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Selling Cosmetics on Amazon: 2026 FDA MoCRA Compliance Guide
Reviewed by Pasquale Carvelli — Regulatory Strategy & International Compliance Advisor, Cosmereg · Last updated: 15th of June 2026
Amazon is one of the largest beauty marketplaces in the world — a search for “cosmetics” returns tens of thousands of listings. But selling makeup, skincare, body care, or hair care on Amazon is no longer just a matter of opening a Seller Central account. Since the Modernization of Cosmetics Regulation Act (MoCRA) took full effect, Amazon and other major marketplaces now expect proof of FDA compliance before your products go live — and they are actively removing listings that can’t provide it.
This guide explains what you need to sell cosmetics on Amazon in the United States in 2026, what MoCRA now requires, and how to get ungated in restricted beauty subcategories.
Why Amazon Has Strict Requirements for Cosmetics
Cosmetics are applied directly to the skin, eyes, and hair. Poorly formulated or unregulated products can cause irritation, allergic reactions, or worse. To protect its customers and its own reputation, Amazon requires beauty and personal care sellers to demonstrate that their products meet U.S. safety and regulatory standards before they can be listed.
How Amazon Regulates Cosmetics: Gated Subcategories
Amazon controls cosmetics through gated (restricted) subcategories. The broad Beauty & Personal Care category is ungated, but many topical subcategories — lotions, makeup, leave-on treatments, and similar products — remain gated. To sell in a gated subcategory, you must pass Amazon’s verification steps, which commonly require:
- Proof of a valid FDA facility registration (or the manufacturer’s FEI number)
- A manufacturer invoice dated within the last 180 days
- A Good Manufacturing Practices (GMP) certificate
- Product safety testing and a Certificate of Analysis (COA)
What MoCRA Now Requires
MoCRA is the most significant update to U.S. cosmetics law since 1938. It replaced the old, voluntary VCRP — which the FDA stopped accepting in March 2023 — with a mandatory framework. Prior VCRP submissions do not satisfy MoCRA. There are two core obligations:
1. Facility Registration (Form FDA 5066). Every facility that manufactures or processes cosmetics for the U.S. market must register with the FDA and renew that registration every two years. Registration requires an FEI number obtained in advance, and is filed electronically through the FDA’s Cosmetics Direct portal.
2. Product Listing (Form FDA 5067). The Responsible Person — the manufacturer, packer, or distributor named on the product label — must list each marketed product with the FDA, including its full ingredient list, and update that listing annually.
The FDA also holds new authority to suspend a facility’s registration if a product is likely to cause serious harm. A suspended registration makes it a prohibited act to sell those products in U.S. commerce — which is exactly the kind of compliance failure that triggers marketplace delisting.
New in 2026: Biennial Registration Renewal
The first wave of MoCRA registrations is now coming up for renewal. In February 2026, the FDA updated the Cosmetics Direct portal with two new fields — Registration Status and Renewal Date — and now sends automated email reminders ahead of each facility’s renewal deadline.
Your renewal date is based on your initial registration date. For example, a facility first registered on February 20, 2024 must renew by February 20, 2026. Facilities can renew early, and those with no changes since their last submission can use an abbreviated renewal. If you registered in the first year of MoCRA, your renewal is either due now or approaching — don’t let it lapse, because a lapsed registration can put your Amazon listings at risk.
Do You Have to Register Your Cosmetics With the FDA?
If you only sell through your own storefront, small-business exemptions may apply. But if you want to sell on Amazon, registration is effectively required to get ungated. Note that MoCRA’s small-business exemptions do not apply to certain higher-risk products, including those that regularly contact the mucous membrane of the eye, injected products, products for internal use, and products intended to alter appearance for more than 24 hours.
If you are a distributor, you’ll need your manufacturer to supply their FDA registration or FEI number. Facilities located outside the U.S. can register after their products are exported for U.S. sale; domestic facilities can register before or after entering commercial distribution.
