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From: TSS ()
Subject: Nutritional Supplements and TSEs i.e. MAD COW disease's BSE/BASE and CJDs
Date: February 9, 2007 at 11:03 am PST

Nutritional Supplements and TSEs i.e. MAD COW disease's BSE/BASE and CJDs


GREETINGS,

I thought some of you might find interest in this data about nutritional supplements and Transmissible Spongiform Encephalopathies.
NOPE, these manufactures probably did not tell you all about this. TSEs like CJD can be of long incubation, if you are lucky. I doubt if all of you knew some of these by-products were even in these supplements. well, now you do.................TSS


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.
http://www.organicconsumers.org/Organic/dietsupp.cfm
(accessed Feb
20, 2002).


http://www.thelancet.com/journals/lancet/article/PIIS0140673603132072/fulltext


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


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;

i will only list animal ingredients of the
following Nutritional Supplements by only
ONE company;

Standard Process Co.

IPLEX;
bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder,
vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried
bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal,
vacuum dried veal bone.

A-FBetafood R
vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine
kidney, bovine orchic glandular extract, bovine liver fat extract.

Arginex R
bovine liver powder.

Adrenal, Desiccated TM
Vacuum dried bovine adrenal.

Albaplex R
bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney PMF
Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal,
vacuum dried bovine kidney, veal bone meal.

Allerplex TM
bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat
extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried
veal bone.

Immuplex R
Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract,
bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine
thymus PMF Extract, bovine thymus Cytosol Extract.

Vasculin R
Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder,
vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum
dried bovine and ovine spleen.

Zypan R
bovine pancreas Cytosol Extract, vacuum dried bovine and ovine spleen.

last i heard, they were getting sued;

Suit Filed Over Mad Cow Disclaimer

By Jason Hoppin
The Recorder
March 23, 2001

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

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

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

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

"It's probably loosely referred to as research," deadpanned Jan
Novakofski, a University of Illinois researcher who studies 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.
=======================
Supplements Association Moves to Eliminate
Bovine Parts From Products


WASHINGTON (Reuters Health) Mar 16 - The nation's largest dietary
supplements industry group has issued new guidance to manufacturers amid
concerns that some alternative health products containing bovine
materials pose a risk of transmitting bovine spongiform encephalopathy
(BSE) to humans.

The guidance, published by the National Nutritional Foods Association
(NNFA), encourages manufacturers to eliminate all neurological bovine
materials
from their products. Consumption of brains and spinal cords from cows
infected with
BSE are widely believed to be the source of new variant Creutzfeldt-Jakob
disease (vCJD) in humans........

snip... full text at;

http://id.medscape.com/

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


better late than never, but leaving regulation up to the industry, will
be like telling the wolf to guard the hen house. allowing that to happen
with some pathogens is one thing, but we better think twice about
human/animal TSE's. This same letter has been around for ten years with
nobody taking heed to the potential dangers...TSS


How serious is this bit of deregulation? Here's what Dr. Lurie told the
Senators:"For BSE (mad cow disease), this means that an unscrupulous
manufacturer could literally take a British cow brain, crush it, dry it
out, formulate it into a dietary supplement and export it to the U.S."

http://commerce.senate.gov/hearings/0404lur.PDF

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 ourcameras 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 (url now dead...tss)


AS you can see below, i was trying to warn the public of this potential and highly likely route of TSE via nutritional supplements years before the above people were. THESE folks have PhDs, so maybe someone will listen now, maybe not $$$

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

http://www.organicconsumers.org/madcow/pill6101.cfm


http://www.islandveg.com/publications/newsletters/01fall.pdf

GERMAN DER SPIEGEL MAGAZINE

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

http://www.spiegel.de/spiegel/0,1518,119306,00.html


MAD COW DISEASE AND NUTRITIONAL SUPPLEMENTS...



Subj: cjd/bse aka MADCOW DISEASE in the U.S.A., please let me count the ways...

