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FDA Warning To L’Oreal Creates Uncertainty For Anti-Redness, Dark Spot Treatments

 
• By Ryan Nelson

In a Feb. 12 warning letter, just the descriptors for two L’Oreal/La Roche-Posay products – a “Localized Redness Intensive Serum” and “Concentrated Dark Spot Correcting Serum” – are cited by FDA as evidence that the products are intended for use as drugs. The warning raises questions about the viability of those categories for cosmetics firms intent on staying off FDA’s radar.

FDA has served L’Oreal SA with the firm’s second warning letter in three years in what could be intended as a signal to the cosmetics industry regarding claims in an increasingly popular segment – products that address hyperpigmentation – as well as a more established benefit in the dermocosmetic arena, redness reduction.

The agency’s Feb. 12

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