Wednesday, March 20, 2013

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



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


 
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
 
 
 
 
 
 
 
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."
 
 
 
 
 
 
 
 
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
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
 
Posted by at No comments:

VETS have discovered 57 tonnes of banned British mutton in the freezers of meat products firm Spanghero – and raised fears of a new BSE scare

Meat firm stored banned mutton




March 19, 2013




VETS have discovered 57 tonnes of banned British mutton in the freezers of meat products firm Spanghero – and raised fears of a new BSE scare just weeks after the horse-meat scandal. The mutton is banned because it is mechanically separated meat which can contain fragments of bone and bone marrow. It was banned for sheep, cattle and goats because of the risk of “prion” protein contamination – the cause of mad cow disease in cattle and scrapie in sheep. Vets found the mutton at the Spanghero warehouses in Castelnaudary and confirmed the result of tests to prosecutors at Carcassonne and the public health department in Paris. It is not yet known if any of the meat has been used in products sold to the public. A fraud investigation will be started as the meat is said to have come from the same Dutch supplier as supplied Spanghero with 750 tonnes of horse meat. Spanghero boss Barthélémy Aguerre told RTL this morning “once again we have been deceived by a supplier”. The company has launched a court action in Paris saying it had been defrauded.











Banned British mutton seized in France




Fifty seven tons of banned British mutton have been seized at a French factory already implicated in the horse meat scandal, health inspectors announced yesterday.



Veterinary scientists said that the meat was “mechanically separated”, a process of extracting it from the bone that is banned in Europe since 2001 and in the UK since April last year.



The ban of mechanically separated beef and mutton came in the wake of the bovine spongiform encephalopathy (BSE), or Mad Cow Disease crisis. This extraction process is still permitted for poultry and pork if labelled as such.



The 57 tons of banned mutton were found at the Spanghero factory in Castelnaudary, near Toulouse, southwestern France.



Spanghero today blamed unnamed British exporters for trying to pass off the illegal meat as bona fide mutton which could be used in sausages and other products.



Spanghero has already been found guilty of knowingly handling horse meat from Romania labeled as beef which ultimately ended up on supermarket shelves in the UK.



Antoine Leroy, the prosecutor of Carcassonne, said the mutton could potentially pass diseases into the human food chain.



“The process and the sale of such meat is banned in Europe’, said Mr Leroy, adding that an analysis was carried out by the Directorate of Veterinary Services in Paris. The same body last month conducted tests on horse meat masquerading as beef. As a precautionary measure all products that may contain the banned mutton have been recalled, said food minister Guillaume Garot. It is not known whether any of the mutton had reached the shop floor.



Spanghero, which employs 300 people, is already facing criminal action over its part in the horse meat scandal.



It was temporarily shut down by the French government for fraudulently selling 750 tons of horse as beef. But under union pressure to save jobs in a time of economic gloom, the agriculture ministry then controversially allowed it to reopen.



Barthelemy Aguerre, the CEO of Spanghero, said that his company had “once again been fooled by our supplier.”



"Spanghero will not be convicted for this in the courts. This meat should quite simply never have left Britain. It’s not our fault,” he said.



In a statement the company said it had ordered the meat as “minced lamb” from Draap Trading, the Cyprus-based Dutch company already accused of being a key player in the horse meat scandal.



Spanghero said it had “received meat presumed to conform to its order” before February 16, the date when it ended commercial relations with Draap. The two batches of illegal frozen meat are currently in cold storage and will be destroyed, it added.



Stephen Rossides, director of the British Meat Processors’ Association, said he wanted clarification on precisely what type of process was used to obtain the meat.



“But if this is material derived by mechanical means from the bones of sheep, then it cannot be legally used in food products,” said.



The BSE crisis in Britain saw the European Union ban British beef exports for 10 years from March 1996.



It sparked stricter rules on meat extraction, including mechanically separated mutton.



Sheep marrow has been linked to Scrapie, a fatal degenerative disease that affects the nervous systems of sheep and goats.



