Docket No. FDA-2011-D-0376 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry Singeltary Submission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Issues; Revised Draft Guidance for Industry; Availability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issuance of a revised draft guidance for industry entitled ``Dietary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revised draft guidance supersedes FDA's July 2011 draft guidance on the same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 The revised draft guidance, when finalized, will help industry in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10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance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electronic or written comments on the draft guidance by October 11, 2016.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.
[[Page 53487]]
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
[[Page 53488]]
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
[[Page 53489]]
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
Publication Date: May 1, 2009 Repository URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687044/pdf/08-1458_finalR.pdf
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
####### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
########
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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