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The Pitfalls and Burdens of Claims

By: Marie Alice Dibon, PharmD
Posted: February 2, 2010, from the February 2010 issue of GCI Magazine.

Every few years, the same question arises: will the U.S. Food and Drug Administration (FDA) ever push to create a “cosmeceuticals” category? The term, widely used by the industry, has no legitimacy. It was created to imply that cosmetics are designed to do more than just beautify, and somehow treat without really being drugs.

Was the intent of industry, when it began using that term, to really see a new category emerge that would have given products more credibility? If so, did the industry ever think that the risk of seeing the U.S. Congress regulate that category was real? And, in this case, what were we thinking? Yes, there would be grounds for such a category in the letter of the law, given the way the U.S. system functions, essentially based on claims. When a product claims to repair DNA, impact stem cells or repair stretch marks or even wrinkles, it is no longer a cosmetic claim. As shrewd as certain legal teams may be in making those claims—managing to not “really” make the claims yet leaving the implication there that these are effects of the finished product—some have been caught at their own game.

But it must be admitted, the actions of the FDA against such claims, or family of claims, have remained mild, at best.

In fact, what seems to be driving the FDA is hardly ever solely the claim and the deception that some claims represent, considering that they are often not backed by solid clinical evidence (no, before-and-after pictures are not solid clinical evidence) and only in vitro studies.