The Network was contacted by a public health practitioner with questions about the authority of the Food and Drug Administration (FDA) to regulate personal care products, particularly soap. The Network researched the subject and found that soap, as it is commonly defined by the public, is actually regulated under three different schemes at the federal level.
Soap is regulated as a drug, cosmetic, or a hazardous substance by the FDA. The exact regulatory scheme is determined in part by the chemical makeup of the product, and to a larger extent, on the intended use of the product.
The intended use of the product is generally determined by looking at a variety of factors: claims stated on the product labeling, advertising on the internet or in other promotional materials, consumer perception of the product, and ingredients that cause the product to be considered a drug or cosmetic because they are well known for these types of uses. The FDA has put out two interesting discussions on soap regulation: Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) and Soap: What It Is and How It Is Regulated.
True soap, which is excluded from the reach of the Federal Food, Drug and Cosmetic Act (FDCA), is defined by the FDA via regulation. To qualify as soap “the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali fatty acid compounds and the product is labeled, sold and represented solely as soap”. The term “solely as soap” appears to have been interpreted by the FDA to mean that the soap is used only for cleaning and has no other function.
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