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.He cited the alpha-hydroxy acid-containing exfoliant treatments -- still a booming category in the industry -- as a possible candidate.Trying to set limits on cosmetic ingredients is a new regulatory angle in the perennial "drug versus cosmetic" debate between the industry and the FDA.Until now the battle has been fought over whether cosmetics marketing claims are overstepping their bounds by making drug claims, a struggle the FDA has frequently won."Our concern is that hormones are questionable ingredients for cosmetics. There are people sensitive to steroids," said Bailey, defending the hormone proposal."We're defining what part of the playing field is cosmetics and what part is drugs," he added. "What we proposed is that if you use this ingredient at a certain level it is for a cosmetic effect. If it's at a higher level, then it would be for a drug use."The FDA's interest in setting hormone limits "is a serious legal question," contended Alan Kaplan, a Washington attorney who has worked on cosmetics and other agency issues. "If the FDA can do this, can they leapfrog and do it with other ingredients?"Bailey said the FDA isn't weighing in on hormones as a means of requiring pre-approval for other cosmetics ingredients. Instead, the agency wants to apply the same standards for cosmetics ingredients as for over-the-counter drugs.Marsha Cohen, a professor with the Hastings College of the Law in San Francisco who specializes in FDA issues, said the hormone proposal is an efficient way to police those cosmetics that contain ingredients which also serve a drug purpose."It seems to me that you would want this regulation because business would want to know what the line is and would want to stay on the right side of it. But if you want to keep selling a dream, then you may not want them to draw this line," she said.Even the FDA acknowledges that the hormone regulations may seem to stray from traditional agency practice, particularly since cosmetics containing hormones have been part of the agency's voluntary registration of cosmetics product ingredients since the program started in 1972."At that time, it was the agency's intent to permit the registration of these types of products as cosmetics, but with the understanding that these products are legally both drugs and cosmetics," the agency said in its proposal."However, the original category designations have been interpreted by cosmetics manufacturers and others to mean that the FDA considered these products to be exclusively cosmetics, which certainly is not the case."The CTFA's Donegan countered that the FDA, in developing its hormone-as-a-drug argument, is ignoring the Food, Drug and Cosmetics Act that defines the difference between a cosmetic and drug, according to a product's "intended use.""Cosmetics ingredients are incorporated in cosmetics products at levels that serve a valid and appropriate cosmetics function, regardless of whether they may also affect the structure or function of the body at those levels," Donegan wrote the FDA in response to its proposal."The intended use of all of these ingredients, however, is to beautify, not to have some therapeutic or related drug effect."

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