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Antiperspirant Makers Sweat Out FDA's Data Request

By Cindy Skrzycki
Tuesday, February 15, 2005; Page E01

In June 2003, the Food and Drug Administration issued a final rule saying that antiperspirants, if formulated and tested properly, could safely and effectively reduce the amount of sweat coming from users -- for up to 24 hours.

The personal-products industry, which sold $1.7 billion worth of stick and spray deodorants and antiperspirants last year, was almost immediately up in arms, so to speak. Since it took the FDA more than 20 years to make the ruling -- because of backlogs in the over-the-counter drug-review system -- they wanted the agency to include extended coverage for longer than 24 hours -- typically 48 hours.

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(An antiperspirant is regulated as an over-the-counter drug because it affects the functioning of the body by plugging up pores. A deodorant is considered a cosmetic because it masks odor by reducing underarm bacteria; it does not stop sweating.)

Revlon Inc. and the Cosmetic, Toiletry, and Fragrance Association quickly filed petitions invoking their First Amendment rights to commercial speech and the provisions of the Administrative Procedure Act, the granddaddy statute of regulatory procedure. They claimed the FDA was overlooking powerful new products that entered the market since the agency's first proposal in 1982.

Revlon's attorney, Peter Barton Hutt, told the FDA that the rule violated the company's right to make "truthful and non-misleading claims" and that the agency did not properly respond to comments. At the same time, Revlon supplied two studies showing it could support its claims of extended efficacy, which the agency acknowledged.

So last October, the FDA said it would reopen the record on the antiperspirant rule. It told companies it was all right to make and market enhanced-duration products as long as they supply studies to back up their claims.

For companies such as Revlon, this was a positive development since it was already selling a Mitchum antiperspirant and deodorant that says on its label: "So effective, you could skip a day."

According to Unilever's "science of sweating" research, humans are the sweatiest animals alive -- and that sweat can be, well, smelly, particularly if it is emotionally induced. Humans can sweat up to 10 liters a day, though normally, it's about 1 liter, with 0.0006 liters per day -- a tenth of a teaspoon or so -- coming from the axilla, better known as the armpit.

Much of the growth in the market has come from new men's antiperspirants, products such as Unilever's Axe, which promises "Dry Pits Win," and Procter & Gamble's High Endurance Old Spice.

Matthew R. Holman, FDA's expert on sunscreens and antiperspirants, said the agency needs proof of whether these extended-duration products work. "If we don't get any data, we're not likely to approve the claim," he said.

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