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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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In the few instances where companies were actually prosecuted by the FDA, there seems to have been other interests at play.

A Short Case Study

When consumer safety is at stake, the FDA acts swiftly. After all, its first priority is the public’s protection. However, it is not often the case with the vast majority of companies making drug claims on their products. But when it is, the FDA’s actions do not stop at the standard warning letter.

In the case of one brand’s eyelash cosmetic, in November 2007, not only was a warning letter issued but the FDA had more than 12,000 units of the product seized. The company stopped manufacturing the product immediately.

In that case, the product was mislabeled (the brand made drug claims, i.e. to increase eyelash growth), it was considered an adulterated cosmetic (it contained an active ingredient, bimatoprost, FDA-approved to treat elevated intraocular pressure) and was potentially dangerous to users as bimatoprost presented side effects that could lead to decreased vision.

It is interesting to note that, in this case, the product was an unapproved version of a glaucoma-treatment drug, Lumigan from Allergan, and the only approved drug in its category. In another fairly recent instance of an FDA warning letter for a beauty product making a drug claim, a a brand owner is informed that the claims made on its product are drug claims. Some of the claims that are listed are the stretch mark claims, but also, and more interestingly, the “better than Botox” claim, and an array of very standard claims found on many other cosmetic products:

  • Optimum glycosaminoglycan and collagen synthesis […] to diminish fine lines, wrinkles and crow’s-feet.
  • Superior wrinkle-reducing properties of a patented oligo-peptide.
  • Significant improvement in wrinkle depth, length, wrinkle volume. [Product] actually increases the synthesis of new collagen ... , making your skin thicker and firmer.