Wrinkle Treatments and Other Anti-aging Products
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.
Where to learn more:
Regulation and Enforcement
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?): To learn about the legal differences between cosmetics and drugs
- "Cosmeceutical": To learn about this marketing term
- Import Alert #66-38: Skin Care Products Labeled as Anti-Aging Creams: Information to help import inspectors identify anti-aging products with unapproved drug claims and keep them off the U.S. market
- Warning Letters Address Drug Claims for Products Marketed as Cosmetics: For examples of anti-aging claims that are considered drug claims
- Warning Letters Highlight Differences Between Cosmetics and Medical Devices
Products and Ingredients
- Alpha Hydroxy Acids and Beta Hydroxy Acids (AHAs and BHAs) and Cosmetics: To learn how products may be cosmetics if they contain these ingredients at low concentrations, or drugs if the concentrations are higher
- Mercury Poisoning Linked to Skin Products: Consumer Update
- Soaps and Lotions: For information on skin care products
Outside of FDA
- Federal Trade Commission: The government agency that regulates advertising claims