What is covered and what needs another path
Covered
- Lotions, balms, scrubs, lip care
- True soap made only from fats and lye
- Cosmetics labeled with ingredient list
Needs a different path
- Drug claims such as treating eczema or acne
- Products for the eye area, injection or internal use without full MoCRA compliance
- Skipping safety substantiation
Three compliance steps
A
Sort soap from cosmetic
True cleansing soap is not a cosmetic and falls to CPSC. Anything with moisturizing or beauty claims is a cosmetic.
B
Meet MoCRA
Small businesses averaging under $1 million are exempt from facility registration and listing for most products, but not from labeling or adverse event reporting.
C
Label and tax
Ingredient list, net contents, warnings, and your name and address. Register for sales tax.
Quick reference
| Item | Rule | Regulator |
|---|---|---|
| Lotion or balm | Cosmetic; label ingredients, keep safety substantiation | FDA (MoCRA) |
| True soap | Consumer product labeling only | CPSC |
| Small business | Exempt from registration and listing for most products | FDA |
| Drug claims | Treating a condition makes it a drug | FDA / FTC |
FAQ
Do I have to register my facility?
Small businesses under the MoCRA threshold are generally exempt, except for certain higher-risk products.
Is my soap a cosmetic?
Not if it only cleanses and makes no cosmetic claims.
Checklist
- Soap or cosmetic decided
- Ingredients listed
- Warnings included
- Adverse event process set
- No drug claims
- Tax registered