What are you searching for?

Sign in
Company News, Regulations

FDA Warns L’Oréal

Food and Drug Administration targets L'Oréal for the third time in as many years over label claims.

Author Image

By: TOM BRANNA

Editor

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:

 
  • “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.

Keep Up With Our Content. Subscribe To Happi Newsletters

Topics