Government health officials have sent a warning letter to L’Oreal USA, indicating that the company is improperly marketing two of its skin care products by suggesting that they are intended for medical purposes, which would classify the products as drugs under the Federal Food, Drug, and Cosmetic Act.
The FDA issued a warning letter to L’Oreal USA on February 12, informing the company that the advertising of “Rosalic AR Intense” and “Mela-D Pigment Control” are in violation of federal law by promoting medical benefits that have not been established or approved by the drug regulatory agency.
The warning letter requests that L’Oreal stop marketing the skincare products with language that makes them sound like drugs, by suggesting that the products affect the structure or any function of the human body.
“Rosalic AR Intense” and “Mela-D Pigment Control” are promoted on the manufacturer’s website using language that indicates the products are intended to cure, mitigate, treat, or prevent diseases, the FDA letter indicates. According to the FDA, the language and application examples displayed on L’Oreal’s website for the products imply they affect the structure or function of the human body, which classifies the products as “new drugs” under the Federal Food, Drug, and Cosmetic Act. Under this act the “new drugs” require approval by the drug regulatory agency and introduction of the products into interstate commerce before granted approval is illegal.
The FDA warns that on L’Oreal’s website, Rosaliac AR Intense products imply drug altering medical benefits by providing localized redness intensive serum, reducing visible redness and sensations of discomfort, reducing redness with a long lasting efficacy, and that usage of the product as an alternative to laser treatment.
The Mela-D pigment Control products were cited in the warning letter for claiming to provide concentrated dark spot correcting serum, treatment of dark spots and discoloration, and specifically recommended for hyperpigmentation and dark spots.
The FDA further claimed that the Rosaliac AR Intense products are offered for treatment of conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, creating a danger to consumers who may not know how to properly use the drug safely for its intended purposes.
Unlike drugs, which are required to be shown to be safe and effective prior to entering the market, cosmetic products are not required to undergo review before being marketed to consumers. However, the FDA sets strict guidelines on how cosmetic products can be marketed to consumers.
Under federal law, cosmetic products are any product that is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or applied to the human body for cleansing or beautifying purposes. Cosmetic products are prohibited from using language that implies the products could heal, cure, or otherwise affect the structure or function of the body.
The warning notice gives L’Oreal USA 15 working days to respond to the letter with the specific steps the company has taken to correct the violations. L’Oreal is also mandated to provide an explanation of each step being taken to identify violations and make corrections to ensure that similar violation will not occur again.
L’Oreal can challenge the FDA’s opinion by submitting the reasoning and any supporting information for the agency to consider. However, failure to comply with either an official challenge of opinion or by taking the corrective action could result in legal action including unlimited seizures, or injunctions.