials.
We appreciate your attention to and cooperation in this matter. If you need more information, please contact Dr. Elisa Elliot by telephone at (202) 205-5140.
Sincerely yours,
/s/
Michael A. Friedman, M.D.
Deputy Commissioner for Operations
Enclosure Appendix A
List of Tissues With Suspected Infectivity
Category I (High infectivity)
brain
spinal cord
Category II (Medium infectivity)
ileum
lymph nodes
proximal colon
spleen
tonsil
dura mater
pineal gland
placenta
cerebrospinal fluid
pituitary gland
adrenal gland
Category III (Low infectivity)
distal colon
nasal mucosa
sciatic nerve
bone marrow
liver
lung
pancreas
thymus gland
List taken from Report of a WHO Consultation on Public Health
Issues Related to Animal and Human Spongiform Encephalopathies,
World Health Organization, Office of International Epizootics,
Geneva, Switzerland, November 12-14, 1991.
Product Description:
Bulk shipments of high-risk bovine tissues and tissue-derived ingredients (see Attachment A for a list of affected products).
Adrenal gland; Bone marrow; Brain; Brain extract; Cerebellum; Cerebrospinal fluid; Cranial nerves; Colon (proximal and distal); Dura mater; Eye; Hypothalamus; Ileum; Lymph nodes; Nasal mucosa; Olfactory bulb or gland;;Pineal gland; Pituitary gland; Placenta; Spinal cord; Spleen; Suprarenal gland; Tonsil
Charge:
As ingredients in dietary supplements, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food [Adulteration, Section 402(a)(3)]." "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and may have been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 402(a)(4)]." As ingredients in cosmetics, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a cosmetic product and appears to have or may have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 601(c)." If final disposition of the bulk lot is undetermined, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be unfit for food [Adulteration, Section 402(a)(3)]." AND "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health [Adulteration, 402(a)(4)]".
Countries (AL) ALBANIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(AD) ANDORRA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(AT) AUSTRIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(BE) BELGIUM
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(BA) BOSNIA-HERCEGOVINA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(BG) BULGARIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(CA) CANADA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(HR) CROATIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(CS) CZECHOSLOVAKIA (DO NOT USE)
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(DK) DENMARK
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(FK) FALKLAND ISLANDS
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(FI) FINLAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(FR) FRANCE
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(DE) GERMANY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(GR) GREECE
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(HU) HUNGARY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(IE) IRELAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(IL) ISRAEL
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(IT) ITALY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(JP) JAPAN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(LI) LIECHTENSTEIN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(LU) LUXEMBOURG
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(MK) MACEDONIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(MC) MONACO
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(NL) NETHERLANDS
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(NO) NORWAY
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(OM) OMAN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(PL) POLAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(PT) PORTUGAL
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(RO) ROMANIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SM) SAN MARINO
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SK) SLOVAKIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SI) SLOVENIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(ES) SPAIN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(SE) SWEDEN
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(CH) SWITZERLAND
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(GB) UNITED KINGDOM
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
(YU) YUGOSLAVIA
(17 Y - - 99) Meat And Meat Products n.e.c., Meat/Exotic Meat Products, n.e.c.
(53 P - - 01) Bovine (Bovine Amniotic Fluid) (Cosmetic Raw Material)
(53 P - - 02) Collagen (Cosmetic Raw Material)
(54 G - - 01) Bovine (Cow, Etc.) (Animal By-Products and Extracts)
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
-
http://www.accessdata.fda.gov/cms_ia/importalert_53.html
Date: Sun, 12 Jan 2003 12:56:44 -0600
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ???
With these known facts about nutritional supplements, I think it imperative to include this potential route and source of TSE and warning in this article.
Why was it not included? I lost my mother to hvCJD DOD 12/14/97, and I probably will not live long enough to know the route and source of her TSE. Exactly one year previously, to the day 12/14/96, my neighbor also lost his mother to sporadic CJD. Both of these cases were confirmed. but my neighbor's mother had been taking a nutritional supplement called IPLEX, made by Standard Process Co.
Here is a listing of potentially TSE-tainted tissues:
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
The CDC came and took the pills, a few years later, I spoke with the late Dr. Gibbs and NIH/CDC and he told me that those particular pills did not show any infectivity with the testing techniques to date, but he also told me -
1. That the testing techniques at that time may not be sufficient to pick up any 'low-level' infectivity. (so, if accumulation plays into this, this could play a big part).
2. She had been taking these type pills for years, could have been another batch.
There have been other people die of CJD that were taking these type nutritional supplements.
So, my point being, I believe this to warrant a potential risk factor, one not to be ignored, especially in the USA where there are many known TSEs, and where there are many unknowns due to the lack of sufficient TSE testing in USA cattle, and especially since the new findings of Collinge et al, where BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc, the commonest sporadic CJD.
I believe these findings to be of substantial importance:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
Friday, January 19, 2001
Holiday Inn Bethesda Versailles I and II 8120 Wisconsin Avenue Bethesda, Maryland
2 PARTICIPANTS Paul W. Brown, M.D., Chairperson William Freas, Ph.D., Executive Secretary
VOTING MEMBERS Ermias D. Belay, M.D. David C. Bolton, Ph.D. Donald S. Burke, M.D. Dean O. Cliver, Ph.D. Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D. Pedro Piccardo, M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D. Elizabeth S. Williams, D.V.M., Ph.D.
VOTING CONSULTANTS Linda A. Detwiler, D.V.M. David Gaylor, Ph.D.
Paul R. McCurdy, M.D. Kenrad E. Nelson, M.D.
NONVOTING CONSULTANT Susan Leitman, M.D.
GUESTS Richard Davey, M.D. Louis Katz, M.D.
snip...
page 501
253
1 DR. BOLTON: I have an additional question about 2 that. What is the assurance that additional locally sourced 3 tracheas are not added into that manufacturing process, thus 4 boosting the yield, if you will, but being returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected brain are likely to infect 8 an organism, either animal or man, when taken orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a gram is enough in a cow, orally; 11 in other words, one good dietary-supplement pill. 12 DR. McCURDY: What I am driving at is the question 13 we are asked is really not do we wish to regulate these 14 things coming in. I think the statements about difficulties 15 in regulating things in the future or near future for new 16 regulations were probably accurate. 17 But I think that we could exhibit some quite 18 reasonable concern about blood donors who are taking dietary 19 supplements that contain a certain amount of unspecified- 20 origin brain, brain-related, brain and pituitary material. 21 If they have done this for more than a sniff or something 22 like that, then, perhaps, they should be deferred as blood 23 donors. 24 That is probably worse than spending six months in 25 the U.K.
