Tuesday, August 16, 2016

Docket No. FDA-2011-D-0376 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry Singeltary Submission

[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)] [Notices] [Pages 53486-53489] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2016-19306]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

 

[Docket No. FDA-2011-D-0376]

 

Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Availability

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION: Notice of availability.

 

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the issuance of a revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The revised draft guidance supersedes FDA's July 2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications).

 

DATES: Although you may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 11, 2016.

 

ADDRESSES: You may submit comments as follows:

 

Electronic Submissions

 

 Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

 

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 If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions'').

 

Written/Paper Submissions

 

 Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.''

 

Instructions: All submissions received must include the Docket No. FDA-2011-D-0376 for ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

 

Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

 

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

 

Submit written requests for single copies of the draft guidance to the Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

 

FOR FURTHER INFORMATION CONTACT: Ali Abdel-Rahman, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1853.

 

SUPPLEMENTARY INFORMATION:

 

I. Background

 

 We are announcing the availability of a revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' This draft guidance supersedes the July 2011 draft guidance on this topic (76 FR 39111; July 5, 2011) and is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. It will not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

 

On October 25, 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding, among other provisions: (1) Section 201(ff) (21 U.S.C. 321(ff)), which defines the term ``dietary supplement'' and (2) section 413 (21 U.S.C. 350b), which describes requirements for NDIs. Among other things, section 413 of the FD&C Act requires the manufacturer or distributor of an NDI, or of a dietary supplement containing the NDI, to submit a premarket notification to FDA (as delegate for the Secretary of Health and Human Services) at least 75 days before introducing the NDI or dietary supplement into interstate commerce, unless the NDI and any other ingredients in the dietary supplement have been present in the food supply as an article used for food in a form in which the food has not been chemically altered (21 U.S.C. 350b(a)(1)). The notification must contain the information, including any citation to published articles, which is the manufacturer or distributor's basis for concluding that a dietary supplement containing the NDI will reasonably be expected to be safe.

 

This draft guidance has several purposes. First, it is intended to help dietary supplement manufacturers and distributors decide whether to submit an NDI notification. In addition, the draft guidance is intended to provide recommendations on how to conduct a safety assessment for an NDI notification and what to include in the notification. In question and answer form, the draft guidance presents FDA's views on what qualifies as an NDI; when an NDI notification is required; the procedures for submitting an NDI notification; the types of data and information that manufacturers and distributors should consider when evaluating the safety of a dietary supplement containing an NDI; and what should be included in an NDI notification. In addition, the draft guidance contains questions and answers about parts of the dietary supplement definition (section 201(ff) of the FD&C Act) that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.

 

We issued the original version of this draft guidance in the Federal Register of July 5, 2011 (the 2011 draft guidance). We gave interested parties an opportunity to submit comments by October 3, 2011. In the Federal Register of September 9, 2011 (76 FR 55927), we extended the comment period to December 2, 2011. We received numerous comments on the 2011 draft guidance. Based on those comments and on meetings with industry and other stakeholders, we realized that the 2011 draft guidance contained gaps and unclear statements that were subject to confusion and misinterpretation. Therefore, we decided to clarify and better explain our thinking on some critical issues, in addition to explaining their public health significance, and to

 

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request additional comments on these issues before publishing a final guidance. We have revised certain questions and answers and added a number of new questions and answers.

 

The major topics on which we have revised or added questions and answers are as follows:

 

Chemical alteration--Dietary supplements containing an NDI are exempt from the notification requirement when they contain only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered. Section IV.B of the revised draft guidance explains FDA's interpretation of ``present in the food supply as an article used for food'' and the public health basis for that interpretation. In addition, section IV.B has been revised to address the question of what constitutes ``chemical alteration'' more fully and to explain FDA's reasoning on this issue, as well as discussing additional examples of when chemical alteration occurs and when it does not. Because no guidance document can cover every possible manufacturing scenario, the draft guidance encourages industry to consult with FDA in advance on such matters.

 

Manufacturing changes that create an NDI--A related issue addressed in section IV.A of the draft guidance is when a manufacturing change alters the structure or properties of an ingredient and creates an NDI for which a notification must be submitted. The revised draft guidance provides examples of manufacturing changes that alter the identity of the ingredient, the key factor in determining whether they also change the regulatory status of the ingredient.

 

Synthetic substances--Section IV.D of the revised draft guidance contains an expanded discussion clarifying FDA's views on when synthetic copies of botanical and other dietary ingredients qualify as dietary ingredients under the FD&C Act. FDA's thinking is based on the text of section 201(ff)(1) of the FD&C Act, which defines some types of dietary ingredients by identity and others by function.

 

New dietary ingredient definition and list of ``grandfathered'' dietary ingredients--In section IV.A of the draft guidance, we revised our response to the question about whether there is an authoritative list of dietary ingredients marketed before October 15, 1994 (a so-called ``grandfathered list'' or ``old dietary ingredient list''). Dietary ingredients marketed before that date are not NDIs and therefore are not subject to the premarket notification requirement in section 413 of the FD&C Act. Although there is currently no authoritative list of ``grandfathered'' ingredients, the revised answer notes that FDA is prepared to compile such a list based on independent and verifiable data to be submitted by industry. The revised answer also discusses FDA's thinking on the regulatory status of dietary ingredients that would be on such a list, as well as the status of dietary ingredients not on such a list.

