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Soapmaking
All Containers›Shop by use case›Soapmaking›Soap, cosmetic or drug›Three categories, not twoShop all soap and wash →
Soap, cosmetic or drug

Three categories, not two

By Dwight Davis, Founder

Updated

On this page5

Everywhere else in this estate a product forks two ways. Soap forks three, and most handmade soap is in a different category from the one its maker believes.

One product, three regimes

The same bar, made the same way from the same oils, can be exempt soap, a cosmetic or an OTC drug.

Which one it is depends on its composition and on what you say about it, and the second matters more than the first.

Exempt soap

Soap meeting the definition in 21 CFR 701.20 is exempt from the FD&C Act's cosmetic provisions.

It falls instead to the Consumer Product Safety Commission, which is a lighter regime: consumer commodity labeling under the Fair Packaging and Labeling Act, and no cosmetic ingredient declaration.

No INCI list, no MoCRA registration, no cosmetic labeling requirements. It is the easiest position in this property and it is narrow.

A cosmetic

The moment the product fails either condition of the exemption, it is a cosmetic.

Which brings the full cosmetic regime: ingredient declaration by INCI in descending order, cosmetic labeling, MoCRA facility registration and product listing where applicable, and safety substantiation, which has no small-business exemption.

This is where most handmade soap actually sits, and most of it is labeled as though it were exempt.

A drug

A claim to treat or prevent a condition, or to affect the structure or function of the body, makes it an OTC drug.

Antibacterial. For acne. For eczema. Antifungal. Each of those is a drug claim, and a drug needs a monograph active at a monograph level, a Drug Facts panel, establishment registration, a drug listing and cGMP.

Which is the same wall lip care runs into, and it is reached from soap by a single word on a label.

References

21 CFR 701.20. FDA interprets "soap" to apply only to articles where the bulk of the non-volatile matter consists of an alkali salt of fatty acids, the detergent properties are due to those alkali-fatty acid compounds, and the product is labeled, sold and represented only as soap. ecfr.gov
US Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). How intended use, established by claims, decides which of the three a product is. fda.gov
US Consumer Product Safety Commission. Soap Business Guidance. Products meeting the FDA soap exemption fall to CPSC rather than FDA, with labeling under the Fair Packaging and Labeling Act and the Federal Hazardous Substances Act where relevant. cpsc.gov
US Food and Drug Administration. Registration & Listing of Cosmetic Product Facilities and Products under MoCRA, including the small-business exemptions and what they do not cover. fda.gov
Written from the federal regulation and FDA and CPSC guidance named on each page, not from a laboratory or a legal practice. Whether a particular product and a particular label make exempt soap, a cosmetic or a drug is a determination about your product, and this is not that determination.