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COSMETICS MAKERS WARY OF FDA PLANS REGS STUDIED FOR SUNSCREENS, HORMONES

By Published on .

BOCA RATON, Fla.-Cosmetics marketers could be the next to be affected by the Food & Drug Administration's regulatory activism.

"This is a very active time at the FDA," Peter Barton Hutt, outside counsel to the Cosmetic, Toiletry & Fragrance Association, warned executives attending the group's recent annual meeting here. "Under President Bush, the FDA was on a strong leash and had a big muzzle. Under President Clinton, the leash and muzzle are off and [FDA Commissioner] David Kessler is in a position to do what he wants."

"I think we [the industry] are in for an extended period of an activist FDA," said Avon Products Chairman Jim Preston.

Of immediate concern is the FDA's sunscreen proposal. In its current form, the plan would regulate any traditional skincare, color cosmetic or hair product containing sunscreen as an over-the-counter drug. The CTFA will respond by March 21 and is expected to seek exemptions for these products.

But the FDA has far more on its plate. The government agency's Dental Products Panel is considering whether plaque claims, having proliferated in toothpastes, should be classified as drug or cosmetic claims.

An even more troublesome FDA proposal seeks to reclassify all beauty products containing more than a certain level of hormones as drugs.

That suggestion has left the CTFA and its industry members worried that a precedent may be established for the regulation of other cosmetic products, including the much-in-demand alpha hydroxy acid-based skin treatments and the latest thigh smoothing creams now sweeping the U.S.

The hormone proposal would only affect "a handful of products," including those with pregnenolone acetate, progesterone and estrogen, said John Bailey, acting branch chief of the FDA's Division of Cosmetics & Colors. Products he cited included four from Dorothy Gray, and Estee Lauder Skin Perfecting Cream Firming Nourisher.

Mr. Bailey said it was unlikely the FDA would try to similarly regulate alpha hydroxy acid levels though it remains a possibility. He acknowledged, however, that the agency is "watching claims made by national marketers."

He also said the FDA is watching alpha hydroxy acid-based products being promoted for use in skincare salons. The agency is trying to get information on salon practices to determine whether some services, such as facial peels using high levels of the ingredient, would best be left to dermatologists.

The spillover effect of the hormone review could also affect a cottage industry of thigh slimming creams containing the prescription asthma drug aminophylline. The FDA is reviewing that ingredient's use.

Although this group of products doesn't encompass such nationally marketed anti-cellulite brands as Christian Dior's hot selling Svelte, industry executives are concerned the FDA may look at claims for those, too.

Observed CTFA VP-General Counsel Thomas Donegan: "It's no secret that we're concerned about the hormone issue ... it could become a stalking horse for going after something else."

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