1/19/01 3681t2.rtf(845) page 501
http://www.fda.gov/ohrms/dockets/ac/cber01.htm
There has been a Nutritional Supplement mad cow warning letter circulating around since about 1990. Every year they issue the same letter to the manufactures asking them to please be sure they source their products from BSE-FREE countries. but we all know, the statement BSE-FREE, is a joke, especially in the USA. I sat in on the 50 state emergency BSE conference call, (uninvited guest) and I know for a fact the so-called 'pharmaceutical grade' bovine source herds, bovines that were to never be fed ruminant materials, the USA cannot for certain say that indeed these cattle have never ingested ruminant feed, in fact, some probably had.
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
Bovine Spongiform Encephalopathy
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
And I would have been doing just fine, until I asked my question. I was surprised my time to ask a question came so quickly.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns] And now a question from Terry S. Singeltary of CJD Watch.
[TSS] Yes, Thank You. U.S. cattle - what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the background, mumbling and "We can't. Have him ask the question again."]
[host Richard] Could you repeat the question?
[TSS] U.S. cattle..what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this] What group are you with?
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking] Could you please disconnect Mr. Singeltary
[TSS] You are not going to answer my question?
[not sure whom speaking] NO
From this point, I was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
[unknown woman] What group are you with?
[TSS] CJD Watch and my Mom died from hvCJD We are trying to tract down CJD and other human TSE's world wide. I was invited to sit in on this from someone inside the USDA/APHIS and that is why I am here. Do you intend on banning me from this conference now?
At this point the conference was turned back up, and I got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, I will try and give you a run-down for now, of the conference.
IF O were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from:
RBARNS@ORA.FDA.GOV 301-827-6906
He would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.
FULL TEXT MY TRANSCRIPT ARCHIVED HERE;
Friday, January 29, 2010 14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)
http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html
now to explore more on this issue of TSEs and Nutritional Supplements. please read further;
Suit Filed Over Mad Cow Disclaimer By Jason Hoppin The Recorder March 23, 2001
A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.
The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.
"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.
The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.
"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies the disease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."
No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.
The case was filed in San Francisco Superior Court.
The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.
Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bones and brains, where BSE is most highly concentrated.
Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S. government-inspected facilities.
"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.
The human manifestation of BSE -- variant Creutzfeld-Jakob disease -- has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.
U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.
"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."
However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.
© 2001 law.com Inc. © 1999-2001 NLP IP Company,
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http://vm.cfsan.fda.gov/~dms/qa-sup5.html
[ Q: ] What is a dietary supplement and how is it regulated?
[ A: ] A dietary supplement is any product taken by mouth that contains a so-called "dietary ingredient" and its label clearly states that it is a dietary supplement.
The "dietary ingredients" in dietary supplements may include vitamins, minerals, herbs, and amino acids as well as substances such as enzymes, organ tissues, metabolites, extracts or concentrates. Dietary supplements can be found in many forms such as pills, tablets, capsules, liquids or powders. They must be identified on the label as a dietary supplement.
How are Dietary Supplements regulated?
The label of a dietary supplement must contain enough information about the composition of the product so that consumers can make informed choices. (The information must be presented in FDA-specified format.) The manufacturer must make sure the label information is truthful and not misleading. The manufacturer is also responsible for making sure that all the dietary ingredients in the supplements are safe. Manufactures and distributors do not need to register with FDA or get FDA approval before producing or selling dietary supplements.
Are advertisements for Dietary Supplements regulated by FDA?
No. The Federal Trade Commission (FTC) handles advertising for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but their work is directed by different laws.
============================================================
U. S. Food and Drug Administration Email this Page To a Friend [email a friend] Center for Food Safety and Applied Nutrition January 3, 2001 [ ]
Overview of Dietary Supplements
What is a dietary supplement?
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
What is a "new dietary ingredient" in a dietary supplement?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
* a vitamin,
* a mineral,
* an herb or other botanical,
* an amino acid,
* a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
* a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.
What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.
Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.
Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. However, FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.
When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.
There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information on new dietary ingredients, go to: http://www.cfsan.fda.gov/~dms/ds-ingrd.html.
What information must the manufacturer disclose on the label of a dietary supplement?
FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.
In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a
"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.
Must all ingredients be declared on the label of a dietary supplement?
Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: http://www.cfsan.fda.gov/~lrd/fr97923a.html. Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.
Where can I get information about a specific dietary supplement?
Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.
Who has the responsibility for ensuring that a dietary supplement is safe?
By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?
No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information on claims that can be made for dietary supplements, see (http://www.cfsan.fda.gov/~dms/hclaims.html). How can consumers inform themselves about safety and other issues related to dietary supplements?
It is important to be well informed about products before purchasing them. Because it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase (see previous question "Where can I get information about a specific dietary supplement?"). In addition, to help consumers in their search to be better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information -- http://www.cfsan.fda.gov/~dms/ds-savvy.html (includes information on how to evaluate research findings and health information on-line) and Claims That Can Be Made for Conventional Foods and Dietary Supplements -- http://www.cfsan.fda.gov/~dms/hclaims.html, (provides information on what types of claims can be made for dietary supplements).
What is FDA's oversight responsibility for dietary supplements?
Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occaisional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency. Does FDA routinely analyze the content of dietary supplements?
In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.
Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product. Who validates claims and what kinds of claims can be made on dietary supplement labels?
FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.
By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail at the following site: (http://www.cfsan.fda.gov/~dms/hclaims.html). Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
How are advertisements for dietary supplements regulated?
The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www.ftc.gov/bcp/menu-health.htm . Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service. How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?
If you think you have suffered a serious harmful effect or illness from a product FDA regulates, including dietary supplements, the first thing you should do is contact or see your healthcare provider immediately. Then, you and your health care provider are encouraged to report this problem to FDA.
Your health care provider can call FDA's MedWatch hotline at 1-800-FDA-1088, submit a report by fax to 1-800-FDA-0178 or on-line at: http://www.fda.gov/medwatch/report/hcp.htm. The MedWatch program provides a way for health care providers to report problems believed to be caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements.
You, or anyone, may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any of the above-mentioned products, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or reporting on-line at: http://www.fda.gov/medwatch/report/consumer/consumer.htm . FDA would like to know when you think a product caused you a serious problem, even if you are not sure that the product was the cause, or even if you do not visit a doctor or clinic. In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site.
