Letter to the Editor We applaud Senators Feinstein and Collins’ efforts to modernize and improve the regulation of cosmetics by the US Food and Drug Administration (FDA).1 Two additional policy points should be considered.
First, products that blur the boundary between cosmetics and drugs warrant additional regulatory scrutiny. Termed cosmeceuticals, these are cosmetics with an active ingredient that often claim drug-like benefits and operate in a regulatory gray zone. For example, In 2007, US marshals on behalf of the FDA seized $2 million of Jan Marini’s Age Intervention Eyelash, a cosmetic that claimed to grow eyelashes. The product was adulterated with bimatoprost, the active ingredient in the topical drug Latisse, and posed an ophthalmic risk.2 Some cosmeceuticals market the inclusion of human stem cell cultured media claiming that the cytokines and growth factors can regenerate skin and restore youth. Given the lack of regulatory oversight, these products may pose a safety risk to consumers. We reviewed warnings sent by the FDA to cosmetics manufacturers for making drug-like claims and noted a 1450% (4 to 62 letters) increase from 2007 to 2011 to 2012 to 2017. Specifically, 8 warning letters were directed to manufacturers promoting stem cell ingredients. At present, the FDA has limited resources to identify and evaluate cosmetics that may include drug-adulterants, such as bimatoprost or high-potency corticosteroids.3
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Janetos TM, Kwa M, Xu S. Regulation of Cosmetics. JAMA Intern Med. 2018;178(7):1000–1001. doi:10.1001/jamainternmed.2018.2452
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