On September 7, 2012, the Food and Drug Administration (FDA) sent a Warning Letter1 to Lancôme, a division of L’Oreal, concerning claims made on the company’s website for its skin care products. The claims appear on ages of the company’s website that describe specific products, which are several clicks from the website’s opening page. This suggests that the FDA conducted more than a quick survey of the company’s labeling. It has been some time since the FDA took aim at scientific claims of “anti-aging” activity for cosmetic products and by targeting a cosmetic industry leader, the agency undoubtedly intends the letter to be an example to others. The Warning Letter was sent to Lancôme by the Office of Compliance within the Center for Food Safety and Nutrition, which houses the Office of Cosmetics and Colors. This implies that the FDA has decided, as a policy matter, to rein in claims made for cosmetics that the agency believes are beyond puffery and that represent serious and drug-like effects upon the structure and function of the body. Previous Warning Letters to the cosmetic industry have tended to include references to drug representations reserved for over-the-counter drug products and have not been issued based solely upon “anti-aging” structure/function intended uses.
The FDA states that claims found on the Lancôme website in August, render them unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and that their marketing with these claims violates the FDC Act. The claims in question include the following:
- “Boosts the activity of genes and stimulates the production of youth proteins.”
- “A powerful combination of unique ingredients—Reconstruction Complex and Pro-Xylane™, a patented scientific innovation—has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality” or “to stimulate cell regeneration to reconstruct skin to a denser quality.”
- “See significant deep wrinkle reduction in UV damaged skin, clinically proven.”
- “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.
- “Unique R.A.R.E. oligopeptide helps to re-bundle collagen.”
To date, the Lancôme website does not appear to have been altered and the company is likely considering how to respond before the 15-working day deadline is reached at the end of this month.
Between 1987 and 1989, the FDA sent Regulatory Letters (now called Warning Letters) to over 30 companies informing them that the agency considers “most of the anti-aging and skin physiological claims ... to be drug claims.” Those Regulatory Letters helped to identify the claims the FDA considered to be outside of the cosmetic category and beyond “puffery.” The FDA classified any claims that a product counteracts, retards, controls aging or the aging process, or that a product rejuvenates, repairs, or renews the skin, as drug claims.
The Warning Letter to L’Oreal serves the same purpose today in delineating the limits of the FDA’s regulatory enforcement discretion in the face of new structure and function claims based upon today’s scientific discoveries.