Not every indie brand has to register under MoCRA. The small-business exemption is real — but it has hard limits. Here’s who is exempt from registration, listing, and GMP, and what still applies to everyone.
Published September 9, 2026 · By Formulate 360 Team· Topics: mocra exemptions, mocra small business exemption, small cosmetics brand exemption, are small brands exempt from mocra, mocra registration exemption
If your cosmetics sales put you under the MoCRA small-business threshold, you are not required to register your facility, list your products, or follow cGMP. That part of the law is real, and it covers most indie beauty brands. CONFIRMED FDA small-business guidance.
But the exemption is narrow. It does not touch two obligations that apply to every responsible person: safety substantiation and serious adverse event reporting. “I'm a small business” is not a get-out-of-jail card for either.
Under MoCRA, a responsible person (the manufacturer, packer, or distributor whose name appears on the label) and a facility can qualify for the small-business exemption. CONFIRMED FDA registration & listing page.
The threshold:a “small business” is a responsible person (or facility owner/operator) whose average gross annual sales in the US of cosmetic products over the previous 3-year period is less than $1,000,000, adjusted for inflation. It is measured on cosmetic sales only, and it adjusts over time. CONFIRMED FDA guidance.
Two obligations survive the small-business status and apply to everyone, including sole founders selling a couple hundred jars a month:
The threshold is about registration, listing, and GMP — not about the safety and reporting duties that fall on the brand whose name is on the label. CONFIRMED FDA — MoCRA (AE reporting and safety substantiation).
Even under the sales threshold, the exemption does not apply to products that:
If any of your products fall in these categories, you are not a “small business” for MoCRA purposes for those products, and facility registration / product listing become live obligations. CONFIRMED FDA.
Exempt now is not exempt forever. The threshold is inflation-adjusted, so it moves. Two habits protect you:
What does "MoCRA" mean?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022 — the law that gave FDA new authority over cosmetics. It created obligations around facility registration, product listing, GMP, serious adverse event reporting, and safety substantiation.
Are small cosmetics brands exempt from MoCRA?
Partly. A responsible person or facility under the $1M/3-year average cosmetics-sales threshold (inflation-adjusted) is exempt from facility registration, product listing, and GMP. But safety substantiation and serious adverse event reporting apply to every responsible person regardless of size.
What is the MoCRA small business exemption threshold?
Less than $1,000,000 in average gross annual US cosmetic sales over the previous 3-year period, adjusted for inflation. The exemption is not automatic — it depends on your cosmetics sales and your product types.
Which products are not covered by the small business exemption?
The exemption does not apply to products that regularly contact the eye’s mucus membrane, are injected, are intended for internal use, or alter appearance for more than 24 hours.
If I’m exempt, do I still have to report adverse events?
Yes. Serious adverse event reporting to FDA within 15 business days, and safety substantiation requirements, apply to every responsible person. The small-business exemption does not cover them.
Do I need an FEI number if I’m exempt?
Only if you register a facility. FDA assigns an Establishment Identifier (FEI) number at registration. If you’re exempt from registration you won’t carry one, but any contract manufacturer or processor you use will have its own.
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