By 8OEM | Published: June 23, 2026 | 10 min read

FDA Cosmetic Registration Guide 2026: How to Legally Sell Cosmetics in the US Market

If you're planning to import cosmetics from China and sell them in the United States, FDA registration is not optional—it's a legal requirement under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. This guide explains everything you need to know about FDA cosmetic registration, from facility registration to product listing and labeling compliance.

What Is MoCRA and Why Does It Matter?

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law on December 29, 2022, represents the most significant expansion of FDA cosmetics oversight since 1938. Key changes include:

• Mandatory facility registration: All facilities manufacturing or processing cosmetics for US distribution must register with FDA every two years
• Mandatory product listing: Each cosmetic product must be listed with the FDA, including ingredients and responsible person information
• Adverse event reporting: Serious adverse events must be reported to FDA within 15 business days
• Safety substantiation: Companies must maintain records demonstrating adequate safety substantiation for their products

Step-by-Step FDA Cosmetic Registration Process

Step 1: Designate a US Responsible Person

Under MoCRA, every cosmetic product sold in the US must have a designated Responsible Person—an individual or entity located in the United States. This can be:

• The US-based importer or distributor
• A US agent designated by the foreign manufacturer
• A regulatory compliance service provider

Step 2: Register Your Facility

The foreign manufacturing facility (e.g., your Chinese OEM factory) must register with FDA through the Cosmetics Direct portal. Required information includes:

• Facility name, address, and contact information
• FEI (FDA Establishment Identifier) number
• Types of cosmetic products manufactured
• Parent company information (if applicable)

Important: Registration must be renewed every two years, with the renewal period starting October 1 of even-numbered years.

Step 3: List Your Products

Each cosmetic product must be listed with FDA, including:

• Product name and category
• Full ingredient list
• Responsible person contact information
• Facility registration number where the product is manufactured

Step 4: Ensure GMP Compliance

FDA has established Good Manufacturing Practice (GMP) requirements for cosmetics. Your factory should hold relevant certifications such as:

• ISO 22716:2007 — International cosmetics GMP standard
• FDA Cosmetic GMP certificate

Labeling Requirements for US Market

FDA has strict labeling requirements for cosmetics. Your product labels must include:

1. Product identity — What the product is (e.g., "moisturizing cream")
2. Net quantity of contents — In both metric and US customary units
3. Ingredient declaration — In descending order of predominance, using INCI names
4. Name and address of manufacturer or distributor — Must include street address, city, state, ZIP code
5. Warning statements — If required (e.g., "For external use only")

How Chinese OEM Factories Handle FDA Compliance

Working with an experienced Chinese cosmetic OEM factory can significantly simplify FDA compliance. Here's what a qualified factory partner should provide:

• Assistance with facility registration via FDA's Cosmetics Direct portal
• Product listing support with complete ingredient documentation
• Label review to ensure compliance with FDA labeling regulations
• GMP certification (ISO 22716, FDA Cosmetic GMP) as proof of manufacturing quality
• Safety substantiation documentation and testing reports

FAQ — FDA Cosmetic Registration

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific regulatory guidance, please consult with FDA compliance professionals.