Cosmetics, Soaps and Drugs, oh my!

Cosmetics are defined by the Food, Drug and Cosmetic Act according to their 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" [FD&C Act, sec. 201(i)].  However, products that meet the definition of “soap” are exempt from the Food, Drug and Cosmetic Act.  According to the FDA the term soap applies to a product when, “The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and fhe product is labeled, sold, and represented solely as soap [21 CFR 701.20].”  If a product is labeled, sold or represented as having any value or properties other than cleansing it is defined as a cosmetic and must be labeled under cosmetic regulations.  Some examples of claims that would change a soap to a cosmetic are: moisturizing, deodorizing, soothing, skin softening and exfoliating.  If claims are made that imply that a soap to cleanse and also “to cure, treat, or prevent disease or to affect the structure or any function of the human body” the soap would be regulated as a drug.

Source:  U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Cosmetics and Colors, July 8, 2002