MoCRA Small Business Exemption: Who Qualifies and What the Letter Should Include

A MoCRA small-business exemption letter is a company’s self-attestation—not a certificate issued or approved by FDA. Its job is to state a defined exemption position, show that the company used the correct test, and point to controlled records that support the conclusion.

FDA made the boundary explicit in its September 9, 2026 cosmetics clarification: the agency does not provide a letter, email, certificate, or other document confirming that a facility or responsible person is exempt from registration or listing. FDA’s registration and listing guidance likewise says it is not generally asking companies to submit their small-business documentation to receive an exemption certificate.

That does not make documentation unnecessary. A marketplace may ask the seller to state and support its own status. TikTok Shop’s current U.S. Beauty and Personal Care Products Requirements, for example, say a seller qualifying for a MoCRA registration exemption may submit self-attested documentation that clearly states the exemption criteria and the seller’s attestation of eligibility.

First, confirm that the small-business test applies

FDA’s registration and listing guidance defines a small business for this purpose as a responsible person, owner, or operator whose average gross annual U.S. sales of cosmetic products for the previous three-year period are less than $1 million, adjusted for inflation, and that does not manufacture or process specified excluded products.

Use the inflation-adjusted threshold for the period being evaluated. FDA recommends using the Bureau of Economic Analysis Implicit Price Deflator for GDP, updated annually, for the adjustment. Do not hard-code “$1 million” into a recurring template as if it never changes. The file should record the calculation date, source series, base amount, factor or method, and resulting threshold.

Passing the sales test is only one part of the analysis. Regardless of sales, the small-business exemptions do not apply to a responsible person or facility engaged in manufacturing or processing:

• cosmetic products that regularly contact the mucous membrane of the eye under customary or usual use;
• injected cosmetic products;
• cosmetic products intended for internal use; or
• cosmetic products intended to alter appearance for more than 24 hours when consumer removal is not part of customary or usual use.

FDA gives eye shadow, eye-makeup remover, liquid or mucosal eyeliner, and false-eyelash adhesive as examples it generally expects to contact the eye’s mucous membrane. It says certain nail polishes, some hair and eyebrow dyes, tattoo inks, and certain leave-on skin preparations may fall within the more-than-24-hours category. Product labeling, directions, and customary use all matter, so a category name alone may not settle the question.

There is also a facility-wide consequence worth documenting. FDA’s guidance says that if a facility manufactures or processes any product in one of the excluded categories, the owner or operator must register the facility and include the required information for all cosmetic products manufactured or processed there—not only the excluded product. Escalate uncertain cases for qualified review before signing an exemption statement.

MoCRA exemption self-attestation template preview

This outline is a drafting aid, not a determination that the exemption applies. Complete the sales and excluded-product analysis first, then tailor the document to the named entity, facilities, products, and live marketplace request.

Do not paste this outline into Seller Center unchanged. A generic letter with blanks, no underlying calculation, or no excluded-product review does not support an exemption position. The sample conclusion below shows the intended level of restraint.

Eight sections a self-attestation should include

1. A precise title and disclaimer

Use a title such as “MoCRA Small-Business Registration and Product-Listing Exemption Self-Attestation.” State on the first page that the document was prepared by or for the named business, was not issued by FDA, and does not claim FDA approval, certification, or endorsement.

2. Entity and contact information

Identify the legal entity, any relevant DBA, business address, contact person, email, and phone number. State whether the signer is evaluating the entity as a responsible person, facility owner or operator, or more than one of those. If a marketplace application or product label uses a different name, identify the connection and attach support.

3. Defined scope

List the facilities, brands, and product families covered—or attach a controlled schedule. State the “as of” date. Avoid an open-ended statement about every current and future product.

4. Three-year measurement period

Specify the three years used for the average. Identify the accounting records used and record the U.S. gross annual sales of cosmetic products for each year in the controlled worksheet. Document what the calculation includes rather than relying on a total-company revenue figure with no product or geography analysis.

5. Inflation-adjusted threshold method

Record the official data source and calculation version used to adjust the statutory amount. Show the calculated average and applicable threshold in the supporting worksheet. The outward-facing letter may state the values or simply state that the documented average is below the threshold, depending on what the requester requires and what the company is prepared to disclose.

6. Excluded-product review

Include a product-by-product or category-by-category checklist addressing all four statutory exclusions. Record the label version and customary-use information reviewed. A single sentence saying “we sell cosmetics only” does not answer this part of the test.

7. Clear conclusion and attestation

Use time-bounded language. A restrained conclusion could read:

“Based on the records identified in the supporting evidence schedule and reviewed as of [date], [legal entity] self-attests that it meets the MoCRA small-business criteria applicable to facility registration and cosmetic product listing for the facilities and products listed in Appendix A. This conclusion is based on the three-year sales test and excluded-product review described in this document.”

Add a separate sentence stating that the document is not issued by FDA and should be reassessed if the underlying facts or applicable requirements change.

8. Signature and document controls

Include the signer’s name, title, signature, and date. Add a document owner, version number, last-verified date, next review date, and a short change history. Annual review is a useful operating cadence because the rolling three-year measurement period and inflation data change, but review sooner after a new product, claim, facility, acquisition, or material sales change.

Keep a supporting evidence schedule behind the letter

The support file should identify, at minimum:

• annual sales reports or accounting extracts and the person who prepared them;
• the three-year calculation worksheet;
• the inflation source and dated calculation;
• the product and facility inventory;
• labels, directions, and relevant product-use analysis;
• documents connecting legal names, DBAs, and label names; and
• the reviewer, approval date, next review date, and superseded versions.

Keep sensitive financial, formulation, and personal data in the controlled backup file. Send only what the marketplace asks for and what is appropriate to disclose. Never alter a source record to make it look cleaner.

What the letter does not establish

FDA’s MoCRA overview says qualifying small businesses are exempt from certain GMP, facility-registration, and product-listing requirements. This letter addresses the company’s documented position; it does not waive other applicable cosmetic safety, labeling, serious-adverse-event, state, product-category, or marketplace requirements. It also does not classify a product as a cosmetic rather than a drug or device.

Do not use an exemption letter when the business does not satisfy both the current sales test and the excluded-product review, when facts are missing, or as a substitute for an active portal record if registration is required. See our FDA MoCRA certificate explainer for the correct evidence paths.

Build a controlled self-attestation file

The Syntera MoCRA Marketplace Compliance Evidence Pack ($39) includes an exemption self-attestation framework and supporting-exemption-evidence checklist, together with the portal, listing, request, index, and last-verified controls needed to answer marketplace requests without mislabeling the result.

For recurring annual review, multiple facilities or product lines, and renewal ownership, use the Syntera MoCRA Compliance Evidence & Renewal Control System ($99). Both are operational aids. Neither is an FDA certificate, FDA verification, legal opinion, or guarantee that a platform will accept the submission.

This page provides general operational information, not legal advice. The application of MoCRA exemptions depends on specific facts and current law. Syntera is not affiliated with or endorsed by FDA or TikTok.

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