Evidence Of CJD/BSE Transmission Via Supplements

Rense.com

Evidence Of CJD/BSE
Transmission Via Supplements
From Terry S. Singeltary Sr.
flounder@wt.net
1-26-3

Jeff - There is not only the potential for some nutritional supplements as a vector for CJD/TSE but another major factor is the vaccine issue as a route for death via CJD/TSE. I worked on this data for over a year and I am telling you straight: they have been covering this up for 30 or 40 years. Most of this data I was able to acquire through FOIAs in both the UK and the US before the BSE-Inquiry became public - after which both governments made most of the documents secret. But that's another story, one I am not finished with yet ;-). Here we go...

---- Original Message ----

Subject: Re: Adverse events associated with dietary supplements:
an observational study
From: Terry S. Singeltary Sr flounder@wt.net
To: mpalmer@landspitali.is, lancet.editorial@lancet.com
CC: john.mcconnell@lancet.com, pamela.das@lancet.com,
james.butcher@lancet.com, rebecca.love@lancet.com,
journal.office@lancet.com
Date: Mon, 13 Jan 2003

Re: Adverse events associated with dietary supplements:
an observational study

LANCET
JANUARY 11, 2003

Greetings to the Lancet and Authors of this article, I hope you don't mind me writing this lengthy letter.

This article and its warning was a long time coming for the supplement industry and the dangers some of its products pose to human health.

Some of these supplements make claims which under no circumstances could they be true. However, what I find most disturbing is that there were no warnings of the potential for transmission to humans of TSEs from some of these nutritional supplements which contain animal organs and some containing the most high risk SRMs (specified risk materials) that could transmit TSEs to humans. Again, I think your article should have mentioned this most disturbing fact.

There have been documented cases of humans taking supplements containing animal organs who subsequently died from CJD. Of course, with no testing to date to confirm the source and route of transmission, it is impossible to confirm this. Also, the incubation period makes it very difficult to trace route and source.

However, with the KNOWN transmission studies to date >from TSEs, and the fact that all the world's cattle that came down with BSE were ingesting a nutritional supplement to super-ovulate cattle. (Not to forget about the potential for some BSE cases to come from vaccinations containing pituitary-derived SRMs.)

TWA LITTLE minute

http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf

COMMERCIAL IN CONFIDENCE

http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf

NOT FOR PUBLICATION

http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf

http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf

NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE

snip...

I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use.

snip...

The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out...

http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf

more on the 1968 medicine act, they forgot to follow

http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf

Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)

http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf

(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)

http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

< FONT SIZE=+1>http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf

TWA LITTLE STATEMENT 331

http://www.bseinquiry.gov.uk/files/ws/s331.pdf

Date: Sun, 12 Jan 2003 12:56:44 -0600
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ???

http://www.vegsource.com/talk/madcow/messages/9912301.html

With these known facts about nutritional supplements, I think it imperative to include this potential route and source of TSE and warning in this article.

Why was it not included? I lost my mother to hvCJD DOD 12/14/97, and I probably will not live long enough to know the route and source of her TSE. Exactly one year previously, to the day 12/14/96, my neighbor also lost his mother to sporadic CJD. Both of these cases were confirmed. but my neighbor's mother had been taking a nutritional supplement called IPLEX, made by Standard Process Co.

Here is a listing of potentially TSE-tainted tissues:

vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.

The CDC came and took the pills, a few years later, I spoke with the late Dr. Gibbs and NIH/CDC and he told me that those particular pills did not show any infectivity with the testing techniques to date, but he also told me -

1. That the testing techniques at that time may not be sufficient to pick up any 'low-level' infectivity. (so, if accumulation plays into this, this could play a big part).

2. She had been taking these type pills for years, could have been another batch.

There have been other people die of CJD that were taking these type nutritional supplements.

