If you plan to sell soap or other personal care products in the US, it's important to understand what your product is and how it is classified. Then, you can determine how it's regulated and label it correctly to ensure compliance with labeling requirements. So, is soap a cosmetic or something else? Let's find out.
Is Soap a Cosmetic?
Products that people call "soap" can be many things—true soaps regulated by the Consumer Product Safety Commission (CPSC), cosmetics, or drugs regulated by the Food and Drug Administration (FDA). It depends on how soap is made, its intended use, and what claims are made about it.
According to the FDA regulatory definition, the term "soap" can only be applied when
- "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 only as soap." (21 CFR 701.20)
In other words, true soap is made with oils and lye and doesn't contain any synthetic detergents. If soap contains synthetic detergents or other ingredients, it's not a true soap. Usually, it's a cosmetic. For example, most, if not all, melt-and-pour soaps are not true soaps and are considered cosmetics based on their ingredients.
Remember that the only claims that can be made about a true soap are that it is soap and that it cleanses. If you make other claims about it, it can become a different product type—a cosmetic or drug.
True soap is what we make at Botanie Soap, using time-tested recipes, and offer for private label use. Explore our collections of all-natural cold-process bar soap and liquid soap to see what we offer and order samples to choose products that your customers will love.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use 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."
According to this definition, a product marketed as soap that isn't a true soap is automatically considered cosmetic if it's used on the human body. But a true soap can also be a cosmetic if cosmetic claims are made about the entire product or one of its ingredients. For example, if you say your soap "contains moisturizing shea butter," it's a cosmetic. And if you say it's a "moisturizing soap," it's a cosmetic as well.
The FD&C Act also provides a definition of drugs 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." Remember that making certain claims can cause your soap to qualify as a drug subject to FDA drug approval and labeling regulations. Some examples of common drug claims for soap are that it "treats acne," "cures eczema," "kills fungi," "antibacterial," "prevents aging, "etc.
That means you need to be very careful about what words and phrases you use to market your soap and what claims you make. If it's simply soap, you can just say that it cleans the skin and nothing else. Suppose you want to use words and phrases in your marketing that would put your products in the cosmetic category (e.g. moisturizing, exfoliating, hydrating). In that case, you have to label your soap as a cosmetic. But don't use words and phrases that will move your products into the drug category.
Soap and Cosmetic Labeling
Proper labeling is important for putting soaps and cosmetic products on the market. As we've noted above, cosmetics are regulated by the FDA, while CPSC regulates true soaps, so soap and cosmetic labeling requirements differ.
True soaps have no specific regulatory requirements, so their labeling requirements are governed by the Fair Packaging and Labeling Act (FPLA). The label must include the name of the product, its net weight, and the manufacturer's or distributor's name and address. The ingredient declaration is not required, but you can include an ingredient list to tell the customers what's in your soap and help them make an informed purchasing decision.
Suppose you want to claim that your soap or its ingredients are certified organic. In that case, your final product probably needs to be certified by the Agricultural Marketing Service of the US Department of Agriculture (USDA), which oversees the National Organic Program (NOP). The NOP regulations include labeling standards based on the percentage of organic ingredients in a product.
If you are looking to launch a unique soap product that meets all the criteria of the FDA definition of soap and is made with organic ingredients, our Custom Manufacturing division can help you get it right. We make true natural soap and have USDA National Organic Program certification as well as NSF / ANSI 305 Made with Organic certification.
FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which expanded the FDA's authority under the FD&C Act law, cosmetics must not be adulterated or misbranded. Cosmetic products must be safe for consumers and properly labeled—the labeling must be truthful and not misleading.
If the product is cosmetic, the following labeling information is required on the principal display panel: the product's name and the net quantity of contents. An information panel must include information about the name and address of the manufacturer or distributor, an ingredient declaration, warnings, and adequate directions for safe use (for cosmetics, which may be hazardous to consumers when misused).
The ingredients must appear in descending order of predominance—the ingredient present in the formula at the highest percentage is listed first, the next highest percentage second, etc. The ingredients less than 1% of the formula can be included at the end of the list in any order.
Bottom Line
"Soap" is a commonly used word, but the term only officially applies to products that meet certain conditions. The product must mainly consist of alkali salts of fatty acids, and they must be the only ingredients that cause the product's cleaning action. The product must also be labeled and marketed only as a soap. If a cleanser does not meet all of these criteria, it may be classified as a cosmetic or a drug, depending on its intended use, although you can still use the word "soap" on the label.