 

We also revised several questions and answers in section IV.A to clarify various matters regarding FDA's interpretation of the terms ``marketed'' and ``dietary ingredient'' in section 413(d) of the FD&C Act, which defines an NDI as a dietary ingredient that was not marketed in the United States before October 15, 1994, and we added more examples of documentation that can be used to show that a dietary ingredient was marketed prior to October 15, 1994.

 

Structuring notifications efficiently and relying on data from prior notifications and master files--We added several questions and answers in section IV.C of this draft guidance to suggest ways manufacturers and distributors can reduce the number of NDI notifications they must file and to clarify when data and information from a previous notification or ``master file'' may be used in a notification. For example, the answer to a new question clarifies that firms may submit an NDI notification that covers the use of the NDI in multiple dietary supplements and includes safety data for a range of doses and/or differing conditions of use. This answer also explains that a firm may submit a confidential ``master file'' containing specifications, manufacturing procedures, and other identity information for an NDI, and may incorporate information from the master file into its own NDI notification or may authorize another firm to rely on information from the master file in a notification for a dietary supplement containing the NDI. We also added a question and answer to describe when a firm may rely on data in another notification. In addition, section IV.C now includes a question and answer with six examples distinguishing situations in which separate notifications are required for different dietary supplements containing the same NDI from situations in which a single NDI notification covers multiple dietary supplements containing the same NDI. Finally, section IV.C now clarifies that, although a combination of NDIs is itself an NDI, a combination of grandfathered dietary ingredients is not, even if that combination has not been used in a dietary supplement before.

 

Identity information to include in an NDI notification--We revised several questions and answers in section VI.A in consideration of comments regarding chemical and botanical information necessary to determine the identity of an NDI. We also added a new question and answer with recommendations about what chemistry information should be included in a notification for an enzyme NDI. In addition, since some of the standard references on nomenclature of plants and microorganisms have been renamed or updated since the 2011 draft guidance, we updated the citations to refer to the most recent edition.

 

Electronic submission--We updated the question and answer in section V.A about electronic submission of NDI notifications. The updated answer states that we are accepting NDI notifications electronically and provides the Internet address for the electronic submission gateway. As before, the answer notes that firms still have the option to submit paper notifications to FDA using the procedure described in 21 CFR 190.6.

 

PDF form for NDI notifications submitted on paper--Because our electronic submission gateway for NDI notifications is now available, we have decided not to provide a competing form for paper notifications. Therefore, we have removed ``Appendix B: 75-Day Pre- Market New Dietary Ingredient Notification Form'' from the draft guidance.

 

Safety information to include in an NDI notification--We revised several questions and answers in sections VI.B and VI.C to clarify our thinking on compiling and evaluating scientific evidence about the safety of NDIs and dietary supplements that contain NDIs. In section VI.B, we clarified our thinking on the use of foreign history of use data. We also added a recommendation to consult ``Principles and Methods for the Risk Assessment of Chemicals in Food,'' a joint publication of the World Health Organization and the Food and Agriculture Organization of the United Nations, as a useful source of information on conducting human clinical studies for NDIs and dietary supplements. In response to comments, we removed all references to FDA's ``Redbook'' guidance, which contains recommendations on toxicity studies and other scientific evidence needed to determine the safety of food additives. We also revised section VI.B to explain that the NDI safety standard is different from the standards for other FDA-regulated products and clarify that evidence for an NDI safety evaluation should be compiled to meet that standard. Although the revised draft

 

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guidance no longer cites the Redbook, we continue to recommend the use of the dietary exposure assessment methodology and some toxicology tests that are also used for the evaluation of food additives because these are standard scientific methods not specific to any particular safety assessment paradigm. Finally, we added a new question at the end of section VI.C to emphasize that this draft guidance contains recommendations about safety information to include in an NDI notification, but these recommendations are not requirements. Other changes--We made clarifying changes, explanatory changes, and editorial changes throughout the document. We also updated references and links and added new references where appropriate.

 

II. Paperwork Reduction Act of 1995

 

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This draft guidance contains proposed collections of information. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a 60-day notice in the Federal Register soliciting public comment on each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, we intend to publish a 60-day notice on the proposed collections of information in this draft guidance in a future issue of the Federal Register. This draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 111 have been approved under OMB control number 0901-0606, and the collections of information in Sec. 190.6 have been approved under OMB control number 0910-0330.

