NUTRITIONAL SUPPLEMENTS and USA MAD COW STRAINS TYPICAL AND ATYPICAL AND CJD

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From: TSS ()
Subject: NUTRITIONAL SUPPLEMENTS and USA MAD COW STRAINS TYPICAL AND ATYPICAL AND CJD
Date: September 19, 2006 at 12:52 pm PST

----- Original Message -----
From: Terry S. Singeltary Sr.
To: LISTSERV@VM.CFSAN.FDA.GOV
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;

Sent: Wednesday, September 13, 2006 11:56 AM
Subject: Creutzfeldt–Jakob disease with Met/Val heterozygosity at codon 129 and type 1 protease-resistant prion protein presenting some florid-type plaques and many Kuru plaques in the cerebellum

Neuropathology
Volume 26 Page 313 - August 2006
doi:10.1111/j.1440-1789.2006.00683.xVolume 26 Issue 4 Case ReportAutopsy case of Creutzfeldt–Jakob disease with Met/Val heterozygosity at codon 129 and type 1 protease-resistant prion protein presenting some florid-type plaques and many Kuru plaques in the cerebellum Yoko Kawauchi,1 Toshiaki Kamitani,1 Saburo Yagish!ta,2 Tetsuyuki Kitamoto3 and Hitaru Kishida1

We report an atypical case of CJD. The clinical course was similar to a classic CJD phenotype, but histopathological study revealed several florid-type plaques in the amygdale and abundant Kuru plaques in the cerebellum that are atypical of classic CJD. Molecular analysis showed methionine/valine heterozygosity at codon 129 and no pathogenic mutation in the coding region of the prion protein gene. Western immunoblots revealed type 1 protease-resistant prion protein (PrPres), and a ration analysis of PrPres showed a high ratio of the diglycosylated form and a low ratio of the non-glycosylated form. Our case could not be precisely classified in any of Parchi's six variants. It suggests the existence of some factors that determine the phenotypic variability other than the codon 129 genotypes in the PrP gene or the physicochemical properties of PrPres.

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1440-1789.2006.00683.x

NOV. 1999

I have several autopsies, stating kuru type amyloid plaques, one of the victims was 41 years of age. Also, my Mom died a most hideous death, Heidenhain Variant Creutzfeldt Jakob disease. Her symptoms resemble that of all the U.K. vCJD victims.

http://bmj.bmjjournals.com/cgi/eletters/319/7220/1312/b#5406

JAN 2000

http://bmj.bmjjournals.com/cgi/eletters/320/7226/8/b#EL1

2001

Full Text

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama

Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States

Email Terry S. Singeltary:

flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?

http://www.neurology.org/cgi/eletters/60/2/176#535

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

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

Classification of sporadic Creutzfeldt–Jakob disease revisited

Ignazio Cali1, Rudolph Castellani3, Jue Yuan1, Amer Al-Shekhlee2, Mark L.
Cohen1, Xiangzhu Xiao1, Francisco J. Moleres1, Piero Parchi4, Wen-Quan Zou1
and Pierluigi Gambetti1
1 Department of Pathology, Case Western Reserve University Cleveland, OH,
USA 2 Department of Neurology, Case Western Reserve University Cleveland,
OH, USA 3 Division of Neuropathology, Department of Pathology University of
Maryland, Baltimore, MD, USA 4 Dipartimento di Scienze Neurologiche,
Università di Bologna Bologna, Italy

http://disc.server.com/discussion.cgi?disc=167318;article=3092;title=CJD%20WATCH

Clinical findings and diagnostic tests in the MV2 subtype of sporadic CJD

Anna Krasnianski1, Walter J. Schulz-Schaeffer2, Kai Kallenberg3, Bettina
Meissner1, Donald A. Collie5, Sigrun Roeber4, Mario Bartl1, Uta Heinemann1,
Daniela Varges1, Hans A. Kretzschmar4 and Inga Zerr1
1 Department of Neurology, Georg-August University Göttingen Germany 2
Department of Neuropathology, Georg-August University Göttingen Germany 3
Department of Neuroradiology, Georg-August University Göttingen Germany 4
Department of Neuropathology, Ludwig-Maximillian University Munich Germany 5
Department of Neuroradiology, Western General Hospital Edinburgh UK

http://disc.server.com/discussion.cgi?disc=167318;article=3093;title=CJD%20WATCH

Determinants of diagnostic investigation sensitivities across the clinical
spectrum of sporadic Creutzfeldt–Jakob disease

