Cosmetics Claims: Stay In Your Lane

Claims to alter one’s appearance are OK, but cosmetics that claim effect on structure or function the body are, legally, drugs.

Eric F. Greenberg
Eric F. Greenberg

What’s in a name? Plenty. A rose-scented moisturizing cream by any other name might smell as sweet, but it might be regulated differently if you label it with the wrong name.

Legally, that’s just about all there is to it, because the way FDA’s law is set up, it’s the intended use of a product that determines whether it’s a cosmetic, drug, food or medical device. The primary place to find the intended use of a product is what the labeling says, though other written/printed materials, advertising or other statements from the manufacturer are also useful indicators of intent. The intended use might be stated explicitly, or merely implied by the labeling or other information.

And yes, even the product name can be evidence of a marketer’s intended use for a product, and cosmetics that are intended to affect the structure or function of the body, rather than affect its mere appearance, are drugs.

That’s because the law defines cosmetics "articles 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." Cosmetics include makeup, skin moisturizers, perfume, nail products and hair dyes, waves, straighteners and removers.

In the past, FDA has taken action against marketers of wrinkle creams claiming anti-aging effects including the physical elimination of wrinkles, because that’s a drug claim, whereas if they had just stuck with claiming to make wrinkles appear smaller or look better, they’d have been OK as cosmetics.

If you look over the FDA Warning Letters to cosmetics companies, in which FDA puts the companies on notice that the agency thinks they committed violations of law, you can find many examples of FDA citing companies for making unlawful drug claims for cosmetics.

Many of these have labeling or advertising make a (seemingly endless) list of self-evidently groundless claims of effect on a long list of physical conditions and diseases. But just because some violators appear to be big-time phonies doesn’t mean that a product making a single violative claim is in the clear.

Of all the types of products that FDA regulates, it probably has the lightest touch on cosmetics, though there are still some important requirements. Cosmetics have to be safe for use and properly labeled (retail packages must list ingredients, and all claims have to be truthful and not misleading and avoid the drug claim pitfall) and the maker or seller is legally responsible for assuring that’s so. The products don’t require FDA approval before they go to market, except for color additives in them, and FDA has a voluntary program under which manufacturers register and file their formulations with the agency.

FDA’s regulatory requirements for drugs are much more comprehensive. Once your would-be cosmetic product is found to be making a drug claim, and FDA says it’s a drug, it’s usually also an unapproved ‘new drug’ because it’s not generally recognized as safe and effective for the use you claim for it, and it’s usually also misbranded because it’s not properly labeled as a drug, and it’s usually also an adulterated drug because it hasn’t been made in accordance with proper Good Manufacturing Practices, and geez give me a minute I need a pain reliever (clearly a drug).

And by the way, it won’t even matter if the claim of effect is true or false, since cosmetics aren’t supposed to be making the claims at all. If they’re false, though, that’s just another sense in which the product is misbranded. Free legal advice: Stick with the right kinds of claims.

Eric Greenberg can be reached at greenberg@efg-law.com. Or visit his firm’s website at www.ericfgreenbergpc.com.

INFORMATIONAL ONLY, NOT LEGAL ADVICE.

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