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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:
- Products that regularly come into contact with the mucous membrane of the eye under customary or usual conditions of use.
- Products that are intended for injection.
- Products that are intended for internal use.
- 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)
Step 2 : Cosmetic Facility Registration with FDA
Step 3 : Cosmetic Label Compliance
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
FDA Cosmetic Registration Fees
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)
Frequently Asked Questions
How do I list cosmetic ingredient with FDA?
Does FDA Approve Cosmetic Labels?
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?
Misbranded cosmetic - How ?
- False or misleading labels
- labelling that fails to provide the mandatory information under FDA regulations
- Not properly displaying the mandatory information
- Labeling that violates the Poison Prevention Packaging Act.
What is FDA GMP Inspection. What are the core areas of Inspection?
- Building and Facilities
- Equipment
- Personnel
- Raw Materials & Packing material control
- Production Process
- Laboratory Control process
- Traceability Records
- Labeling
- Transportation & Complaints