Missouri Direct-to-Consumer Guide 04 of 24
Body Care
Soaps, lotions, balms and scrubs
Federal Rules Apply
MoCRA2022 federal cosmetics law
$1MSmall-business threshold (3-yr average)
SoapTrue soap is outside cosmetics
0Missouri cosmetic license identified
What is covered, and what needs a different path
Covered
- True soap labeled only as soap
- Lotions and balms with substantiated safety
- Small businesses under the MoCRA threshold
Needs a different path
- Drug claims such as treats eczema
- Eye-area, injectable or internal products (no small-business relief)
- Unlabeled or unlisted products over threshold
Three compliance steps
ASort soap from cosmetics
Only cleansing products made from fats and alkali and sold as soap escape cosmetic rules.
BCheck the small-business exemption
Under the threshold you skip facility registration and product listing, but safety substantiation and labeling still apply.
CLabel and report
Ingredient list, domestic contact, and a process for adverse event reports.
Quick reference
| Item | Rule | Regulator |
|---|
| Soap | Outside FDA cosmetic definition if cleansing only | FDA / CPSC |
| Lotion or balm | Cosmetic: labeling and safety substantiation | FDA |
| Registration | Small businesses generally exempt | FDA |
| Drug claims | Treat or cure claims make it a drug | FDA |
| Sales tax | Retail sales are taxable; Missouri sales tax license, state plus local rate | MO DOR |
FAQ
Do I register with FDA?
Not if you qualify as a small business and make no excluded product types.
Do I need a Missouri license?
None specific to cosmetics was identified.
Can I claim a product heals?
No. Therapeutic claims create drug obligations.
Printable checklist
- Classify: soap or cosmetic
- Check small-business threshold
- Write safety substantiation file
- Label with ingredients
- Set adverse event process
- Register for sales tax