Don’t Turn Your Cosmetic Into a Drug
One of the most common Amazon gating problems has nothing to do with paperwork: it’s your claims. If a product claims to treat a condition or affect the body’s structure or function — anti-acne, anti-dandruff, antiperspirant, sunscreen (SPF) — the FDA classifies it as an over-the-counter drug, not a cosmetic. That triggers a stricter set of requirements. Review your labels and listings carefully before you submit.
Adverse Event Reporting and Recordkeeping
MoCRA also requires the Responsible Person to report serious adverse events to the FDA within 15 business days and to retain adverse event records for a set period (six years for most businesses, three for eligible small businesses). Amazon expects sellers to have a process in place for tracking and reporting customer complaints. (See our guide to adverse event reporting for cosmetics.)
How to Get Ungated in Cosmetics on Amazon
Once your FDA registration is in place:
- In Seller Central, click Add a Product.
- Search for the item you want to sell.
- If it’s restricted, click Listing Limitations Apply.
- Click Request Approval and submit your FDA registration document (and any other requested documentation).
The exact documents vary by product, but the principle is consistent: provide clear proof that your product is safe and compliant, and you should be approved. If your first request is declined, you can reapply with stronger supporting documents such as a GMP certificate or COA.
Get Compliant Before You List
MoCRA compliance is now the price of admission to Amazon’s beauty marketplace, and the rules keep evolving. Cosmereg helps brands, manufacturers, and distributors handle FDA facility registration, product listing, labeling and ingredient review, biennial renewals, and adverse event reporting — so your products stay live and compliant.
Talk to our FDA regulatory consultants: call +1 727 350 9380 (U.S.) or contact our team to make sure your products meet FDA cosmetic requirements before you list.
Related reading: FDA Cosmetic Registration · MoCRA for Cosmetics · US FDA Regulations
Frequently Asked Questions
Do I need FDA registration to sell cosmetics on Amazon?
To sell in Amazon’s gated cosmetic subcategories, yes — you generally need to prove a valid FDA facility registration, or supply your manufacturer’s FEI number. Under MoCRA, facility registration and product listing are mandatory for most cosmetics sold in the U.S.
What is MoCRA and how does it affect Amazon sellers?
MoCRA (the Modernization of Cosmetics Regulation Act) is the U.S. law that made FDA facility registration and product listing mandatory for cosmetics. It replaced the voluntary VCRP. Amazon and other marketplaces now require proof of MoCRA compliance and delist products that can’t provide it.
How do I register my cosmetic facility with the FDA?
Obtain an FEI number, then file Form FDA 5066 electronically through the FDA’s Cosmetics Direct portal. The Responsible Person also lists each product using Form FDA 5067. Registration must be renewed every two years.
How often do I have to renew my FDA cosmetic registration?
Every two years. Your renewal date is based on your initial registration date. As of 2026, the Cosmetics Direct portal shows your Registration Status and Renewal Date and sends automated reminders. Facilities with no changes can use an abbreviated renewal.
Are small businesses exempt from MoCRA?
Some small businesses are exempt from facility registration and product listing, but the exemption does not apply to higher-risk products — such as those that contact the eye’s mucous membrane, are injected, are for internal use, or alter appearance for more than 24 hours. It also does not remove Amazon’s own gating requirements.
What documents does Amazon ask for to get ungated in cosmetics?
Commonly: proof of FDA registration (or the manufacturer’s FEI number), a manufacturer invoice from the last 180 days, a GMP certificate, and product safety testing with a Certificate of Analysis (COA).
When does a cosmetic become an FDA-regulated drug?
When it claims to treat a condition or affect the body’s structure or function — for example anti-acne, anti-dandruff, antiperspirant, or SPF sunscreen claims. These are regulated as over-the-counter drugs with stricter requirements.
Pasquale Carvelli is a Regulatory Strategy & International Compliance Advisor for Cosmereg, an international regulatory affairs company supporting manufacturers, distributors, and brand owners navigating complex compliance frameworks across multiple jurisdictions.
Through a multidisciplinary network of certified safety assessors and regulatory experts, he oversees strategic compliance pathways for cosmetic, food, and supplement products entering regulated markets.
