FDA Frequently Asked Questions About Soap

The Food and Drug Administration (FDA) often receives questions from soap makers about how their products are regulated. The following information is intended to help small-scale soap producers understand the laws and regulations they need to know.

How does traditional soap differ from synthetic detergents?

Ordinary soap is made by combining fats or oils with an alkali (such as lye). Fats and oils (which can come from animal, vegetable, or mineral sources) are broken down into free fatty acids, which then combine with the alkali to form crude soap. The alkali reacts with the oil, turning the initially liquid mixture into a bar of soap. When made correctly, no lye should remain in the finished product. In the past, people often made soap at home using animal fat and lye extracted from wood ash.

True soap is rare on the market today. Most body cleansers, whether liquid or solid, are synthetic detergent products. Detergent-type cleansers are popular because they lather easily in water and do not form a sticky residue. Many of these detergent products are marketed as "soap," but according to the regulatory definition they are not true soap.

What is the FDA's regulatory definition of "soap" (21 CFR 701.20)?

The FDA's regulatory definition requires all three of the following conditions to be met for a product to be classified as "soap" in the regulatory sense:

1. Its composition: To be regulated as "soap," the product must be composed mainly of "alkali salts of fatty acids," that is, the substance obtained by combining fats or oils with an alkali (such as lye).

2. The ingredient that causes its cleansing action: To be regulated as "soap," these "alkali salts of fatty acids" must be the only substance that causes the product's cleansing action. If the product contains synthetic detergents, it is a cosmetic, not a soap. You may still use the word "soap" on the label.

3. Its use: To be regulated as soap, the product must be labeled and sold only for soap use. If its use includes moisturizing, making the user smell pleasant, or deodorizing, then it is a cosmetic. If the product is intended to treat or prevent disease, such as killing germs, or treating a skin condition (such as acne or eczema), then it is a drug. You may still use the word "soap" on the label. A product may also be both a cosmetic and a drug.

How are different "soap" products regulated?

- If your product meets the FDA's regulatory definition of "Soap," then the product is regulated by the Consumer Product Safety Commission (CPSC), not the FDA. Please direct questions about the requirements for these products to the CPSC.

- If it is a cosmetic, that is, it meets the definition of a cosmetic, then it is regulated by the FDA. The Federal Food, Drug, and Cosmetic Act (FD&C Act) partly defines cosmetics by intended use, as "articles intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, Section 201(i)]. Except for any color additives it contains, the product and its ingredients do not require FDA approval before going to market. It is your responsibility to ensure the product is safe for consumers when used as intended and is properly labeled.

The 2022 Modernization of Cosmetics Regulation Act (MoCRA) requires registering with the FDA and listing cosmetic product facilities and products.

- For detailed information on registration and listing requirements and exemptions, see Registration and Listing of Cosmetic Product Facilities and Products.

- For more resources, see: Small Businesses and Homemade Cosmetics: Fact Sheet.

- If it is a drug, then it is regulated by the FDA. The FD&C Act partly defines drugs by 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, Section 201(g)(1)]. Drugs must conform to the regulations for certain OTC drug categories (called "monographs") or new drug approval requirements. You need to register your business with the FDA and list your products.

What if my ingredients are "natural" or "organic"?

The laws and regulations enforced by the FDA do not define "natural" or "organic." Whether ingredients come from plant, animal, mineral, or synthetic sources, your product is subject to the same requirements. Do not assume that using only plant-derived ingredients makes your product safe.