cosmetics or drugs

Are Wrinkle Treatments Cosmetics?

Americans spend a lot of money on creams, lotions and other cosmetics that promise to improve their skin, hair, and even eyelashes.

 
Some products are marketed with claims that they will make people look younger. But are these products cosmetics? It depends.

  • Products intended to make people more attractive are generally cosmetics. For example, moisturizing is a cosmetic claim. So, if a product is intended to make lines and wrinkles less noticeable, simply by moisturizing the skin, it’s a cosmetic. Similarly, makeup or “primers” intended to make the signs of aging less noticeable just by hiding them are also cosmetics.
  • But, products intended to affect the structure or function of the body, such as the skin, are drugs, or sometimes medical devices, even if they affect the appearance. So, if a product is intended, for example, to remove wrinkles or increase the skin’s production of collagen, it’s a drug or a medical device.

Under the law, cosmetics must be safe when consumers use them according to product labeling, or the way in which the products are customarily used. But the law does not require cosmetics to be approved by FDA before they go on the market. Drugs, however, must have FDA approval for both safety and effectiveness before they go on the market. Similarly, medical devices must go through FDA’s clearance process.

FDA is concerned about drug claims made for products marketed as cosmetics, such as skin care products with anti-wrinkle or anti-aging claims that involve supposed effects on the structure or function of the skin.

Are Some Cosmetics Promising Too Much?
Americans spend a lot of money on creams, lotions and other cosmetics that promise to improve their skin, hair, and even eyelashes.

But sometimes those promises go too far.

The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify them as drugs, not cosmetics. FDA has issued warning letters citing drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and Web sites. Some examples of the drug claims cited are acne treatment, dandruff treatment and hair restoration.

These letters state that the products are being marketed with drug claims—indicating that they are intended to treat or prevent disease, or change the body’s structure or functions. The agency tells companies that they need to remove any drug claims from their products’ labeling or seek FDA approval to market these products as drugs.

“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,” says Linda M. Katz, M.D., MPH, director of FDA’s Office of Cosmetics and Colors. “These products must be evaluated by FDA as drugs before the companies can make claims about changing the skin or treating disease.”

Some of the drug claims have included promises to increase production of collagen and elastin, resulting in skin that is more elastic and firmer, with fewer wrinkles.

Some get even more specific, such as claims that products reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery. Others promise to treat medical conditions, such as acne, rosacea, eczema, and psoriasis.

For more information, please visit the FDA website.

Photo: Julia P