Date: 31/07/00 17:51:30 GMT Daylight Time


SOMETHING TO CHEW ON

http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2

In reading the recent article in the BMJ about the potential BSE tests being developed in the U.S. and Bart Van Everbroeck reply. It does not surprize me, that the U.S. has been concealing vCJD. There have been people dying from CJD, with all the symptoms and pathological findings that resemble U.K. vCJD for some time. It just seems that when there is one found, they seem to change the clerical classification of the disease, to fit their agenda. I have several autopsies, stating kuru type amyloid plaques, one of the victims was 41 years of age. Also, my Mom died a most hideous death, Heidenhain Variant Creutzfeldt Jakob disease. Her symptoms resemble that of all the U.K. vCJD victims. She would jerk so bad at times, it would take 3 of us to hold her down, while she screamed "God, what's wrong with me, why can't I stop this." 1st of symptoms to death, 10 weeks, she went blind in the first few weeks. But, then they told me that this was just another strain of sporadic CJD. They can call it what ever they want, but I know what I saw, and what she went through.

Sporadic, simply means, they do not know. My neighbors Mom also died from CJD. She had been taking a nutritional supplement which contained the following; vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. As I said, this woman taking these nutritional supplements, died from CJD. The particular batch of pills that was located, in which she was taking, was tested. From what I have heard, they came up negative, for the prion protein. But, in the same breath, they said their testing, may not have been strong enough to pick up the infectivity. Plus, she had been taking these type pills for years, so, could it have come from another batch?

snip...end


http://www.freedomtocare.org/page142.htm

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


http://www.rense.com/general34/evidenBSE.htm


Scrapie (Mad Sheep Disease) May Pose a Risk to Humans
From New Scientist magazine (UK) Online News March 28, 2001

Suspect symptoms


What if you can catch old-fashioned CJD by eating meat from a sheep infected
with scrapie?


Exclusive from New Scientist magazine

http://www.organicconsumers.org/meat/scrapiecjd.cfm



Singeltary suspected an environmental cause in his mother's demise, a feeling reinforced a year later when a neighbor died of sporadic CJD. For years, the neighbor had been taking nutritional supp- lements that contained cow brain extracts.

"The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Assoc- iation 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 supp- lements before consuming them.

Health-care providers and the more than 100 million Americans who consume these products should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products."

Animal ingredients of Nutritional Supplements by only ONE company;

Standard Process Co.

IPLEX;

bovine EYE PMG Extract, veal bone PMG Extract, bovine liver powder, vaccuum dried porcine stomach, vacuum dried bovine adrenal, vacuum dried bovine kidney, bovine adrenal, vacuum dried BOVINE BRAIN, bone meal,vacuum dried veal bone.

A-FBetafood R

vacuum dried bovine prostate, bovine liver powder, vacuum dried bovine kidney, bovine orchic glandular extract, bovine liver fat extract.

Arginex R

bovine liver powder, Adrenal, Desiccated TM, Vacuum dried bovine adrenal.

Albaplex R

bovine liver PMG Extract, vacuum dried bovine adrenal, bovine kidney

PMF Extract, bovine thymus Cytosol Extract, bovine liver powder, bone meal, vacuum dried bovine kidney, veal bone meal.

Allerplex TM

bovine lung PMF Extract, bovine adrenal PMF Extract, bovine liver fat extract (yakriton), bone meal, vacuum dried bovine kidney, vacuum dried veal bone.

Immuplex R

Bovine liver PMG Extract, bovine liver powder, veal bone PMF Extract, bovine spleen PMF Extract, vacuum dried bovine and ovine spleen, bovine thymus PMF Extract, bovine thymus Cytosol Extract.

Vasculin R

Bovine Heart PMG Extract, veal bone PMF Extract, bovine liver powder, vacuum dried porcine duodenum, bovine adrenal Cytosol Extract, vacuum dried bovine and ovine spleen.

WASHINGTON (Reuters Health) Mar 16 2001 - The nation's largest dietary supplements industry group has issued new guidance to manufacturers amid concerns that some alternative health products containing bovine mate- rials pose a risk of transmitting bovine spongiform encephalopathy (BSE) to humans.

The guidance, published by the National Nutritional Foods Association (NNFA), encourages manufacturers to eliminate all neuro- logical bovinematerials from their products. Consumption of brains and spinal cords from cows infected with BSE are widely believed to be the source of new variant Creutzfeldt-Jakob disease (vCJD) in humans.

We hope that the above data informs, but not overwhelms, the reader. For the technically literate there are numerous articles and links available via. www.google.com searching for mad cow disease. If you have any questions for

Terry Singeltary write or e-mail theleaguecitynews@aol.com and we will forward them to him.

http://www.organicconsumers.org/madcow/supplements11004.cfm

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...

