The CPSC regulates true soaps that meet the FDA’s interpretation at 21 CFR § 701.20 which outlines the following requirements for a “true soap”:
What it’s made of:
The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids (
i.e.
, the material you get when you combine fats or oils with an alkali such as lye).
What ingredients cause its cleaning action:
The detergent properties of the product are due to the alkali-fatty acid compounds. Inclusion of synthetic detergents could classify the product as a cosmetic, although the product may be labeled as “soap.”
How it’s intended to be used:
The product is labeled, sold, and represented only as soap. Making claims such as moisturizing skin, making the user smell nice, or deodorizing the body could classify the product as a cosmetic; making claims such as intending to treat skin conditions (like acne or eczema) or killing germs could classify the product as a drug.
Further, the Modernization of Cosmetics Regulation Act of 2022 amended the Federal Food, Drug, and Cosmetic Act by including the definition of a “cosmetic product” as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product,” 21 U.S.C. § 364(2); therefore, inclusion of ingredients commonly recognized as having cosmetic properties may classify the product as a cosmetic even if no cosmetic claims are made. Firms may wish to contact the FDA for guidance whether their products fall under FDA’s jurisdiction.
See the following FDA guidance pages to determine whether you are, in fact, making a true soap or whether you’re making a cosmetic or drug:
For more information, visit our soap business guidance page.
In the regulatory world, traditional soaps made primarily from fats and alkalis are regulated by the CPSC; however, many “soaps” on the market today are, in fact, not just soap. They are cleansers, detergents, or other types of products that may be regulated as a cosmetic or a drug by the Food and Drug Administration (FDA). CPSC staff recommends that you carefully review the following FDA guidance pages to determine whether you are, in fact, making a true soap or whether you’re making a cosmetic or drug:
The word “soap” is not specifically defined by any statute enforced by the CPSC or FDA. The FDA interprets the term soap at 21 CFR § 701.20 as products that meet ALL of the following conditions:
Further, the Modernization of Cosmetics Regulation Act of 2022 amended the Federal Food, Drug, and Cosmetic Act by including the definition of a “cosmetic product” as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product,” 21 U.S.C. § 364(2); therefore, inclusion of ingredients commonly recognized as having cosmetic properties may classify the product as a cosmetic even if no cosmetic claims are made. Firms may wish to contact the FDA for guidance whether their products fall under FDA’s jurisdiction.
As noted above, CPSC regulates true soaps, while cosmetics or drugs are regulated by FDA. To that end, CPSC does not have specific requirements for soaps. In general, soaps would be subject to the Federal Hazardous Substances Act (FHSA) and the Consumer Product Safety Act (CPSA). If the product meets the definition of a hazardous substance under the FHSA, then it must bear precautionary labeling. Note that such labeling for standard soap is uncommon and usually reserved for strong degreasing soaps that could cause eye irritation. For more information, visit our FHSA business guidance page.
Soaps that are primarily intended to be used by children 12 years of age or younger are classified as children’s products. These products must bear a permanent tracking label and be tested for total lead content by a third-party, CPSC-accepted laboratory. Manufacturers of children’s soaps must issue a Children’s Product Certificate (CPC) for their products, verifying compliance with the applicable children’s product safety rules. For more information, visit our children’s product guidance page.
For more information, please contact the Small Business Ombudsman (SBO) team: