When a serum claim becomes a drug claim

The legal line

A cosmetic is intended to cleanse, beautify, promote attractiveness or alter the appearance. A product intended to affect the structure or any function of the body is a drug. Intended use is judged from claims: on the label, the website, social media, and what staff say.FDA: cosmetic or drug

Words that cross it

Appearance: “smoother-looking”, “radiant”, “hydrated look”, “visibly refreshed”. Structure or function: “stimulates collagen”, “repairs”, “regenerates cells”, “heals”, “grows hair”. The second list turns a serum into an unapproved drug in the eyes of the regulator.

Pairing a serum with a device does not change that, and a statement that a device drives a product into living tissue makes the problem worse, not better. Keep the device’s function and the topical’s appearance claim as two separate statements.

Checks before you stock a topical

Ask for the maker’s MoCRA facility registration and product listing, and its safety substantiation.FDA: MoCRA Read its marketing as a regulator would. If the maker’s own site makes drug claims, your practice inherits the problem when it repeats them.