US regulatory guide

The MoCRA small-business exemption.

MoCRA exempts genuinely small cosmetic businesses from its heaviest duties. But the exemption is narrower than most founders assume, several product categories void it entirely, and it never touches the duties that actually protect you in a dispute. Here is where the line runs.

A small cosmetics business reviewing its MoCRA obligations

Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026

Who qualifies as a small business under MoCRA?

A business whose average gross annual US cosmetic sales over the previous three-year period are under $1,000,000, a figure the FDA adjusts for inflation. A qualifying small business is exempt from facility registration, product listing and Good Manufacturing Practice requirements.

The test is a rolling three-year average of US cosmetic sales specifically, not worldwide revenue, and not your best or worst single year. The FDA's own summary of the threshold is in its small-business fact sheet.

The FDA small businesses fact sheet with the MoCRA small-business exemption highlighted
The FDA's Small Businesses and Homemade Cosmetics fact sheet, with the MoCRA small-business exemption highlighted. Captured 26 July 2026. View the official text.

Which products void the exemption?

Four categories: products that regularly contact the mucous membrane of the eye, products that are injected, products intended for internal use, and products that alter appearance for more than 24 hours where removal is not part of ordinary use. One such product removes the exemption.

The exemption is all-or-nothing: a single eyeliner, eye cream or lash serum in the range puts the whole business back under the registration and listing duties. Reading your catalogue against these categories is the first step of any exemption analysis, and the step most brands get wrong on their own.

What does an exempt business still have to do?

Everything except register, list and follow the formal GMP rule. Safety substantiation, compliant labeling (including the adverse-event contact required on labels since 29 December 2024) and serious adverse-event reporting apply to every firm selling cosmetics in the US, exempt or not.

This is the part that catches founders who read "exempt" as "unregulated". It also explains the paperwork trap on platforms like TikTok Shop, which ask exempt sellers for FDA certificates that do not exist; our marketplace guide covers what to send instead. Each product still needs adequate substantiation of safety on file, the label must still meet US label requirements, and a serious adverse event still has to reach the FDA within 15 business days. The in-force duties are listed on the FDA's MoCRA page.

Does the exemption apply to foreign brands selling into the US?

The threshold is measured on US cosmetic sales, so a foreign brand with modest US revenue can qualify. But the exemption covers registration, listing and GMP only. It does not remove the need for a US contact on the label, nor the labeling and adverse-event duties that apply from the first unit sold.

For a foreign brand above the threshold, the machinery is the standard one: facility registration with a US Agent, plus product listing by the Responsible Person named on the label.

What happens when I outgrow the exemption?

Once your three-year average crosses the threshold, or you launch a product in a voiding category, the registration, listing and GMP duties attach. Track the average as you grow and plan the filings before the crossing year, not after; registrations then renew every two years from your own registration date.

The renewal mechanics are covered in our MoCRA renewal guide, and the full regime (registration, listing, US Agent, records) in the complete MoCRA guide. If you want the exemption analysis done properly against your actual catalogue and sales, request a US compliance quote.

Related reading

The rest of the US picture.

Not sure if you qualify?

We check your catalogue against the voiding categories and your sales against the threshold, and set up registration and listing only if you actually need them.