FDA Warning Letter To L’Oreal Marketing. The U.S. Food and Drug Administration (FDA) has issued a February 12 warning letter to L’Oreal for the improper marketing of its Rosaliac AR Intense and Mela-D Pigment Control. According to Regulatory Affairs Professionals Society (RAPS), the agency said these products are being marketed as drugs rather than cosmetic products.
Cosmetic products are not heavily regulated by the FDA. Drugs and medical devices, however, need to have evidence backing their safety and efficacy before they are placed on the market. Cosmetic companies can, however, be reprimanded for making false claims about their products.
Cosmetic Product Is Intended To Be Rubbed
According to RAPS, a cosmetic product is defined as an item “intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness or altering the appearance.”
The letter said the products were marketed in a way that makes them drugs under the FD&C Act. The FDA cited claims that the product could reduce “visible redness and sensations of discomfort” and “treat dark spots and discolorations” as improper because they suggest that the products can be used to “cure, mitigation, treatment or prevention of disease”, particularly, rosacea.
This is not the first time the FDA has warned L’Oreal over improper marketing. In 2012, a similar letter was sent to the company’s subsidiary, Lancôme USA, for making claims that their product could rebuild collagen, regenerate hydroproteins, repair micro-injuries, boost the activity of genes and promote cell regeneration.