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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.

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“Basically, if you come eat on someone else’s plate, particularly one as powerful as Allergan, and you also manage to be loud about it—even if your product is not dangerous—you are more likely to get in trouble,” adds Steinberg, “But frankly, the FDA has a lot on its plate, and customer safety is its priority. It can’t possibly go after everybody that makes a claim that looks like a drug claim. It has to focus its efforts.”

Steinberg believes that there is no immediate indication that the FDA will reinforce the regulatory burden on cosmetics, given how difficult it is for the agency to keep up with the enforcement of current regulations.

George McCarty, former technical director at a major U.S. private label manufacturing company and now an independent consultant with 40 years’ experience in the industry, still believes that a lot of the claims made today could get the industry in trouble.

“When you say that you help DNA repair or that you increase collagen production, you are making a drug claim,” he says. “The moment you start saying that you are changing skin physiology, may it be by repairing damage or affecting any skin function, it doesn’t matter whether you limit yourself to the epidermis. And in most cases, we know full well we don’t limit ourselves to that. All small molecules pass the dermal-epidermal junction (DEJ). “At some point, the FDA is going to have to rule more tightly on this. Maybe it will demand more studies, maybe it will create new drug categories or maybe it will just ask us to prove that [product ingredients/activity does] not pass the DEJ.”

That would definitely be bad news for an industry that is already inundated with regulations, with no hopes in sight for anything to lighten the load.