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Regulatory News | 03 December 2014 | By Alexander Gaffney, RAC
In recent years, a handful of cosmetic manufacturers have come under the harsh scrutiny of the US Food and Drug Administration (FDA) over claims their products could do far more than just change the skin’s aesthetics. Now the agency is again going after a marketer of cosmetic products, saying the company’s creams and moisturizers are more like drugs than beauty 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 by 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.
But in recent years, FDA has begun to take increasing notice of cosmetic marketers.
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.
Now another marketer of cosmetic products has fallen under FDA’s microscope. In a Warning Letter to California-based Cell Vitals issued on 24 November 2014, FDA claims three of the company’s products are actually drugs masquerading as cosmetics.
One product, a moisturizer, was marketed as having “antibacterial” and “anti-cancer” properties. Another product marketed as a cleanser was claimed to be able to strengthen capillaries, reduce inflammation and help “heal” the skin. A third product, a “Stem Cell Eye Cream,” was marketed as being able to activate collagen synthesis, protect cells from inflammation, and repair skin damage caused by ultraviolet rays.
Since those conditions are protected under the FD&C Act and reserved for products regulated as drugs, FDA said Cell Vitals must immediately either stop using those claims to market its three products, or seek approval for them using a New Drug Application (NDA).
The company has 15 days in which to respond to FDA’s letter.
Warning Letter to Cell Vitals
Tags: Cosmetic, Regulation of Cosmetics, Warning Letter