Safety controversy brews

The FDA has alleged, for example, the following:

• A maker of "facial spray" products got word from FDA that it considered its cosmetics to actually be drugs simply because of the label claims made for them. There were lots of claims, such as one product that would minimize sagging skin, remove wrinkles, and "old age", that another would relieve sunburn, and that another would grow hair.

• Also called a drug was another company's skin-care product touting relief for acne.

• A third company's product was also alleged to be a drug because it claimed it would regenerate cells, reduce wrinkles, and get rid of cellulite.

• A widely advertised hair growth product was alleged to be a drug.

When cosmetics get into trouble this way, it's often because their labels tout drug-like benefits. For example, they may illegally claim to reverse or prevent a disease, or to affect the structure or function of the body. (There are also examples in which the FDA alleged that cosmetics were adulterated because of bacterial contamination.)

The FDA's allegations against various cosmetics serve as a useful illustration of important concepts in food and drug law. Federal law is a repository of an almost metaphysical truth, that the intended use of a product, usually revealed by its labeling, determines which category of product it is under the law (a cosmetic, a drug, a medical device, or a food, for example). Since the regulatory obligations differ for each category, that's an important determination to make.

Cosmetic products include shampoos, toothpastes, hair colors, deodorants, makeup, lipstick, perfume, and nail polish. Cosmetics, by definition, are supposed to be intended for "cleansing, beautifying, promoting attractiveness, or altering the appearance."

Cosmetics aren't approved by the FDA in advance (except for color additives they might contain), and neither are their labels. Cosmetics companies have the legal responsibility to assure that their products are safe and labeled in accordance with FDA requirements. If a product is a drug, it commonly can't hit the market unless it first has FDA marketing approval or meets the specifications for the relevant regulation governing over-the-counter drugs. Typically, these products don't meet those requirements and so they are unlawful.

The FDA can take action against violators after they enter the market. They send the company a Warning Letter, and might follow that up (but rarely do) with product seizure, injunction against sale, or criminal prosecution.

So the wrong label claims can make a product a drug, and not just sort of and not just by analogy, but strictly by definition. Yes, a product's chemical composition matters, of course, and you would often lose an argument that a product containing a known drug ingredient was anything other than a drug. Still, the claims for a product that reveal its intended use are quite commonly the grounds of FDA regulatory action against unapproved new drugs or misbranded products. Don't forget, FDA's objection is not that the claims aren't true, as such, it's that cosmetic products are, by definition, prohibited from making them. [HCP]

--By Eric Greenberg, Principal Attorney, and Kerry Rost, Associate, Eric F. Greenberg, P.C.