So, my point being, I believe this to warrant a potential risk factor, one not to be ignored, especially in the USA where there are many known TSEs, and where there are many unknowns due to the lack of sufficient TSE testing in USA cattle, and especially since the new findings of Collinge et al, where BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc, the commonest sporadic CJD.

I believe these findings to be of substantial importance:

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

Friday, January 19, 2001

Holiday Inn Bethesda Versailles I and II
8120 Wisconsin Avenue Bethesda, Maryland

2 PARTICIPANTS
Paul W. Brown, M.D., Chairperson
William Freas, Ph.D., Executive Secretary

VOTING MEMBERS
Ermias D. Belay, M.D. David C. Bolton, Ph.D. Donald S. Burke, M.D.
Dean O. Cliver, Ph.D.
Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D. Pedro Piccardo,
M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D. Elizabeth S.
Williams, D.V.M., Ph.D.

VOTING CONSULTANTS
Linda A. Detwiler, D.V.M.
David Gaylor, Ph.D.

Paul R. McCurdy, M.D.
Kenrad E. Nelson, M.D.

NONVOTING CONSULTANT
Susan Leitman, M.D.

GUESTS
Richard Davey, M.D. Louis Katz, M.D.

snip...

page 501

253

1 DR. BOLTON: I have an additional question about
2 that. What is the assurance that additional locally sourced
3 tracheas are not added into that manufacturing process, thus
4 boosting the yield, if you will, but being returned to the
5 U.S. as being produced from U.S.-sourced raw material?
6 DR. McCURDY: Are there data to indicate how many
7 grams, or whatever, of infected brain are likely to infect
8 an organism, either animal or man, when taken orally?
9 DR. BROWN: If I am not mistaken, and I can be
10 corrected, I think a half a gram is enough in a cow, orally;
11 in other words, one good dietary-supplement pill.
12 DR. McCURDY: What I am driving at is the question
13 we are asked is really not do we wish to regulate these
14 things coming in. I think the statements about difficulties
15 in regulating things in the future or near future for new
16 regulations were probably accurate.
17 But I think that we could exhibit some quite
18 reasonable concern about blood donors who are taking dietary
19 supplements that contain a certain amount of unspecified-
20 origin brain, brain-related, brain and pituitary material.
21 If they have done this for more than a sniff or something
22 like that, then, perhaps, they should be deferred as blood
23 donors.
24 That is probably worse than spending six months in
25 the U.K.

1/19/01
3681t2.rtf(845) page 501

http://www.fda.gov/ohrms/dockets/ac/cber01.htm

There has been a Nutritional Supplement mad cow warning letter circulating around since about 1990. Every year they issue the same letter to the manufactures asking them to please be sure they source their products from BSE-FREE countries. but we all know, the statement BSE-FREE, is a joke, especially in the USA. I sat in on the 50 state emergency BSE conference call, (uninvited guest) and I know for a fact the so-called 'pharmaceutical grade' bovine source herds, bovines that were to never be fed ruminant materials, the USA cannot for certain say that indeed these cattle have never ingested ruminant feed, in fact, some probably had.

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr." <flounder@wt.net>
Reply-To: Bovine Spongiform Encephalopathy <BSE-L@uni-karlsruhe.de>
To: BSE-L@uni-karlsruhe.de

Bovine Spongiform Encephalopathy
<BSE-L@UNI-KARLSRUHE.DE>

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 POSTED HERE;

(don't let the url address fool you of it's contents)

http://vegancowboy.org/TSS-part1of8.htm

now to explore more on this issue of TSEs and Nutritional Supplements. please read further;

Suit Filed Over Mad Cow Disclaimer
By Jason Hoppin
The Recorder
March 23, 2001

A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.

The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.

"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.

The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.

"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies the disease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."

No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.

The case was filed in San Francisco Superior Court.

The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.

Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bones and brains, where BSE is most highly concentrated.

Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S. government-inspected facilities.

"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.

The human manifestation of BSE -- variant Creutzfeld-Jakob disease -- has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.

U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.

