Selling cosmetics on Amazon in the US now sits on two layers: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which FDA summarizes as facility registration, product listing, safety substantiation, and 15-business-day serious adverse event reporting, and Amazon’s own Beauty approval, which lists “Modernization of Cosmetics Regulation Act (MoCRA) compliance documentation” among the documents a seller may need to provide (FDA MoCRA page, content current as of Aug 10, 2026; Amazon, How to sell beauty products, dated Feb 17, 2026; both checked 2026-10-07).
Who carries which duty depends on the role your company plays: the facility that manufactures or processes registers it, and the “responsible person” (the name on the label) lists each product. Certain small businesses with under $1,000,000 in average gross annual US cosmetic sales are exempt from registration, listing, and GMP, but not if they make eye-area, injected, internal-use, or long-wear products.
This is a compliance-orientation guide, not legal advice. Whether a given product is a cosmetic or a drug is a classification question it does not answer.
Fact Block: What These Claims Rest On
| Source (all checked 2026-10-07) | What it establishes |
|---|---|
| Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — FDA | The core duties: registration, listing, safety substantiation, adverse events, recall authority, small business exemption |
| Registration & Listing of Cosmetic Product Facilities and Products — FDA, current as of 09/09/2026 | Who registers vs who lists; the “responsible person” definition; biennial renewal; Cosmetics Direct |
| FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing — FDA, Nov 8, 2023 | The July 1, 2024 enforcement date |
| GMP for Cosmetic Products listening session slides — FDA, June 1, 2023 | FDA’s own wording of the $1,000,000 small business threshold |
| 21 U.S.C. § 364h — via Cornell LII | Statutory text of the small business exemption and its four exclusions |
| How to sell beauty products — Amazon, Feb 17, 2026 | Amazon’s Beauty approval documents, restricted and prohibited examples, dangerous goods |
MoCRA Amazon Sellers: Who Owes What
MoCRA splits its duties by role, not by sales channel. FDA’s registration page draws the line in two sentences: “Manufacturers and processors must register their facilities with the FDA,” and “A responsible person must list each marketed cosmetic product with the FDA” (checked 2026-10-07).
The definition that decides most Amazon cases is on the same page: “Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.”
| Your role on Amazon | Facility registration | Product listing | Adverse event reports and safety records |
|---|---|---|---|
| Private label brand; a contract manufacturer makes the product; your company name is on the label | The contract manufacturer’s facility registers | Your company, if it is the name on the label | Your company, as responsible person |
| Brand that makes the product in its own facility | Your facility registers | Your company lists | Your company |
| Reseller or wholesaler of another brand’s sealed product (your name is not on the label) | Not your facility | The brand whose name is on the label | The brand whose name is on the label |
| Arbitrage seller of retail cosmetics | Not your facility | The brand on the label | The brand on the label |
| Small business under the § 364h threshold, making none of the four excluded product types | Exempt | Exempt | Still applies (the exemption covers GMP, registration, and listing only) |
The rows apply FDA’s definitions to common Amazon business models; the label itself is the test. Being off the hook for listing does not end a reseller’s exposure: Amazon’s approval can still ask for the brand’s MoCRA paperwork.
The MoCRA Obligations, One by One
The FDA MoCRA page (checked 2026-10-07) states each duty in one sentence.
1. Facility registration (manufacturers and processors)
“Manufacturers and processors must register their facilities with FDA and renew their registration every two years.” FDA’s registration page adds the statutory anchor: “Every person who is required to register a facility must renew such registration biennially (i.e., every two years) (section 607(a)(2) of the FD&C Act).”
For a private label seller, this duty belongs to the factory; ask for its registration details before you order.
2. Product listing (responsible person)
“A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.” Listing is per product, and the ingredient list has to match what is in the bottle.
FDA describes its submission tool on the registration page: “Cosmetics Direct is an FDA provided Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing.”
3. Safety substantiation records
“A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products.” The FDA summary does not prescribe a test list. For an Amazon brand, the formula file, supplier documents, and testing should exist before launch, held by whoever is named on the label.
4. Serious adverse event reports within 15 business days
“A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days.” On Amazon, the first signal of a reaction often arrives as a buyer message, a return comment, or a review.
5. Mandatory recall authority
“FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.” How Amazon handles a recalled listing, including suppression and removal, is covered in our guide to Amazon product recalls for sellers.
6. Rulemaking still on FDA’s list
The FDA page also describes rules FDA is required to write, including fragrance allergen labeling and standardized testing methods for asbestos in talc-containing cosmetics. Those affect formulation and labels rather than registration.
Who Qualifies for the Small Business Exemption
The statute sets the number. 21 U.S.C. § 364h(a) covers businesses “whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation,” and says they are “not subject to the requirements of section 364b or 364c of this title” (GMP, and facility registration plus product listing) (checked 2026-10-07 via Cornell LII).
FDA’s June 1, 2023 GMP listening session slides put it in plain words: “MoCRA exempts certain small businesses (a business with average gross annual sales for the previous three-year period of less than $1,000,000) from GMP.” FDA’s MoCRA page and its registration page both state that the exemption also covers registration and listing, without repeating the dollar figure.
