The Food and Drug Administration (FDA), the authority controlling drugs and cosmetics marketed in the United States, sent Lancôme a warning letter involving claims associated with a series of the brand’s skincare products [1].
Medical claims
The FDA says to have reviewed Lancôme’s US website and identified, for some products, a series of claims that are should not be considered as belonging to the cosmetic category. The U.S. agency gives some examples of claims that could be considered as litigious, for instance: "Boosts the activity of genes and stimulates the production of youth proteins", " See significant deep wrinkle reduction in UV damaged skin, clinically proven".
According to the FDA, these claims are problematic because they imply that the concerned products are intended to affect the structure or any function of the human body, they are therefore pharmaceutical claims, according to the U.S. law. The agency also states that its warning letter is not an all-inclusive statement and that the brand is responsible for ensuring the compliance of all its products with all the U.S. regulations.
Actually, what does the FDA reproach Lancôme is the nature of the claims. The agency does not question whether they are true or not. Indeed, as provided by the U.S. regulations and according to the FDA’s point of view, a product producing the effects claimed by Lancôme is not a cosmetic but a drug.
Cosmetic or drug?
Under U.S. law, drugs are defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals". [2]
In practice, the border between cosmetics and drugs is far from being as clear in the United States as it is within the European regulatory framework, and a claim considered as "medical" may be enough to switch from the first to the second category.
In such a context, how to decide whether a product is a cosmetic, a drug, or both? Under the U.S. law, this is determined by a product’s intended use. The type of claims stated on the product labelling, in advertising, on the Internet, or in other promotional materials, is the first tool used by the FDA to determine whether a product is a cosmetic or a drug. Consumer perception and ingredients in the product also have to be taken into account.
The L’Oréal’s brand is not the first to stumble over the intricacies of the U.S. regulation that fundamentally differs from the legal framework in which European brands are used to work. Thus, one can find on the FDA’s website, a "yellow list" of all businesses to which the federal agency sent warnings due to the medical nature (under U.S. law) of their claims. Actually, most of the big names in the cosmetics business are listed, among any others.
Before another name be dropped on the list, Lancôme has 15 days to submit the FDA with its arguments or the corrective measures it intends to take.
