Federal Rules ApplyBody Care
Soaps, lotions, balms and scrubs. Selling direct to consumers in Maine.
State licenseNone identified
Federal lawMoCRA
Small businessUnder $1M exempt from registration
RecordsSafety substantiation
What is covered
Covered by this path
- Lotions, balms, scrubs
- Soaps that make cosmetic claims
- Lip products
Needs a different path
- Drug claims such as acne or eczema treatment
- Products for ingestion
- Sunscreens (OTC drug)
Three compliance steps
ACheck your size
MoCRA exempts small businesses averaging under $1 million a year from facility registration and product listing.
BKeep required records
Adverse event reporting, safety substantiation and ingredient labeling still apply.
CLabel correctly
Include identity, net quantity, ingredients in descending order and a responsible-person address.
Quick reference
| Item | Rule | Regulator |
|---|
| Facility registration | Exempt if small business | FDA (MoCRA) |
| Adverse events | Record and report serious ones | FDA (MoCRA) |
| Plain soap | Regulated as soap, not a cosmetic, if cleansing only | FDA / CPSC |
| Drug claims | Not allowed without approval | FDA |
Frequently asked
Is handmade soap a cosmetic?Only if it makes cosmetic claims. Plain cleansing soap is treated differently.
Printable checklist
Revenue under $1M noted
Ingredient list
Safety substantiation file
Adverse event log
Label with address