MoCRA small-business exemption statement: who can use it

If your business meets MoCRA's small-business sales test and doesn't manufacture or process any of the four excluded product groups, section 612 exempts it from the cosmetic GMP and registration/listing requirements covered by that section. (Section 612, 21 USC 364h) TikTok Shop asks qualifying sellers for a self-attested statement of eligibility. (TikTok Shop beauty requirements)

Don't wait for FDA to sign it: FDA's September 9, 2026 announcement says it doesn't provide certificates, letters, or emails confirming that a facility or responsible person is exempt from cosmetic registration or listing. (FDA announcement)

Check the sales test and the business making the statement

The statute covers responsible persons and facility owners or operators whose average gross annual US sales of cosmetics for the previous three years are below $1 million, adjusted for inflation, subject to the product exclusions. (Section 612, 21 USC 364h) Use gross cosmetic sales for that period when reviewing the test, and don't substitute profit or a single month's receipts. Keep the calculation with your records and verify the applicable inflation adjustment before signing if your conclusion depends on it.

Check your own business and the factory separately, because the statute applies its conditions to responsible persons and facility owners or operators. (Section 612, 21 USC 364h) FDA's guidance says a facility making any excluded product must register and include the required information for all the cosmetics it manufactures or processes. (21 USC 364h(b); FDA guidance, question 8) Ask a separate factory for its own evidence rather than signing on its behalf.

Who can't use this exemption

The exemption doesn't cover a responsible person or facility engaged in manufacturing or processing any of these four groups. (Section 612, 21 USC 364h)

Cosmetics that regularly contact the eye's mucous membrane during customary or usual use. (Section 612(b)(1))
Cosmetics that are injected, regardless of the business's size. (Section 612(b)(2))
Cosmetics intended for internal use, regardless of the business's size. (Section 612(b)(3))
Cosmetics intended to alter appearance for more than 24 hours during customary or usual use, when removal by the consumer isn't part of that customary or usual use. (Section 612(b)(4))

FDA's examples include eye shadow and false eyelash adhesive for the eye-contact group, and certain nail polishes or hair dyes for the lasting-appearance group. (FDA guidance, questions 6–7) Don't shorten the fourth test to “anything lasting over a day”; check the consumer-removal condition too.

A statement you can edit and sign

Use the draft below only after checking every declaration, replace the bracketed fields, and remove these instructions from your submission. This version uses sales below the unadjusted $1 million base as a conservative drafting choice; don't sign it if that isn't true for your business.

Self-attestation of small-business exemption under MoCRA

Business name: [full business name]

Business address: [street, city, state or region, postal code, country]

Role and scope: [responsible person / facility owner or operator; identify the business and facility covered]

Products covered: [product names]

We self-attest that our business meets the small-business conditions in section 612 of the Federal Food, Drug, and Cosmetic Act, including its inflation-adjusted sales test. Our average gross annual US cosmetic sales for [previous three-year period] were [amount], below $1,000,000.

We don't manufacture or process cosmetics that regularly contact the eye's mucous membrane during usual use, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours during usual use when consumer removal isn't part of that usual use. (Section 612(b)) We therefore claim section 612's exemption from the cosmetic GMP and facility registration/product listing requirements it specifies, for the business identified above. (Section 612(a))

This is our own declaration, covering the named business only, and isn't a statement issued by FDA.

Signed: [signature] Name and title: [name, title] Date: [date]

What this statement doesn't settle

This exemption doesn't remove other applicable duties, including labeling, safety substantiation records, and serious adverse event reporting within 15 business days. (21 USC 364h(a), which exempts only from 364b and 364c; 364a adverse events; 364d safety substantiation; 364e labeling; FDA MoCRA overview) We can't verify FDA cosmetic registration numbers through a public search, because FDA doesn't provide a public company-name or number lookup for those records. (FDA registration resources)

This guide and editable statement are not legal advice; sign only declarations you've checked.

For a free check of how your documents line up, visit MadeCheck's certificate check.