02.25.15
The Food and Drug Administration has issued a warning letter to L'Oréal for its Rosalic AR Intense and Mela-D Pigment Control products. According to FDA, the products make drug claims under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)].
Specifically, FDA took umbrage with claims for Rosaliac AR Intense:
Specifically, FDA took umbrage with claims for Rosaliac AR Intense:
- “Localized Redness Intensive Serum”
- “RECOMMENDED FOR: Redness-prone skin, experiencing overall redness, flushing and sensations of discomfort”
- “Reduces visible redness and sensations of discomfort”
- “[F]ormula combining 3 effective ingredients to help reduce redness with a long lasting efficacy”
- “I have rosaceaon my neck when I get warm or under stress. This product really works to keep it under control!!!”
- “I have broken capillaries and generalized redness on several areas of my face. I was told laser treatment was the only fix. Then…the miracle of Rosalic AR!”
- "With powerful Ambophenol [0.5%] to visibly reduce redness"
Mela-D Pigment Control:
- “Concentrated Dark Spot Correcting Serum”
- “Use to treat dark spots and discolorations”
- “Recommended For: Hyperpigmentation and Dark Spots”
- "With 2% Kojic Acid to visibly reduce the intensity of dark spots"
According to FDA, both Rosalic AR Intense and Mela-D Pigment Control products are not generally recognized as safe and effective for the above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.