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

What is the difference between traditional soap and synthetic detergent?

Ordinary soap is made by combining fats or oils with an alkali, such as caustic soda. Fats and oils (which can be from animal, vegetable, or mineral sources) are broken down into free fatty acids, which are then combined with the alkali to form crude soap. The alkali reacts with the oil, turning the initial liquid into a bar of soap. When made correctly, no caustic soda remains in the finished product. In the past, homemade soap was often made using animal fats and caustic soda extracted from wood ash. 

There is very little real soap on the market today. Most body cleansers, whether liquid or solid, are synthetic detergent products. Detergent-based cleansers are popular because they foam easily in water and do not form a sticky deposit. Many of these detergent products are available in"Soap" is a marketing term, but it is not true soap according to regulatory definitions.

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

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

1.Its ingredients:To be regulated as "soap," a product must consist primarily of "alkaline salts of fatty acids," which are substances resulting from combining a fat or oil with an alkali, such as caustic soda.

2.Ingredients responsible for its cleansing action:To be regulated"Fatsoap” These “alkaline salts of fatty acids” must be the only substances responsible for the product’s cleansing action. If a product contains synthetic detergents, it is a cosmetic, not a soap. You can still use the word “soap” on the label.

3.Its uses:To be regulated as soap, a product must be labeled and marketed solely for its intended use as soap. If its uses include moisturizing, making the user smell pleasant, or deodorizing, it is a cosmetic. If a product is intended to treat or prevent disease, such as by killing germs, or to treat skin conditions like acne or eczema, it is a drug. You can still useThe word "soap". A product may also be both a cosmetic and a medicine.

How are different “soap” products regulated?

·If your product meets the FDA's regulatory definitionof"Soap”, the product is regulated by the Consumer Product Safety Commission (CPSC), not the FDA. Direct questions about these product requirements to the CPSC.

·If it is a cosmetic, that is, it meets the definition of a cosmetic, thenFDA oversight.Federal Food, Drug, and Cosmetic Act (FD&C Act)The FD&C Act defines cosmetics, in part, by their intended use as “articles intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the body…for cleansing, beautifying, increasing attractiveness, or altering the appearance” [FD&C Act, Section 201(i)]. Except for any colorant present, the product and its ingredients must be labeled before marketing.No need forFDA approved. It is your responsibility to ensure that your product is safe for consumers when used for its intended purpose and is properly labeled.

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

·For detailed information on registration and listing requirements and exemptions, see Registration and Listing of Cosmetic Facilities and Products.name。

·For more resources, see: Small Business and Homemade Cosmetics in a Nutshell.

·If it's a drug, it's regulated by the FDA. The Federal Food, Drug, and Cosmetic 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 man or other animals" [FD&C Act, Section 201(g)(1)]. Drugs must comply with regulations (called "monographs") for certain categories of over-the-counter drugs or with new drug approval requirements. You'll need to register your establishment with the FDA and list your products.

If my ingredients areWhat about "natural" or "organic"? 

The laws and regulations enforced by the FDA don't define "natural" or "organic." Whether the ingredients are derived from plants, animals, minerals, or synthetics, your product is subject to the same requirements. Don't assume that using only plant-derived ingredients makes your product safe.