Food Labeling Compliance Seminar – September 24-25, 2018 in Kansas City, MO

Specializing in FDA Regulatory Matters

Cosmetics Defined

FDA regulated the cosmetic industry under the authority of the Federal Food Drug & Cosmetic Act and the Fair Packaging and Labeling Act. Cosmetics are defined by 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)).

Cosmetics include products such as:

  • skin moisturizers,
  • perfumes,
  • lipsticks,
  • fingernail polishes,
  • makeup,
  • cleansing shampoos,
  • permanent waves,
  • hair colors,
  • deodorants,
  • Any substance intended for use as a component of a cosmetic product.

Cosmetics AND Drugs:

If a product has two intended uses, it may be considered a cosmetic AND a drug. Examples of these products are:

  • Anti-dandruff shampoo which claims to reduce dandruff
  • Antiperspirants which claim to reduce sweating
  • Makeup and moisturizers with sun protection claims or wrinkle reducing claims
  • “Essential oils” which market with “aromatherapy” claims

Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.


While the term “cosmeceutical”, or a product that is a combination of a cosmetic and a drug is commonplace in the market, the FD&C does not recognize this as a product category and it has no meaning under the law.

(Soap is not considered a cosmetic and is regulated by the Consumer Safety Product Commission.)