When is Soap Not a Cosmetic?
Applies to lye/oil soap sold in the United States
In the United States, the Food Drug and Cosmetic Act defines a cosmetic. That definition specifically excludes soap, however the term “soap" is not defined.1
“Soap" can mean many different things, but the FDA interprets the term "soap" to apply only to articles that meet the all of the following conditions:2
(1)The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids.
(2)The detergent properties of the article are due to the alkali-fatty acid compounds.
(3) The product is labeled, sold and represented only as soap.
The first two requirements have to do with theformulation and chemistry of the product. The third requirement has to do with the labeling and marketing.
As with most legal things, a great deal of it has to do with the exact definitions of the words used.
1. The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids.
Bulk: the main part; the majority or highest percentage.
Nonvolatile: Not volatile (evaporating easily or quickly, such as fragrances or essential oils).
Alkali salt of fatty acids: The result of saponification of animal or vegetable fats. Technically, it's the salt (the result of mixing an alkali and an acid) resulting from mixing an alkali (sodium or potassium hydroxide) with fatty acids (the acids which make up the triglycerides in animal or vegetable oils or fats, such as lauric acid or stearic acid).
In other words, the majority of the solid, non-evaporating part of the soap is made up of saponified oils. It can have other ingredients such as clays, herbs, spices, or color, but the soap is the bulk of it.
2. The detergent properties of the article are due to the alkali-fatty acid compounds.
Detergent properties: Cleaning or cleansing properties; Surfactants.
Alkali-fatty acid compounds: Saponified animal or vegetable oils/fats.
In other words, what causes it to foam, bubble, and clean is the soap, not some other added ingredient (such as a different type of detergent or surfactant).
3. The product is labeled, sold and represented only as soap.
Labeled: The information on the label; in specific, the product identity as statedon the label of the product.
Represented: Described or portrayedin a particular way; Assertedor declaredas being of a specified character or kind. 3
In other words, on the label the product is identified as “soap" and on the label, in any accompanying labeling, or in other materials advertising the product, the product is only described or portrayed as soap without any other intended use.
Who Regulates Soap?
The FDA regulates food, drugs, cosmetics, medical devices and tobacco. Soap that isn't a cosmetic is therefore not regulated by the FDA.
However, soap is a product that is used in the home –a consumer commodity. As such it is regulated by the Federal Trade Commission (FTC) for labeling and marketing, and the Consumer Product Safety Commission (CPSC)for safety
Federal Trade Commission (FTC)
The Federal Trade Commission administers the Fair Packaging and Labeling Act for consumer commodities (such as soap).4 It is the FTC Regulations which specify what must be on the label of a soap product.5 (See Soap: Label Requirements[link to new article])
Consumer Product Safety Commission (CPSC)
The Consumer Product Safety Commission oversees the safety of consumer products, including soap. Currently there are no restrictions or special safety requirements for soap, except in the case of soap marketed specifically for children. (See: Children's Products[link to upcoming article])
1 21 USC 321(i)
2 21 CFR 701.20(a)
3 Oxford English Dictionary, s.v. “represent, v.¹", July 2023. https://doi.org/10.1093/OED/8410347154
4 Fair Packaging and Labeling Act -15 USC 1451-1461
5 16 CFR §§ 500-503
