Maryland direct-to-consumer guide, 2026
Body Care
Soaps, balms, lotions, scrubs and cosmetics
MoCRA Rules Apply$1MSmall-business MoCRA exemption
SafetySubstantiation required
15 daysSerious adverse event report
FDAPrimary regulator
What is covered
YESCovered by this path
- Lotions, balms, scrubs, lip care
- Plain soap made of fats and alkali
- Hair and beard products
NONeeds a different path
- Products claiming to treat acne or eczema
- Sunscreen with SPF claims
- Homemade products labeled as drugs
Three compliance steps
ASort cosmetic from drug
Cosmetics beautify or cleanse. Treatment claims make it a drug with far stricter rules
BMeet MoCRA basics
Keep safety substantiation, report serious adverse events within 15 business days, and label with a responsible-person address
CCheck the small-business exemption
Businesses under the average-sales threshold are exempt from facility registration and product listing
Quick reference
| Item | Rule | Regulator |
|---|
| Labeling | Ingredients in descending order, net quantity, warnings | FDA |
| Safety substantiation | Required for every product | FDA |
| Facility registration | Exempt under the small-business threshold | FDA |
| Plain soap | Regulated by CPSC, not FDA, if only cleansing | CPSC |
| Sales tax | Taxable at 6% | Comptroller |
FAQ
Am I exempt from MoCRA?
Small businesses are exempt from registration and listing, not from safety, labeling and reporting.
Is soap a cosmetic?
True soap is CPSC-regulated; added cosmetic claims change that.
Can I say it heals skin?
No; that is a drug claim.
Checklist