From: Terry S. Singeltary Sr.
Sent: Tuesday, March 19, 2013 2:46 PM
To: gomezj@gao.gov
Subject: GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have
Opportunities to Expand Its Use of Reported Health Problems to Oversee
Product
GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to
Expand Its Use of Reported Health Problems to Oversee Products
Highlights of GAO-13-244, a report to congressional requesters
March 2013
DIETARY SUPPLEMENTS
FDA May Have Opportunities to Expand Its Use of Reported Health Problems to
Oversee Products
Why GAO Did This Study
Dietary supplements, such as vitamins and botanical products, are a
multibillion dollar industry; national data show that over half of all U.S.
adults consume them. FDA regulates dietary supplements and generally relies on
postmarket surveillance, such as monitoring AERs, to identify potential
concerns. Since December 2007, firms receiving a serious AER have had to report
on it to FDA within 15 days. In January 2009, GAO reported that FDA had taken
several steps to implement AER requirements and had recommended actions to help
FDA identify and act on safety concerns for dietary supplements. GAO was asked
to examine FDA’s use of AERs in overseeing dietary supplements. This report
examines the (1) number of AERs FDA has received since 2008, their source, and
types of products identified; (2) actions FDA has taken to ensure that firms are
complying with AER requirements; (3) extent to which FDA is using AERs to
initiate and support its consumer protection efforts; and (4) extent to which
FDA has implemented GAO’s 2009 recommendations. GAO analyzed FDA data, reviewed
FDA guidance, and interviewed FDA officials.
What GAO Recommends
GAO recommends, among other things, that FDA explore options to obtain
poison center data, if determined to be useful; collect information on how it
uses AERs; provide more information to the public about AERs; and establish a
time frame to finalize guidance related to GAO’s 2009 recommendations. FDA
generally concurred with each of GAO’s recommendations.
What GAO Found
From 2008 through 2011, the Department of Health and Human Services’ Food
and Drug Administration (FDA) received 6,307 reports of health problems—adverse
event reports (AER)—for dietary supplements; 71 percent came from industry as
serious adverse events as required by law, and most of these AERs were linked
with supplements containing a combination of ingredients, such as vitamins and
minerals or were otherwise not classified within FDA’s product categories.
However, FDA may not be receiving information on all adverse events because
consumers and others may not be voluntarily reporting these events to FDA,
although they may be contacting poison centers about some of these events. From
2008 to 2010, these centers received over 1,000 more reports of adverse events
linked to dietary supplements than did FDA for the same period. FDA officials
said that they are interested in determining whether the poison center data
could be useful for their analysis and have held discussions with American
Association of Poison Control Centers representatives, but cost is a factor.
To help ensure firms are complying with AER requirements (i.e., submitting
serious AERs, maintaining AER records, and including firms’ contact information
on product labels), FDA increased its inspections of supplement firms and took
some actions against noncompliant firms. Specifically, FDA increased firm
inspections from 120 in 2008 to 410 from January 1 to September 30, 2012. Over
this period, FDA took the following actions: 3 warning letters, 1 injunction,
and 15 import refusals related to AER violations, such as not including contact
information on the product label or submitting a serious AER.
FDA has used AERs for some consumer protection actions (e.g., inspections
and warning letters) but may be able to expand their use. FDA officials said
that most AERs do not initiate or support such actions because it is difficult
to establish causality between the product and the health problem based on the
limited information in an AER. However, FDA does not systematically collect
information on how it uses AERs for consumer protection actions; by collecting
this information, it may be able to assess whether AERs are being used to their
fullest extent. In addition, FDA is not required to provide information to the
public about potential safety concerns from supplement AERs as it does for
drugs. Making such information public, if consistent with disclosure provisions
in existing law, could expand FDA’s use of AERs and improve consumer awareness
and understanding of potential health events associated with dietary
supplements.
