FDA Issues Warning Letter to L’Oreal for Skin Pigmentation Claims

Recently, the US Food and Drug Administration issued a Warning Letter to L’Oreal USA for marketing its cosmetic products, “Rosalic AR Intense” and “Mela-D Pigment Control,” with claims deemed by FDA to be drug claims.

FDA’s Warning Letter to L’Oreal may signal that the Agency is once again closely scrutinizing personal care product marketing claims. FDA last took aggressive enforcement action against cosmetic products back in 2012 when it issued similar Warning Letters to 8-10 cosmetics companies for marketing products with aggressive anti-aging performance claims. FDA states in the L’Oreal Warning Letter that use of the below noted performance claims causes the products to be adulterated and misbranded under the Federal Food, Drug and Cosmetic Act:

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 rosacea on 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”

While cosmetics are commonly marketed to consumers for a variety of skin conditions, FDA frequently objects to product promotions that specifically mention the name of a skin condition (e.g., rosacea), as well as when performance claims are used, which may suggest to FDA that a product is intended for use in the cure, mitigation, treatment, or prevention of disease and/or is intended to affect the structure/function of the human body.


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