NOTE: The identity of the reporter and/or patient is kept confidential.
For a general, not serious, complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number: http://www.fda.gov/opacom/backgrounders/complain.html.
For more recent information on Dietary Supplements See http://www.cfsan.fda.gov/~dms/supplmnt.html
http://vm.cfsan.fda.gov/~dms/ds-oview.html
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. T01-09 Print Media: 202-205-4144 February 5, 2001 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA FDA ISSUES LETTER TO INDUSTRY ON FOODS CONTAINING BOTANICAL AND OTHER NOVEL INGREDIENTS
The Food and Drug Administration (FDA) recently issued a letter to the food industry restating the requirements of the Federal Food, Drug, and Cosmetic Act regarding the marketing of conventional foods containing novel ingredients, including botanicals. FDA is issuing this letter because of the significant growth in the marketing of foods containing these ingredients.
FDA is concerned that some botanical and other novel ingredients that are being added to conventional foods are neither approved food additives, nor generally recognized as being safe for these uses. This letter serves as a reminder to the industry of the longstanding legal requirements governing conventional food products.
In issuing this letter, FDA is also reminding manufacturers about the legal requirements regarding claims on conventional foods. The Food Drug and Cosmetic Act allows for certain claims such as:
* health claims -- a claim characterizing the relationship between a food substance and a disease or health related condition;
* nutrient content claims -- a claim characterizing the level of a nutrient in a food; and
* structure/function claims -- a claim characterizing the effect of a food on the structure or function of the body.
FDA must review health claims and nutrient content claims prior to marketing, unless the claim has been authorized by regulation or by statute under the authoritative statement notification procedure.
Manufacturers are encouraged to contact the agency regarding the regulatory status of ingredients and claims they intend to use for foods.
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01070.html
more listings of potential TSE carrying nutritional supplements, only a few of hundreds out there;
IPLEX; (listing only potentially TSE tainted tissues) vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
also this is another;
Immuplex Ingredients;
Bovine Liver PMG Extract, zinc-iron-copper liver chelate, bovine liver powder, veal bone PMG Extract, ascorbic acid, nutritional yeast, bovine spleen PMG Extract, high selenium yeast, vaccum dried bovine and ovine spleen, bovine thymus PMG Extract, bovine thymus Cytosol Extract, mixed tocopherois, high chromium yeast, pyridoxal 5-phosphate, vitamin A esters, calcium lactate, folic asid and cyanocabalamin.
Two capsules supple 165 mg Bovine Liver PMG Extract, 45 mg Bovine spleen PMG Extract, 40 mg Vacuum Dried Bovine and Ovine Spleen, 35 mg. Bovine Thymus PMG Extract and 35 mg Bovine Thymus Cytosol Extract.
METABOLIFE; Bovine Complex; Glandular system; Ovaries, Prostate, Scrotum and Adrenal (usda cattle) [big deal...tss]
12,500 cattle ever checked for a TSE in the U.S.A. in the 12 year program (to aug. 2001)
in that 12 years, the U.S. has raised 1.5 BILLION head of cattle including calf crop. 100 million in the USA in any given year.
37 MILLION slaughtered annually
190,000 DOWNERS annually
=========================================
Subject: Metabolife
Date: Mon, 7, Dec 1998 14:21:35 -0800
From: Rand Smith
To: "'flounder@wt.net'"
Dear Sir,
We are looking at reformulation. I agree that slow virus diseases present a problem in some areas of the world.
Our product uses healthy USDA inspected cattle for the glandular extract.
If you have any links to more information on this subject I would like to examine them.
Thank you for your interest and concern.
Dr. Smith
============================
here is the famous yearly token letter from FDA to supplements manufacturer;
Letter to Manufacturers of Biological Products - Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)
Department of Health and Human Services Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448
April 19, 2000
To Manufacturers of Biological Products
The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.
CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:
1.Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.
2.Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.
3.Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities.
It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephone number 301-734-8364, website address http://www.aphis.usda.gov/ncie, and codified at 9 CFR 94.18 (see attached).
Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:
Dr. David Asher, Office of Blood Research and Review 301-827-3524 Dr. Paul Richman, Office of Vaccines Research and Review 301-827-3070 James Crim, Office of Therapeutics Research and Review 301-827-5101
Thank you for your attention to this matter.
Sincerely,
---- signature ---
Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And Research
Attachment
http://www.fda.gov/cber/ltr/bse041900.htm
also, you can go to this FDA dockets page, and skroll down until you see EMC 597 'Terry S. Singeltary Sr.' highlighted in blue. this also has some very interesting information. It is a PDF file;
http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/030100.htm
another thing most disturbing, the USA imports supplements with SRMs from known BSE countries. and if you don't think scrapie or CWD can transmit to man as easily or as difficult as BSE (depends whom you have watched suffer and die from this horrible disease) well, i would like to see this proof of this (transmission studies only). but let us not forget the potential threat of BSE in sheep.
another fine example;
snip...
In fact, the salesman now tells us he doesn't sell the machines anymore. But the quest for youth goes beyond facial creams and exotic contraptions, anti-agers are also ingesting some pretty wild-sounding dietary supplements. "Live proteins from sheep and pig from France, processed," says a representative.
Life-Cell Technologies touts the benefits of supplements that contain processed pig and sheep organs. "I have a lot of body builders and professional athletes that use these products because they strengthen and stimulate the different glands and organs," says one woman. The idea, she implied, often is that ingesting ground up animal organs will strengthen human organs or even cure thyroid and adrenal diseases. "To my knowledge you can't just take pulverzied organs and feed them to somebody and think they're not going to have thyroid disease anymore or hypo-adrenalism," says Dr. Wexler. It would be kind of a medical miracle, wouldn't it? "It would be amazing, truly amazing," says Dr. Wexler. "Dateline" attended another anti-aging conference and expo in Chicago - this time with our cameras in plain view.
Remember the exhibitor selling processed pig and sheep organs? We pressed her for scientific documentation. We asked, what is the science behind the idea? The woman tells us, "You would have to go on the Internet and get information, scientific studies." But this is her company, isn't it? "Yes it is," she says. "And if you don't mind, I don't want to be interviewed. I don't."
"Dateline" tells her, "They are simple questions that any consumer would ask." Everywhere "Dateline" went at the anti-aging expo we heard a lot about so-called "scientific studies." "Well, it comes from 3,000 studies," a man at the expo tells us.