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; 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. 254 1 DR. BROWN: That is exactly right. I think that 2 is why the discussion has apparently been on things that are 3 not directly related to these questions because, in order to 4 think about deferrals for blood donors who are taking 5 dietary supplements with things like bovine brain in them, 6 it is very important that we know that those products are 7 safe. 8 I think we have heard enough to suggest that they 9 may not be. 10 DR. McCURDY: There is one other item that needs 11 to be considered and that is what proportion of blood donors 12 are doing this; that is, how many blood donors would you 13 lose, and I don't know what the demographics--there is 14 fairly good information on the demography of blood donors. 15 I have no idea what the demography of people who take these 16 supplements is. Maybe they are old men like me and aren't 17 going to be blood donors anymore. 18 DR. BROWN: The wording of the question is not as 19 demanding as the wording of other deferral questions; that 20 is, the question here is consider recommending. We are 21 not even recommending at this point. We are saying to the 22 FDA, please think about this. It is worth thinking about. 23 DR. DETWILER: One point about brain from Europe, 24 and Jean Philippe is still here, those are considered 25 specified risk material and it is not correct to be 255 1 incinerated; correct? Or destroyed? Brain and spinal cord 2 and other high-risk tissues in Europe? 3 DR. NORTON: In tomorrow morning's British Medical 4 Journal, which has appeared on-line today, there is an 5 article called U.S. Takes Precautions against BSE. One 6 paragraph says, Even though the U.S. and U.K. governments 7 ban the practice of feeding cattle products to cows, in the 8 early 1990s, some U.K. renderers continued to manufacture 9 and ship contaminated meat and bonemeal around the world. 10 British export statistics show that thirty-seven tons of 11 meal made from offal was sent to the United States in 1997, 12 well after the U.S. government banned imports of such risky 13 meat. The ultimate use of these imports has not been 14 identified. 15 That will appear tomorrow morning. 16 DR. DETWILER: That actually was in The New York 17 Times. That is a direct quote out of The New York Times 18 article. We called the reporter on that. That statement, 19 the thirty-seven tons, was taken out of the U.S. 20 Geographical BSE Risk Assessment. What they didn't put in 21 there, in the statement, was the remainder of the GBR is at 22 that time, the big labeling for that category in the U.K., 23 because it was illegal for them to ship it to us from their 24 own regs. It is illegal for us to get that. 25 We did go and try and trace that so that wasn't [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf http://www.fda.gov/ohrms/dockets/ac/cber01.htm


snip...


http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm


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').

http://www.fda.gov/OHRMS/DOCKETS/AC/01/slides/3681s2_09.pdf

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.
>
> http://www.gao.gov/cgi-bin/getrpt?GAO-03-494
> http://www.gao.gov/highlights/d03494high.pdf
>
> -------- 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.
>
> http://www.gao.gov/cgi-bin/getrpt?GAO-03-494
> http://www.gao.gov/highlights/d03494high.pdf
>
> GREETINGS GAO:
>
> i was suprised 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...
> ===============================
> Sender: "Patricia Cantos"
> To: "Terry S Singeltary Sr. (E-mail)"
> Subject: Your submission to the Inquiry
> Date: Fri, 3 Jul 1998 10:10:05 +0100
>
> 3 July 1998
> Mr Terry S Singeltary Sr.
> E-Mail: Flounder at wt.net
> Ref: E2979
>
> Dear Mr Singeltary,
>
> Thank you for your E-mail message of the 30th of June 1998 providing the
> Inquiry with your further comments. Thank you for offering to provide the
> Inquiry with any test results on the nutritional supplements your
> mother was taking before she died.
>
> As requested I am sending you our general Information Pack and a copy of the
> Chairman's letter. Please contact me if your system cannot read the attachments.
>
> Regarding your question, the Inquiry is looking into many aspects of the
> scientific evidence on BSE and nvCJD. I would refer you to the
> transcripts
> of evidence we have already heard which are found on our internet site at
> http://www.bse.org.uk. Could you please provide the Inquiry with a
> copy of
> the press article you refer to in your e-mail? If not an approximate date
> for the article so that we can locate it?
> In the meantime, thank you for you comments. Please do not hesitate to
> contact me on 0171 261 8332 should you have any queries.
>
> Yours sincerely
> Patricia Cantos
> Families Team Leader
> Attachments
> TSS
> ==============
> -------- 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 ########


18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf


PAUL BROWN M.D.

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf


9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf

Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm

Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm


03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf


03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf


Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf


In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf


Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518




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