By  on March 4, 1994

WASHINGTON -- A Food and Drug Administration proposal to limit two hormones used in moisturizers and to ban another type altogether is shaping up to be this year's big battle between the agency and the cosmetics industry.

"[The FDA] is taking the position that simply because an ingredient has a cosmetic purpose, at a certain level it becomes a drug," said Thomas J. Donegan Jr., vice president and general counsel for the Cosmetic Toiletry and Fragrance Association.

"They haven't raised any safety concerns. If they can document there is a legitimate safety concern -- and we don't think there is -- then they would have a legitimate reason to act."

Furthermore, if the FDA gets its way, Donegan said, the industry fears a precedent would be established for other ingredients. "We think this is a back door," he said.

In 1989, the agency proposed standards for over-the-counter drugs containing the hormones pregnenolone acetate or progesterone.

These same hormones are now the subject of the new limits being proposed for cosmetics.

The hormones, labeled by the CTFA as "classic cosmetic ingredients in classic cosmetics products," are used in moisturizers to retain water and firm the skin.

The proposals call for limiting the concentration of pregnenolone acetate to 0.5 percent and progesterone to 5 percent, based on a National Academy of Sciences and National Research Council study.

The study concluded that hormones not exceeding this level don't affect the "structure or function of the body." This is the standard by which a drug is measured.

In addition, the FDA wants to ban so-called "natural estrogens" in cosmetics, citing the lack of scientific data determining at what point the hormones affect the body's structure or function.

In proposing to stop estrogen use in cosmetics, the agency said it is erring on the side of caution because available data shows that "at some levels the ingredients affect the structure or function of the body."

John Bailey, acting branch chief of the FDA's Division of Cosmetics and Colors, said the FDA hasn't precluded the use of a similar regulatory format in the future for other ingredients.

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