FDA issues warning letter to L’Oréal, La Roche-Posay

In a letter to L’Oreal USA dated Feb. 12, 2015, the FDA advised the company of two products offered for sale on its website, www.laroche-posay.us, that are promoted for uses that classify the products as drugs under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act.

“The claims on your website indicate that the products are intended for use in the cure, mitigation, treatment or prevention of diseases and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act,” William A. Correll, acting director of the office of compliance, Center for Food Safety and Applied Nutrition, wrote in the letter.

The two products at issue with the FDA are Rosaliac AR Intense and Mela-D Pigment Control.

Some of the products’ claims providing evidence they are intended for use as drugs included “localized redness intensive serum,” “reduces visible redness and sensations of discomfort,” “concentrated dark spot-correcting serum,” and “use to treat dark spots and discolorations.”

According to the letter, L’Oréal has 15 working days after its receipt of the letter to respond with a detailed explanation as to the steps being taken to correct the violations, or to provide reasoning as to why the company does not believe the products are in violation of the Act.

Reference: www.fda.gov.