FDA Advises Shoppers to be Wary of Too-Good-to-Be-True Cosmetic Claims

FDA Advises Shoppers to be Wary of Too-Good-to-Be-True Cosmetic Claims
Image: Pixabay
March 31, 2015

While the average shopper may not see the difference between cosmetics and drugs, the differences are quite stark to the U.S. Food and Drug Administration (FDA).

That means that when a company markets its cosmetics in such a way that it starts to fall into drug territory, the agency will step in with a warning.

To put it simply, if it can be simply put, the FDA defines a cosmetic as a product designed for, "cleansing, beautifying, promoting attractiveness, or altering the appearance."

Makeup, for example, is an obvious cosmetic. Under federal law, the makers of your favorite cosmetics don't need FDA approval before they hit the store shelves. They do, however, need to follow good manufacturing practices and ensure a safe product.

A drug is defined, in part, as a product "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease," or "intended to affect the structure or any function of the body."

Drugs, like Tylenol, are required to get FDA approval before they can be sold.

The minute your favorite face cream starts to claim that it can cure, mitigate, treat or prevent a disease, like acne, rosacea, eczema, or psoriasis, it starts to fall into drug territory. The same can be said if it claims to reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery.

In order to make these types of claims, the maker of that face cream needs to provide solid evidence of the fact.

"Consumers need to know that these drug claims have not been proven to FDA when they are making a decision to purchase one of these products," Linda M. Katz, director of FDA's Office of Cosmetics and Color, said in a statement. "These products must be evaluated by FDA as drugs before the companies can make claims about changing the skin or treating disease."

Companies that run afoul of these rules typically get warning letters from the FDA asking that the manufacturer change the packaging so that the claims are removed. The proliferation of cosmetics makes it difficult for the FDA to keep up, meaning there are plenty of products out there with unsubstantiated claims.

Making things a bit more confusing is that some products are regulated as both a drug and a cosmetic. Your antiperspirant deodorant or your lotion with sunscreen are evaluated by the FDA like a drug, but generally considered cosmetics.

Unfortunately, the FDA says there's no easy answer when it comes to choosing these types of products.

"If a skin cream says it works better than a facelift," said FDA dermatologist Jane Liedtka, "well, people wouldn't be getting facelifts anymore."