Cosmeceutical Claims May Be Headed Into FDA's Radar
This article was originally published in The Tan Sheet
Executive Summary
FDA under the Obama administration may cast a sharper eye on cosmeceuticals than the agency has in years past, according to Georgia C. Ravitz, a food and drug law lawyer at Arent Fox
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FDA under the Obama administration may cast a sharper eye on cosmeceuticals than the agency has in years past, according to Georgia C. Ravitz, a food and drug law lawyer at Arent Fox. "In the last 15 years there has been major acceptance by FDA of anti-wrinkle claims and related claims. But there could be some pushback now from our new FDA chief and her administration," Ravitz said June 30. Presenting at the annual Cosmeceuticals Conference in New York, the attorney identified cosmetic nanotechnology as an area that could invite particular scrutiny from authorities. FDA Commissioner Margaret Hamburg has indicated the agency will take a "hard look" at nanotechnology in cosmetics, according to Ravitz. Cosmeceuticals that claim to stimulate stem cells also may be on FDA's radar, she said. Although the agency made no official statements on the topic, "they are aware of it and you should expect greater FDA scrutiny," Ravitz said. FDA's "Cosmetic" Definition Is So 1938 FDA cosmetics law is tied to the definition the agency uses to separate cosmetics from non-cosmetic products, Ravitz noted. The agency codified the cosmetics definition in the 1938 Food, Drug, and Cosmetic Act; it identifies cosmetics as "articles intended to be rubbed, poured ... or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness or altering the appearance." Ravitz commented: "It is amazing to think about how advanced the cosmetic and cosmeceutical technologies have become, and then when you look at this incredibly basic definition of what FDA considers to be a lawful cosmetic, there is a major disconnect." FDA defines drugs as substances intended to affect the structure or function of the body in order to diagnose, cure, treat or prevent disease. If cosmeceuticals, as marketed - and as the portmanteau word suggests - can provide benefits to the skin that go beyond beautifying or covering up imperfections, they fall into a gray area between the two definitions. FDA does not officially recognize the term "cosmeceutical." A product that has drug-like effects is a drug and must be regulated as such, according to the agency (1 (Also see "No Concealing Cosmeceutical Claims From NAD, FTC" - Pink Sheet, 14 Jul, 2008.)). "One of the difficulties is that you have this great technology for cosmeceuticals but you really can't talk about it very much with respect to the marketing of the products," Ravitz said. A claim "can be as true as the ground I'm standing on, and FDA is not going to care about it if, in fact, they have concluded it's not a lawful cosmetic claim," she added. Interpreting "Intended" Use Key to the definition of cosmetic is the word "intended," the attorney observed. Technology approaching the performance level of drugs may go unexamined and unchallenged in a cosmeceutical product as long as associated claims and marketing language indicate the item is intended for cosmetic use. However, "at different times in the FDA, the notion of intended use has either been broadened or narrowed," Ravitz noted. FDA may take into consideration not only a product's labeling and advertising but also consumer perceptions, the product's mechanism of action and "foreseeable effect on the structure or function of the body," all of which constitute subjective versus objective intent, she said. Ravitz believes FDA will lean toward a subjective interpretation of intended use under its new leadership. At a minimum, manufacturers need to be careful about the language they use to make claims, she said. - Molly Laas ( 2 [email protected] ) |