At one booth the product is called transfer factor, and the active ingredient is colostrum - the potent pre-milk fluid in a lactating mother's breast.
"We actually filtrate the transfer factor out of the colostrum," says one man. From where, mothers? "No," the man tells us. "From bovine colostrum, from cows."
http://www.msnbc.com/news/550100.asp?cp1=1
----- Original Message -----
From: "TERRY SINGELTARY"
To:
Sent: Thursday, March 19, 2009 8:47 PM
Subject: [CJD-L] Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)
10.3201/eid1505.081458 Suggested citation for this article: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of print]
Chronic Wasting Disease Prions in Elk Antler Velvet
Rachel C. Angers,1 Tanya S. Seward, Dana Napier, Michael Green, Edward Hoover, Terry Spraker, Katherine O'Rourke, Aru Balachandran, and Glenn C. Telling Author affiliations: University of Kentucky Medical Center, Lexington, Kentucky, USA (R.C. Angers, T.S. Seward, D. Napier, M. Green, G.C. Telling); Colorado State University, Fort Collins, Colorado, USA (E. Hoover, T. Spraker); US Department of Agriculture, Pullman, Washington, USA (K. O'Rourke); and Canadian Food Inspection Agency, Ottawa, Ontario, Canada (A. Balachandran) 1Current affiliation: MRC Laboratory of Molecular Biology, Cambridge, UK.
Chronic wasting disease (CWD) is a contagious, fatal prion disease of deer and elk that continues to emerge in new locations. To explore the means by which prions are transmitted with high efficiency among cervids, we examined prion infectivity in the apical skin layer covering the growing antler (antler velvet) by using CWD-susceptible transgenic mice and protein misfolding cyclic amplification. Our finding of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among cervids. Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions. The fact that CWD prion incubation times in transgenic mice expressing elk prion protein are consistently more rapid raises the possibility that residue 226, the sole primary structural difference between deer and elk prion protein, may be a major determinant of CWD pathogenesis.
snip...
Discussion
The transmission of CWD prions in antler velvet from 2 naturally affected elk to mice in 2 Tg models demonstrates that this tissue contains low, but detectable, amounts of CWD prions. In addition, serial PMCA amplified otherwise undetectable levels of PrPSc in antler velvet. We characterized CWD prion infectivity by end-point titration. The .6 log i.c.ID50/g CWD prion titer estimated by this method contrasts with .9 log i.c.ID50/g titers of mouse-adapted scrapie prions in rodent brains (9) and .7.7.7 log i.c.ID50/g titers of BSE prions estimated by bioassay in transgenic mice (10,11). The linear relationship between dose and incubation time (12) provides an opportunity to estimate the level of prions in materials containing an unknown amount of infectivity. The attack rates of <100%>30 months (28). Prion strain properties are also critical when considering the potential for interspecies transmission. The existence of multiple CWD strains has been suggested by several studies (4,25,29,30), but strain isolation and host range characterization have not been reported. Finally, it is worth considering that if CWD were to cross the species barrier into humans, this transmission source might not be recognized if the disease profile overlapped with one of the forms of sporadic CJD reported in North America.
Possible Role for Residue 226 in CWD Pathogenesis
Previous studies that demonstrated more rapid CWD prion incubation times in Tg mice expressing elk PrP (24,29) than in Tg(CerPrP)1536+/. mice (4) raised the possibility that the single amino acid difference at residue 226 between elk and deer PrP (5) may influence CWD pathogenesis (29). However, when the transmission characteristics of CWD isolates were directly compared in Tg mice expressing differing levels of deer or elk PrP, Tamguney et al.
Page 8 of 17
concluded that CWD incubation times were related solely to the level of PrP transgene expression (25). We compared CWD transmission in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice, which express PrP at levels .5-fold higher than PrP in wild type mouse brain (Figure 1A), and found that CWD transmission was consistently and substantially more rapid in Tg(CerPrP-E226)5037+/. mice. Our results appear compatible with more efficient CWD prion propagation by elk cellular prion protein (CerPrPC) containing E at residue 226 than by deer CerPrPC containing Q at this position. Consistent with this interpretation, despite 5-fold lower levels of transgene expression in Tg(CerPrP-E226)5029+/. than in Tg(CerPrP)1536+/. mice, mean incubation times of the D92 isolate were equivalent in these 2 lines (Table). Nonetheless, undetected differences in CerPrPC expression, for example in particular cell types, might result in more rapid disease and/or altered pathologic changes. The generation of transgenic mice expressing elk and deer coding sequences using gene replacement strategies would seem to be an excellent approach for resolving this issue. The different responses to CWD in Tg mice also appear to recapitulate aspects of CWD pathogenesis in the natural hosts. Previous limited comparative transmission studies indicated that CWD developed .25% more rapidly in orally challenged elk than deer (31). Although plaques were not detected in brains of CWD-affected elk, florid plaques have been observed in the brains of diseased deer (32,33). Similar differences in pathologic changes were observed in Tg(CerPrP-E226)5037+/. and Tg(CerPrP)1536+/. mice (Figure 4). Structural analyses suggest that residue 226 is located within a region of PrPC proposed to interact with a factor (34), possibly equivalent to the postulated protein X (35). Although mutation of the equivalent residue from Q to lysine (K) in epitope-tagged mouse PrP had no effect on PrPSc formation in transfected chronically infected ScN2A cells, the effects of the Q-to-E substitution were not assessed (36).
Acknowledgments We thank Dongyue Zhuang for excellent technical assistance. This work was supported by grants 2RO1NS040334-04 from the National Institute
http://www.cdc.gov/eid/content/15/5/pdfs/08-1458.pdf
snip...
1998 MY SUBMISSION TO THE BSE INQUIRY ENGLAND
Sender: "Patricia Cantos"
To: "Terry S Singeltary Sr. (E-mail)"
Subject: Your submission to the Inquiry
Date: Fri, 3 Jul 1998 10:10:05 +0100
3 July 1998 Mr Terry S Singeltary Sr. E-Mail: Flounder at wt.net Ref: E2979
Dear Mr Singeltary,
Thank you for your E-mail message of the 30th of June 1998 providing the Inquiry with your further comments. Thank you for offering to provide the Inquiry with any test results on the nutritional supplements your mother was taking before she died.
As requested I am sending you our general Information Pack and a copy of the Chairman's letter. Please contact me if your system cannot read the attachments.
