Registration and Listing Requirements for Cosmetic Product Facilities and Products - Sobel Network Shipping Co., Inc.

Registration and Listing Requirements for Cosmetic Product Facilities and Products

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938. This new law aims to enhance the safety of cosmetic products that consumers use daily.

New Authorities Under MoCRA

Facility Registration

Manufacturers and processors are required to register their facilities with the FDA and renew their registration every two years. The FDA has the authority to suspend a facility’s registration if it determines that a cosmetic product manufactured or processed there poses a reasonable probability of causing serious adverse health consequences or death. The suspension can also occur if the FDA believes other products from the facility might be similarly affected due to pervasive issues that cannot be isolated to specific products. During suspension, it is prohibited to distribute or sell cosmetic products from that facility in the United States.

Product Listing

A responsible person must list each marketed cosmetic product with the FDA, including its ingredients, and provide updates annually. A responsible person is defined as the manufacturer, packer, or distributor whose name appears on the product label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Exemptions

For Industry Decision Tool

The FDA has developed a decision tool to help determine if registration of a cosmetic product facility is required. To use the tool, visit the Decision Tool page and answer a series of questions.

Options for Registration and Listing Submissions

Electronic Submissions

Cosmetics Direct

Cosmetics Direct is an FDA-provided Structured Product Labeling (SPL) authoring tool designed for cosmetic product facility registration and listing. It features user-friendly data entry forms, initial validations, and submission capabilities to the FDA without needing the Electronic Submissions Gateway (ESG).

The SPL, sanctioned by Health Level Seven (HL7) for exchanging product and facility information, serves as a regulatory standard for product labeling. The FDA adopted SPL in 2005 to improve safety and usability by standardizing product information. For more details, see the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures.

Electronic Submissions Gateway (ESG)

As an alternative, registrations and listings can be submitted online through the FDA’s ESG or any SPL authoring software, including SPL Xforms. The ESG system requires a free account, which can take one to three weeks to set up. Registrants are advised to apply for ESG accounts well before the submission deadline. Technical assistance is available at [email protected].

SPL Xforms

SPL Xforms is an option for creating SPL files for facility registration and product listing. For troubleshooting and advice, visit SPL Xforms or contact [email protected].

Paper Submissions

The FDA encourages electronic submissions for efficiency. However, paper forms are available:

  • Form FDA 5066: Registration of Cosmetic Product Facility
  • Form FDA 5067: Cosmetic Product Listing

Compliance Dates

The FDA will not enforce the requirements for facility registration and product listing until July 1, 2024, providing an additional six months beyond the December 29, 2023, deadline for compliance.

Facilities that began manufacturing or processing cosmetics after December 29, 2022, and products first marketed after this date also have until July 1, 2024, to comply with the registration and listing requirements.

For more information, see the Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.

Additional Guidance

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (December 2023)

This document provides FDA guidance on the registration and listing process for cosmetic product facilities and products as mandated by MoCRA.

Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (November 2023)

This document outlines the FDA’s intent to delay enforcement of registration and listing requirements for six months to allow the industry sufficient time to comply.

FEI Search Portal for Required Facility Registration Number

The FDA will use the FDA Establishment Identifier (FEI) as the required facility registration number. Facilities need to obtain an FEI number before registration. To check if an entity already has an FEI number, refer to the FEI Search Portal. If not, instructions for requesting an FEI number are available at the FEI Search Portal.

Voluntary Registration

The FDA welcomes voluntary registration and listing submissions from entities exempt from MoCRA registration and listing provisions. Voluntary submissions must include all mandatory fields due to system technical limitations.