S. J. Collins1,*, P. Sanchez-Juan2,*, C. L. Masters1, G. M. Klug1, C. van
Duijn2, A. Poleggi3, M. Pocchiari3, S. Almonti3, N. Cuadrado-Corrales4, J.
de Pedro-Cuesta4, H. Budka5, E. Gelpi5, M. Glatzel6,13, M. Tolnay6, E.
Hewer6, I. Zerr7, U. Heinemann7, H. A. Kretszchmar8, G. H. Jansen9, E.
Olsen9, E. Mitrova10, A. Alpérovitch11, J.-P. Brandel11, J. Mackenzie12, K.
Murray12 and R. G. Will12

http://disc.server.com/discussion.cgi?disc=167318;article=3090;title=CJD%20WATCH

Inherited prion disease with six octapeptide repeat insertional
mutation—molecular analysis of phenotypic heterogeneity

Simon Mead, Mark Poulter, Jon Beck, Thomas E. F. Webb, Tracy A. Campbell,
Jacqueline M. Linehan, Melanie Desbruslais, Susan Joiner, Jonathan D. F.
Wadsworth, Andrew King, Peter Lantos and John Collinge
MRC Prion Unit, Department of Neurodegenerative Diseases, Institute of
Neurology and Department of Neuropathology, King's College Hospital London,
UK

http://disc.server.com/discussion.cgi?disc=167318;article=3087;title=CJD%20WATCH

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).

http://www.standardprocess.com/sp_catalog_product_detail.asp

http://www.standardprocess.com/sp_catalog_search.asp

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.

http://www.standardprocess.com/faq_sp_quality_manufacturing.asp

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.

http://www.standardprocess.com/lit/InformationSheets/AnimalTissuesL8115.pdf

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.

###

http://www.fda.gov/bbs/topics/news/2005/NEW01229.html

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).

http://www.thelancet.com/journal/vol361/iss9368/full/llan.361.9368.correspondence.25505.1

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006

The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end

http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r

AND NOT TO FORGET what the OIG has said time and time again over the years;

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

03-025IF 03-025IF-631 Linda A. Detwiler [PDF]

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf

Specified Risk Materials (SRMs)

I am in full support of the interim final rule which prohibits SRMs from

being included in food for human consumption. In addition to the list of

tissues published in this rule, I am requesting that additional tissues be

added to the list. These would include dura

("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus

to rectum). The scientific justification is provided below. THESE SRMs

should also be prohibited from ANY FDA regulated food or product intended

for human consumption, including but not limited to flavorings, extracts,

etc. ...

Dr. Linda Detwiler comments in full;

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf

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

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf

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

THE SEVEN 1/2 SCIENTIST REPORT *** ;-)

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

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

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

FACT, cows still being fed to cows in the USA in 2006, 8/4/97 partial and voluntary feed ban was a joke, and still is ;

Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST

PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV

http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html

Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS

______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS

______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN

END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

###

http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html

Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html

Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html

Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html

CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html

Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391

May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).

Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.

This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.

You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

Carol S. Sanchez
Acting District Director
New Orleans District

http://www.fda.gov/foi/warning_letters/g5883d.htm

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

03-025IFA
03-025IFA-2

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

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA

https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed

Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE
SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

EFSA concludes that the current GBR level of USA, CANADA, AND MEXICO is III,
i.e. it is likely but not confirmed that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent. As long as there are no
significant changes in rendering or feeding, the stability remains
extremely/very unstable.

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)
of Canada

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[Last updated 08 September 2004]
[Publication Date 20 August 2004]

http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)
of Mexico

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[Last updated 08 September 2004]
[Publication Date 20 August 2004]

http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/565.html

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)
of the United States of America (USA)

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[Last updated 08 September 2004]
[Publication Date 20 August 2004]

http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm

Could you get mad cow from a pill ?
Some doctors say a class of pills that promise smarts, energy, and
sexual vitality may cause mad-cow disease.
The government isn't worried. Should you be?