Regarding your question, the Inquiry is looking into many aspects of the scientific evidence on BSE and nvCJD. I would refer you to the transcripts of evidence we have already heard which are found on our internet site at http://www.bse.org.uk. Could you please provide the Inquiry with a copy of the press article you refer to in your e-mail? If not an approximate date for the article so that we can locate it? In the meantime, thank you for you comments. Please do not hesitate to contact me on 0171 261 8332 should you have any queries.
Yours sincerely Patricia Cantos Families Team Leader Attachments TSS
==============
My neighbors Mom also died from CJD. She had been taking a nutritional supplement which contained the following; vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. As I said, this woman taking these nutritional supplements, died from CJD. The particular batch of pills that was located, in which she was taking, was tested. From what I have heard, they came up negative, for the prion protein. But, in the same breath, they said their testing, may not have been strong enough to pick up the infectivity. Plus, she had been taking these type pills for years, so, could it have come from another batch?
http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406
IPLEX, mad by standard process;
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
also;
i will only list animal ingredients of the following Nutritional Supplements by only ONE company;
Standard Process Co.
IPLEX; bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder, vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal, vacuum dried veal bone.
A-FBetafood R vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine kidney, bovine orchic glandular extract, bovine liver fat extract.
Arginex R bovine liver powder.
Adrenal, Desiccated TM Vacuum dried bovine adrenal.
Albaplex R bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney PMF Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal, vacuum dried bovine kidney, veal bone meal.
Allerplex TM bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried veal bone.
Immuplex R Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract, bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine thymus PMF Extract, bovine thymus Cytosol Extract.
Vasculin R Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder, vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum dried bovine and ovine spleen.
Zypan R bovine pancreas Cytosol Extract, vacuum dried bovine and ovine spleen.
last i heard, they were getting sued;
Suit Filed Over Mad Cow Disclaimer
By Jason Hoppin The Recorder March 23, 2001
A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.
The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.
"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.
The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.
"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies thedisease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."
No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.
The case was filed in San Francisco Superior Court.
The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.
Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bonesand brains, where BSE is most highly concentrated.
Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S.government-inspected facilities.
"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.
The human manifestation of BSE -- variant Creutzfeld-Jakob disease --has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.
U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.
"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."
However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.
© 2001 law.com Inc. =======================
Supplements Association Moves to Eliminate Bovine Parts From Products
WASHINGTON (Reuters Health) Mar 16 - The nation's largest dietary supplements industry group has issued new guidance to manufacturers amid concerns that some alternative health products containing bovine materials pose a risk of transmitting bovine spongiform encephalopathy (BSE) to humans.
The guidance, published by the National Nutritional Foods Association (NNFA), encourages manufacturers to eliminate all neurological bovine materials from their products. Consumption of brains and spinal cords from cows infected with BSE are widely believed to be the source of new variant Creutzfeldt-Jakob disease (vCJD) in humans........
snip... full text at;
http://id.medscape.com/
see ;
http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html
-------- Original Message --------
Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
Date: Thu, 01 May 2003 16:04:35 -0400
From: "Marcia G Crosse" To:
CC: "Charles W Davenport" , "Carolyn Feis Korman" , "Martin Gahart"
Mr. Singletary,
We were informed by representatives of Metabolife, Inc. that Metabolife 356 was reformulated to remove bovine complex as an ingredient in the product, approximately September 2001. We did not independently verify the contents of the product.
Sincerely, Marcia Crosse Acting Director Health CarePublic Health and Science Issues U.S. General Accounting Office 441 G Street, N.W. Washington, D.C. 20548
===================
-------- Original Message --------
Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
Date: Thu, 01 May 2003 15:48:52 -0500
From: "Terry S. Singeltary Sr."
To: Marcia G Crosse
CC: Charles W Davenport , Carolyn Feis Korman , Martin Gahart References:
THANK YOU!
MIRACLES DO HAPPEN! ;-)
now all we need to do is;
snip......
one small step for man, one giant leap for mankind ;-)
however;
''We did not independently verify the contents of the product''
???
TSS
####### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ########
see history of mad cow in a pill ;
Thursday, March 19, 2009
Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)
http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html
####### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ########
http://www.wellsphere.com/cjd-article/chronic-wasting-disease-prions-in-elk-antler-velvet-nutritional-supplements-and-cjd/628645
'Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from 3 US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated. (neighbors Mom, whom also died from CJD, had been taking bovine based supplement, which contained brain, eye, and many other bovine/ovine tissues for years, 'IPLEX'). What is
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47
Posted Apr 09 2009 7:13pm
http://stanford.wellsphere.com/cjd-article/use-of-materials-derived-from-cattle-in-human-food-and-cosmetics-docket-no-2004n-0081-rin-0910-af47/641209
http://cjdmadcowbaseoct2007.blogspot.com/2008/04/use-of-materials-derived-from-cattle-in.html
http://www.epa.gov/EPA-IMPACT/2008/April/Day-17/i1142.htm
http://lists.iatp.org/listarchive/archive.cfm?id=123840
http://cjdmadcowbaseoct2007.blogspot.com/2008/04/use-of-materials-derived-from-cattle-in.html
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3; Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique, France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious Disease control, Sweden; 5Georg August University, Germany; 6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans. Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian v CJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfillment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
It is clear that the designing scientists must also have shared Mr Bradley’s surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley’s surprise at the results because all the
dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts
[BBC radio 4 FARM news]
http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
2) Infectious dose:
To cattle: 1 gram of infected brain material (by oral ingestion)
http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml
Tuesday, January 19, 2010
CVM's OR Develops New PCR-Based Method for Testing Animal Feed
http://madcowfeed.blogspot.com/2010/01/cvms-or-develops-new-pcr-based-method.html
NOW that we have established that this infamous part of the USA BSE MAD COW TRIPLE FIRE WALL was a farce, let's look further into the historical myth of no mad cows in the USA (well, they estimate at 1 in a million slip by into the food system), but i dispute that by many more. The BSE surveillance program was/is terribly flawed as well.
bottom line, and i say this with full confidence, with the present and past surveillance of BSE/TSE in the USA, and the continued feed violations, in the TONS, no one will ever know the true extent of any strain of mad cow disease in the USA. you don't have to just take my word on it, read the facts. blunder, after blunder, after blunder. they have all been posted here, i would be glad to go over any and or all of them one by one for any that doubts me. i can sum it all up real quick, Canada is looking to find, and the USA has never, EVER, done that. it's been just the opposite for the USA. don't believe me, or the facts, here is what Dr. Paul Brown of the cdc/nih et al ;
PAUL BROWN COMMENT TO ME ON THIS ISSUE
Tuesday, September 12, 2006 11:10 AM
"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."
