Home › Is a peptide skincare product a cosmetic or a drug?

Is a peptide skincare product a cosmetic or a drug?

All rules below are US rules, from FDA's page "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)".^[1] This page is non-clinical. It explains the legal categories and makes no claim about whether any ingredient works.

What counts as a cosmetic

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" (sec. 201(i)). FDA lists skin moisturizers among the examples.^[1]

What counts as a drug

The same Act defines drugs, in part, as articles "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and articles "(other than food) intended to affect the structure or any function of the body of man or other animals" (sec. 201(g)(1)).^[1]

A product can be both

FDA says some products meet both definitions when they have more than one intended use, such as a moisturizer marketed with sun-protection claims. Those products must meet the rules for both.^[1]

"Cosmeceutical" is not a legal category

FDA says the FD&C Act "does not recognize any such category as 'cosmeceuticals.'" A product is a drug, a cosmetic, or both.^[1]

Claims decide intended use

FDA says intended use can be set by claims on labels, in ads, online or in other promotion, by consumer perception, and by ingredients with a well-known therapeutic use. It says certain claims "may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic", and gives examples such as claims that a product will "regenerate cells".^[1] So when you read a peptide product page, the wording matters as much as the ingredient list.

Approval is different

FDA says cosmetic products and ingredients, other than color additives, "do not require FDA approval before they go on the market". Drugs generally need FDA approval through a New Drug Application or must conform to an OTC monograph.^[1] So, apart from color additives, a cosmetic does not need FDA approval before it goes on sale.