Michigan direct-to-consumer compliance guide, 2026

Body Care

Lotions, balms and scrubs: small makers skip FDA registration but not safety and labeling.

Federal Rules Only

Eye-area, injected, internal or long-lasting non-removable products keep full MoCRA duties
SPF, acne, dandruff or antiperspirant claims: over-the-counter drug rules
Claims to treat skin disease: unapproved drug claims
Ingestible products: food or supplement route

Three compliance steps

A
Test your size and your products
Average your last three years of US cosmetic sales. Under $1 million exempts you from facility registration and product listing, unless you make a high-risk product type.
B
Document safety and label fully
Keep safety substantiation for every product, list ingredients, add a domestic address, phone or electronic contact for adverse events, and state net quantity.
C
Report, record and tax
Report serious adverse events to FDA within 15 business days and keep records three years. Collect 6% Michigan sales tax; toiletries are taxable.

Item	Rule	Regulator
Facility registration, listing	Exempt if average sales under $1M over 3 years and no high-risk products	FDA
Safety substantiation	Required for every product, no small business exemption	FDA
Label contact	Domestic address, phone or electronic contact for adverse event reports	FDA
Serious adverse events	Report within 15 business days; keep records 3 years if small business	FDA
Drug claims	SPF, acne, dandruff claims trigger drug requirements	FDA
Sales tax	Toiletries are taxable; food is exempt	MI Treasury

No. It removes registration and listing only. Safety substantiation, labeling and adverse event reporting still apply.

Soap made only from fats and alkali and marketed only as cleansing is not a cosmetic, but cosmetic claims or added ingredients can change that.

MDARD's licensing pages cover food, feed and plants. Check with your local government for home business rules.