FDA has partially implemented all of GAO’s 2009 recommendations, such as
issuing guidance for new dietary ingredients, clarifying the boundary between
dietary supplements and conventional foods, and expanding partnerships to
improve consumer understanding. Specifically, FDA developed draft guidance in
2009, 2011, and 2012 to address three GAO recommendations about dietary
supplement oversight and formed new partnerships to conduct consumer outreach.
However, FDA has not issued final guidance in two cases. FDA officials said that
they plan to complete implementation, but they have provided no time frame to do
so. With final guidance in place, firms may be able to make more informed
product development and marketing decisions, which could ultimately reduce FDA’s
enforcement burden in these areas.
full report ;
PRAISE THE LORD, MIRACLES DO HAPPEN !
THANK YOU !
GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to
Expand Its Use of Reported Health Problems to Oversee Products
GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to
Expand Its Use of Reported Health Problems to Oversee Products TSS SUBMISSION
FOR THE FOLLOWING REASONS, I FULLY support stringent regulations on
nutritional supplements, especially with SRM materials against the TSE prion aka
mad cow type disease.
WE now know that more tissues are potential carriers of the TSE prion agent
than originally thought to have, especially with the atypical BASE L-type BSE.
IN this case, I think that all animal tissue should be banned from
nutritional supplements.
there is no safe dose for prion disease ;
Wednesday, August 24, 2011
*** There Is No Safe Dose of Prions
Monday, February 01, 2010
Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and
Cosmetics
snip...
1998 MY SUBMISSION TO THE BSE INQUIRY ENGLAND
Sender: "Patricia Cantos"
To: "Terry S Singeltary Sr. (E-mail)"
Subject: Your submission to the Inquiry
Date: Fri, 3 Jul 1998 10:10:05 +0100
3 July 1998 Mr Terry S Singeltary Sr. E-Mail: Flounder at wt.net Ref: E2979
Dear Mr Singeltary,
Thank you for your E-mail message of the 30th of June 1998 providing the
Inquiry with your further comments. Thank you for offering to provide the
Inquiry with any test results on the nutritional supplements your mother was
taking before she died.
As requested I am sending you our general Information Pack and a copy of
the Chairman's letter. Please contact me if your system cannot read the
attachments. Regarding your question, the Inquiry is looking into many aspects
of the scientific evidence on BSE and nvCJD. I would refer you to the
transcripts of evidence we have already heard which are found on our internet
site at http://www.bse.org.uk. Could you
please provide the Inquiry with a copy of the press article you refer to in your
e-mail? If not an approximate date for the article so that we can locate it? In
the meantime, thank you for you comments. Please do not hesitate to contact me
on 0171 261 8332 should you have any queries.
Yours sincerely Patricia Cantos Families Team Leader Attachments TSS
==============
My neighbors Mom also died from CJD. She had been taking a nutritional
supplement which contained the following; vacuum dried bovine BRAIN, bone meal,
bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine
kidney, and vacuum dried porcine stomach. As I said, this woman taking these
nutritional supplements, died from CJD. The particular batch of pills that was
located, in which she was taking, was tested. From what I have heard, they came
up negative, for the prion protein. But, in the same breath, they said their
testing, may not have been strong enough to pick up the infectivity. Plus, she
had been taking these type pills for years, so, could it have come from another
batch?
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
snip...see full text ;
snip...
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 (http://www.google.com)/
searching for mad cow disease. If you have any questions for
Terry Singeltary write or e-mail
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000096/!x-usc:mailto:theleaguecitynews@aol.com
and we will forward them to him.
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; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf
snip...
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 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 T
o: 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
########
snip...see full text ;
Volume 15, Number 5—May 2009
Research
Chronic Wasting Disease Prions in Elk Antler Velvet
see full text ;
Tuesday, March 5, 2013
Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening
of the Comment Period FDA-2004-N-0188-0051 (TSS SUBMISSION)
FDA believes current regulation protects the public from BSE but reopens
comment period due to new studies
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 telephonenumber 301-734-8364, website addresshttp://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,
Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And
Research
Attachment
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."
