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

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

The US Food and Drugs Administration has issued a letter to L’Oreal USA advising the firm to consider reclassifying two La Roche-Posay skincare products as drugs.

In a letter to L’Oreal USA dated February 12, the FDA advised the company that claims it makes on the La Roche-Posay website about the medical effectiveness of two products requires them to be classified as drugs according to section 201 of the Federal Food, Drug and Cosmetic Act.

The two products are Rosaliac AR Intense and Mela-D Pigment Control.

Statements about the products which have been flagged up by the FDA include, “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 to respond with an explanation detailing 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.

William A. Correll, Acting Director of the Office of Compliance at the Centre for Food Safety and Applied Nutrition, wrote, “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.”