On September 7, 2012, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to high-end cosmetics maker, Lancôme USA, due to product claims on the company’s website.  The FDA has taken the position that these claims demonstrate the products are “intended to affect the structure and function of the body” rendering them drugs under the Federal Food, Drug, and Cosmetic Act.  The products cited by the FDA include those in the Génifique, Absolue, and Rénergie lines of products.  The specific claims made for these products to which the FDA objects include:

• “boosts the activity of genes and stimulates the production of youth proteins.” 
• “boosts the activity of genes.” 
• “…has been shown to improve the condition around the stem cells and 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.”

While the allegedly violative products do not explicitly claim to treat diseases or health conditions, it appears that their references to biological activity involving “genes,” “proteins,” “stem cells,” “peptides,” and “collagen” are viewed by the FDA as being outside the realm of what the Agency considers to be acceptable cosmetic claims.  This is significant because nearly identical claims for cosmetics and cosmeceuticals have become commonplace in today’s “new age” cosmetics market.

In the last decade, the FDA has issued few Warning Letters for cosmetics and generally has only done so when product claims include direct references to diseases and health conditions like acne, eczema, diabetes, or cancer.  However, the FDA’s Warning Letter to Lancôme signals a potentially significant new enforcement position that the Agency may be taking towards cosmetics, and, more specifically, towards cosmeceuticals that include scientific language to describe their biologically-enhanced benefits.  Lancôme has 15 days to respond to the FDA’s Warning Letter.  We will continue to follow this and other FDA enforcement actions related to cosmetics.  For additional information on this issue, please contact Georgia C. Ravitz or Jim Hartten at Arent Fox LLP. Click here to view the FDA’s Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htm