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 theactive
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
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.
snip...
"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.
Angesichts langjähriger Versäumnisse sei die Reaktion der Behörden
"beängstigend langsam", rügen Verbraucherschutzgruppen wie das Ärztekomitee für
verantwortliche Medizin. Sein Präsident Neal Barnard fordert: "Wir sollten von
den Fehlern der Europäer lernen und strikte Vorsichtsregeln verhängen."
snip...
see full text pdf article ;
vCJD in the USA * BSE in U.S.15 November 1999
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?
----- Original Message ----- From: Terry S. Singeltary Sr.
Cc: FDA-DSFL@vm.cfsan.fda.gov ; Amy.Odegaard@fda.hhs.gov ;
Kathleen.Smith1@fda.hhs.gov ; Diane.Schmit@fda.hhs.gov
Sent: Saturday, September 16, 2006 12:46 PM
Subject: NUTRITIONAL SUPPLEMENTS and USA MAD COW STRAINS TYPICAL AND
ATYPICAL AND CJD
Greetings FDA list serve,
WHEN is the fda going to get tough on these nutritional supplements that
still contain potential TSE agent that could cause CJD. after years and years of
complaining about bovine brain in the standard process IPLEX supplements, they
finally sometime recently changed this from bovine brain to porcine brain, but
what about all the human guinea pigs that did take these supplements IPLEX, when
it did contain bovine brain? i suppose they are just walking 'case studies' for
a long incubating disease i.e. USA strain of human bovine TSE, dare i say BSE or
BASE? BUT, if we look at the total ingredient list just for IPLEX, it is still a
potential supplement for mad cow disease i.e. CJD of whatever phenotypes that
exist in the USA and all of North America.
right, we dont have mad cow disease in the USA and all CJD in USA is
spontaneous, and mission accomplished in Iraq.
FACT is sCJD in the USA has tripled in the past few years or so, and we now
have unknown strains in the USA;
snip...
you must NOT continue to ignore this! please..........
IPLEX R
Proprietary Blend: 967 MG Arrowroot flour, inositol, calcium lactate,
porcine eye PMG™ extract, phosphoric acid, dried buckwheat (leaf) juice,
buckwheat (seed), veal bone PMG™ extract, carrot (root), bovine liver, magnesium
citrate, porcine stomach, choline bitartrate, nutritional yeast, bovine adrenal,
defatted wheat (germ), alfalfa flour, bovine kidney, dried alfalfa juice,
allantoin, mushroom, manganese glycerophosphate, bovine adrenal Cytosol™
extract, porcine brain, bovine bone, dl-methionine, oat flour, soybean lecithin,
veal bone, mixed tocopherols (soy), carrot oil, and peanut (bran).
HERE IS OLD INGREDIENT LIST FOR IPLEX ;
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
IF you go to Standard Process FAQ page, the very first question and answer
is a lie ;
Where do the bovine organs used in the supplements come from?
We purchase animal tissues and glands only from facilities inspected by the
U.S. Food and Drug Administration, U.S. Department of Agriculture, and state
departments of agriculture. The USDA will not allow the import of bovine
materials from BSE infected countries.
IT seems Standard Process uses the excuse of USDA stamp of approval, and we
all know that this stamp of approval is nothing more than a stamp of lies and
deciet, proven time and time again by the OIG ;
MORE LIES HERE ;
When Standard Process received the FDA's November 1992 letter to dietary
supplement manufacturers regarding BSE and imports, the company promptly
instituted further procedures to assure that its USDA inspected suppliers were
aware of and adhering to the FDA's advice not to use bovine materials from BSE
affected countries. Standard Process was inspected by the FDA with respect to
this issue and the FDA was satisfied that the company had proper procedures in
place.
TRY telling this to my old neighbors mother, whom died after taking IPLEX
for years of CJD on 12-14-96 CONFIRMED. oddly enough exactly one year later, to
the day, my mother died from the Heidenhain Variant of CJD, also CONFIRMED.