"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."

However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.

© 2001 law.com Inc. © 1999-2001 NLP IP Company,

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

http://vm.cfsan.fda.gov/~dms/qa-sup5.html

[ Q: ] What is a dietary supplement and how is it regulated?

[ A: ] A dietary supplement is any product taken by mouth that contains a so-called "dietary ingredient" and its label clearly states that it is a dietary supplement.

The "dietary ingredients" in dietary supplements may include vitamins, minerals, herbs, and amino acids as well as substances such as enzymes, organ tissues, metabolites, extracts or concentrates. Dietary supplements can be found in many forms such as pills, tablets, capsules, liquids or powders. They must be identified on the label as a dietary supplement.

How are Dietary Supplements regulated?

The label of a dietary supplement must contain enough information about the composition of the product so that consumers can make informed choices. (The information must be presented in FDA-specified format.) The manufacturer must make sure the label information is truthful and not misleading. The manufacturer is also responsible for making sure that all the dietary ingredients in the supplements are safe. Manufactures and distributors do not need to register with FDA or get FDA approval before producing or selling dietary supplements.

Are advertisements for Dietary Supplements regulated by FDA?

No. The Federal Trade Commission (FTC) handles advertising for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but their work is directed by different laws.

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

U. S. Food and Drug Administration
Email this Page
To a Friend [email a friend]
Center for Food Safety and Applied Nutrition
January 3, 2001
[ ]

Overview of Dietary Supplements

What is a dietary supplement?

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

What is a "new dietary ingredient" in a dietary supplement?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:

* a vitamin,

* a mineral,

* an herb or other botanical,

* an amino acid,

* a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or

* a concentrate, metabolite, constituent or extract.

A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. However, FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?

The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.

There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information on new dietary ingredients, go to: http://www.cfsan.fda.gov/~dms/ds-ingrd.html.

What information must the manufacturer disclose on the label of a dietary supplement?

FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a

"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

Must all ingredients be declared on the label of a dietary supplement?

Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: http://www.cfsan.fda.gov/~lrd/fr97923a.html. Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?

Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

Where can I get information about a specific dietary supplement?

Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.

Who has the responsibility for ensuring that a dietary supplement is safe?

By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?

No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information on claims that can be made for dietary supplements, see (http://www.cfsan.fda.gov/~dms/hclaims.html). How can consumers inform themselves about safety and other issues related to dietary supplements?

It is important to be well informed about products before purchasing them. Because it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase (see previous question "Where can I get information about a specific dietary supplement?"). In addition, to help consumers in their search to be better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information -- http://www.cfsan.fda.gov/~dms/ds-savvy.html (includes information on how to evaluate research findings and health information on-line) and Claims That Can Be Made for Conventional Foods and Dietary Supplements -- http://www.cfsan.fda.gov/~dms/hclaims.html, (provides information on what types of claims can be made for dietary supplements).

What is FDA's oversight responsibility for dietary supplements?

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occaisional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency. Does FDA routinely analyze the content of dietary supplements?

In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?

No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product. Who validates claims and what kinds of claims can be made on dietary supplement labels?

FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.

By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail at the following site: (http://www.cfsan.fda.gov/~dms/hclaims.html). Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.

How are advertisements for dietary supplements regulated?

The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www.ftc.gov/bcp/menu-health.htm . Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service. How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?

If you think you have suffered a serious harmful effect or illness from a product FDA regulates, including dietary supplements, the first thing you should do is contact or see your healthcare provider immediately. Then, you and your health care provider are encouraged to report this problem to FDA.

Your health care provider can call FDA's MedWatch hotline at 1-800-FDA-1088, submit a report by fax to 1-800-FDA-0178 or on-line at: http://www.fda.gov/medwatch/report/hcp.htm. The MedWatch program provides a way for health care providers to report problems believed to be caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements.