 

III. Other Issues for Consideration

 

Although FDA welcomes comments on any aspect of this draft guidance, we particularly invite comment on the following: What processes alter the identity of an ingredient marketed prior to October 15, 1994, and thus create an NDI? We are especially interested in recommendations for clearer examples or criteria to differentiate changes in manufacturing methods and starting materials that alter the identity of the ingredient from changes that do not. What processes ``chemically alter'' an ingredient within the meaning of section 413(a)(1) of the FD&C Act, and why? Conversely, what processes do not cause chemical alteration, and why? Are there certain processes, such as tinctures, that sometimes result in chemical alteration and sometimes do not? What criteria should be used to evaluate whether an ingredient has been chemically altered? We are especially interested in receiving scientific information that shows whether a particular process actually results in chemical alteration. What method of compiling independent and verifiable data on the marketing of dietary ingredients before October 15, 1994, would be most effective? How should an authoritative list of ``grandfathered'' ingredients based on such data be developed and implemented? As FDA considers the development of final guidance, we will review comments received on this revised version, as well as comments on the 2011 draft guidance that are still relevant.

 

IV. Electronic Access

 

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the draft guidance.

 

V. References

 

The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

 

1. International Programme on Chemical Safety, ``Principles and Methods for the Risk Assessment of Chemicals in Food,'' Environmental Health Criteria 240 (2009), available at: http://www.who.int/foodsafety/publications/chemical-food/en/. 2. The official name of the Redbook is ``Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients,'' available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm.

 

Dated: August 9, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016-19306 Filed 8-11-16; 8:45 am] BILLING CODE 4164-01-P

 


 

Docket No. FDA-2011-D-0376 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry Singeltary Submission

 

My name is Terry S. Singeltary Sr., and I would kindly like to submit my comments and my concern on Docket No. FDA-2011-D-0376 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry.

 

I believe that the FDA consistently misses the ELEPHANT IN THE ROOM, when it pertains to these Nutritional Supplements, and that would be the Transmissible Spongiform Encephalopathy TSE Prion aka mad cow type disease, and tissues and organs used in some of these Nutritional Supplements.

 

By continuing to allow _any_ type of tissue or organ of animals of any species in the manufacturing of any Nutritional supplements, especially with the atypical TSE prion disease showing up in many species, you risk humans to Creutzfeldt Jakob Disease CJD aka mad cow type disease. The FDA has been warning of this since around 2001 or sooner, voluntarily. as you can surely see, voluntary does NOT work, we all know it, all one has to do is look at the August 1997 mad cow feed ban.

 

all the FDA is doing, and has done for decades, is allow the public that are consuming these type supplements to be exposed to the TSE PRION aka MAD COW type agent.

 

all they can do now is wait, 10, 20, maybe 50 years, for a slow incubating TSE Prion disease, that once clinical, is 100% fatal.

 

By continuing to ignore these risk factors, you continue to risk exposing consumers to the TSE PRION aka mad cow type disease, and you have known it for decades.

 

* YOU must ban all animal tissue and organs from any Nutritional Supplement. 

 

To date, there has been no studies finished that I am aware of that have studied the atypical TSE tissue and organs for titre of infectivity in each species, so you do not know, yet you continue to expose humans to the TSE prions to these type supplements. This is what happened to those 300K+ of those typical c-BSE mad cow cases in the UK, all they were doing was ingesting a Nutritional Supplement that contained tissues and organs of cows infected with mad cow disease. officials and scientist to date have no clue as to the atypical TSE Prion disease and tissue infectivity there from. 

 

Once the feed ban took hold, the epidemic of BSE in the UK dropped.

 

SEE THE DRASTIC REDUCTION OF CONFIRMED BSE CASES IN THE UK ONCE THE FEED BAN TOOK HOLD FROM THE TOP YEAR DOWN TO THE FIRST ZERO YEAR ;

 

1992 36680 SLAUGHTERED SUSPECTS IN WHICH BSE CONFIRMED

 

2013 0 0 0 0 0 0 0 0

 


 


 


 


 


 

Saturday, January 31, 2015

 

RAPID ADVICE 17-2014 : Evaluation of the risk for public health of casings in countries with a “negligible risk status for BSE” and on the risk of modification of the list of specified risk materials (SRM) with regard to BSE

 


 

In the USA, USDA et al sometimes serves SRM’s up as appetizers or horderves.

 

Monday, June 20, 2016

 

*** Specified Risk Materials SRMs BSE TSE Prion Program

 


 

See what one of the top PRION Doctors says about these type Nutritional Supplements here ;

 

Research Project: TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES: THE ROLE OF GENETICS, STRAIN VARIATION, AND ENVIRONMENTAL CONTAMINATION IN DISEASE CONTROL

 

Title: Chronic Wasting Disease Prions in Elk Antler Velvet

 

Authors

 

item Angers, R - UNIVERSITY OF KENTUCKY item Napier, D - UNIVERSITY OF KENTUCKY item Seward, T - UNIVERSITY OF KENTUCKY item Green, M - UNIVERSITY OF KENTUCKY item Spraker, T - COLORADO STATE UNIVERSITY item O'Rourke, Katherine item Balachandran, A - CANADIAN FOOD INSPCTN AG item Telling, G - UNIVERSITY OF KENTUCKY

 

Submitted to: Emerging Infectious Diseases Publication Type: Peer Reviewed Journal Publication Acceptance Date: February 1, 2009

 


 

Citation: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. 2009. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis 15(5):696-703.

