On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics. Section 201(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 321(i)) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The Warning Letter alleges that marketing claims on the company’s website cause the products to be new drugs under section 201(p) (21 U.S.C. § 321(p)) and marketed without prior approval in violation of section 505(a) (21 U.S.C. § 355(a)).
The Warning Letter points to marketing claims for products in Lancôme’s Génifique, Absolue, and Rénergie product lines, including the ability to “re-bundle collagen,” “boost the activity of genes and stimulate the production of youth proteins,” “improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality,” and bring about “significant deep wrinkle reduction in UV damaged skin.” Because the claims “indicate that these products are intended to affect the structure or any function of the human body,” FDA contends the products are promoted for uses that cause them to be drugs under section 201(g)(1)(C) of the FDCA (21 U.S.C. § 321(g)(1)(C)) and for which they are not generally recognized as safe and effective.
Also on September 7, CFSAN issued a Warning Letter to Greek Island Labs regarding website claims for several of its skin care, eyebrow, and eyelash products. Among other things, the letter objects to claims that the products can strengthen hair growth, combat hair loss, reduce acne blemishes, and heal or prevent scarring, as well as claims that characterize the products as anti-inflammatory or anti-infectious. According to FDA, these claims demonstrate that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or function of the body, causing them to be drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) (21 U.S.C. §§ 321(g)(1)(B) and (C)).
FDA has now issued 16 Warning Letters over the past decade—five in the last two years alone—objecting to cosmetic claims regarding acne treatment, cellulite reduction, stretch mark reduction, wrinkle removal, dandruff treatment, hair restoration, and eyelash growth. These most recent Warning Letters bring to mind the 1987 Estée Lauder series of anti-aging FDA letters and underscore the Agency’s renewed concern about anti-aging claims. They also signify a potential shift in FDA’s enforcement focus toward the cosmetics industry at large, with an emphasis on internet marketing and mechanism-of-action claims.