You, or anyone, may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any of the above-mentioned products, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or reporting on-line at: http://www.fda.gov/medwatch/report/consumer/consumer.htm . FDA would like to know when you think a product caused you a serious problem, even if you are not sure that the product was the cause, or even if you do not visit a doctor or clinic. In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site.

NOTE: The identity of the reporter and/or patient is kept confidential.

For a general, not serious, complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number: http://www.fda.gov/opacom/backgrounders/complain.html.

For more recent information on Dietary Supplements See http://www.cfsan.fda.gov/~dms/supplmnt.html

http://vm.cfsan.fda.gov/~dms/ds-oview.html

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. T01-09
Print Media: 202-205-4144
February 5, 2001
Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA
FDA ISSUES LETTER TO INDUSTRY ON FOODS CONTAINING BOTANICAL AND OTHER NOVEL INGREDIENTS

The Food and Drug Administration (FDA) recently issued a letter to the food industry restating the requirements of the Federal Food, Drug, and Cosmetic Act regarding the marketing of conventional foods containing novel ingredients, including botanicals. FDA is issuing this letter because of the significant growth in the marketing of foods containing these ingredients.

FDA is concerned that some botanical and other novel ingredients that are being added to conventional foods are neither approved food additives, nor generally recognized as being safe for these uses. This letter serves as a reminder to the industry of the longstanding legal requirements governing conventional food products.

In issuing this letter, FDA is also reminding manufacturers about the legal requirements regarding claims on conventional foods. The Food Drug and Cosmetic Act allows for certain claims such as:

* health claims -- a claim characterizing the relationship between a food substance and a disease or health related condition;

* nutrient content claims -- a claim characterizing the level of a nutrient in a food; and

* structure/function claims -- a claim characterizing the effect of a food on the structure or function of the body.

FDA must review health claims and nutrient content claims prior to marketing, unless the claim has been authorized by regulation or by statute under the authoritative statement notification procedure.

Manufacturers are encouraged to contact the agency regarding the regulatory status of ingredients and claims they intend to use for foods.

http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01070.html

more listings of potential TSE carrying nutritional supplements, only a few of hundreds out there;

IPLEX; (listing only potentially TSE tainted tissues) vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.

also this is another;

Immuplex Ingredients;

Bovine Liver PMG Extract, zinc-iron-copper liver chelate, bovine liver powder, veal bone PMG Extract, ascorbic acid, nutritional yeast, bovine spleen PMG Extract, high selenium yeast, vaccum dried bovine and ovine spleen, bovine thymus PMG Extract, bovine thymus Cytosol Extract, mixed tocopherois, high chromium yeast, pyridoxal 5-phosphate, vitamin A esters, calcium lactate, folic asid and cyanocabalamin.

Two capsules supple 165 mg Bovine Liver PMG Extract, 45 mg Bovine spleen PMG Extract, 40 mg Vacuum Dried Bovine and Ovine Spleen, 35 mg. Bovine Thymus PMG Extract and 35 mg Bovine Thymus Cytosol Extract.

METABOLIFE; Bovine Complex; Glandular system; Ovaries, Prostate, Scrotum and Adrenal (usda cattle) [big deal...tss]

12,500 cattle ever checked for a TSE in the U.S.A. in the 12 year program (to aug. 2001)

in that 12 years, the U.S. has raised 1.5 BILLION head of cattle including calf crop. 100 million in the USA in any given year.

37 MILLION slaughtered annually

190,000 DOWNERS annually

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

Subject: Metabolife
Date: Mon, 7, Dec 1998 14:21:35 -0800
From: Rand Smith <rsmith@metabolife.com>
To: "'flounder@wt.net'" <flounder@wt.net>

Dear Sir,

We are looking at reformulation. I agree that slow virus diseases present a problem in some areas of the world.

Our product uses healthy USDA inspected cattle for the glandular extract.

If you have any links to more information on this subject I would like to examine them.

Thank you for your interest and concern.