 

Interpretive Summary: Chronic wasting disease (CWD) is a fatal neurologic disease of deer and elk in the United States and Canada. The disease is associated with accumulations of infectious proteins in the brain, nervous system, blood, and a limited number of other tissues. In this study, the investigators examined elk antler velvet, the covering that grows on elk antlers every year. Antler velvet is rich in blood and nervous supply and may represent a source of infectious material as the velvet is shed every year. Antler velvet and brain tissue from four infected elk was examined by immunohistochemistry and biochemical methods, with no evidence of the abnormal prion protein in antler velvet. The same preparations were tested in genetically engineered mice susceptible to CWD. Mice in both inoculated groups developed prion disease. This finding demonstrates that antler velvet from CWD infected elk contain infectious material and may represent a risk material to other elk. Technical Abstract: Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy or prion disease of captive and free ranging white tailed deer, mule deer, Rocky Mountain elk and moose in the some parts of the United States and Canada. The presence of the disease has sharply curtailed movement of captive animals and reduced the domestic or international market for some cervid by-products. The disease appears to be transmitted by Rocky Mountain elk relatively late in the disease course, but the sources of the infectious material remain undefined. Brain and lymphoid tissue contain the highest levels of the abnormal prion protein, the marker for disease, and transmission in white tailed deer can be accomplished by blood transfusion from experimentally infected deer to naive deer. In this study, the investigators examined the transmission potential of antler velvet, a highly vascularized and innervated epidermal tissue covering the growing antler. Antler velvet is shed each year and is widely used as a nutritional supplement. Genetically engineered mice susceptible to CWD were inoculated with homogenates of paired brain and antler velvet from 4 elk with CWD. Mice in both groups developed a transmissible spongiform encephalopathy. These findings demonstrate prion infectivity accumulates in antler velvet and may have impact on marketing of this product.

 

Last Modified: 7/24/2016

 


 

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

 

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...

 

Implications for Horizontal CWD Transmission and Human Exposure

 

Our studies indicate that antler velvet represents a previously unrecognized source of CWD prions in the environment. Whereas oral transmission of rodent-adapted scrapie prions is known to be ≈5 orders of magnitude less efficient than transmission by intracerebral inoculation (14,15), the relative efficiency of oral CWD prion transmission is unknown. Multiple exposures to low levels of CWD prions in the environment (16,17), as well as increased infectivity when prions are bound to soil minerals (18), are factors that may influence transmission.

 

The appearance of variant Creutzfeldt-Jakob disease in humans exposed to bovine spongiform encephalopathy (BSE) (19,20) and the demonstration of CWD prions in muscle (3) placed the human species barrier to CWD prions at the forefront of public health concerns. Our studies indicate that antler velvet represents an additional source for human exposure to CWD prions. Widely used in traditional Asian medicine to treat a variety of ailments including impotence, arthritis, and high blood pressure, antler velvet can be readily purchased in caplet form and its usage has increased worldwide.

 

Fortunately, to date there is no epidemiologic evidence that rates of CJD in the CWD-endemic region (Colorado, USA) have increased (21,22). Also reassuring is the inefficient in vitro conversion of human PrP to protease-resistant PrP by CWD (23). Two studies have shown that CWD prions failed to induce disease in Tg mice expressing human PrP (24,25). However, the failure of BSE to be transmitted to Tg mice expressing human prion protein (HuPrP) was cited as early evidence of a BSE transmission barrier in humans (26); subsequent studies demonstrated a strong effect of the codon 129 polymorphism on transmissibility of BSE prions (27). To date, only mice expressing HuPrP with methionine at 129 have been challenged with CWD. In support of the argument that humans might be susceptible to CWD, intracerebral inoculation of squirrel monkeys produced disease after >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.

 

snip...end

 


 

Volume 15, Number 5—May 2009

 

Research

 

Chronic Wasting Disease Prions in Elk Antler Velvet

 


 


 


 


 

ABOUT that deer antler spray and CWD TSE PRION...

 

I have been screaming this since my neighbors mom died from cjd, and she had been taking a supplement that contained bovine brain, bovine eyeball, and other SRMs specified risk materials, the most high risk for mad cow disease.

 

just saying...

 

I made a submission to the BSE Inquiry long ago during the BSE Inquiry days, and they seemed pretty interested.

 

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 ;

 


 

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...

 

snip...end...tss

 

everyone I tell this too gets it screwed up...MY MOTHER WAS NOT TAKING THOSE SUPPLEMENTS IPLEX (that I ever knew of). this was my neighbors mother that died exactly one year _previously_ and to the day of sporadic CJD that was diagnosed as Alzheimer’s at first. my mother died exactly a year later from the Heidenhain Variant of Creutzfeldt Jakob Disease hvCJD, and exceedingly rare strains of the ever growing sporadic CJD’s. _both_ cases confirmed. ...kind regards, terry

 

TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS

 

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;

 

what about potential mad cow candy bars ?

 

see their potential mad cow candy bar list too...

 

THESE are just a few of MANY of just this ONE COMPANY...TSS

 

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 snip...

