The law that defines cosmetics leaves soap out, so a true soap isn't a cosmetic and sits outside FDA's cosmetic rules. FDA reads "soap" narrowly: the bulk of the product is alkali salts of fatty acids, it cleans because of them, and it's labeled, sold and represented only as soap. A cold process or hot process bar that only says "soap" fits. Add a claim beyond cleaning, moisturizing, deodorizing, and it becomes a cosmetic; claim it treats acne or kills germs and it's a drug. Syndet bars, liquid body washes and most "soaps" made with synthetic detergents are cosmetics from the start. In the example below, a soap maker sorts seven products and finds one claim that turns a bar into a drug. Below is the test, the example, what each category brings, and a free checklist.
The short version
- True soap: mostly alkali salts of fatty acids, cleans because of them, labeled and sold only as soap.
- True soap is outside FDA's cosmetic rules; the Consumer Product Safety Commission oversees products like it.
- A cosmetic claim, moisturizing, deodorizing, softening, makes a soap a cosmetic.
- A drug claim, acne, eczema, antibacterial, SPF, makes it a drug.
- Detergent bars and body washes are cosmetics whatever they're called.
- Cosmetics follow cosmetic labeling and MoCRA, with exemptions for small businesses.
- TaroStack gives each batch a lot and keeps its curing dates. More below.
The test
| Question | True soap if | Rule |
|---|---|---|
| What is it made of? | The bulk of its nonvolatile matter is an alkali salt of fatty acids | 21 CFR 701.20(a) |
| Why does it clean? | Its detergent properties come from those alkali-fatty acid compounds | 21 CFR 701.20(a) |
| How is it sold? | Labeled, sold and represented only as soap | 21 CFR 701.20(a) |
The definition of cosmetic, things applied to the body for cleansing, beautifying or altering the appearance, ends "except that such term shall not include soap" (21 U.S.C. 321(i)). Body cleansers that aren't soap by that test are cosmetics, and a cosmetic bar, for example, carries an accurate net weight in pounds and ounces (21 CFR 701.20(b)). Anything intended to diagnose, cure, mitigate, treat or prevent disease is a drug (21 U.S.C. 321(g)(1)). This is general information, not legal advice.
An example: seven products, sorted
Salt Marsh Soap Co., a made-up soap maker in Charleston, South Carolina, I use in these examples, sells to gift shops:
| Product | True soap makeup? | Claim | What it is |
|---|---|---|---|
| Lavender bar, labeled "soap" | Yes | None beyond cleaning | True soap |
| Shea butter bar, "moisturizing" | Yes | Moisturizing | Cosmetic |
| Charcoal bar, "clears acne" | Yes | Clears acne | Drug |
| Liquid body wash | No: synthetic detergent | None | Cosmetic |
| Hand lotion | No | Softens skin | Cosmetic |
| Lip balm with SPF 15 | No | Sun protection | Drug |
| Lavender bath soak | No | A relaxing scent | Cosmetic |
The same cold process recipe sits in all three bars, and the label decides what each one is. The lavender bar is the only one outside FDA's cosmetic rules. The shea bar's "moisturizing" makes it a cosmetic, which is fine with cosmetic labeling. The charcoal bar's "clears acne" makes it a drug, which a small soap maker can't meet, so the claim goes: "charcoal soap" is all the label says now. The SPF lip balm is a sunscreen, a drug; Salt Marsh drops the SPF and sells it as a plain lip balm. How to label the cosmetics is in cosmetic labeling requirements, and what MoCRA asks of a small maker in MoCRA small business.
Words that change what a bar is
| Says | Makes it |
|---|---|
| "Soap", "handmade soap", "lavender soap" | Still true soap, if the makeup fits |
| "Moisturizing", "nourishing", "softens skin", "deodorant" | A cosmetic |
| "Antibacterial", "kills germs", "for acne", "for eczema", "heals" | A drug |
Words on a website, a market sign or a shop's shelf talker count as much as words on the label: FDA looks at how the product is represented, not only the wrapper. How to start and run a soap business is in how to start a soap business.
Get the checklist
Download the soap, cosmetic or drug checklist. One sheet: one line for each product with yes or no for a true soap makeup and whether it cleans because of it, the claims it makes, and whether any is a drug claim, where what it is and what that means fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The checklist sorts the products. The soap itself still needs its batches: oils and lye bought by the lot, bars cut and cured for weeks, each batch on a rack with a date it's ready, and a shop's order picked from the batch that's finished curing.
How TaroStack does it
TaroStack gives each batch a lot and keeps its curing dates.
Each batch its lot. A batch of lavender bars takes its oils, lye and lavender oil off stock, records the lots it consumed, and gets a lot of its own with its production date. How to number them is in how to create batch numbers for soap.
Curing kept apart. A batch still curing can be held, kept out of what can be sold until it's ready, so a shop's order is picked from cured bars.
From batch to shop. Each order records the lots each shop got as it ships, so one recall report shows where a batch went if a lavender oil supplier ever calls.
| The job | Notebook | In TaroStack |
|---|---|---|
| A batch's lot and date | Written on the rack | Each batch's own lot |
| Bars still curing | A sign on the rack | A hold until ready |
| Which oils went in | Not recorded | Recorded automatically |
| Which shops got a batch | Search the invoices | One recall report |
Lots, batches, holds and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.