Minnesota direct-to-consumer guide, 2026
Body Care
Soaps, lotions, balms, scrubs, and other products used on skin and hair.
Federal Cosmetic Rules + State PFAS BanWhat is covered and what needs a different path
What’s covered
- Lotions, balms, scrubs, and lip products with cosmetic claims only
- True soap made of fat and alkali, cleansing claim only (CPSC, not FDA)
- Small makers under the $1M MoCRA line, with safety and labeling duties
Needs a different path
- Products that claim to treat or prevent a condition (sunscreen, acne, eczema) are drugs
- Anything with intentionally added PFAS
- Using color additives not approved for cosmetics
Three compliance steps
Sort your product
Cosmetics are for cleansing or beautifying. Drug claims need FDA drug compliance. True soap follows consumer product rules instead.
Meet MoCRA labeling
Show identity, net quantity, ingredients in descending order, warnings, and a domestic address or phone for adverse events. Keep safety substantiation on file. Under $1M average sales you are exempt from facility registration and product listing.
Keep PFAS out and collect tax
Minnesota bans intentionally added PFAS in cosmetics. Charge 6.875% plus local tax on retail sales.
Quick reference
| Item | Rule | Regulator |
|---|---|---|
| Facility registration, listing | Small-business exemption below $1M average annual sales | FDA |
| Adverse events | Serious events reported within 15 business days | FDA |
| Safety substantiation | Required for every product; keep records | FDA |
| PFAS | Intentionally added PFAS banned in cosmetics since Jan 1, 2025 | MPCA |
| Sales tax | Body care is taxable at 6.875% plus local | MN Revenue |
Frequently asked questions
Is handmade soap regulated by FDA?
True soap is generally regulated by CPSC. Add cosmetic claims or non-soap detergents and it becomes an FDA cosmetic.
Do I report PFAS if I add none?
The reporting duty applies to products with intentionally added PFAS. Keep supplier statements anyway.
Can I make a sunscreen?
SPF claims make it an over-the-counter drug with FDA drug requirements. That is a different path.
Printable checklist
- Classify each product: soap, cosmetic, or drug
- Ingredient list and net quantity on label
- Domestic contact for adverse events
- Safety substantiation file
- PFAS supplier statements
- Minnesota sales tax ID
MoCRA thresholds are federal reference rules.