 

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

 


 


 


 

see full text ;

 


 

everyone I tell this too gets it screwed up...MY MOTHER WAS NOT TAKING THOSE SUPPLEMENTS IPLEX (that I ever knew of). this was my neighbors mother that died exactly one year _previously_ and to the day of sporadic CJD that was diagnosed as Alzheimer’s at first. my mother died exactly a year later from the Heidenhain Variant of Creutzfeldt Jakob Disease hvCJD, and exceedingly rare strains of the ever growing sporadic CJD’s. _both_ cases confirmed. ...kind regards, terry

 

TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS

 

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;

 

what about potential mad cow candy bars ?

 

see their potential mad cow candy bar list too...

 

2003 - 2004 Product Catalog

 

Standard Process Inc.

 

NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal organs) bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

 

NATURAL PEANUT BUTTER STANDARDBAR

 

bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

 

USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;

 

bovine orhic glandular extract

 

UTROPHIN PMG

 

bovine uterus PMG

 

VASCULIN

 

bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen

 

IPLEX (neighbors mom died from CJD while taking these pills for years)

 

bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal

 

MYO-PLUS

 

bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract, bovine spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN

 

NEUROPLEX

 

bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT, BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE BOVINE BRAIN...

 

NEUROTROPHIN PMG

 

BOVINE BRAIN PMG

 

NIACINAMIDE B6 VM

 

bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN

 

OCULOTROPHIN PMG BOVINE EYE PMG

 

ORCHEX

 

bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen, ovine spleen, BOVINE BRAIN

 

OSTARPLEX

 

veal bone PMG extract, veal bone PMG extract, bovine liver, porcine stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN

 

PARAPLEX

 

bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract

 

PITUITROPHIN PMG

 

RUMAPLEX

 

BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine spleen, bovine liver

 

SENAPLEX

 

bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal, bovine kidney, bovine orchic extract, bovine spleen, ovine spleen ..........

 

THESE are just a few of MANY of just this ONE COMPANY.

 

FOR the following reason, I implore that the FDA take serious action in further protecting the consumer from the TSE agent via nutritional supplements.

 

THESE are just a few of MANY of just this ONE COMPANY...TSS

 

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7

 


 


 

see full text ;

 


 

Does all that e-mail spam promising sexual vitality actually hide serious risk of contracting MAD COW DISEASE?

 

Volume 361, Number 9368 03 May 2003

 

Correspondence

 

Tighter regulation needed for dietary supplements in USA

 

Sir--Mary Palmer and colleagues (Jan 11, p 101)1 found that dietary supplements have the potential to cause serious adverse effects. The investigators state that research on the hazards and risks of dietary supplements should be a priority. The safety of individuals who consume these products is important, and organisations such as the US Food and Drug Administration (FDA) need to take initiative by enforcing stricter regulations on supplements. Several commonly used products--for example ginkgo biloba, St John's Wort, and ephedrine--can have serious adverse effects.2 Although the FDA requires multiple studies on the safety and efficacy for pharmaceutical products before placing them on the market, standards are less robust for dietary supplements. In the USA, under the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplements are subject to the same regulatory requirements as food. There are no provisions that require FDA approval for the safety or effectiveness of supplements,3 which leaves consumers and manufacturers essentially responsible for the health effects of these products. The DSHEA of 1994 needs to be revised so that dietary supplements are subject to the same regulations as pharmacological drugs. The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Association are already taking steps to achieve these changes. However, they face immense opposition from groups such as the National Nutritional Foods Association, the American Herbal Association, and the Council for Responsible Nutrition. To overcome such resistance, consumer organisations, health-care providers, and government agencies need to approach this subject in unison. The public needs to be able to assess the risks and benefits of dietary supplements before consuming them. Health-care providers and the more than 100 million Americans who consume these products4 should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products.

 

Nipa Kinariwala

 

----------------------------------------------------------

 

700 Bolinwood Drive, Apartment 12A, Chapel Hill, NC 27514, USA (e-mail nskinari at aol.com) 1 Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003; 361: 101-06. [Text ] 2 Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999; 59: 1239-45. [PubMed ] 3 Unites States Food and Drug Administration. Overview of dietary supplements. Jan 3, 2001. http://www.cfsan.fda.gov/~dms/ds-oview.html (accessed Feb 20, 2002). 4 Pear R. Feds call for tighter control over nutritional supplements. Organic Consumers Association, April 17, 2001.

 


 

(accessed Feb 20, 2002).

 


 

snip...end tss letter to fda.

 

=================== 2013 ================

 

my plight with Metabolife, the GAO et al, and my submission to the BSE inquiry, about mad cow in a pill ;

 

Wednesday, March 20, 2013

 

GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Product

 

From: Terry S. Singeltary Sr.

 

Sent: Tuesday, March 19, 2013 2:46 PM

 

To: mailto:gomezj%40gao.gov Cc: mailto:siggerudk%40gao.gov ; mailto:youngc1%40gao.gov ; mailto:oighotline%40gao.gov

 


 

Monday, February 01, 2010

 

Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics Import Alert 17-04

 


 

Thursday, March 19, 2009

 

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]

 


 

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a

 

Comment Number: EC –2

 

Accepted - Volume 7

 


 

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7

 

snip...

