In the latest escalation between US regulators and cosmetic companies, the US Food and Drug Administration (FDA) has issued a warning to cosmetic giant L’Oréal —the company's second letter in three years—accusing it of improperly marketing several of its skin care products.
Cosmetic products are lightly regulated by US federal regulators. Unlike drugs, which must be shown to be safe and effective prior to being allowed on the market, cosmetics are not required to undergo review before being marketed to consumers.
However, cosmetic products are limited in the types of claims they can make to consumers. Under federal law, cosmetics are any article “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.” In other words, the products are intended to either clean the body or beautify it—not to heal it, cure it or otherwise affect its structure or function.
For more on the regulation of cosmetic products, please see FDA’s explainer here.
Since this is a fairly simple standard, FDA has traditionally sent few Warning Letters to cosmetic manufacturers. Unless the cosmetic products pose an acute health risk to consumers—such as when it sent warnings to marketers of Brazilian blowouts, which contained the carcinogen formaldehyde—or have made an egregious claim, FDA has targeted its enforcement resources toward other regulated products.
Shifting Enforcement Focus
But in recent years, FDA has begun to take increasing notice of cosmetic companies' marketing efforts.
In 2012, FDA sent five Warning Letters to cosmetic companies, all for allegedly marketing their products using claims which caused them to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act).
Notable among those letters were two to cosmetic giants: L’Oreal, whose subsidiary Lancôme USA was the recipient of one letter, and Avon, which was the direct recipient of another. Marketing efforts by the two companies claimed their products could, among other things, rebuild collagen, regenerate hydroproteins, repair micro-injuries, boost the activity of genes and stimulate cell regeneration.
For more on FDA’s previous Warning Letters, please see our prior coverage here.
Then, in December 2014, FDA fired off a new Warning Letters to cosmetic company Cell Vitals, which it also accused of selling cosmetic products using claims restricted to drug products.
L'Oreal Back in FDA's Sights
Now L’Oréal is back in the sights of FDA. In a 12 February 2015 Warning Letter to the company's CEO, FDA said two of the company's products—Rosaliac AR Intense and Mela-D Pigment Control—had been marketed in such a way as to make them drugs under the FD&C Act.
Among the claims cited by FDA as being improper were ones stating the products could reduce "visible redness and sensations of discomfort" and "treat dark spots and discolorations."
These claims, FDA explained, served to imply the products could be used in the "cure, mitigation, treatment or prevention of disease"—specifically, the skin condition rosacea.
FDA said the Rosaliac AR Intense product, in particular, was marketed to patients with rosacea—a condition "not amenable to self diagnosis."
FDA said the company needs to "take prompt action to correct the violations" cited in FDA's Warning Letter.
As of the time of posting, L’Oréal was still marketing its product on its website using the claims cited by FDA.
FDA Warning Letter