Selling Cosmetics on Amazon: FDA Compliance Requirements

Why Amazon Sellers Must Comply with MoCRA

The Modernization of Cosmetics Regulation Act (MoCRA) applies to every entity that manufactures, processes, packs, distributes, or markets cosmetic products in the United States. This includes companies selling exclusively through e-commerce platforms like Amazon, Shopify, Etsy, and other online marketplaces.

A common misconception among Amazon sellers is that MoCRA only applies to large cosmetics companies or traditional retail brands. In reality, MoCRA makes no distinction based on business size, sales channel, or revenue level. The small business exemption that previously delayed registration requirements for some companies expired on December 29, 2025.

Additionally, Amazon itself has begun requiring proof of FDA compliance for certain product categories. Sellers in the beauty and personal care category may be asked to provide facility registration numbers, product listing documentation, or proof of a designated Responsible Person. Non-compliance can result in listing suppression or account suspension.

MoCRA Requirements for Amazon Sellers

As an Amazon cosmetics seller, you must comply with each of these MoCRA requirements:

• Facility Registration (FD&C Act §607): The facility where your products are manufactured must be registered with FDA through Cosmetics Direct. This applies whether you manufacture products yourself, use a contract manufacturer, or import from overseas.
• Product Listing (FD&C Act §607A): Every cosmetic product you sell must be individually listed with FDA, including complete ingredient lists and product category information. See our product listing guide.
• Responsible Person Designation: Every product must have a designated Responsible Person — the entity whose name appears on the product label. The Responsible Person bears legal obligations for adverse event reporting and compliance. Read our Responsible Person guide.
• Adverse Event Reporting: Serious adverse events must be reported to FDA within 15 business days. You need a system for receiving, assessing, and reporting consumer complaints that qualify as serious adverse events.
• Labeling Compliance: Product labels must include all required elements, including a domestic contact (phone number or email) for adverse event reporting. See labeling requirements.

FBA vs. Merchant Fulfilled: What's Different?

Whether you use Fulfillment by Amazon (FBA) or fulfill orders yourself does not change your MoCRA obligations, but it does affect some practical considerations:

Important: Amazon FBA warehouses are not considered "facilities" that you need to register. FDA registration applies to the location where your products are actually manufactured, processed, or packed — not where they are stored for distribution. However, if you operate a home-based packing or labeling operation, that location may qualify as a facility requiring registration.

Foreign Sellers and Import Requirements

If you are a foreign company selling cosmetics on Amazon in the U.S., you have additional requirements:

• U.S. Agent designation: Your foreign manufacturing facility must designate a U.S. Agent who serves as FDA's point of contact in the United States. Assurentry provides U.S. Agent services for cosmetics.
• Responsible Person must be U.S.-based: The Responsible Person on the label must have a domestic (U.S.) address and phone number or electronic contact. Foreign companies typically designate their U.S. importer, distributor, or agent as the Responsible Person.
• Import compliance: Cosmetics shipments to Amazon FBA warehouses are subject to FDA import review at the border. An unregistered facility or unlisted product can trigger detention and refusal of your goods.
• English-language labeling: All products sold in the U.S. must have English-language labels that comply with 21 CFR Part 701 and MoCRA requirements.

Common Compliance Mistakes Amazon Sellers Make

Based on our experience helping Amazon sellers, these are the most frequent compliance failures:

• Assuming contract manufacturers handle registration. Your contract manufacturer should register their own facility, but you are still responsible for ensuring product listing, labeling compliance, and adverse event reporting. The Responsible Person obligation falls on the entity whose name is on the label — typically the brand owner, not the contract manufacturer.
• Missing adverse event reporting setup. Amazon buyer messages and reviews can contain adverse event reports. You need a process to monitor these channels, assess whether reports qualify as "serious" under MoCRA, and file MedWatch reports with FDA within 15 business days when required.
• Incorrect or missing label elements. Many Amazon cosmetics brands use minimal packaging that omits required label elements — particularly the domestic adverse event contact information now required by MoCRA.
• Not listing all products. Some sellers list their top-selling products with FDA but neglect to list every variation (different shades, sizes, or formulations). Each distinct product must be listed separately.
• Ignoring private label obligations. If you are a private label brand selling products manufactured by someone else under your brand name, you are the Responsible Person and must ensure all MoCRA obligations are met.

Action Plan for Amazon Cosmetics Sellers

Here is a step-by-step compliance checklist for Amazon cosmetics sellers:

1. Verify facility registration. Confirm that the facility manufacturing your products is registered through Cosmetics Direct. If you use a contract manufacturer, request their FDA registration number.
2. List all products with FDA. Submit product listings for every cosmetic product you sell on Amazon, including all variants (shades, sizes, formulations).
3. Designate your Responsible Person. Determine who the Responsible Person is (usually the entity on the label) and ensure they have a U.S. domestic contact for adverse event reporting.
4. Audit your labels. Review all product labels for compliance with 21 CFR Part 701 and MoCRA requirements. Ensure adverse event contact information is present.
5. Set up adverse event monitoring. Create a process to monitor Amazon buyer messages, reviews, and customer service inquiries for potential adverse event reports.
6. Designate a U.S. Agent (if foreign). Foreign manufacturers need a U.S. Agent. Contact Assurentry for U.S. Agent services.
7. Keep records. Maintain records of facility registration, product listings, adverse event reports, safety substantiation, and all correspondence with FDA for at least 6 years.