FDA WARNING_LETTER - Lancome - September 07, 2012

On September 7, 2012, the FDA issued a Warning Letter to Lancôme USA after reviewing their website in August 2012. The FDA determined that several Lancôme products, including Génifique Youth Activating Concentrate and Absolue Precious Cells Advanced Regenerating and Reconstructing Cream, were promoted with claims that cause them to be classified as drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act).

Examples of violative claims include "boosts the activity of genes and stimulates the production of youth proteins," "stimulate cell regeneration to reconstruct skin to a denser quality," and "helps to re-bundle collagen." These claims indicate the products are intended to affect the structure or function of the human body.

Because these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act. Marketing new drugs without prior FDA approval, in the form of an approved New Drug Application (NDA), violates section 505(a) of the Act.

Lancôme was instructed to take prompt action to correct all violations, including reviewing their website, product labels, and other labeling to ensure compliance. Failure to do so could result in enforcement actions such as injunctions or product seizure. Lancôme was required to respond in writing within fifteen working days, detailing corrective steps or providing reasoning if they