The Food and Drug Administration (FDA) has issued a warning to the president of Lancôme USA about claims made for some of its cosmetic products, noting that they are being promoted “for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act. The claims on your web site indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act.”

Among the claims that FDA targets are (i) for Génifique Youth Activating products, “[B]oosts the activity of genes and stimulates the production of youth proteins”; (ii) for Absolute Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen, “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”; and (iii) for Rénergie Microlift Eye R.A.R.E.™ Intense Repositioning Eye Lifter, “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques … helps recreate a younger, lifted look in the delicate eye area” and “[U]nique R.A.R.E. oligopeptide helps to re-bundle collagen.”

According to the agency, “[y]our products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act. … [A] new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application.” Unless the company addresses and corrects these issues, FDA warns that it may take enforcement action without further notice, including “injunctions against manufacturers and distributors of illegal products and seizure of such products.”