June 1, 2001 Health Magazine by Susan Freinkel

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

GERMAN DER SPIEGEL MAGAZINE

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

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

I THINK that the FSIS, USDA, APHIS, FDA, and everyone else envolved in this
mess has had plenty of time to get this right, i mean just look at the feed
ban violations alone in 2006, let alone all years preveously, since the
partial and voluntary Aug. 4, 1997 ban was put into place. IN my opinion,
these industry friendly regulations and the agencies that put them into
place, or not, have all failed the public terribly. just how bad will only
be known in the years and decades to come, for there failure has exposed us
all to the mad cow agent, in more ways than one. the incubation period is
the only saving grace. maybe we will all die from something else before
clinical disease appears, maybe not. and even if the agent only appears to
infect and kill only a few in the years and decades to come, it
will not make right, what every federal agency failed to do, and that is
protect the consumer. ONLY by Gods grace and a mircale will this disease
disappear anytime soon, and I pray that it does. However, it will not be
from anything that any of these industry friendly agencies have done,
because what they have done is fail from day one with BSE regulations, and
they still fail today. YOUR only fooling yourself with the infamous Enhanced
June 2004 BSE surveillance system. THOSE test and protocols for them were
flawwed from day one, and everyone around the globe (except USDA/APHIS/FSIS)
knows it. I call for a redo of that same program, only this time lets use
the most sensitive testing, lets use proper protocol, and lets not cherry
pick the cows that are to be tested, or not. you cannot render a stumbling
and staggering suspect mad cow before any test at all, that's not fare
either. no more suspect BSE samples sitting on the shelves for 4 to 7+
months, and it should not take an act of Congress to finally get them
confirmed. FINALLY, THE BSE MRR POLICY MUST BE REPEALED, AND THE BSE GBR
RISK ASSESSMENTS MUST BE ADHERED TO, and strengthened to include all TSE.
anything less is not acceptable and will only amplify and spread the BSE/TSE
agent. ...

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
Friday, January 19, 2001
Holiday Inn Bethesda Versailles I and II
8120 Wisconsin Avenue Bethesda, Maryland
2 PARTICIPANTS
Paul W. Brown, M.D., Chairperson
William Freas, Ph.D., Executive Secretary
VOTING MEMBERS
Ermias D. Belay, M.D. David C. Bolton, Ph.D. Donald S. Burke, M.D.
Dean O. Cliver, Ph.D.
Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D. Pedro Piccardo,
M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D. Elizabeth S.
Williams, D.V.M., Ph.D.
VOTING CONSULTANTS
Linda A. Detwiler, D.V.M.
David Gaylor, Ph.D.
Paul R. McCurdy, M.D.
Kenrad E. Nelson, M.D.
NONVOTING CONSULTANT
Susan Leitman, M.D.
GUESTS
Richard Davey, M.D. Louis Katz, M.D.
snip...
page 501
253
1 DR. BOLTON: I have an additional question about
2 that. What is the assurance that additional locally sourced
3 tracheas are not added into that manufacturing process, thus
4 boosting the yield, if you will, but being returned to the
5 U.S. as being produced from U.S.-sourced raw material?
6 DR. McCURDY: Are there data to indicate how many
7 grams, or whatever, of infected brain are likely to infect
8 an organism, either animal or man, when taken orally?
9 DR. BROWN: If I am not mistaken, and I can be
10 corrected, I think a half a gram is enough in a cow, orally;
11 in other words, one good dietary-supplement pill.
12 DR. McCURDY: What I am driving at is the question
13 we are asked is really not do we wish to regulate these
14 things coming in. I think the statements about difficulties
15 in regulating things in the future or near future for new
16 regulations were probably accurate.
17 But I think that we could exhibit some quite
18 reasonable concern about blood donors who are taking dietary
19 supplements that contain a certain amount of unspecified-
20 origin brain, brain-related, brain and pituitary material.
21 If they have done this for more than a sniff or something
22 like that, then, perhaps, they should be deferred as blood
23 donors.
24 That is probably worse than spending six months in
25 the U.K.
1/19/01
3681t2.rtf(845) page 501
http://www.fda.gov/ohrms/dockets/ac/cber01.htm

There has been a Nutritional Supplement mad cow warning letter circulating around since about 1990. Every year they issue the same letter to the manufactures asking them to please be sure they source their products from BSE-FREE countries. but we all know, the statement BSE-FREE, is a joke, especially in the USA. I sat in on the 50 state emergency BSE conference call, (uninvited guest) and I know for a fact the so-called 'pharmaceutical grade' bovine source herds, bovines that were to never be fed ruminant materials, the USA cannot for certain say that indeed these cattle have never ingested ruminant feed, in fact, some probably had.
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
Bovine Spongiform Encephalopathy

Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
And I would have been doing just fine, until I asked my question. I was surprised my time to ask a question came so quickly.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns]
And now a question from Terry S. Singeltary of CJD Watch.
[TSS]
Yes, Thank You. U.S. cattle - what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the background, mumbling and "We can't. Have him ask the question again."]
[host Richard]
Could you repeat the question?
[TSS]
U.S. cattle..what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this]
What group are you with?
[TSS]
CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking]
Could you please disconnect Mr. Singeltary
[TSS]
You are not going to answer my question?
[not sure whom speaking]
NO
From this point, I was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
[unknown woman]
What group are you with?
[TSS]
CJD Watch and my Mom died from hvCJD We are trying to tract down CJD and other human TSE's world wide. I was invited to sit in on this from someone inside the USDA/APHIS and that is why I am here. Do you intend on banning me from this conference now?
At this point the conference was turned back up, and I got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, I will try and give you a run-down for now, of the conference.
IF O were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from:
RBARNS@ORA.FDA.GOV
301-827-6906
He would be glad to give you one ;-)
Rockville Maryland,
Richard Barns Host
BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.
FULL TEXT MY TRANSCRIPT POSTED HERE;
(don't let the url address fool you of it's contents)
http://vegancowboy.org/TSS-part1of8.htm

