How to Register Your Cosmetics with FDA in 2025

What Is FDA Cosmetic Registration & Why It is essential for Your Business?

The FDA regulates cosmetics to ensure public safety, though they do not approve cosmetics before sale. Instead, MoCRA requires manufacturers and processors to:

• Register all cosmetic manufacturing facilities with the FDA
• List every cosmetic product and its ingredients on the FDA database
• Report adverse events associated with your products
• Maintain proper labeling as per FDA guidelines

Failing to register and list can lead to serious consequences including detention of products at U.S. borders or forced recalls.

Who Needs to Register Cosmetics with FDA?

FDA registration is mandatory, If you are any of the following-

• Cosmetic product manufacturers
• Brand owners and private labelers
• Importers and exporters of cosmetics
• Contract manufacturers

Step by Step FDA Cosmetic Registration Process

Step 1: Confirm Your Product is a Cosmetic

Make sure your product meets the FDA’s definition of a cosmetic (used for cleansing, beautifying or altering appearance). If it claims to treat or prevent disease, it may be classified as a drug instead.

Step 2: Create an FDA Account

Register on the FDA’s Cosmetics Direct Portal. You will need to set up a login using Login.gov and link it to the FDA’s system.

Step 3: Register Your Manufacturing Facility

Under the MoCRA 2022 law, all facilities that manufacture or process cosmetics must register with the FDA. Include the facility name, location and contact details.

Step 4: Submit Product Listing

After registration, submit these for each product-

• 1. Product and brand name
• 2. Full ingredient list
• 3. Product category (moisturizer, lipstick)
• 4. Manufacturing facility details

Step 5: Ensure Safety Documentation

You must have evidence that your product is safe for consumer use under labeled conditions. This should be ready in case of FDA inspection.

Step 6: Keep Information Updated

Renew your facility registration annually and update your product listing if you change the formula, label or discontinue the product.

How Samrat Associates Can Help You with FDA Cosmetic Registration

Navigating FDA requirements can be overwhelming, especially with complex electronic submission systems. Here is how we can support you:

• 1. Facility Registration
  We register your cosmetic manufacturing or processing facility with the FDA, securing your FDA Establishment Identifier (FEI) number.
• 2. Product Listing & Ingredient Review
  We accurately list your products and ingredient details with the FDA to ensure full MoCRA compliance.
• 3. U.S. Agent Services
  For international brands, we provide the required U.S. Agent service, ensuring smooth FDA communications.
• 4. Label Review & Compliance
  We audit your product labels for FDA compliance, including warnings, contact info and ingredient disclosures.
• 5. Ongoing Support & Renewals
  Stay compliant with bi annual registration renewals, product updates and adverse event reporting assistance.

Don’t risk your U.S. market entry with incomplete or inaccurate FDA registrations. Contact Samrat Associates now to ensure your cosmetic product FDA compliance and launch your brand with confidence.