FDA’s Role


Under the current law, cosmetics and their ingredients (with the exception of color additives) are not regulated or overseen by the FDA. There are regulations, however, that prohibit or restrict the use of certain dangerous cosmetic ingredients, including mercury, vinyl chloride, chloroform, and methylene chloride, among others.
Under the current law, the FDA also does not substantiate or approve efficacy or safety claims of cosmetic products. Furthermore, the terms ‘hypoallergenic,’ ‘non-comedogenic,’ ‘fragrance-free,’ ‘gluten-free,’ ‘natural,’ and ‘dermatologist recommended or tested’ are not regulated or overseen by the FDA.

  Cosmetics are “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 skin moisturizers, makeup, perfume, nail polish, deodorants, permanent waves, and hair colors.

Cosmetic companies and manufacturers have the responsibility to ensure the safety of their products. They are not, however, required to submit safety information or product formulation to the FDA. Safety recalls of cosmetics are voluntarily taken by manufacturers or distributors to remove products that are hazardous or deceptive to the public. The FDA is not authorized to order recalls of cosmetics.
In addition, no registration is required to import cosmetics into the United States. The FDA works closely with U.S. Customs and Border Protection to monitor imports. Imported cosmetics that do not comply with FDA regulations are refused entry. The FDA issues cosmetic import alerts to customs officials to prevent the import of dangerous or untested cosmetics into the United States marketplace.
Unlike cosmetics, drugs and medical devices are products that are intended for the treatment or prevention of disease, or that affect the structure or function of the body, and require FDA approval. Drugs may be OTC (over-the-counter) or prescription.

FDA's Role FAQs

What is a cosmetic?

Cosmetics are “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 skin moisturizers, makeup, perfume, nail polish, deodorants, permanent waves, and hair colors. Cosmetics and their ingredients (with the exception of color additives) are not regulated or overseen by the FDA.

Under the current laws, the FDA does not substantiate or approve efficacy or safety claims of cosmetics. Furthermore, the terms ‘hypoallergenic,’ ‘non-comedogenic,’ ‘gluten-free,’ ‘natural,’ ‘fragrance-free,’ and ‘dermatologist recommended or tested’ are not regulated or overseen by the FDA.

Cosmetics generally do not contain any ingredients that treat or prevent disease, or that affect the structure or function of the body.

What is a drug?

Unlike cosmetics, drugs and medical devices are products that are intended for the treatment or prevention of disease, or that affect the structure or function of the body, and require FDA approval.

Drugs may be OTC (over-the-counter) or prescription.

What are FDA monographs?

FDA monographs are specific ingredients that have been approved in OTC drugs to prevent or treat medical conditions by self-medication. OTC drugs do not require a prescription from a physician. Examples include benzoyl peroxide for acne, colloidal oatmeal for eczema, or sunscreen ingredient for photoaging. OTC drugs that make a claim to treat or prevent a medical condition must contain a monographed ingredient. If an OTC drug makes a claim to prevent or treat disease but product doesn’t contain a monographed ingredient, it must first be approved by the FDA as a new drug.

Are cosmetics required to undergo safety testing?

No. Cosmetics and their ingredients (with the exception of color additives) are not regulated or overseen by the FDA. There are regulations, however, that prohibit or restrict the use of certain dangerous cosmetic ingredients, including mercury, vinyl chloride, chloroform, and methylene chloride, among others.

Under the current laws, the FDA does not substantiate or approve efficacy or safety claims of cosmetic products. Furthermore, the terms ‘hypoallergenic,’ ‘non-comedogenic,’ ‘fragrance-free,’ ‘gluten-free,’ ‘natural,’ and ‘dermatologist recommended or tested’ are not regulated or overseen by the FDA.

Cosmetic companies and manufacturers have the responsibility to ensure the safety of their products. They are not, however, required to submit safety information or product formulation to the FDA. Safety recalls of cosmetics are voluntarily taken by manufacturers or distributors to remove products that are hazardous or deceptive to the public. The FDA is not authorized to order recalls of cosmetics.

Does the FDA approve cosmetics?

No. Under the current law, cosmetics and their ingredients (with the exception of color additives) do not require FDA approval or specific safety testing prior to sales.