Is soap regulated by the FDA?

What changes the answer

• Synthetic detergents. Syndet bars, most liquid body washes and shampoos clean with synthetic surfactants, so they are cosmetics even when labeled "soap".
• Cosmetic claims. Claims such as moisturizing, deodorizing, fragrancing or making skin softer make even a true soap a cosmetic, because it is no longer represented only as soap.
• Drug claims. Antibacterial, acne or eczema claims make the product a drug, which must follow an OTC monograph or have an approved application.
• What applies to cosmetic soap. A cosmetic bar must follow FDA cosmetic labeling, including ingredient declaration and an accurate net weight, and MoCRA facility registration and product listing unless the small business exemption applies.
• What applies to true soap. CPSC's Federal Hazardous Substances Act labeling rules can apply if the product is hazardous, and FTC labeling rules on net quantity apply to consumer commodities.

What to do

1. Check the formula: is the cleansing ingredient sodium or potassium salts of fatty acids, such as saponified oils, with no synthetic detergent doing the cleaning?
2. Check every claim on the label, website and listing. One word like "moisturizing" changes the category.
3. If it is a cosmetic, label it under 21 CFR part 701, list ingredients in descending order, register the facility and list the product under MoCRA unless exempt, and add the adverse event contact required by MoCRA.
4. If it is a drug, follow the OTC monograph labeling with a Drug Facts panel and drug establishment registration.