The exemption is lost by product type, not just by size. Under § 364h(b), it does not apply to anyone who manufactures or processes:
- “Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual” (think mascara and eyeliner)
- “Cosmetic products that are injected”
- “Cosmetic products that are intended for internal use”
- “Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual”
Three points sellers tend to miss:
- The threshold counts US cosmetic sales only, averaged over three years.
- “Adjusted for inflation” is in the statute and not in FDA’s slide. If your sales are close, check FDA’s current guidance for the adjusted figure.
- The exemption does not touch adverse event reporting or safety substantiation. Neither appears in § 364h, and FDA’s MoCRA page lists the exemption only against GMP, registration, and listing.
Key Dates Sellers Ask About
FDA’s compliance policy notice of November 8, 2023 set the enforcement start: “FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024” (checked 2026-10-07).
| Event | Date | Source |
|---|---|---|
| Statutory deadline for registration and listing | December 29, 2023 | FDA compliance policy notice |
| FDA enforcement of registration and listing begins | July 1, 2024 | FDA compliance policy notice |
| FDA guidance on registration and listing updated | December 11, 2024 | FDA cosmetics news page |
For a brand launching on Amazon in 2026, there is no grace period left to lean on.
Where Amazon Fits In
Amazon’s public page How to sell beauty products (Feb 17, 2026, checked 2026-10-07) adds four points on top of the FDA rules.
Approval. “Many beauty products need approval before you can sell them.” Documents Amazon says you might need include “Copies of invoices showing the purchase of 10 or more units,” a GMP certificate, a Certificate of Analysis (COA), and “Modernization of Cosmetics Regulation Act (MoCRA) compliance documentation,” which the same page describes as “Facility registration, product listings, and safety records.” See Amazon gated categories and ungating for how approval works.
Restricted and prohibited examples. Amazon lists “Products that must meet MoCRA requirements for facility registration and adverse event reporting” as a restricted example, and “Cosmetics with more than 12% hydrogen peroxide” as prohibited.
Dangerous goods. The page names “Hairspray and spray deodorants” and nail polish and perfume as dangerous goods examples, and says sellers of these products need the FBA Dangerous Goods program. MoCRA registration does not replace the hazmat review; see Amazon hazmat and the dangerous goods review.
Expiration dates. Amazon says beauty products “should include expiration dates or Period After Opening (PAO) symbols when required by regulations.” FBA’s shelf-life minimums for personal care and beauty are in our FBA expiration date requirements guide.
Compliance documents that Amazon requests per ASIN surface in the Manage Your Compliance dashboard. Amazon’s insurance rules are separate again, in Amazon product liability insurance.
Common Mistakes
- Assuming the factory’s registration covers the brand. Registration is the facility’s duty; listing belongs to the name on the label. A private label brand usually needs both done, by two different parties.
- Reading “small business” as “exempt from MoCRA.” The exemption covers GMP, registration, and listing. Adverse event reporting and safety records still apply, and eye-area or long-wear products lose the exemption entirely.
- Listing once and forgetting. FDA asks for updates annually, and a reformulation changes the ingredient list.
- Calling it “FDA approval.” FDA’s pages describe registration and listing, not approval of cosmetics.
Pre-Launch Checklist
- Confirm whose name will print on the label, because that party is the responsible person.
- Get the manufacturer’s FDA facility registration details in writing before the order.
- Decide whether any product is eye-area, injected, internal-use, or long-wear, since those cannot use the small business exemption.
- Work out three-year average US cosmetic sales if you plan to rely on the exemption.
- List each product through Cosmetics Direct (or SPL) with its ingredients, unless exempt.
- Assemble safety substantiation records for each product.
- Set a routing rule for buyer reports of reactions so serious events reach the responsible person well inside 15 business days.
- Prepare the Amazon approval pack: invoices, GMP certificate, COA, and MoCRA documentation.
- Check aerosols, nail polish, and fragrances for the dangerous goods review.
Frequently Asked Questions
Do I need to register with FDA to sell cosmetics on Amazon?
Facility registration is for “Manufacturers and processors,” per FDA’s registration page (checked 2026-10-07). A seller that does not make or process the product does not register a facility. If your company’s name is on the label, though, it is the responsible person and lists the product.
I resell another brand’s sealed cosmetics. Does MoCRA apply to me?
The listing, adverse event, and safety record duties fall on the responsible person, defined by FDA as the manufacturer, packer, or distributor “whose name appears on the label.” If that is the brand, the brand carries them. Amazon’s Beauty approval may still ask you for MoCRA documentation.
What is the MoCRA small business threshold?
Average gross annual US sales of cosmetic products under $1,000,000 over the previous three years, “adjusted for inflation” (21 U.S.C. § 364h, checked 2026-10-07). It does not cover eye-area, injected, internal-use, or long-wear products.
Conclusion
MoCRA on Amazon reduces to one question: whose name is on the label? That party lists every product, keeps the safety records, and reports serious adverse events within 15 business days; the factory registers its facility. The small business exemption is narrower than its name suggests. Settle the FDA side first; the Amazon approval pack reuses the same documents.