PAUL BROWN CDC ET AL COMMENT TO THE MEDIA ON THIS ISSUE ;
"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end
http://www.upi.com/
http://usdameatexport.blogspot.com/2009/09/japans-new-leaders-seen-tougher-on-us.html
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
Statement on Texas cow with central nervous system symptoms
Main Category: Public Health Article
Date: 05 May 2004 - 0:00 PDT
The Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.
FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.
Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).
FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.
Source: FDA http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm092863.htm
Monday, October 19, 2009
Atypical BSE, BSE, and other human and animal TSE in North America Update October 19, 2009
http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html
full text please see ;
Tuesday, January 26, 2010
Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity Draft 09/24/09
http://fdafailedus.blogspot.com/2010/01/establishing-fully-integrated-national.html
PLEASE BE AWARE ;
The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
http://www.oie.int/boutique/extrait/06heim937950.pdf
Saturday, January 2, 2010
Human Prion Diseases in the United States January 1, 2010 ***FINAL***
http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html
my comments to PLosone here ;
http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd
Thursday, January 28, 2010
Multiorgan Detection and Characterization of Protease-Resistant Prion Protein in a Case of Variant CJD Examined in the United States
http://creutzfeldt-jakob-disease.blogspot.com/2010/01/multiorgan-detection-and.html
Friday, January 29, 2010
14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)
18.173 page 189
Experimental Challenge of Cattle with H-type and L-type Atypical BSE
A. Buschmann1, U. Ziegler1, M. Keller1, R. Rogers2, B. Hills3, M.H. Groschup1. 1Friedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany, 2Health Canada, Bureau of Microbial Hazards, Health Products & Food Branch, Ottawa, Canada, 3Health Canada, Transmissible Spongiform Encephalopathy Secretariat, Ottawa, Canada
Background: After the detection of two novel BSE forms designated H-type and L-type atypical BSE the question of the pathogenesis and the agent distribution of these two types in cattle was fully open. From initial studies of the brain pathology, it was already known that the anatomical distribution of L-type BSE differs from that of the classical type where the obex region in the brainstem always displays the highest PrPSc concentrations. In contrast in L-type BSE cases, the thalamus and frontal cortex regions showed the highest levels of the pathological prion protein, while the obex region was only weakly involved.
Methods:We performed intracranial inoculations of cattle (five and six per group) using 10%brainstemhomogenates of the two German H- and L-type atypical BSE isolates. The animals were inoculated under narcosis and then kept in a free-ranging stable under appropriate biosafety conditions.At least one animal per group was killed and sectioned in the preclinical stage and the remaining animals were kept until they developed clinical symptoms. The animals were examined for behavioural changes every four weeks throughout the experiment following a protocol that had been established during earlier BSE pathogenesis studies with classical BSE.
Results and Discussion: All animals of both groups developed clinical symptoms and had to be euthanized within 16 months. The clinical picture differed from that of classical BSE, as the earliest signs of illness were loss of body weight and depression. However, the animals later developed hind limb ataxia and hyperesthesia predominantly and the head. Analysis of brain samples from these animals confirmed the BSE infection and the atypical Western blot profile was maintained in all animals. Samples from these animals are now being examined in order to be able to describe the pathogenesis and agent distribution for these novel BSE types. Conclusions: A pilot study using a commercially avaialble BSE rapid test ELISA revealed an essential restriction of PrPSc to the central nervous system for both atypical BSE forms. A much more detailed analysis for PrPSc and infectivity is still ongoing.
http://www.isid.org/14th_icid/
http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf
http://www.isid.org/publications/ICID_Archive.shtml
From: xxxx
To: Terry Singeltary
Sent: Saturday, December 05, 2009 9:09 AM
Subject: 14th ICID - abstract accepted for 'International Scientific Exchange'
Your preliminary abstract number: 670
Dear Mr. Singeltary,
On behalf of the Scientific Committee, I am pleased to inform you that your abstract
'Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009'
WAS accepted for inclusion in the INTERNATIONAL SCIENTIFIC EXCHANGE (ISE) section of the 14th International Congress on Infectious Diseases. Accordingly, your abstract will be included in the "Intl. Scientific Exchange abstract CD-rom" of the Congress which will be distributed to all participants.
Abstracts accepted for INTERNATIONAL SCIENTIFIC EXCHANGE are NOT PRESENTED in the oral OR poster sessions.
Your abstract below was accepted for: INTERNATIONAL SCIENTIFIC EXCHANGE
#0670: Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009
Author: T. Singeltary; Bacliff, TX/US
Topic: Emerging Infectious Diseases Preferred type of presentation: International Scientific Exchange
This abstract has been ACCEPTED.
#0670: Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009
Authors: T. Singeltary; Bacliff, TX/US
Title: Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009
Body: Background
An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and feed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.
Methods
12 years independent research of available data
Results
I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.
Conclusion
I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries.
I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.
Keywords: Transmissible Spongiform Encephalopathy Creutzfeldt Jakob Disease Prion
http://www.isid.org/14th_icid/
http://www.isid.org/publications/ICID_Archive.shtml
http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf
full text ;
http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html
Wednesday, February 11, 2009
Atypical BSE North America Update February 2009
Both of the BSE cases ascertained in the US native-born cattle were atypical cases (H-type), which contributed to the initial ambiguity of the diagnosis. 174, 185 In Canada, there have been 2 atypical BSE cases in addition to the 14 cases of the classic UK strain of BSE2: one was the H-type, and the other was of the L-type.198
snip...end
source : Enhanced Abstract Journal of the American Veterinary Medical Association January 1, 2009, Vol. 234, No. 1, Pages 59-72 Bovine spongiform encephalopathy Jane L. Harman, DVM, PhD; Christopher J. Silva, PhD
http://avmajournals.avma.org/doi/ref/10.2460/javma.234.1.59
http://bse-atypical.blogspot.com/2009/06/l-type-bse-h-type-bse-c-type-bse-ibnc.html
Wednesday, October 08, 2008
Idiopathic Brainstem Neuronal Chromatolysis (IBNC): a novel prion protein related disorder of cattle?
