Before you sell handmade soap in the US, it's worth understanding a distinction that surprises many new makers: the rules that apply to your soap depend not just on what's in it, but on what you say it does. Call it "soap" and describe it only as a cleanser, and it may be regulated one way. Say it moisturizes, and different rules may apply. Say it treats acne, and it's a different category again. This guide explains the three categories in plain terms. It isn't legal advice — check the official guidance for your products.
What is "true soap" under US rules?
In the US, "true soap" is a product whose cleaning action comes mainly from alkali salts of fatty acids — what you get when oils react with lye — and that is labeled, sold and represented only as soap. True soap is regulated by the Consumer Product Safety Commission (CPSC) rather than the FDA.
The definition comes from the FDA's regulation at 21 CFR 701.20, and the CPSC's soap guidance explains that the CPSC regulates products meeting it.
When does soap become a cosmetic or a drug?
| Category | Typical examples of claims | Regulated by |
|---|---|---|
| True soap | "Cleansing bar", "handmade soap" — cleaning only | CPSC |
| Cosmetic | Moisturizing, deodorizing, making skin smell nice, beautifying | FDA (as a cosmetic) |
| Drug | Treating acne or eczema, killing germs, antibacterial | FDA (as a drug) |
According to the CPSC, claims like moisturizing the skin or deodorizing the body can make a product a cosmetic, and claims to treat skin conditions or kill germs can make it a drug. A product can also fall outside "true soap" if its cleaning action comes mainly from synthetic detergents, even if it's called soap. See the CPSC's soap FAQ for their summary.
Why do claims matter so much?
Because they change which rules apply. Cosmetics have their own labeling requirements, such as ingredient declarations, and drugs face much stricter requirements. The Modernization of Cosmetics Regulation Act of 2022 also added requirements for cosmetics, with some exemptions for small businesses. If your soap is a cosmetic because of how you market it, those rules apply to you.
A practical takeaway: be deliberate about the words on your label, listing and social posts. Describing a bar as "moisturizing" is a common way makers unintentionally move from true soap into cosmetic territory.
What should you put on a soap label?
Requirements depend on your product's category, so check the official guidance. Many makers include, regardless of category:
- The product name and what it is.
- Net weight of the bar.
- Your business name and location.
- Ingredients, which also helps customers with allergies or sensitivities.
- Batch or date information for tracking.
How does labeling affect your costs and pricing?
Labels are part of your packaging cost, and compliance can add time: designing labels, printing, applying them and keeping records. Include label costs in your packaging per bar and label-application time in your batch hours. How much it costs to make a bar of soap shows where packaging fits into your cost per bar.
It's also worth reading about wholesale soap pricing.
