Mastering Compliance: A Step-by-Step Guide for Obtaining a FEI and Adhering to MoCRA and FDA Regulations in the Cosmetic Industry

Unlocking the Potential of the FDA Establishment Identifier (FEI) in the Dynamic Cosmetic Industry

In a groundbreaking move, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was officially implemented into existence on December 29, 2022. This pivotal legislation has reshaped the landscape for cosmetic manufacturers and processors, mandating the registration of their operations and the listing of cosmetic products.

At the core of this regulatory evolution lies the FDA Establishment Identifier (FEI), a distinctive alphanumeric code. It is the very foundation – the fundamental basis that supports the entire registration procedure for cosmetic facilities with the FDA.

 

Under MoCRA, the FDA has gained new authorities, with two critical components:

1. Facility Registration
   • Manufacturers and processors are required to register their facilities with the FDA, renewing every two years.
   • FDA can suspend a facility’s registration if it determines that a cosmetic product poses a risk of serious health consequences or death.
   • Suspension extends to other products if there is a pervasive failure not isolated to specific items.
2. Product Listing
   • Responsible persons (manufacturers, packers, or distributors) must list each marketed cosmetic product with detailed ingredient information, updated annually.

 

 

Exemptions to Ease Industry Transition

Recognizing the significant impact of these regulations, the FDA provides exemptions:

• Compliance Dates Extension: The FDA won’t enforce requirements related to cosmetic product facility registration and listing until July 1, 2024, giving the industry an additional six months post the December 29, 2023, statutory deadline.
• New Facility or Product Exemption: Facilities engaging in manufacturing or processing post-December 29, 2022, and cosmetic products first marketed after this date are exempt until July 1, 2024.

 

 Why is obtaining a FEI is so crucial and essential?

• FEI as a Registration Number: The FDA establishes the FEI as the required facility registration number. FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain a FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal.
• Checking for FEI: Owners or operators can use the FEI Search Portal to check for an existing FEI number.
• Requesting an FEI: For those without an FEI, a request can be made through the FEI Search Portal.

 

New Requirements for Facility Registration

Who Must Register: Generally, every person that owns or operates a “facility” that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register with FDA. “Facility” and “manufacturing or processing of a cosmetic product”

 

What Information Is Submitted:

• the name of the owner and/or operator of the facility
• the facility’s name, physical address, email address, and telephone number
• for any foreign facility, the contact information for the U.S. agent
• the facility registration number, if any, previously assigned
  • It is important to note that the facility registration number will be the FDA Establishment Identifier (FEI)
• all brand names under which cosmetic products manufactured or processed in the facility are sold
• the product category or categories (set forth in the Draft Guidance Appendix) and responsible person for each cosmetic product manufactured or processed at the facility
• type of submission (initial, amended, biennial renewal, or abbreviated renewal)

 

FDA is also requesting the submission of the following optional information:

• parent company name (if applicable)
• facility DUNS number
• additional contact information for individuals associated with the registration

A careful review of Appendix A is recommended as FDA is relying on these product categories, which may be too broad or not broad enough.

 

Electronic Submissions for Efficiency

• Cosmetics Direct: An FDA-provided Structured Product Labeling (SPL) authoring tool streamlines cosmetic product facility registration and listing, offering user-friendly data entry and SPL submission without using the Electronic Submissions Gateway (ESG).
• ESG Submissions: Alternatively, submissions can be made through the ESG, with users urged to apply for an account well in advance.

Balancing Electronic and Paper Submissions

• FDA Encourages Electronic Submissions: Electronic submissions are encouraged for efficiency, with the FDA offering technical assistance.
• Paper Submissions: Recognizing diverse industry needs, paper forms will be available.

Conclusion

As the regulatory landscape evolves, understanding and adherence to MoCRA and FDA guidance are crucial for industry players. Compliance is not just a legal requirement but a commitment to ensuring consumer safety and the sustainability of the cosmetic industry.