FDA Urged To Consider
Ban On Cow Brain Products
By Ori Twersky

WASHINGTON (Reuters Health) - The US Food and Drug Administration (FDA) may soon consider banning the sale of any product containing cow brains or spinal tissue, whether made abroad or here in the US.
Expert advisors to the FDA voted 18 to 1 on Friday in favor of urging the federal agency to begin assessing the necessity and feasibility of passing regulations to either ban or restrict the use of products containing these tissues, due to the theoretical risk of "mad cow" disease.
These products range from soup stock and sausage casings to cosmetics, drugs, medical devices and dietary supplements.
Under federal law, the FDA is authorized to make and enforce regulations needed to prevent the introduction and spread of communicable diseases. It is also authorized to regulate drugs, dietary supplements, cosmetics and most foods except meat, poultry and eggs.
Mad cow disease, also known as bovine spongiform encephalopathy (BSE), is limited to cattle. But the consumption of BSE-tainted meat has been linked to the emergence of a new variant of Creutzfeldt-Jakob disease (vCJD), a rare and invariably fatal degenerative brain malady. There is also no evidence that vCJD can be contracted from anything but tainted meat.
The FDA's Transmissible Spongiform Encephalopathies Advisory Committee's vote was based largely upon the potential risk products containing cow brain or spinal tissue could pose to Americans.
Since 1996, over 100 cases of vCJD have been documented in France and the United Kingdom, where the mad cow epidemic began around 1980. Regulations have since been passed to limit the spread of BSE throughout Europe and worldwide.
The US instituted a BSE surveillance program in 1990. To date, no cases of mad cow disease or vCJD have been detected in this country.
The FDA already has already banned the importation of products containing cow-derived material from countries with documented BSE cases. It has also asked blood collection centers to defer donors who spent 6 months or more in the UK between 1980 and 1996. However, no case of vCJD or CJD transmission via blood or blood products has ever been documented or reported.
The FDA committee said its primary concern in making its recommendation was the lack of a definitive, real-time test to identify incubating infections. The committee added it was also concerned that the US could inadvertently import contaminated products, especially dietary supplements. The FDA had previously issued an advisory on importing dietary supplements from countries with documented BSE cases, but not from those that appear to be BSE-free.
"I don't think there is any measurable risk at this time, but it is unknown," explained Committee Chair Dr. David C. Bolton in an interview with Reuters Health following the vote. "The question is how vigilant do we want to be."
Bolton, head of the molecular laboratory at the New York State Institute for Basic Research in Staten Island, added that while the US may appear to have stopped the importation of such products, no country could be presumed BSE-free, including the US.
"It is likely that a case of BSE and vCJD as well could occur in the US," Bolton said.
Still, the committee stopped short of recommending the passage of regulations.
Bolton said this decision was made because there presently is a lack of scientific data upon which to base actual policy.
In the UK, Bolton explained, up to one million infected cattle may have entered the food chain before resulting in the 100 documented infections. But the committee still felt the FDA should consider more stringent regulations because consequences were dire for each individual with vCJD, he added.
"It a small risk statistically, but it's fatal and tragic to the individual," Bolton observed.
Should the FDA follow its committee's recommendation, which the agency generally does, it will undoubtedly face criticism.
Critics have charged that the FDA has already overstepped its bounds and created the perception of a public health threat when there was none by passing precautionary regulations and advisories. These critics have also charged that the FDA could be creating a slippery slope by distorting the meaning of a real public health threat versus a minimal individual risk.
Among those critics of the FDA's policies is Dr. Scott C. Ratzan, a widely recognized authority on mad cow disease and the editor-in-chief of the George Washington University Center for International Health's Journal of Health Communication.
"We have to careful, but one in five billion is still no risk," Ratzan told Reuters Health.
But if the FDA should follow its committee recommendation, there are unlikely to be any immediate consequences. The FDA's rule-making process could take months and even years to complete, while the agency reviews the available data and upcoming studies.
In the meantime, Bolton suggested that consumers might want to exercise individual discretion.
"I personally love a good steak," Bolton told Reuters Health. "But I do not take dietary supplements and would not eat cow brains."

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