Business Guidance FAQ

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 regulated as a cosmetic or a drug by the Food and Drug Administration (FDA). CPSC staff recommends that you carefully review the FDA’s guidance webpages, including: “Is it a Cosmetic, a Drug, or Both? (Or Is it Soap?),” “Soap: FAQs,” and also “Soaps & Lotions” to determine whether you are, in fact, making a soap, cosmetic, drug, or some combination of these products.

The FDA’s regulations address three conditions:

1. What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
2. What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. However, the word “soap” can be used on the label.
3. How it’s intended to be used: To be regulated as soap, the product must be labeled and marketed for use as soap only. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as kill germs, or treat skin conditions, such as acne or eczema, it’s a drug. Again, the word “soap” can be used on the label.

You can read the entire FDA regulation at: 21 CFR §701.20.

The CPSC regulates only true soaps (not cosmetics or drugs) that are made primarily of fats and alkalis and that are manufactured for consumer use. To that end, except for products primarily intended for use by children age 12 or younger, CPSC does not have specific requirements for soaps.

Soaps that are primarily intended to be used by children age 12 and under are considered to be children’s products by CPSC. These products must bear a permanent tracking label, and they must be tested for total lead content by a CPSC-accepted third party laboratory. Manufacturers of children’s soaps must issue a Children’s Product Certificate for their products, verifying compliance with these standards.

There are no specific CPSC-enforced regulations regarding the labeling of soap ingredients. However, you may need to provide cautionary labeling on the product if the product meets the definition of a “hazardous substance” under the Federal Hazardous Substances Act (FHSA) – a law administered by the CPSC. This is not common and is usually for soaps like strong degreasing soaps that could cause an eye irritation.

If labeling is required, then Section 2(p)(1) of the FHSA, 15 U.S.C. § 1261(p)(1), states that hazardous substances must bear certain cautionary statements on their labels.  These statements include: signal words; 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; and, when appropriate, first-aid instructions.

According to the FHSA, a product is  a hazardous substance if the substance, or a mixture of substances, is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat, or other means, and if the substance or mixture of substances may cause substantial personal injury or substantial illness during customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children. A determination that a product is toxic may be based on the results of animal tests or on human experience.

Ultimately, it is the responsibility of a manufacturer or importer of a product to determine whether its product meets the definition of a “hazardous substance” and if so, make sure to fulfill its obligations under the FHSA for appropriate precautionary labeling.  

Generally speaking, traditional soaps that fall under CPSC’s jurisdiction do not need to follow the FDA’s requirements as well.