 

Dr. Paul Bown, one of the top TSE PRION scientist at NIH. what did Paul Brown say about this previously;

 

i bring your attention to (page 500) Dr. Paul Brown statements;

 

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; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf

 


 

snip...

 


 

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

 


 

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)

 


 

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').

 


 

my plight with metabolife and there 'bovine complex' about risk factors of TSE in there product ;

 

Terry S. Singeltary Sr. wrote:

 

 ######## Bovine Spongiform Encephalopathy > > #########

 

1. Dietary Supplements: Review of Health-Related Call Records for

 

Users of Metabolife 356. GAO-03-494, March 31.

 


 


 

-------- Original Message --------

 

Subject: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''

 

Date: Thu, 01 May 2003 11:23:01 –0500

 

From: "Terry S. Singeltary Sr."

 

To: NelliganJ at gao.gov

 

The General Accounting Office (GAO) today released the following reports and testimonies: ‘'

 

REPORTS;

 

1. Dietary Supplements: Review of Health-Related Call Records for

 

Users of Metabolife 356. GAO-03-494, March 31.

 


 


 

GREETINGS GAO:

 

i was surprised that i did not see any listing of bovine tissue in metabolife on it's label. have they ceased using these desiccated tissues???

 

i see that the lable on this product METABOLIFE 356, does not state that it has any tissues of desiccated bovine organs?

 

i no the product use to, so i am curious if they have ceased the use of the tissues of cattle they _use_ to use (see below)???

 

METABOLIFE 356

 

BOVINE COMPLEX/GLANDULAR SYSTEM

 

OVARIES, PROSTATE, SCROTUM AND ADRENAL

 

USDA SOURCE CATTLE

 

i tried warning them years ago of this potential threat of CJD/TSEs;

 

From: Randy Smith

 

To: "'flounder at wt.net'"

 

Subject: Metabolife

 

Date: Mon, 7 Dec 1998 14:21:35 –0800

 

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

 

============

 

From: Randy Smith

 

To: "'flounder at wt.net'"

 

Subject: RE: [Fwd: Your submission to the Inquiry]

 

Date: Wed, 9 Dec 1998 10:37:07 –0800

 

Terry,

 

Thank you for your note and the information links you forwarded to me.

 

I am new to Metabolife International, however hopefully as my role here enlarges I well have a greater impact on formulation and product development.

 

Metabolife International does believe in placing safety first. And I am going to do my best to see that we continue to do so.

 

Sincerely,

 

Dr. Smith

 

============

 

-----Original Message-----

 

From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]

 

Sent: Wednesday, December 09, 1998 5:49 PM

 

To: rsmith at metabolife.com

 

Subject: [Fwd: Your submission to the Inquiry]

 

Dr. Smith, I am truly impressed with you honesty, THANKS.....I am not just spouting off about the potential dangers, here. THEY ARE REAL.....I have forwarded an e-mail from the BSE Inquiry, in which I made a statement about them........You might want to go to the site and read through it........IT WILL TAKE A WHILE........ THINGS ARE HAPPENING HERE SIR, THAT YOU ARE NOT AWARE OF, AND AS MOST PEOPLE ARE NOT...............I JUST HOPE, THAT THE REFORMULATION YOU SPEAK OF, IS IN FACT GOING TO TAKE PLACE.

 

The Department of Health, here in the U.S., is also worried about the potential dangers involved hear............Terry/MADSON

 

==================================================

 

From: Randy Smith

 

To: "'flounder at wt.net'"

 

Subject: RE: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]

 

Date: Fri, 18 Dec 1998 09:55:17 –0800

 

Return-Receipt-To: Randy Smith

 

Thanks very much for the info. I appreciate all these articles I can get. It does sound very familiar - just follow the green ($) trail.

 

-----Original Message-----

 

From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]

 

Sent: Friday, December 18, 1998 5:15 PM

 

To: rsmith at metabolife.com

 

Subject: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]

 

Randy, thought you might be interested in > > this...............MADSON!!!!!1

 

snip...

 

===============================

 

-------- 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

 


 


 


 

Could you get mad cow from a pill ? Some doctors say a class of pills that promise smarts, energy, and sexual vitality may cause mad-cow disease.

 

The government isn't worried. Should you be?

 

June 1, 2001

 

Health Magazine

 

by Susan Freinkel

 


 

The German Magazine Der Spiegel came out to the house here and interviewed me in 2001 (I think), about that token purina mad cow feed mill blunder, and they were very concerned about these type supplements that carried the SRMs that could very well carry the TSE prion agent. ...please see ;

 

GERMAN DER SPIEGEL MAGAZINEDie

 

BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax.

