Is FDA Turning the Clock Back on Anti-Aging Claims?
In a surprise move last week, the US Food and Drug Administration (FDA) ever so quietly – and for reasons not yet completely clear – withdrew Import Alert 66-38, “Skin Care Products labeled as Anti-Aging Creams” (IA 66-38). For almost 30 years, that Import Alert had been heavily utilized by the FDA as a basis for preventing the importation of skin care and cosmetic products labeled with “anti-aging” claims. The Import Alert cites claims that a product will “COUNTERACT” or “RETARD” the aging process, or “REJUVENATE,” “REPAIR,” or “RESTRUCTURE” the skin, as examples of statements that the FDA could view as “drug” claims, which could result in denial of entry at the port.
Not only was IA 66-38 the basis for port-of-entry detentions, it has also widely been used by the class action plaintiffs’ bar as a basis for asserting that various anti-aging cosmetics offered for sale on the domestic market are being improperly promoted in violation of the Federal Food, Drug, and Cosmetic Act, which in turn allegedly violated state consumer protection laws.
Although the FDA has confirmed that IA 66-38 has officially been withdrawn, the FDA’s rationale for doing so, and what it will mean going forward for the anti-aging industry, remains murky. The withdrawal may represent a recognition that anti-aging claims of this type are widely and appropriately used in the labeling of domestically manufactured products (and thus should not form a basis for import detention). It is also possible that the withdrawal is part of a larger re-examination of cosmetics policy as part of the Trump Administration’s current regulatory reform efforts. Of course, the FDA still has the legal authority to detain cosmetic and skin care products bearing “drug” claims under another Import Alert 66-41, entitled “Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S.” Nevertheless, we are optimistic that the withdrawal of IA 66-38 will breathe new life into the anti-aging marketplace.
Arent Fox's Food, Drug, Medical Device & Agricluture group will continue to monitor developments involving FDA’s withdrawal of IA 66-38 and what it means for the personal care products industry. If you have any questions, please contact Georgia Ravitz, Naomi Halpern, or the Arent Fox professional who usually handles your matters.