Cosmetic, drug or soap?
The FDA's line, in the FDA's words.
Our explanation written by Grimy Hands
The FDA sorts these products by their intended use, and it says intended use can be established by claims on labeling, in advertising and online, and by consumer perception. A product sold for cleansing or moisturizing fits the law's definition of a cosmetic. A product intended to treat or prevent disease fits the definition of a drug, and some products are both.
Soap is a special case. Under the FDA criteria quoted here, the bulk of the product's nonvolatile matter must consist of an alkali salt of fatty acids, its detergent properties must come from those alkali-fatty acid compounds, and it must be labeled, sold and represented solely as soap. Products meeting those criteria are regulated by the CPSC, not the FDA. A human-body cleanser that doesn't meet all the soap criteria is classified by its intended use as a cosmetic, a drug, or both.
Leaving a maker's drug-type wording off this site wouldn't change how the product is classified, because the FDA looks at the maker's claims wherever they appear. So a product whose own page positions it with claims about killing germs, healing or relieving skin conditions is held back, not listed with those claims removed.
Our explanation of the FDA page quoted below. It adds no facts of its own and doesn't rate or recommend any product.
What the FDA says
Whether a product is a cosmetic or a drug under the law is determined by a product's intended use.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics 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"
The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease"
Some products meet the definitions of both cosmetics and drugs.
Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic.
Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market.
Not every product marketed as soap meets FDA's definition of the term.
Products that meet this definition of soap are regulated by the Consumer Product Safety Commission (CPSC), not by FDA.
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug.
Examples include antibacterial cleansers and cleansers that are also intended to treat acne.
Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin.
Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials.
Consumer perception, which may be established through the product's reputation.
FDA interprets the term "soap" to apply only when the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids
the product's detergent properties are due to the alkali-fatty acid compounds
and the product is labeled, sold, and represented solely as soap
How this site uses it
Before a product is listed, its maker's own page is read for drug-type positioning: claims about killing germs, healing, relieving or repairing skin, or treating skin conditions. A product with such claims is held back, not listed with the claims removed, because removing words here wouldn't change what the maker claims. Products sold as over-the-counter drugs aren't listed either. This is the site's listing rule, not a ruling on any product's legal status.
General information, not medical advice. HSE: Skin dryness and cracking are early signs of dermatitis and shouldn't be ignored – you should check with your GP or if available, your occupational health service if you notice these signs.
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