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:
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) | FDA
- Soaps & Lotions | FDA
- Frequently Asked Questions on Soap | FDA
For more information, visit our soap business guidance page.
There are no specific regulations regarding soap; however, any household product that meets the definition of a hazardous substance under the FHSA must bear cautionary labeling warning of the principal hazard(s) associated with the product and enabling the consumer to use and store the product safely about the household. A cautionary label includes:
- Signal word
- Affirmative statements of the principal hazard(s) associated with a hazardous substance
- The common or usual name, or chemical name of the hazardous substance
- The name and place of business of the manufacturer, packer, distributor, or seller
- Statements of precautionary measure to follow
- Instructions, when appropriate, for special handling and storage
- The statement “Keep out of the reach of children” or its practical equivalent
- When appropriate, first aid instructions
If the product does not meet the definition of a hazardous substance under the FHSA, there are no specific labeling requirements.
For more information cautionary labeling, visit our FHSA business guidance page.
To require labeling, a product must first: be toxic; be corrosive; be an irritant; be a strong sensitizer; be flammable or combustible; or generate pressure through decomposition, heat, or other means. The product must also have the potential to cause substantial personal injury or substantial illness during or as a result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children. See 15 U.S.C. § 1261(f) for the full definition of a “hazardous substance.”
For more information on cautionary labeling, visit our FHSA business guidance page.
CPSC does not oversee any requirement to list the ingredients of a soap on the label.
Soaps that are a hazardous substance under the FHSA must identify the substance responsible for the hazard as part of the cautionary label. For more information on cautionary labeling, visit our FHSA business guidance page.
Generally speaking, true soaps that fall under CPSC’s jurisdiction do not need to follow FDA’s requirements because they would not be considered cosmetics or drugs; however, the applicable requirements for each product must be assessed individually.