 


 

DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen) USA: Loch in der Mauer Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax.Link auf diesen Artikel im Archiv:

 


 

"Löcher wie in einem Schweizer Käse" hat auch Terry Singeltary im Regelwerk der FDA ausgemacht. Der Texaner kam auf einem tragischen Umweg zu dem Thema: Nachdem seine Mutter 1997 binnen weniger Wochen an der Creutzfeldt-Jakob-Krankheit gestorben war, versuchte er, die Ursachen der Infektion aufzuspüren. Er klagte auf die Herausgabe von Regierungsdokumenten und arbeitete sich durch Fachliteratur; heute ist er überzeugt, dass seine Mutter durch die stetige Einnahme von angeblich kräftigenden Mitteln erkrankte, in denen - völlig legal - Anteile aus Rinderprodukten enthalten sind.

 

Von der Fachwelt wurde Singeltary lange als versponnener Außenseiter belächelt. Doch mittlerweile sorgen sich auch Experten, dass ausgerechnet diese verschreibungsfreien Wundercocktails zur Stärkung von Intelligenz, Immunsystem oder Libido von den Importbeschränkungen ausgenommen sind. Dabei enthalten die Pillen und Ampullen, die in Supermärkten verkauft werden, exotische Mixturen aus Rinderaugen; dazu Extrakte von Hypophyse oder Kälberföten, Prostata, Lymphknoten und gefriergetrocknetem Schweinemagen. In die USA hereingelassen werden auch Blut, Fett, Gelatine und Samen. Diese Stoffe tauchen noch immer in US-Produkten auf, inklusive Medizin und Kosmetika. Selbst in Impfstoffen waren möglicherweise gefährliche Rinderprodukte enthalten. Zwar fordert die FDA schon seit acht Jahren die US-Pharmaindustrie auf, keine Stoffe aus Ländern zu benutzen, in denen die Gefahr einer BSE-Infizierung besteht. Aber erst kürzlich verpflichteten sich fünf Unternehmen, darunter Branchenführer wie GlaxoSmithKline, Aventis und American Home Products, ihre Seren nur noch aus unverdächtigem Material herzustellen.

 

"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...

 


 


 


 

Sunday, November 10, 2013

 

LARGE CJD TSE PRION POTENTIAL CASE STUDY AMONG HUMANS WHO TAKE DEER ANTLER VELVET WILL BE ONGOING FOR YEARS IF NOT DECADES, but who's cares $

 


 

Volume 15, Number 5—May 2009

 

Research

 

Chronic Wasting Disease Prions in Elk Antler Velvet

 


 


 


 


 

see full text ;

 

Sunday, July 24, 2016

 

Chronic Wasting Disease Prions in Elk Antler Velvet and Marketing of this Product in Nutritional Supplements for Humans?

 

Research Project: TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES: THE ROLE OF GENETICS, STRAIN VARIATION, AND ENVIRONMENTAL CONTAMINATION IN DISEASE CONTROL

 


 

Sunday, July 17, 2016

 

CHRONIC WASTING DISEASE CWD TSE PRION GLOBAL REPORT UPDATE JULY 17 2016

 


 

Thursday, February 25, 2016

 

U.S. Food & Drug Administration (FDA) FDA/CFSAN Cosmetics Update: Cosmetics Program; Import and Domestic and Transmissible Spongiform Encephalopathy TSE Prion Disease Risk Factors

 

***WARNING TO ALL CONSUMERS AND COUNTRIES AROUND THE WORLD***

 

***Note: FDA labs do not conduct BSE analysis and thus no sampling guidance is issued for BSE. ***

 


 

Monday, May 02, 2016

 

*** Zoonotic Potential of CWD Prions: An Update Prion 2016 Tokyo ***

 


 

Tuesday, July 12, 2016

 

Chronic Wasting Disease CWD, Scrapie, Bovine Spongiform Encephalopathy BSE, TSE, Prion Zoonosis Science History

 

see history of NIH may destroy human brain collection

 


 

Saturday, April 23, 2016

 

SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016

 

Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X

 


 

Saturday, July 23, 2016

 

BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION SURVEILLANCE, TESTING, AND SRM REMOVAL UNITED STATE OF AMERICA UPDATE JULY 2016

 


 

Tuesday, July 26, 2016

 

Atypical Bovine Spongiform Encephalopathy BSE TSE Prion UPDATE JULY 2016

 


 

Tuesday, August 9, 2016

 

Concurrence with OIE Risk Designations for Bovine Spongiform Encephalopathy [Docket No. APHIS-2015-0055]

 


 

Saturday, July 16, 2016

 

Importation of Sheep, Goats, and Certain Other Ruminants [Docket No. APHIS-2009-0095]RIN 0579-AD10

 

WITH great disgust and concern, I report to you that the OIE, USDA, APHIS, are working to further legalize the trading of Transmissible Spongiform Encephalopathy TSE Pion disease around the globe.

 

THIS is absolutely insane. it’s USDA INC.

 


 

Thursday, August 4, 2016

 

Secretary's Advisory Committee on Animal Health [Docket No. APHIS-2016-0046] TSE PRION DISEASE

 


 

Thursday, August 04, 2016

 

MEETING ON THE FEASIBILITY OF CARRYING OUT EPIDEMIOLOGICAL STUDIES ON CREUTZFELDT JAKOB DISEASE 1978 THE SCRAPIE FILES IN CONFIDENCE CONFIDENTIAL SCJD

 


 

Monday, June 29, 2015

 

*** RESTRICTED – POLICY CJD IN ADOLESCENTS (16 year old Vickey Rimmer), FARMERS WITH BSE HERDS, AND FARMERS WIFE with Sporadic CJD

 


 

Evidence That Transmissible Mink Encephalopathy Results from Feeding Infected Cattle

 

Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.

 

snip...

 

The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...

 


 


 


 

In Confidence - Perceptions of unconventional slow virus diseases of animals in the USA - APRIL-MAY 1989 - G A H Wells

 

3. Prof. A. Robertson gave a brief account of BSE. The US approach was to accord it a very low profile indeed. Dr. A Thiermann showed the picture in the ''Independent'' with cattle being incinerated and thought this was a fanatical incident to be avoided in the US at all costs. ...

 


 

”The occurrence of CWD must be viewed against the contest of the locations in which it occurred. It was an incidental and unwelcome complication of the respective wildlife research programmes. Despite it’s subsequent recognition as a new disease of cervids, therefore justifying direct investigation, no specific research funding was forthcoming. The USDA veiwed it as a wildlife problem and consequently not their province!” ...page 26.

 


 

Tuesday, August 02, 2016

 

Chronic wasting disease of deer – is the battle to keep Europe free already lost?

 


 

Tuesday, April 12, 2016

 

The first detection of Chronic Wasting Disease (CWD) in Europe free-ranging reindeer from the Nordfjella population in South-Norway.

 


 

Tuesday, June 14, 2016

 

*** Chronic Wasting Disease (CWD) in a moose from Selbu in Sør-Trøndelag Norway ***

 


 

Thursday, July 07, 2016

 

Norway reports a third case Chronic Wasting Disease CWD TSE Prion in 2nd Norwegian moose

 

14/06/2016 - Norway reports a third case

 


 

Saturday, July 16, 2016

 

Chronic wasting Disease in Deer (CWD or Spongiform Encephalopathy) The British Deer Society 07/04/2016

 

Red Deer Ataxia or Chronic Wasting Disease CWD TSE PRION?

 

could this have been cwd in the UK back in 1970’S ???

 


 


 


 


 

SEE FULL TEXT ;

 


 

Wednesday, August 10, 2016

 

Arkansas Chronic Wasting Disease CWD TSE Prion Potentially Trucked in from Missouri, what about Florida and ?

 


 

Saturday, July 09, 2016

 

Texas Intrastate – within state movement of all Cervid or Trucking Chronic Wasting Disease CWD TSE Prion Moratorium

 


 

Friday, July 01, 2016

 

*** TEXAS Thirteen new cases of chronic wasting disease (CWD) were confirmed at a Medina County captive white-tailed deer breeding facility on June 29, 2016***

 


 

*** How Did CWD Get Way Down In Medina County, Texas?

 

DISCUSSION Observations of natural outbreaks of scrapie indicated that the disease spread from flock to flock by the movement of infected, but apparently normal, sheep which were incubating the disease.

 

There was no evidence that the disease spread to adjacent flocks in the absent of such movements or that vectors or other host species were involved in the spread of scrapie to sheep or goats; however, these possibilities should be kept open...

 


 


 


 

Tuesday, August 02, 2016

 

TEXAS TPWD Sets Public Hearings on Deer Movement Rule Proposals in Areas with CWD Rule Terry S. Singeltary Sr. comment submission

 


 

Friday, July 29, 2016

 

IOWA CHRONIC WASTING DISEASE CWD TSE PRION TOTAL TO DATE 304 CASES WILD AND CAPTIVE REPORT UPDATE JULY 2016

 


 

Wednesday, July 27, 2016

 

Arkansas CWD 101 positive cases documented to date, Biologists to take additional samples in in southern Pope County, Aug. 1-5

 


 

Friday, August 05, 2016

 

MINNESOTA CHRONIC WASTING DISEASE SURVEILLANCE AND TESTING CWD TSE PRION UPDATE

 


 

Monday, August 01, 2016

 

Florida Fish and Wildlife Conservation Commission CWD TSE Prion Surveillance Monitoring Programs and Testing

 


 

Tuesday, July 19, 2016

 

MONTANA CHRONIC WASTING DISEASE CWD TSE PRION UPDATE STILL SHOWS ONLY 9 CAPTIVE CASES CONFIRMED FROM Philipsburg Kesler Game game since 1999

 


 

Sunday, July 17, 2016

 

Virginia Chronic Wasting Disease CWD As of March 2016 has diagnosed 13 CWD-positive white-tailed deer

 


 

Sunday, July 17, 2016

 

West Virginia Chronic Wasting Disease CWD has been found in 195 white-tailed deer As of June 2016

 


 

Friday, February 05, 2016

 

*** Report of the Committee on Wildlife Diseases FY2015 CWD TSE PRION Detections in Farmed Cervids and Wild ***

 


 

Sunday, May 08, 2016

 

WISCONSIN CHRONIC WASTING DISEASE CWD TSE PRION SPIRALING FURTHER INTO THE ABYSS UPDATE

 


 

Terry S. Singeltary Sr.



 

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