Soap making can seem straightforward, but understanding what exactly goes into your bar and how it’s regulated is crucial, especially for small-scale producers. This article explores the composition of soap, differentiating it from synthetic detergents and delving into the regulatory definition provided by the FDA.
Traditional Soap vs. Synthetic Detergents
True soap results from a chemical reaction between fats or oils and an alkali, traditionally lye. The fats and oils, sourced from animals, vegetables, or minerals, break down into free fatty acids. These acids then combine with the alkali to create what we know as crude soap. This process, when done correctly, consumes all the lye, leaving none in the final product. Historically, people commonly crafted soap at home using rendered animal fats and lye extracted from wood ashes.
Today, the market predominantly features synthetic detergents rather than authentic soaps. These detergent cleansers, available in both liquid and solid forms, are favored for their ability to lather readily in water and resist forming gummy residues. While many of these products are marketed as “soap,” they often do not meet the regulatory definition of true soap.
The FDA’s Regulatory Definition of Soap
The Food and Drug Administration (FDA) has a precise definition of soap, outlined in 21 CFR 701.20, that includes three specific conditions:
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Composition: To be classified as “soap” under FDA regulations, the product must primarily consist of “alkali salts of fatty acids.” These salts are the result of combining fats or oils with an alkali substance such as lye. In essence, what is a soap made of is primarily these alkali salts.
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Cleaning Action Source: The cleaning action of the product must solely derive from these “alkali salts of fatty acids.” If the product incorporates synthetic detergents, it is considered a cosmetic, irrespective of whether the term “soap” is used on the label.
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Intended Use: To be regulated as soap, the product must be explicitly labeled and marketed exclusively for use as soap for cleaning. Products intended for purposes such as moisturizing, fragrance, or deodorizing are classified as cosmetics. Products intended to treat or prevent disease, such as acne or eczema, are classified as drugs. A product can be classified as both a cosmetic and a drug. More information can be found at Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).
Regulation of Different “Soap” Products
How a “soap” product is regulated depends on its classification based on the FDA’s definitions.
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Cosmetics: If the product meets the definition of a cosmetic, as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act), it falls under FDA regulation. Cosmetics are defined 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)]. Cosmetic products and their ingredients generally do not require FDA approval before being marketed, except for color additives. Manufacturers are responsible for ensuring product safety and proper labeling. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) mandates registration and listing of cosmetic product facilities and products with FDA.
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Drugs: If the product is a drug, as defined by the FD&C Act 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 is regulated by the FDA. Drug products must comply with regulations (“monographs”) for non-prescription drugs or requirements for new drug approval. Registration of the firm and listing of products with the FDA are required. Inquiries can be directed to FDA’s Center for Drug Evaluation and Research (CDER’s) Small Business and Industry Assistance at [email protected] or CDER’s Division of Drug Information at [email protected].
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Cosmetic and Drug: Products classified as both cosmetic and drug must adhere to the regulations governing both categories. Further details are available at Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).
“Natural” or “Organic” Ingredients
The FDA does not have regulatory definitions for terms like “natural” or “organic.” The same regulations apply to products regardless of whether their ingredients are plant-based, animal-based, mineral-based, or synthetic. It is critical to understand that simply using plant-derived ingredients does not automatically ensure product safety. See Product Testing of Cosmetics for further reading. Additional information regarding “organic” requirements can be found at [‘Organic’ Cosmetics](/cosmetics/cosmetics-labeling-claims/organic-cosmetics “”Organic” Cosmetics”) and the National Organic Program (USDA).
Conclusion
Understanding what is a soap made of and how it’s regulated is essential for both consumers and producers. Whether you’re crafting soap on a small scale or simply choosing the right cleanser for your skin, being informed about the ingredients and the regulatory landscape ensures safety and compliance. The FDA provides valuable resources to navigate these complexities and stay informed about the evolving world of soap and personal care products.
