KENNEDY COMPROMISE WITH BEAUTY INDUSTRY ENDS IMPASSE ON FDA

Byline: Joyce Barrett

WASHINGTON — Publicly berated for the past week by Sen. Edward Kennedy (D, Mass.), the beauty industry has settled a dispute over the right of states to enact labeling requirements for cosmetics.
The dispute centered on a provision in the Food and Drug Administration reform package, now before the Senate, that would have banned states from requiring warning labels on nonprescription drugs and cosmetics. Kennedy had been vigorously fighting this provision.
The agreement was announced Thursday after the cosmetics industry approached Kennedy’s staff in an effort to end the standoff.
Under the agreement, states cannot issue labeling requirements if the FDA already has its own rules on a specific product. But states can issue their own regulations if there is no FDA rule. Kennedy said that the reason to preserve states’ ability to act is important because the FDA has been “so weak.”
Ed Kavanaugh, president of the Cosmetic, Toiletry and Fragrance Association, characterized the agreement as a victory for the industry and said in a statement that the industry “walked away with an essential principle intact: product labeling should strive to be uniform across all 50 states, and the federal government is best suited to set national standards.
“This agreement means that the FDA can and will continue to preempt the states on issues where they take a position.”
FDA regulations over cosmetics are largely after the fact because there is no requirement for pre-market approval for products or ingredients. If complaints are received about a product or there are scientific data showing a product or ingredient is dangerous, the agency then has the power to investigate. The agency does not have the authority to force product recalls but can obtain court orders insisting that manufacturers don’t produce or distribute any more of the dangerous product.
The FDA operates under a 1938 law, written at a time when cosmetic formulas were simpler and science was not as advanced, said John E. Bailey, director of the FDA’s Office of Cosmetics and Colors. Kennedy’s effort comes at a time when states are increasingly attempting to enact tougher laws governing cosmetics, he said. They have so far largely been unsuccessful because of efforts to defeat them by the cosmetic industry, Bailey said.
“States can augment what happens at the federal level,” Bailey said. “They have a great deal of flexibility and are interested in filling this perceived gap in our regulations.” Bailey predicted that, if the agreement were to survive the legislative process and become law, the cosmetics industry could attempt to preempt state initiatives by petitioning the FDA for labeling regulations on certain products.
Speaking to reporters after announcing the compromise on the Senate floor, Kennedy said the administration had agreed to the revision, but added that the issue had been presented as a labeling issue and not as a safety issue, which he still insists it is.
Cosmetics labeling, however, was only one of Kennedy’s objections to the FDA reform package. Because of other reasons, Kennedy still isn’t ready to endorse the reform package, but an aide said changes currently being negotiated could persuade him.
He forced the compromise with the industry despite little support among his Senate colleagues for his continued filibuster on the FDA bill. He did have support from the administration, which had threatened to veto the FDA measure if the cosmetic labeling preemption were included.
In announcing the compromise, Kennedy pointed out that several items on the market such as alpha hydroxy acid, feminine hygiene products and talc posed safety threats to consumers. On the fruit-derived alpha hydroxy acids, the Cosmetic Ingredient Review panel concluded in 1996 after a two-year study that the face-peeling treatment was not harmful. The FDA had raised concerns that the acids could strip skin of its natural protective barriers to sun and the elements.
The popularity of moisturizers containing alpha hydroxy acids as exfoliants has greatly fueled cosmetics industry sales in recent years. FDA officials have called alpha hydroxy acids a new breed of products, combining cosmetics and pharmaceutical qualities, a hybrid they call “cosmaceutical.” That description has been rejected by the industry. The FDA received a 1996 complaint that Alpha Natural All Over Body Polisher, by Del Laboratories Inc., caused pain and tissue damage, according to FDA records.
Kennedy complained that feminine hygiene products, with sales of about $100 million yearly, pose serious health hazards because some have been shown to cause upper reproductive tract infections, pelvic inflammatory disease, ectopic pregnancies and infertility. For these reasons, they need improved warning labels to inform consumers of the hazards, Kennedy said. There were no complaints filed with FDA in 1996 on feminine hygiene products, according to records. Earlier this year the FDA convened a joint advisory committee meeting to consider the safety of vaginal douche products and found some correlation between douches and ectopic pregnancies. The committee recommended that the labeling be reviewed and strengthened, and the FDA is still considering the recommendation.
On talcum powder, Kennedy said it also needs warning labels because it has been suspected of causing cancer, and may be linked to ovarian cancer. According to 1996 FDA records, a complaint was made that Odyssey Perfumed Talc by Avon Products Inc. caused dermatitis.
Almost three years ago the FDA reviewed data on talc and found a nominal link between ovarian cancer and talc. No action has been taken.

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