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FDA Cosmetic Registration

FDA Cosmetic Registration

FDA Cosmetic Registration is compulsory for manufacturers and processors must register their facility with FDA and renew their registration every two years. It also mandates for Cosmetic Listing. The responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.

 

The MoCRA provides exemptions for certain small businesses from adhering to Good Manufacturing Practices (GMP), registration, and product listing requirements. However, these exemptions do not apply to manufacturers or facilities that produce specific types of cosmetic products. These include:

 

  1. Products that regularly come into contact with the mucous membrane of the eye under customary or usual conditions of use.
  2. Products that are intended for injection.
  3. Products that are intended for internal use.
  4. Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use, and where removal by the consumer is not part of such conditions of use.

 

Additionally, exemptions may exist for certain products and facilities that are subject to requirements for drugs and devices

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FDA Cosmetic Registration Process

Step 1 : Appoint FDA US Agent (Only for Foreign Facilities)

We are FDA Cosmetic Registration consultants and US FDA Agents who can help with FDA Cosmetic Registration

Step 2 : Cosmetic Facility Registration with FDA

Register the Manufacturing and processing facilities with the FDA and renew their registration every two years.

Step 3 : Cosmetic Label Compliance

Make sure the product label complies with the FDA regulation before it reaches the port of entry or selling point. We are Regulatory Consultants who do a complete and thorough review of your label.

Step 4 : Cosmetic Product Listing

A responsible person (manufacturer / Trader / Distributor) must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually to FDA.

Step 5: Market in USA

Soon after FDA cosmetic registration and cosmetic Listing, you may start marketing the cosmetic product in the USA.

FDA Cosmetic Registration Fees

FDA Cosmetic Registration

We are FDA Consultants and US Agent for Foreign facilities.  We provide GMP, FDA Registration and Listing service along with FDA Pre-inspection service.

  • US Agent Service  with Cosmetic Registration: 649 USD (5 days)
  • Cosmetic Label Review: 949 USD ( 20 days)
  • Cosmetic Listing : 649 USD (10 days)

COSMETIC REGISTRATION FORM
COSMETIC LISTING FORM
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Frequently Asked Questions

How do I list cosmetic ingredient with FDA?

Electronically submit each cosmetic formulation followed by FDA will issue a Ingredient Statement Number for each formulation.

Does FDA Approve Cosmetic Labels?

NO, the FDA will not approve any label.

FDA does provide labelling guidance. It is the responsibility of the manufacturer/distributor to make sure the labelling complies with all requirements.

Why Amazon ask for Certificate of Compliance?

FDA does not approve cosmetics or issue any certificates to cosmetic manufacturers.

Amazon will make sure the cosmetics listed with them are required to comply with FDA labelling requirements including net weight, statement of identity, directions for use, warnings, contact information and ingredients. Obtaining a Certificate of Compliance from third-party regulatory consultants is one possible way to get a cosmetic product back on Amazon.

What is GMP? How to avoid adulterating?

Manufacturers following strict GMP for cosmetics can minimize the potential for adulterated cosmetics.

Misbranded cosmetic - How ?

  1. False or misleading labels
  2. labelling that fails to provide the mandatory information under FDA regulations
  3. Not properly displaying the mandatory information
  4. Labeling that violates the Poison Prevention Packaging Act.

What is FDA GMP Inspection. What are the core areas of Inspection?

FDA inspect all areas on sampling basis in a company to determine its adherence with GMP during an inspection. These areas include

  1. Building and Facilities
  2. Equipment
  3. Personnel
  4. Raw Materials & Packing material control
  5. Production Process
  6. Laboratory Control process
  7. Traceability Records
  8. Labeling
  9. Transportation & Complaints

Is Compliance to Modernization of Cosmetics Regulation Act of 2022 (MoCRA) compulsory?

Yes, Its compulsory from July 1, 2024

When to re-register as under MoCRA by VCRP Registered facilities?

MoCRA registration and listing are mandatory from July 1, 2024.