It is one of several spongiform encephalopathies related to BSE, which can be passed on to humans who eat food contaminated with the brain, spinal cord or digestive tract of infected carcasses.



The UK authorities question the food safety risks of eating mechanically separated meat.



“We don’t agree with the European Commission’s interpretation of the issue. But we have agreed to abide by the Commission’s demands (to ban it),” said Mr Rossides. “So if in any way those requirements are being breached anywhere in Europe, and I still have questions over that, that would be a matter of concern.”














why do we not want to do TSE transmission studies on chimpanzees $






5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.



snip...



R. BRADLEY












Wednesday, February 16, 2011



IN CONFIDENCE



SCRAPIE TRANSMISSION TO CHIMPANZEES



IN CONFIDENCE









Sunday, December 12, 2010


EFSA reviews BSE/TSE infectivity in small ruminant tissues News Story 2 December 2010










Sunday, April 18, 2010


SCRAPIE AND ATYPICAL SCRAPIE TRANSMISSION STUDIES A REVIEW 2010










Thursday, December 23, 2010


Molecular Typing of Protease-Resistant Prion Protein in Transmissible Spongiform Encephalopathies of Small Ruminants, France, 2002-2009


Volume 17, Number 1 January 2011









Thursday, November 18, 2010


Increased susceptibility of human-PrP transgenic mice to bovine spongiform encephalopathy following passage in sheep










Monday, April 25, 2011



Experimental Oral Transmission of Atypical Scrapie to Sheep



Volume 17, Number 5-May 2011









Friday, February 11, 2011


Atypical/Nor98 Scrapie Infectivity in Sheep Peripheral Tissues











RESEARCH




Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 17, No. 5, May 2011




Experimental Oral Transmission of Atypical Scrapie to Sheep




Marion M. Simmons, S. Jo Moore,1 Timm Konold, Lisa Thurston, Linda A. Terry, Leigh Thorne, Richard Lockey, Chris Vickery, Stephen A.C. Hawkins, Melanie J. Chaplin, and John Spiropoulos




To investigate the possibility of oral transmission of atypical scrapie in sheep and determine the distribution of infectivity in the animals’ peripheral tissues, we challenged neonatal lambs orally with atypical scrapie; they were then killed at 12 or 24 months. Screening test results were negative for disease-specifi c prion protein in all but 2 recipients; they had positive results for examination of brain, but negative for peripheral tissues. Infectivity of brain, distal ileum, and spleen from all animals was assessed in mouse bioassays; positive results were obtained from tissues that had negative results on screening. These fi ndings demonstrate that atypical scrapie can be transmitted orally and indicate that it has the potential for natural transmission and iatrogenic spread through animal feed. Detection of infectivity in tissues negative by current surveillance methods indicates that diagnostic sensitivity is suboptimal for atypical scrapie, and potentially infectious material may be able to pass into the human food chain.




SNIP...




Although we do not have epidemiologic evidence that supports the effi cient spread of disease in the fi eld, these data imply that disease is potentially transmissible under fi eld situations and that spread through animal feed may be possible if the current feed restrictions were to be relaxed. Additionally, almost no data are available on the potential for atypical scrapie to transmit to other food animal species, certainly by the oral route. However, work with transgenic mice has demonstrated the potential susceptibility of pigs, with the disturbing fi nding that the biochemical properties of the resulting PrPSc have changed on transmission (40). The implications of this observation for subsequent transmission and host target range are currently unknown.




How reassuring is this absence of detectable PrPSc from a public health perspective? The bioassays performed in this study are not titrations, so the infectious load of the positive gut tissues cannot be quantifi ed, although infectivity has been shown unequivocally. No experimental data are currently available on the zoonotic potential of atypical scrapie, either through experimental challenge of humanized mice or any meaningful epidemiologic correlation with human forms of TSE. However, the detection of infectivity in the distal ileum of animals as young as 12 months, in which all the tissues tested were negative for PrPSc by the currently available screening and confi rmatory diagnostic tests, indicates that the diagnostic sensitivity of current surveillance methods is suboptimal for detecting atypical scrapie and that potentially infectious material may be able to pass into the human food chain undetected.




Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 17, No. 5, May 2011













1: J Infect Dis 1980 Aug;142(2):205-8



Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.




Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.





Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.





snip...




The successful transmission of kuru, Creutzfeldt-Jakob disease, and scrapie by natural feeding to squirrel monkeys that we have reported provides further grounds for concern that scrapie-infected meat may occasionally give rise in humans to Creutzfeldt-Jakob disease.




PMID: 6997404












Recently the question has again been brought up as to whether scrapie is transmissible to man. This has followed reports that the disease has been transmitted to primates. One particularly lurid speculation (Gajdusek 1977) conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of mink are varieties of a single "virus". The U.S. Department of Agriculture concluded that it could "no longer justify or permit scrapie-blood line and scrapie-exposed sheep and goats to be processed for human or animal food at slaughter or rendering plants" (ARC 84/77)" The problem is emphasised by the finding that some strains of scrapie produce lesions identical to the once which characterise the human dementias"




Whether true or not. the hypothesis that these agents might be transmissible to man raises two considerations. First, the safety of laboratory personnel requires prompt attention. Second, action such as the "scorched meat" policy of USDA makes the solution of the acrapie problem urgent if the sheep industry is not to suffer grievously.




snip...




76/10.12/4.6

















Nature. 1972 Mar 10;236(5341):73-4.





Transmission of scrapie to the cynomolgus monkey (Macaca fascicularis).





Gibbs CJ Jr, Gajdusek DC.


Nature 236, 73 - 74 (10 March 1972); doi:10.1038/236073a0



Transmission of Scrapie to the Cynomolgus Monkey (Macaca fascicularis)



C. J. GIBBS jun. & D. C. GAJDUSEK


National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland


SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey (Macaca fascicularis) with an incubation period of more than 5 yr from the time of intracerebral inoculation of scrapie-infected mouse brain. The animal developed a chronic central nervous system degeneration, with ataxia, tremor and myoclonus with associated severe scrapie-like pathology of intensive astroglial hypertrophy and proliferation, neuronal vacuolation and status spongiosus of grey matter. The strain of scrapie virus used was the eighth passage in Swiss mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton, Berkshire).











Sunday, April 18, 2010


SCRAPIE AND ATYPICAL SCRAPIE TRANSMISSION STUDIES A REVIEW 2010








IT is of my opinion, that the OIE and the USDA et al, are the soul reason, and responsible parties, for Transmissible Spongiform Encephalopathy TSE prion diseases, including typical and atypical BSE, typical and atypical Scrapie, and all strains of CWD, and human TSE there from, spreading around the globe.



I have lost all confidence of this organization as a regulatory authority on animal disease, and consider it nothing more than a National Trading Brokerage for all strains of animal TSE, just to satisfy there commodity. AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization.



JUST because of low documented human body count with nvCJD and the long incubation periods, the lack of sound science being replaced by political and corporate science in relations with the fact that science has now linked some sporadic CJD with atypical BSE and atypical scrapie, and the very real threat of CWD being zoonosis, I believed the O.I.E. has failed terribly and again, I call for this organization to be dissolved. ...






Tuesday, July 17, 2012


O.I.E. BSE, CWD, SCRAPIE, TSE PRION DISEASE Final Report of the 80th General Session, 20 - 25 May 2012








Thursday, December 20, 2012


OIE GROUP RECOMMENDS THAT SCRAPE PRION DISEASE BE DELISTED AND SAME OLD BSe WITH BOVINE MAD COW DISEASE










Comment:

 



Para 72 and following sections


Mechanically recovered meat: Should you not suggest more urgent action over mechanically recovered meat, given that this seems to be the route of infection for vCJD?



It is all very well to have the 1995 controls in the UK, but are they 100 per cent effective? How can a consumer know if a product contains MRM from another country, where there may be either no, or very ineffective, controls?



