FDA WARNING_LETTER - Loreal Usa

The FDA issued a Warning Letter to L'Oréal USA regarding products sold on www.laroche-posay.us, specifically "Rosalic AR Intense" and "Mela-D Pigment Control." An FDA review in December 2014 found that claims made for these products on the website cause them to be considered unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.

The products are promoted for uses such as "cure, mitigation, treatment, or prevention of disease" and "affect the structure or any function of the human body." Examples of drug claims for "Rosalic AR Intense" include "Reduces visible redness and sensations of discomfort" and "help reduce redness with a long lasting efficacy," with user testimonials mentioning "rosacea" and "broken capillaries." For "Mela-D Pigment Control," claims include "Use to treat dark spots and discolorations" and "Hyperpigmentation and Dark Spots."

Since these products are not generally recognized as safe and effective for these uses, they are "new drugs" and require prior FDA approval, which they lack, violating sections 201(p) and 505(a) of the Act. Furthermore, "Rosaliac AR Intense" is misbranded under section 502(f)(1) because it addresses conditions not amenable to self-diagnosis, meaning adequate directions for layperson use cannot be provided.

L'Oréal USA is required to