How does FDA define a cosmetic?
A cosmetic is defined by its intended use, 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. A drug is defined as “(a) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…and (b) articles (other than food) intended to affect the structure or any function of the body of man or other animals”. A cosmetic that makes a drug claim will be classified as a drug by FDA and thus considered misbranded if the cosmetic does not have approval from FDA.
How do you determine "intended use"?
Intended use may be established through the following:
- Statements on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or function of the human body.
- Consumer perception, which may be established through the product's reputation.
- Ingredients that may cause the product to be considered a drug because the ingredient is well known to the public and industry to have therapeutic use.