Having read your report and the BSE Inquiry report, I suggest there is doubt about whether MRM can be safely eaten. It is very hard to be sure exactly what is in MRM and whether it is safe. Given this, your advice should surely be to advise consumers not to eat products which may contain MRM but to stick to cuts of meat which are clearly identifiable. It is often children who eat these MRM products.



I don`t know if there is the possibility to reply to these questions. I tried speaking to someone in your press office but he just quoted the report at me, which I can read very well for myself.ct contains MRM from another country, where there may be either no, or very ineffective, controls?



Having read your report and the BSE Inquiry report, I suggest there is doubt about whether MRM can be safely eaten. It is very hard to be sure exactly what is in MRM and whether it is safe. Given this, your advice should surely be to advise consumers not to eat products which may contain MRM but to stick to cuts of meat which are clearly identifiable. It is often children who eat these MRM products.



I don`t know if there is the possibility to reply to these questions. I tried speaking to someone in your press office but he just quoted the report at me, which I can read very well for myself.






 
 
 
 
 


 

snip...see more on MRM’s or MSM’s i.e. mechanically removed meats or mechanically separated meats here ;






Wednesday, March 14, 2012



 


PINK SLIME, MRM’s, BSE AKA MAD COW DISEASE, AND THE USDA NSLP












Mysterious BSE-like disease found in sheep (UK sheep goat export]



By Terry S. Singeltary Sr. Published April 9, 2004



Health



Download this document





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


Subject: Re: Mysterious BSE-like disease found in sheep (UK sheep goat export]
Date: Sat, 10 Apr 2004 09:52:54 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
References:











Wednesday, January 18, 2012


BSE IN GOATS CAN BE MISTAKEN FOR SCRAPIE February 1, 2012







******



[2]

UK: caprine BSE Date: Sat 3 Dec 2011 Source: Emerging Infectious Diseases 17(12) 12 [edited]
 
 
 
 





Isolation of prion with BSE properties from farmed goat



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



[Authors: Spiropoulos J, Lockey R, Sallis RE, Terry LA, Thorne L, Holder TM, et al. Animal Health and Veterinary Laboratories Agency, Weybridge, Surrey, UK]



Abstract



--------



Transmissible spongiform encephalopathies are fatal neurodegenerative diseases that include variant Creutzfeldt-Jakob disease in humans, scrapie in small ruminants, and bovine spongiform encephalopathy (BSE) in cattle. Scrapie is not considered a public health risk, but BSE has been linked to variant Creutzfeldt-Jakob disease. Small ruminants are susceptible to BSE, and in 2005 BSE was identified in a farmed goat in France. We confirm another BSE case in a goat in which scrapie was originally diagnosed and retrospectively identified as suspected BSE. The prion strain in this case was further characterized by mouse bioassay after extraction from formaldehyde-fixed brain tissue embedded in paraffin blocks. Our data show that BSE can infect small ruminants under natural conditions and could be misdiagnosed as scrapie. Surveillance should continue so that another outbreak of this zoonotic transmissible spongiform encephalopathy can be prevented and public health safeguarded.



Transmissible spongiform encephalopathies (TSEs) are fatal diseases characterized by neurodegenerative changes in the central nervous system that include vacuolation, gliosis, and accumulation of an abnormal isoform (PrPSc) of a naturally occurring host-encoded protein (PrPC) (1). According to the prion hypothesis, PrPSc is the major or the sole infectious agent (1). Although this hypothesis has not received universal acceptance, PrPScis ubiquitous in all known naturally occurring TSEs, and its detection is widely used for their diagnosis.



Bovine spongiform encephalopathy (BSE), a TSE of cattle, was first detected in 1986 (2) and has since been linked with emerging TSEs in other species (3,4) including humans (5,6). Because of its ability to cross species barriers and particularly its zoonotic potential, BSE is considered a public health risk, and extensive measures have been established to detect and eliminate the disease.



