FDA often receives questions from soap makers about how their products are regulated. Here is information to help small-scale soap producers understand the laws and regulations they need to know about.
How are traditional soaps and synthetic detergents different?
Ordinary soap is made by combining fats or oils and an alkali, such as lye. The fats and oils, which may be from animal, vegetable, or mineral sources, are degraded into free fatty acids, which then combine with the alkali to form crude soap. The alkali reacts with the oils, turning what starts out as liquid into blocks of soap. When made properly, no lye remains in the finished product. In the past, people commonly made their own soap using animal fats and lye that had been extracted from wood ashes.
Today there are very few true soaps on the market. Most body cleansers, both liquid and solid, are synthetic detergent products. Detergent cleansers are popular because they make suds easily in water and don't form gummy deposits. Many of these detergent products are marketed as "soap" but are not true soap according to the regulatory definition of the word.
What’s FDA's regulatory definition of soap (21 CFR 701.20)?
FDA’s regulatory definition of soap includes the following three conditions; all three conditions must be met to be a soap under FDA’s regulatory definition:
- 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.
- 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. You can still use the word “soap” on the label.
- How it's intended to be used:To be regulated as soap, it must be labeled and marketed only for use as soap. 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. If the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You can still use the word “soap” on the label. The product may be both a cosmetic and a drug. Learn more at Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).
How are different “soap” products regulated?
- If your product meets FDA'sregulatory definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about requirements for these products to CPSC.
- If it’s a cosmetic, meaning that it meets the definition of a cosmetic, it’s regulated by FDA. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics, in part, 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)]. Neither the product nor its ingredients need approval by FDA before they go on the market, except for any color additives it contains. It is your responsibility to make sure your product is safe for consumers when it is used as intended, and to make sure it is properly labeled.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires registration and listing of cosmetic product facilities and products with FDA.
- To learn about the registration and listing requirements, as well as exemptions, see .
- For more resources, see: Fact Sheet for Small Businesses and Homemade Cosmetics.
- If it’s a drug, it’s regulated by FDA. The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. It must comply with the regulations (called “monographs”) for certain categories of non-prescription drugs or requirements for new drug approval. You will need to register your firm and list your products with FDA.
For more information, you can contact FDA’s Center for Drug Evaluation and Research (CDER’s) Small Business and Industry Assistance at CDERSBIA@fda.hhs.gov or, for general drug-related inquiries, CDER's Division of Drug Information at druginfo@fda.hhs.gov.
- If it’s both a cosmetic and a drug, it must meet the requirements for both cosmetics and drugs. To learn more, see Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).
What if my ingredients are “natural” or “organic”?
- Thelaws and regulations that FDA enforces do not have definitions for “natural” or “organic.” The same requirements apply to your product no matter whether the ingredients are plant, animal, mineral, or synthetic. It’s important not to assume that using only ingredients from plants will make your products safe.
To learn more, see Product Testing of Cosmetics. To learn more about “organic” requirements, see ‘Organic’ Cosmetics and the National Organic Program (USDA).
Resources For You
- Antibacterial Soap? You Can Skip It, Use Plain Soap and Water
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- How to Report a Cosmetic Related Complaint
- FDA issues final rule on safety and effectiveness of antibacterial soaps