http://bse-atypical.blogspot.com/2008/10/idiopathic-brainstem-neuronal.html
Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle to a Primate
Emmanuel E. Comoy1*, Cristina Casalone2, Nathalie Lescoutra-Etchegaray1, Gianluigi Zanusso3, Sophie Freire1, Dominique Marcé1, Frédéric Auvré1, Marie-Magdeleine Ruchoux1, Sergio Ferrari3, Salvatore Monaco3, Nicole Salès4, Maria Caramelli2, Philippe Leboulch1,5, Paul Brown1, Corinne I. Lasmézas4, Jean-Philippe Deslys1
1 Institute of Emerging Diseases and Innovative Therapies, CEA, Fontenay-aux-Roses, France, 2 Istituto Zooprofilattico Sperimentale del Piemonte, Turin, Italy, 3 Policlinico G.B. Rossi, Verona, Italy, 4 Scripps Florida, Jupiter, Florida, United States of America, 5 Genetics Division, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America
Abstract Top Background Human variant Creutzfeldt-Jakob Disease (vCJD) results from foodborne transmission of prions from slaughtered cattle with classical Bovine Spongiform Encephalopathy (cBSE). Atypical forms of BSE, which remain mostly asymptomatic in aging cattle, were recently identified at slaughterhouses throughout Europe and North America, raising a question about human susceptibility to these new prion strains.
Methodology/Principal Findings Brain homogenates from cattle with classical BSE and atypical (BASE) infections were inoculated intracerebrally into cynomolgus monkeys (Macacca fascicularis), a non-human primate model previously demonstrated to be susceptible to the original strain of cBSE. The resulting diseases were compared in terms of clinical signs, histology and biochemistry of the abnormal prion protein (PrPres). The single monkey infected with BASE had a shorter survival, and a different clinical evolution, histopathology, and prion protein (PrPres) pattern than was observed for either classical BSE or vCJD-inoculated animals. Also, the biochemical signature of PrPres in the BASE-inoculated animal was found to have a higher proteinase K sensitivity of the octa-repeat region. We found the same biochemical signature in three of four human patients with sporadic CJD and an MM type 2 PrP genotype who lived in the same country as the infected bovine.
Conclusion/Significance Our results point to a possibly higher degree of pathogenicity of BASE than classical BSE in primates and also raise a question about a possible link to one uncommon subset of cases of apparently sporadic CJD. Thus, despite the waning epidemic of classical BSE, the occurrence of atypical strains should temper the urge to relax measures currently in place to protect public health from accidental contamination by BSE-contaminated products.
snip...
In summary, we have transmitted one atypical form of BSE (BASE) to a cynomolgus macaque monkey that had a shorter incubation period than monkeys infected with classical BSE, with distinctive clinical, neuropathological, and biochemical features; and have shown that the molecular biological signature resembled that seen in a comparatively uncommon subtype of sporadic CJD. We cannot yet say whether BASE is more pathogenic for primates (including humans) than cBSE, nor can we predict whether its molecular biological features represent a clue to one cause of apparently sporadic human CJD. However, the evidence presented here and by others justifies concern about a potential human health hazard from undetected atypical forms of BSE, and despite the waning epizoonosis of classical BSE, it would be premature to abandon the precautionary measures that have been so successful in reversing the impact of cBSE. We would instead urge a gradual, staged reduction that takes into account the evolving knowledge about atypical ruminant diseases, and both a permanent ban on the use of bovine central nervous system tissue for either animal or human use, and its destruction so as to eliminate any risk of environmental contamination.
Citation: Comoy EE, Casalone C, Lescoutra-Etchegaray N, Zanusso G, Freire S, et al. (2008) Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle to a Primate. PLoS ONE 3(8): e3017. doi:10.1371/journal.pone.0003017
Editor: Neil Mabbott, University of Edinburgh, United Kingdom
Received: April 24, 2008; Accepted: August 1, 2008; Published: August 20, 2008
Copyright: © 2008 Comoy et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This work has been supported by the Network of Excellence NeuroPrion.
Competing interests: CEA owns a patent covering the BSE diagnostic tests commercialized by the company Bio-Rad.
* E-mail: emmanuel.comoy@cea.fr
http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0003017
http://www.chsc.or.kr/xe/?mid=reference&listStyle=webzine&sort_index=readed_count&order_type=asc&page=9&document_srl=3656&cpage=
P2-110 TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY TO MICROCEBUS MURINUS, A NON-HUMAN PRIMATE. DEVELOPMENT OF CLINICAL SYMPTOMS AND TISSUE DISTRIBUTION OF PRPRES
Nadine Mestre-Frances1, Anne-Gaelle Biacabe2, Sylvie Rouland1, Thierry Baron2, Jean-Michel Verdier1, 1INSERM U710, Montpellier, France; 2AFSSA, Lyon, France. Contact e-mail: nfrances@univmontp2. fr
Background: Atypical BSE cases have been observed in Europe, Japan and North America. They differ in their PrPres profiles from those found in classical BSE. These atypical cases fall into 2 types, depending on the molecular mass of the unglycosylated PrPres band observed by Western blot: the L-type (lower molecular mass than the typical BSE cases) and H-type (higher molecular mass than the typical BSE cases).
Methods: Height animals (4 males and 4 females) were intracerebrally inoculated with 50 l of a 10% brain homogenates of atypical (L and H-type) French BSE cases.
Results: Only one of the four lemurs challenge with H-type BSE died without clinical signs after 19 months post inoculation (mpi), the 4 animals inoculated with L-type BSE died at 19 mpi (2 males) and 22 mpi (2 females). Three months before their sacrifice, they developed blindness, tremor, abnormal posture, incoordinated movements, balance loss. Symptoms get worse according to the disease progression, until severe ataxia. The brain tissue were biochemically and immunocytochemically investigated for PrPres. For the H-types, spongiform changes without PrPres accumulation were observed in the brainstem. Western blot analysis confirmed that no PrPres was detected into the brain. For the L-types, severe spongiosis was evidenced into the thalamus, the striatum, the mesencephalon, and the brainstem, whereas into the cortex the spongiosis was evidenced, but the vacuolisation was weaker. Strong deposits of PrPres was detected by western blot, PET-blot and immunocytochemistry in the CNS: dense accumulation was observed into the thalamus, the striatum, and the hippocampus whereas in the cerebral cortex, PrPres was prominently accumulated in plaques. Western blot analysis confirmed the presence of protease-resistant prion protein.
Conclusions: L-type infected lemurs showed survival times considerably shorter than for classical BSE strain, indicating that the disease is caused by a very virulent distinct prion strain.
http://download.journals.elsevierhealth.com/pdfs/journals/1552-5260/PIIS1552526008013447.pdf
Journal of Virology, April 2008, p. 3697-3701, Vol. 82, No. 7 0022-538X/08/$08.00+0 doi:10.1128/JVI.02561-07 Copyright © 2008, American Society for Microbiology. All Rights Reserved.
Evaluation of the Human Transmission Risk of an Atypical Bovine Spongiform Encephalopathy Prion Strain
Qingzhong Kong,1* Mengjie Zheng,1 Cristina Casalone,2 Liuting Qing,1 Shenghai Huang,1, Bikram Chakraborty,1 Ping Wang,1 Fusong Chen,1 Ignazio Cali,1 Cristiano Corona,2 Francesca Martucci,2 Barbara Iulini,2 Pierluigi Acutis,2 Lan Wang,1 Jingjing Liang,1 Meiling Wang,1 Xinyi Li,1 Salvatore Monaco,3 Gianluigi Zanusso,3 Wen-Quan Zou,1 Maria Caramelli,2 and Pierluigi Gambetti1* Department of Pathology, Case Western Reserve University, Cleveland, Ohio 44106,1 CEA, Istituto Zooprofilattico Sperimentale, 10154 Torino, Italy,2 Department of Neurological and Visual Sciences, University of Verona, 37134 Verona, Italy3
Received 30 November 2007/ Accepted 16 January 2008
Bovine spongiform encephalopathy (BSE), the prion disease in cattle, was widely believed to be caused by only one strain, BSE-C. BSE-C causes the fatal prion disease named new variant Creutzfeldt-Jacob disease in humans. Two atypical BSE strains, bovine amyloidotic spongiform encephalopathy (BASE, also named BSE-L) and BSE-H, have been discovered in several countries since 2004; their transmissibility and phenotypes in humans are unknown. We investigated the infectivity and human phenotype of BASE strains by inoculating transgenic (Tg) mice expressing the human prion protein with brain homogenates from two BASE strain-infected cattle. Sixty percent of the inoculated Tg mice became infected after 20 to 22 months of incubation, a transmission rate higher than those reported for BSE-C. A quarter of BASE strain-infected Tg mice, but none of the Tg mice infected with prions causing a sporadic human prion disease, showed the presence of pathogenic prion protein isoforms in the spleen, indicating that the BASE prion is intrinsically lymphotropic. The pathological prion protein isoforms in BASE strain-infected humanized Tg mouse brains are different from those from the original cattle BASE or sporadic human prion disease. Minimal brain spongiosis and long incubation times are observed for the BASE strain-infected Tg mice. These results suggest that in humans, the BASE strain is a more virulent BSE strain and likely lymphotropic.
-------------------------------------------------------------------------------- * Corresponding author. Mailing address: Department of Pathology, Case Western Reserve University, Cleveland, OH 44106. Phone for Pierluigi Gambetti: (216) 368-0586. Fax: (216) 368-2546. E-mail: pxg13@case.edu. Phone for Qingzhong Kong: (216) 368-1756. Fax: (216) 368-2546. E-mail: qxk2@case.edu
Published ahead of print on 30 January 2008.
Present address: Department of Patient Education and Health Information, Cleveland Clinic Foundation, Cleveland, OH 44195.
-------------------------------------------------------------------------------- Journal of Virology, April 2008, p. 3697-3701, Vol. 82, No. 7 0022-538X/08/$08.00+0 doi:10.1128/JVI.02561-07 Copyright © 2008, American Society for Microbiology. All Rights Reserved.
http://jvi.asm.org/cgi/content/abstract/82/7/3697?etoc.
Atypical BSE in Cattle
BSE has been linked to the human disease variant Creutzfeldt Jakob Disease (vCJD). The known exposure pathways for humans contracting vCJD are through the consumption of beef and beef products contaminated by the BSE agent and through blood transfusions. However, recent scientific evidence suggests that the BSE agent may play a role in the development of other forms of human prion diseases as well. These studies suggest that classical type of BSE may cause type 2 sporadic CJD and that H-type atypical BSE is connected with a familial form of CJD.
http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2=
Monday, December 14, 2009 R.I.P. MOM DOD
Similarities between Forms of Sheep Scrapie and Creutzfeldt-Jakob Disease Are Encoded by Distinct Prion Types
> Sporadic CJD type 1 and atypical/ Nor98 scrapie are characterized by fine (reticular) deposits,
http://nor-98.blogspot.com/2009/12/similarities-between-forms-of-sheep.html
see also ;
> All of the Heidenhain variants were of the methionine/ methionine type 1 molecular subtype.
http://cjdusa.blogspot.com/2009/09/co-existence-of-scrapie-prion-protein.html
Thursday, January 07, 2010
Scrapie and Nor-98 Scrapie November 2009 Monthly Report Fiscal Year 2010 and FISCAL YEAR 2008
http://scrapie-usa.blogspot.com/2010/01/scrapie-and-nor-98-scrapie-november.html
BSE prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein
Emmanuel A. Asante, Jacqueline M. Linehan, Melanie Desbruslais, Susan Joiner, Ian Gowland, Andrew L. Wood, Julie Welch, Andrew F. Hill, Sarah E. Lloyd, Jonathan D.F. Wadsworth, and John Collinge1 MRC Prion Unit and Department of Neurodegenerative Disease, Institute of Neurology, University College, Queen Square, London WC1N 3BG, UK 1Corresponding author e-mail: j.collinge@prion.ucl.ac.ukReceived August 1, 2002; Revised September 24, 2002; Accepted October 17, 2002.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC136957/?tool=pubmed
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
*** CJD USA RISING, with UNKNOWN PHENOTYPE ;
5 Includes 41 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 46 cases with type determination pending in which the diagnosis of vCJD has been excluded.
http://www.cjdsurveillance.com/pdf/case-table.pdf
Monday, February 01, 2010
Import Alert 57-20 and 84-03 Human Dura Mater and risk factors there from due to Creutzfeldt Jakob Disease (CJD)
http://creutzfeldt-jakob-disease.blogspot.com/2010/02/import-alert-57-20-and-84-03-human-dura.html
TERRY S. SINGELTARY SR.
Labels: Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics
posted by Terry S. Singeltary Sr. at
5:03 PM
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