FDA Warning To L’Oreal Creates Uncertainty For Anti-Redness, Dark Spot Treatments
This article was originally published in The Rose Sheet
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.
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A key component of FDA’s enforcement strategy in the cosmetics space is monitoring companies’ websites for overreaching product claims and issuing warning letters accordingly. Examination of past offenders’ current sites and updated claims offers potential visibility into language the agency will and will not tolerate when it comes to promoting skin-care benefits.
Cosmetic firms already are being closely watched by FDA for overreaching product claims, but if formal good manufacturing practices are established for the sector down the road under regulatory reform legislation, companies could be targeted increasingly with warning letters like that issued to Beauty & Health International for quality-control violations at its Garden Grove, California facility.