Scrapie, a naturally occurring TSE affecting small ruminants, has been known for centuries (7) and is not considered to pose a public health risk (8). Under experimental conditions, however, small ruminants are susceptible to BSE, with pathogenesis and clinical signs that are not readily distinguishable from scrapie (9-12). Additionally, the fact that small ruminants were exposed to BSE-contaminated food before the exclusion of meat and bone meal from ruminant feedstuffs led to the possibility that sheep and goats on commercial farms could be affected by BSE that could be misdiagnosed as scrapie (13,14). The response to this potential risk was the implementation of extensive statutory active surveillance, elimination, and breeding for resistance programs in the European Union (EU).



In 2005, as part of a review of historical TSE-positive cases of sheep and goats in France, a specimen from a goat slaughtered for human consumption in 2002 was reported to be "indistinguishable from a BSE isolate on the basis of all identification criteria available." (15). In response to this report, 2 retrospective studies were initiated in the United Kingdom to analyze archived samples from goat cases that were initially diagnosed as scrapie (16,17). Because only fixed material was available, both studies had to use differential immunohistochemical analysis (D-IHC), a technique that can discriminate scrapie from experimentally induced BSE in sheep (18). These studies identified a single case, originally diagnosed in 1990 as scrapie, that had a D-IHC signature indistinguishable from BSE (16).



Given the wide phenotypic variance of scrapie in sheep and our limited knowledge of this variance in goats, the D-IHC result on its own was insufficient for an unequivocal diagnosis. In accordance with EU regulation 36/2005 (19), the case was referred to the EU Reference Laboratory Strain Typing Expert Group, which recommended further investigation by bioassay.



Bioassay is conventionally undertaken by using unfixed tissues to prepare inocula. Much historical tissue is available only as formalin fixed or formalin fixed and paraffin wax embedded. TSE infectivity persists in such material but with a lower infectious titer than with unfixed frozen tissue (20). However, the potential effects on biological activity, and therefore strain characterization, of fixation and processing are unknown. Thus, further investigation of this case required an extensive panel of controls. We report the results of the bioassay analysis and confirm the diagnosis of BSE in a goat in the United Kingdom.



-- Communicated by: Terry S Singeltary Sr flounder9@verizon.net




[Interested readers should access the original text via the source URL above to view the full text an the references cited. The following has been extracted from the Discussion.



"The 2 cases of naturally occurring BSE in small ruminants, the one reported here and the one identified in France (15), occurred in different countries, during different time periods, and before strict BSE control measures were fully implemented. Therefore, the most likely origin of these 2 cases would be exposure to BSE-contaminated food supplements. Although in France goats constitute 14.3 percent of the small ruminant population, in the United Kingdom they account for only 0.3 percent of small ruminants. It is intriguing, therefore, that the only naturally occurring BSE cases in small ruminants in France and particularly in the United Kingdom were detected in goats and not in sheep, although they have also been exposed to contaminated food supplements. A possible explanation could be that goats are generally managed more intensively than sheep and thus might have been exposed to higher doses of the infectious agent because of the more frequent use of concentrates in intensive dairy farming. Similar observations have been reported in cattle, in which the incidence of BSE was significantly higher in dairy herds and in which management is much more intensive than in beef herds (34). In the United Kingdom, most of the commercial goat herds are kept for milk production in a typically intensive production system, similar to dairy cattle.



The BSE case we have confirmed was 1 of 26 historic goat samples examined in the United Kingdom collected during 1984-2002 (16,17). Since 1993, scrapie in goats has been a notifiable disease in the United Kingdom, and since 2005, samples from all suspected cases of TSE in small ruminants are required to be tested for BSE-like features by using Western blotting (WB) (19). No BSE cases have been identified, although an intermediate case in a goat was reported and is under investigation by bioassay for final resolution (35,36). This screening of brain samples from all small ruminant cases offers reassurance that BSE is not present in the contemporary small ruminant population. However, application of WB to sheep experimentally co-infected with BSE and scrapie detected only the scrapie agent (37). Also, in contrast to BSE, where infectivity is mainly confined to the nervous system, in small ruminants the BSE agent is widely distributed in peripheral tissues and can be transmitted horizontally (11,38). Therefore, feed ban measures alone would be inadequate to control a BSE outbreak in small ruminants. Also, it would be impossible to prevent BSE from entering the human food chain through consumption of food products derived from small ruminants.