There have been other instances where victims of CJD were taking supplements
that could carry the 100% lethal agent of TSE in the USA, that died from CJD.
coincidence or source? until this agent can be destroyed by standard process,
until this TSE agent can be detected in standard process and other supplement
products, the following rule should be repealed, and a ban on all tissues and
organs from any species that has been documented to have a TSE should be
implemented immediately. ...
FOR IMMEDIATE RELEASE Media Inquiries: Michael Herndon P05-58 301-827-6242
September 6, 2005 Consumer Inquiries: 888-INFO-FDA
FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in
Human Food and Cosmetics"
The U.S. Food and Drug Administration today published several amendments to
the July 2004 interim final rule, "Use of Materials Derived from Cattle in Human
Food and Cosmetics," that will allow the use of certain cattle-derived material
in human foods and cosmetics.
The rule prohibits the use of cattle-derived materials that can carry the
infectious agent for bovine spongiform encephalopathy (BSE), or mad cow disease,
in human foods, dietary supplements, and in cosmetics. Based on the scientific
information provided during the interim final rule's comment period, which
demonstrates that a part of the cow's digestive tract called the distal ileum
can be consistently and effectively removed from the other sections of the small
intestine, it is no longer necessary to designate the entire small intestine as
a prohibited cattle material.
As a result, FDA is amending the rule to allow use of the small intestine
in human food and cosmetics, provided that the distal ileum has been removed.
The U.S. Department of Agriculture is publishing today a similar amendment to
its interim final rule on BSE.
The amendments also clarify that milk and milk products, hides and
hide-derived products, and tallow derivatives are not prohibited for use in
human food and cosmetics.
Finally, FDA has reconsidered the recommended method for determining
insoluble impurities in a type of solid fat known as tallow, in response to
information submitted to the agency, to cite a method that is less costly to use
and requires less specialized equipment.
FDA issued the interim final rule to minimize human exposure to materials
that studies have demonstrated are highly likely to contain the BSE agent in
cattle with the disease. The amended interim final rule provides the same level
of protection against the agent that causes BSE as the original provisions.
The amendments to the interim final rule are effective on October 7, 2005
and comments are being are accepted on the amendments through November 7, 2005.
###
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.
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. http://www.organicconsumers.org/Organic/dietsupp.cfm
(accessed Feb 20, 2002).
snip...end tss letter to fda.
===================
Thursday, February 14, 2013
The Many Faces of Mad Cow Disease Bovine Spongiform Encephalopathy BSE and
TSE prion disease
Saturday, December 15, 2012
Bovine spongiform encephalopathy: the effect of oral exposure dose on
attack rate and incubation period in cattle -- an update 5 December 2012
2012
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases
constitute an unforeseen first threat that could sharply modify the European
approach to prion diseases.
Second threat
snip...
MAD COW USDA ATYPICAL L-TYPE BASE BSE, the rest of the story...
***Oral Transmission of L-type Bovine Spongiform Encephalopathy in Primate
Model
***Infectivity in skeletal muscle of BASE-infected cattle
***feedstuffs- It also suggests a similar cause or source for atypical BSE
in these countries.
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans.
The present study demonstrated successful intraspecies transmission of
H-type BSE to cattle and the distribution and immunolabeling patterns of PrPSc
in the brain of the H-type BSE-challenged cattle. TSE agent virulence can be
minimally defined by oral transmission of different TSE agents (C-type, L-type,
and H-type BSE agents) [59]. Oral transmission studies with H-type BSEinfected
cattle have been initiated and are underway to provide information regarding the
extent of similarity in the immunohistochemical and molecular features before
and after transmission.
In addition, the present data will support risk assessments in some
peripheral tissues derived from cattle affected with H-type BSE.
2012 CALIFORNIA ATYPICAL L-TYPE BASE BSE MAD COW, SPONTANEOUS AND FEED $$$
Saturday, May 26, 2012
Are USDA assurances on mad cow case 'gross oversimplification'?
