FDA places restrictions on materials in cosmetics

Saturday, July 10, 2004

WASHINGTON -- The government told cosmetics makers Friday they can no longer use brain and spinal cord tissue from older cattle in lipstick, hair sprays and other products.

The new Food and Drug Administration regulations come in the wake of the first U.S. case of mad cow disease last December. They are aimed at preventing the disease from reaching people, where it can cause a rare but similar fatal condition, variant Creutzfeldt-Jakob disease.

Mad cow -- also known as bovine spongiform encephalopathy, or BSE -- causes the brains of affected animals to waste away.

Consumer groups complained that the regulations are insufficient, saying the government should also ban the same tissues from younger cattle and extend the prohibition to use in animal feed.

"While the risk is small, if there does happen to be an ingredient from a BSE-infected cow, the consequences would be incredibly drastic," said Rachel Weintraub, assistant general counsel of the Consumer Federation of America.

For instance, she said, cosmetics include sprays that could contain animal protein, which could be inhaled.

Caroline Smith DeWaal, head of food safety for the Center for Science in the Public Interest, said it's virtually impossible for a consumer to know from the label whether a banned product is in cosmetics.

The agency and businesses ought to put out lists of products containing bovine-derived material "so people can throw out old cosmetics and purchase new ones that are subject to this requirement," DeWaal said.

Cosmetic manufacturers said they already require their suppliers to certify that the cattle-derived ingredients sold to them are free of materials that carry BSE.

The Cosmetic, Toiletry and Fragrance Association said it is reviewing the new FDA requirements but noted that the agency has indicated in the past that the U.S. cosmetics supply is safe.

"Although our current rules are strong, when it comes to public health and safety we cannot be content with the status quo," Health and Human Services Secretary Tommy Thompson said in announcing the new prohibitions.

The FDA said it will further study the idea of keeping the cattle protein out of feed for animals, a concept it endorsed in January.

Some cattle tissue, notably the brains and spinal cords of animals over 30 months of age, can harbor prions, the misshapen proteins blamed for mad cow. The Agriculture Department earlier this year banned those tissues and other material, such as skulls and nervous system tissue connected to the spinal cord, from the products it regulates.

Among the new proposals is the removal of the risky materials from all animal feed, including pet food, to control against the possibility that feed containing prions could wind up fed to cattle even though it was meant for other species. The proposal is in line with a recommendation in February by an international review panel created by the Agriculture Department.

The agency also banned from use in cosmetics cattle-derived tallow with a concentration of impurities greater than 0.15 percent. Rendering plants make tallow from fat, and the impurities could include prions.

The rule will allow the rendering industry to keep supplying tallow, which is used in cosmetics as well as pharmaceuticals, said Tom Cook, president of the National Renderers Association, a trade group.

"BSE has never been considered a factor in tallow anyway," Cook said, adding that the industry had feared the FDA might restrict tallow impurity so much that plants couldn't produce a grade of tallow in sufficient quantities to meet the demand for it.

By calling for more public comment on the feed question, the agency delayed implementing proposals it made in January to ban cattle blood in feed for calves, CSPI's DeWaal said. "The Bush administration seems to be breaking its promise to more formally regulate animal feed," she said.

But William Hueston, director of the Center for Animal Health and Food Safety at the University of Minnesota and a member of an international review panel established after the mad cow case last year, challenged the claim that the government was moving too slowly.

"I spent nine years in the federal government, and I would say that this is still remarkably fast," said Hueston. "They are pushing this aggressively within the context of our democratic system. Our government is not designed for stuff that moves fast."


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Food and Drug Administration: http://www.fda.gov/

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