Because TSEs in goats are still a problem, particularly in Mediterranean countries, our data suggest that extensive surveillance and breeding schemes must remain in place to prevent a BSE outbreak in small ruminants and to safeguard public health. This report also highlights several issues regarding the use of mouse bioassay to identify TSE strains. As governing bodies seek confirmation of equivocal cases that are identified worldwide, they must be aware of the limitations, cost, and timescale demands of confirming such cases." - Mod.CP]




[See http://healthmap.org/r/1lNY for the interactive HealthMap/ProMED map of the United Kingdom. - Mod.MPP]






******




snip...




******



[5]



Switzerland: BSE Date: Fri 16 Dec 2011 Source: Prionics AG, e-scope newsletter [edited] http://escope.prionics.com/issue/2011-december-4/



In spring 2011, 2 new cases of BSE were discovered in Switzerland [see ProMED-mail posting Prion disease update 2011 (10) 20111107.3317]. Both cases were detected using the Prionics(R)-Check BSE tests. A report has now been published showing that these cases represent a novel type of BSE. What are the consequences of these new BSE cases?



After a period of 4 years without BSE positive cows, in spring this year [2011] Switzerland was shaken by the discovery of 2 new BSE cases detected only one month apart from each other. The cases appeared in different areas of Switzerland and involved animals aged 8 and 15 years, which were tested with the Prionics(R)-Check BSE tests as part of the active disease surveillance program. Bettina Bernhard, Head of the Prionics diagnostic laboratory reported that: "It was the 1st time in 4.5 years that we had found a BSE positive sample in our laboratory. Based on the results from the Prionics(R)-Check WESTERN, we immediately saw that the fingerprint of the prion protein was not that of the classical BSE cases we have detected before. We then informed the Swiss National Reference Laboratory and veterinary authorities and the positive result was confirmed with the Prionics(R)-Check PrioSTRIP."




Novel type of BSE?




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




BSE cases that differ from the classical BSE strain have been detected before, however, with low incidence. These atypical strains, designated BASE/L-BSE and H-BSE, were first reported in 2004 in Italy and France. Both strains were detected as part of routine surveillance using the Prionics(R)-Check WESTERN and ELISA tests. The recent publication by Torsten Seuberlich of the Swiss National and OIE [World Organisation for Animal Health] Reference Laboratories for BSE and Scrapie and his colleagues, is showing that these 2 Swiss cases not only differ from classical BSE, but also from the atypical BSE cases found in other countries. It appears that the 2 BSE cases detected in Switzerland seem to represent a novel type of atypical BSE. Dr Seuberlich explains: "We are now undertaking further investigations into these 2 cases and until there is more clarity, surveillance should continue to be carried out at a high level and disease awareness should be increased. Furthermore, we have to ensure that diagnostic techniques are applied that identify such cases."




Continued vigilance needed




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




Whereas consumption of meat from cows affected by classical BSE has been associated with vCJD, the public health hazard from atypical BSE is unclear. Little is known about its origin and whether it can be transmitted to other animals. These cases show, however, that BSE has not been completely eradicated and that the disease can continue to occur even with current preventive measures (such as the meat-and-bone meal ban) in place. The appearance of new strains of the prion protein could also indicate that BSE is still evolving. Continuous monitoring will be needed to keep these new strains under surveillance.





-- Communicated by: Terry S Singeltary Sr flounder9@verizon.net





[[See http://healthmap.org/r/1AFv for the interactive HealthMap/ProMED map of Switzerland. - Mod.MPP]




























































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