Dr. Smith

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

here is the famous yearly token letter from FDA to supplements manufacturer;

Letter to Manufacturers of Biological Products -
Recommendations Regarding Bovine Spongiform
Encephalopathy (BSE)

Department of Health and Human Services
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

April 19, 2000

To Manufacturers of Biological Products

The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.

CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:

1.Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.

2.Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.

3.Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities.

It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephone number 301-734-8364, website address http://www.aphis.usda.gov/ncie, and codified at 9 CFR 94.18 (see attached).

Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:

Dr. David Asher, Office of Blood Research and Review
301-827-3524
Dr. Paul Richman, Office of Vaccines Research and Review
301-827-3070
James Crim, Office of Therapeutics Research and Review
301-827-5101

Thank you for your attention to this matter.

Sincerely,

---- signature ---

Kathryn C. Zoon, Ph.D.
Director
Center for Biologics Evaluation And Research

Attachment

http://www.fda.gov/cber/ltr/bse041900.htm

1992 copy of token TSE nutritional supplement letter to manufacturers;

http://www.vegsource.com/talk/lyman/messages/7318.html

also, you can go to this FDA dockets page, and skroll down until you see EMC 597 'Terry S. Singeltary Sr.' highlighted in blue. this also has some very interesting information. It is a PDF file;

http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/030100.htm

another thing most disturbing, the USA imports supplements with SRMs from known BSE countries. and if you don't think scrapie or CWD can transmit to man as easily or as difficult as BSE (depends whom you have watched suffer and die from this horrible disease) well, i would like to see this proof of this (transmission studies only). but let us not forget the potential threat of BSE in sheep.

another fine example;

snip...

In fact, the salesman now tells us he doesn't sell the machines anymore. But the quest for youth goes beyond facial creams and exotic contraptions, anti-agers are also ingesting some pretty wild-sounding dietary supplements. "Live proteins from sheep and pig from France, processed," says a representative.

Life-Cell Technologies touts the benefits of supplements that contain processed pig and sheep organs. "I have a lot of body builders and professional athletes that use these products because they strengthen and stimulate the different glands and organs," says one woman. The idea, she implied, often is that ingesting ground up animal organs will strengthen human organs or even cure thyroid and adrenal diseases. "To my knowledge you can't just take pulverzied organs and feed them to somebody and think they're not going to have thyroid disease anymore or hypo-adrenalism," says Dr. Wexler. It would be kind of a medical miracle, wouldn't it? "It would be amazing, truly amazing," says Dr. Wexler. "Dateline" attended another anti-aging conference and expo in Chicago - this time with our cameras in plain view.

Remember the exhibitor selling processed pig and sheep organs? We pressed her for scientific documentation. We asked, what is the science behind the idea? The woman tells us, "You would have to go on the Internet and get information, scientific studies." But this is her company, isn't it? "Yes it is," she says. "And if you don't mind, I don't want to be interviewed. I don't."

"Dateline" tells her, "They are simple questions that any consumer would ask." Everywhere "Dateline" went at the anti-aging expo we heard a lot about so-called "scientific studies." "Well, it comes from 3,000 studies," a man at the expo tells us.

At one booth the product is called transfer factor, and the active ingredient is colostrum - the potent pre-milk fluid in a lactating mother's breast.

"We actually filtrate the transfer factor out of the colostrum," says one man. From where, mothers? "No," the man tells us. "From bovine colostrum, from cows."

http://www.msnbc.com/news/550100.asp?cp1=1

i don't expect this to get published. i am nobody, i am no doctor and i have no PhDs. but i thought this data most important, and i was most concerned that no mention of this potential route of TSEs were not mentioned in your fine article...

CJD WATCH

http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm

thank you,
kindest regards,

i am sincerely,

Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
<flounder@wt.net>

CJD WATCH

http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm

MADCOW DISEASE WITH TERRY S. SINGELTARY SR.

http://www.vegsource.com/talk/madcow/index.html

TSS
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