Much of the advice online about selling homemade cosmetics is pre-MoCRA — and some of it is now flat-out wrong. “You don’t need to register with FDA” was true in 2021. In 2026, it depends.
Here’s what home formulators, Etsy sellers, and small-batch brands actually need to do.
The big change: your kitchen can be a “facility”
Under MoCRA, a facility is any place that manufactures or processes cosmetics for sale in the U.S. — including your home, studio, or workshop. If you make the product (not just slap a label on someone else’s), you’re operating a facility.
Non-exempt facilities must register with FDA and list every product. The full process: FDA Registry for Cosmetics.
The small business exemption — read the fine print
You may be exempt from registration and listing if your facility averaged under $1,000,000 in U.S. gross annual sales over the preceding 3 tax years.
But the exemption does not apply if you make: products for the eye area; injectables; products for internal use; products that alter appearance for more than 24 hours under labeled use.
And crucially, the exemption covers only registration and listing. You still need safety substantiation, adverse event recordkeeping, and compliant labeling.
When you don’t need to register at all
You generally don’t need facility registration if you only label, relabel, package, repackage, hold, or distribute products made by someone else. Buy bulk and fill containers yourself, though, and you’re manufacturing — registration applies.
Labeling: the rules that sink small brands
Over half of FDA cosmetic warning letters cite labeling. Your labels need: statement of identity, net contents, full INCI ingredient list, your business name and address; domestic contact information for adverse event reports (new under MoCRA — a U.S. address, phone, or website); no drug claims (“heals eczema,” “treats acne”) — those reclassify your product as a drug.
Safety and adverse events apply to you too
Small-batch doesn’t mean exempt from safety obligations. You need a safety file supporting your formula (what goes in it), and you must record customer complaints and report serious adverse events to FDA within 15 business days.
New to MoCRA? Start with our complete MoCRA Compliance Guide for Cosmetic Brands (2026).
Frequently asked questions
Do I need FDA approval before selling my homemade lotion? No — FDA doesn’t pre-approve cosmetics. But you may need to register your facility and list the product (unless exempt), and you always need compliant labeling and safety substantiation.
Does the small business exemption mean I can ignore MoCRA? No. It exempts you from facility registration and product listing only. Labeling, safety substantiation, and adverse event obligations still apply.
I sell on Etsy — does MoCRA apply? Yes. The sales channel doesn’t matter. If you manufacture cosmetics for U.S. sale, MoCRA applies whether you sell on Etsy, your own site, or at farmers’ markets.
What if I only sell lip balm? Lip balm is a cosmetic. The product type doesn’t exempt you — only the small-business sales threshold (with its product exceptions) does.
My supplier says their ingredients are “FDA approved” — am I covered? No. FDA doesn’t approve cosmetic ingredients (except color additives). Supplier claims don’t substitute for your own safety substantiation and labeling compliance.
This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on FDA’s published guidance and are current as of September 2026; always verify requirements against FDA’s official sources before acting.