SNIP...
What irks many scientists is the USDA’s April 25 statement that the rare
disease is “not generally associated with an animal consuming infected feed.”
The USDA’s conclusion is a “gross oversimplification,” said Dr. Paul Brown,
one of the world’s experts on this type of disease who retired recently from the
National Institutes of Health. "(The agency) has no foundation on which to base
that statement.”
“We can’t say it’s not feed related,” agreed Dr. Linda Detwiler, an
official with the USDA during the Clinton Administration now at Mississippi
State.
In the May 1 email to me, USDA’s Cole backed off a bit. “No one knows the
origins of atypical cases of BSE,” she said
The argument about feed is critical because if feed is the cause, not a
spontaneous mutation, the California cow could be part of a larger outbreak.
SNIP...
in the url that follows, I have posted
SRM breaches first, as late as 2011.
then
MAD COW FEED BAN BREACHES AND TONNAGES OF MAD COW FEED IN COMMERCE up until
2007, when they ceased posting them.
then,
MAD COW SURVEILLANCE BREACHES.
Friday, May 18, 2012
Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy
(BSE) in the United States Friday May 18, 2012
Wednesday, May 30, 2012
PO-028: Oral transmission of L-type bovine spongiform encephalopathy
(L-BSE) in primate model Microcebus murinus
1997 USDA/FDA MAD COW BSE PARTIAL AND VOLUNTARY MAD COW FEED BAN...10 YEARS
LATER ;
2007
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
snip...please see full text;
Saturday, December 15, 2012
Bovine spongiform encephalopathy: the effect of oral exposure dose on
attack rate and incubation period in cattle -- an update 5 December 2012
Thursday, February 21, 2013
National Prion Disease Pathology Surveillance Center Cases Examined January
16, 2013
Monday, January 14, 2013
Gambetti et al USA Prion Unit change another highly suspect USA mad cow
victim to another fake name i.e. sporadic FFI at age 16 CJD Foundation goes
along with this BSe
Monday, December 31, 2012
Creutzfeldt Jakob Disease and Human TSE Prion Disease in Washington State,
2006–2011-2012
Tuesday, December 25, 2012
CREUTZFELDT JAKOB TSE PRION DISEASE HUMANS END OF YEAR REVIEW DECEMBER 25,
2012
Friday, November 23, 2012
sporadic Creutzfeldt-Jakob Disease update As at 5th November 2012 UK, USA,
AND CANADA
Tuesday, March 19, 2013
Alzheimer's Association 2013 Alzheimer's Disease Facts and Figures
Today, an American develops Alzheimer's disease every 68 seconds. In 2050,
an American will develop the disease every 33 seconds.
layperson
Terry S. Singeltary Sr.
P.O. Box
Bacliff, Texas USA 77518
From: OIGHotline
Sent: Friday, March 29, 2013 2:40 PM
Subject: RE: GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May
Have Opportunities to Expand Its Use of Reported Health Problems to Oversee
Product
RE: GIMS
#13-0229
GAO’s Office of Inspector General (OIG) has received your
email to our hotline. Your case has been assigned the following GIMS Case
#13-0229. Please refer to the GIMS case number when communicating with our
office.
From: Terry S. Singeltary
Sr. [mailto:flounder9@verizon.net]
Sent: Tuesday, March 19, 2013 3:47 PM
To: Gomez, Jose (Alfredo)
Cc: Siggerud, Katherine A; Young, Charles; OIGHotline
Subject: GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Product
Sent: Tuesday, March 19, 2013 3:47 PM
To: Gomez, Jose (Alfredo)
Cc: Siggerud, Katherine A; Young, Charles; OIGHotline
Subject: GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Product
GAO-13-244, Mar 18,
2013 Dietary Supplements FDA May Have Opportunities to Expand Its Use of
Reported Health Problems to Oversee Products
Highlights of
GAO-13-244, a report to congressional requesters
snip...end...tss
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