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No "Mad-Cow" Risk from Diet Suppleme

United Press International

Saturday, March 17, 2001

WASHINGTON, Mar 17, 2001 (United Press International via COMTEX) -- Nutritional supplements containing animal products do not present any threat of mad cow disease to U.S. consumers, the leading trade group representing the supplement industry said Friday.

"There is no correlation between dietary supplements and mad cow," said David Seckman, CEO of the National Nutritional Foods Association. He told United Press International that even so-called glandular products offer no risk of infection.

Nutritional supplements containing ground cow and pig glands, including the spleen and thyroid, are used by some people to treat rheumatoid arthritis and other joint conditions. But these products represent "less that one-half of one percent" of the industry's annual sales of $16 billion, he said. Others contain neurological tissue, but these are also carefully monitored to ensure their safety.

The concern about nutritional supplements and the risk of Creutzfeld-Jakob Disease (CJD), a progressive and fatal degenerative brain condition that has been linked to mad cow disease or bovine spongiform encephalopathy (BSE), first arose at a recent meeting at the Food and Drug Administration, Seckman said.

"A doctor who was there told agency officials that he had been disturbed by the number of products containing animal organs when he visited a health food store," Seckman said in a telephone interview.

Although the FDA does not regulate most dietary supplements, its Center for Food Safety and Applied Nutrition does monitor some products sold for human health.

"There really aren't that many of them, and those that are out there come from suppliers with protected herds. There hasn't been a single nutritional supplement product linked to the disease," said Seckman.

A spokeswoman for the FDA said that nutritional supplements contain such minute amounts of glandular products that they pose little risk.

Seckman also said that concerns about gelatin capsules are unfounded, because they come from the same suppliers that provide them to drug manufacturers and are therefore inspected closely for safety.

Gelatin is manufactured primarily from the hides of swine and the bones and hides of cattle. During processing, these source materials are exposed to extremely harsh conditions, including prolonged exposure to highly acid or alkaline solutions. Gelatin is used in a wide variety of consumer and medical products regulated by the FDA, ranging from candies and desserts to vaccines, drugs, medical devices, dietary supplements and cosmetics.

Since 1992, FDA has requested that manufacturers of FDA-regulated products not use bovine-derived materials from BSE countries. In 1994, on the basis of the scientific information available at that time, FDA stated that it did not object to the use, in the manufacture of pharmaceutical grade gelatin, of bovine-derived products from countries classified by the U.S. Department of Agriculture as having BSE in their cattle population.

But in 1996, following outbreaks of BSE among British cattle, scientists found a possible link between BSE and a new variant of CJD.

While it is not certain how BSE may be spread to humans, evidence indicates that humans may acquire the disease after consuming BSE-contaminated cattle products.

FDA issued an "import alert" in 1996 asking supplement manufacturers not to use gelatin products from BSE countries and more recently added bulk glandular materials, the FDA spokesman said. In 1997, after hearing the evidence, weighing newer scientific information and thoroughly discussing the issues, an FDA committee concluded that material from BSE countries should not be used in gelatin products.

"All of our capsules comply with these rules," said Steckman.

"BSE is not a new issue. It has been around for six years now and there have been around one hundred deaths, all but four of which have occurred in England. "Still, people question us all the time about the risk," he noted.

Another supplement, chondroitin, is made from the trachea of cows. Also used for collagen tissue support, less than five percent of chontroitin supplements contain trachea and these are either from domestic herds or from countries where there have been no cases of mad cow, he said and even most manufacturers are switching to other animal sources, he said .

Between 1989 and 2000, at least 1,642 cases of BSE have been identified among cattle in Belgium, Denmark, France, Germany, Ireland, Italy, Liechtenstein, the Netherlands, Portugal, Spain and Switzerland.

Neither BSE among cattle, nor the new human variant of CJD, have been found in the United States. The Department of Health and Human Services is working with the U.S. Department of Agriculture and other partners in taking special precautionary steps to prevent BSE, commonly known as "mad cow disease," from entering the United States and posing a public health threat.

By KURT SAMSON, UPI Medical Writer

Copyright 2001 by United Press International.

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