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

Suit Filed Over Mad Cow Disclaimer
By Jason Hoppin
The Recorder
March 23, 2001
A small San Francisco litigation firm has teamed up with Milberg, Weiss, Bershad, Hynes & Lerach to sue a health supplements manufacturer, alleging the company misrepresents the danger of acquiring mad cow disease through its products.
The suit, filed under California's unfair business practices statute, alleges that Wisconsin's Standard Process Inc. uses, in part, crackpot science to allay customers' fears about the transmission of bovine spongiform encephalopathy, also known as mad cow disease.
"Standard Process either knowingly or recklessly has omitted a material fact by failing to inform consumers that the overwhelming majority of reputable scientists and physicians have concluded that mad-cow disease is transmitted to humans by prions in bovine meat and/or bovine organs," Bushnell, Caplan & Fielding's Alan Caplan wrote.
The complaint points to a statement by the company about the safety of its products which suggests that pesticides may be to blame for mad cow outbreaks, not the consumption of meat.
"It's probably loosely referred to as research," deadpanned Jan Novakofski, a University of Illinois researcher who studies the disease. "The evidence for that kind of concept [versus the consumption theory] is about an ounce to a pound."
No cases of mad cow have ever been reported in the United States, and the plaintiff in the case, James Gorman, does not suffer from the disease. Instead, he is seeking damages for misrepresentation, fraud, unfair advertising and unfair business practices.
The case was filed in San Francisco Superior Court.
The product, a vitamin supplement called Iplex 5100, is sold through licensed health professionals, including acupuncturists, nutritionists and the like.
Iplex 5100 is made in part, with cow parts: eyes, kidneys, livers, bones and brains, where BSE is most highly concentrated.
Standard Process did not return a phone call seeking comment, but the company's Web site says it purchases bovine products only from U.S. government-inspected facilities.
"Standard Process has never used any glandular substances or bovine tissue derivatives from animals in any BSE-infected country," the company states.
The human manifestation of BSE -- variant Creutzfeld-Jakob disease -- has killed more than 80 people in Great Britain, and new outbreaks have recently been reported in several European countries.
U.S. officials have worried that dietary supplements may provide an entry point for the disease, which has been detected here in animals other than cows.
"The health food industry is totally unregulated," Novakofski said. "You go to the health food store and no one's ever tested anything."
However, Standard Process says its Wisconsin production facility is regulated by the U.S. Food and Drug Administration, and that its cow products are certified by the government.
© 2001 law.com Inc. © 1999-2001 NLP IP Company,
============================================
http://vm.cfsan.fda.gov/~dms/qa-sup5.html

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

snip... FULL TEXT ;

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

I can only imagine the lawsuits in the years and decades to come over human TSE via the animal source, and the 'friendly fire' route via the medical and surgical arena. I dont think the FDA will be able to escape litigation with there infamous yearly token 'dear manufacturer' letter to the supplements industry. The FDA is as guilty as the manufacturer themselves, they have known for decades the risk, but failed to act, and they fail to act to this day. I was impressed however with the recent multimillion dollar fine to the red cross for there inaction against potential tainted blood, but that was like closing the barn door after the mad cows got loose. ...

CJD WATCH MESSAGE BOARD
Anonymous
Re: FDA Fines American Red Cross $4.2 Million (BLOOD CJD)
Thu Sep 14, 2006 15:53
71.248.154.242

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________
PRODUCT
Source Plasma, Recall # B-1708-6
CODE
Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,
MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,
MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,
MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,
04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,
05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,
05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,
05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,
05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,
05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,
05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,
05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,
05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.
Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on risk factors for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA, NC, and MD

______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;
b) Fresh Frozen Plasma, Recall # B-1715-6;
c) Platelets, Recall # B-1716-6
CODE
a), b), and c) Unit: 2443732
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by letters dated
November 11, 2003 and December 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and WI

END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html

PRODUCT
Fresh Frozen Plasma, Recall # B-1751-6
CODE
Unit: 4936623
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September
16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk
factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html

these usa mad cow blood for humans are a dime a dozen, they come out just
about every week ;

http://disc.server.com/discussion.cgi?disc=167318;article=2971;title=CJD%20WATCH

http://disc.server.com/discussion.cgi?disc=167318;article=2972;title=CJD%20WATCH

Thank you,

I am sincerely,

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