MoCRA Compliance: Understanding the FDA's Cosmetic Product Listing Requirements and Updates

The FDA's Modernization of Cosmetics Regulation Act of 2022 (MoCRA) mandates that any cosmetic product intended for retail sale in the U.S.A. must be listed with the FDA before being marketed.

Maintaining accurate data is crucial. If there are any changes or updates to your product after the initial submission, the Responsible Person (the company whose name appears on the label) must update the listing.

Key Requirements for Updating Your Cosmetic Product Listing

The FDA has recently revised its cosmetic requirements, introducing limitations and a specific process for updating information in a submitted Cosmetic Product Listing.

Four specific fields are considered fixed in an existing product listing and cannot be modified through a standard update process. These fields are:

  • Product Name: The primary name used for marketing the cosmetic product.
  • Ingredients (Formula): This includes the full composition, encompassing fragrance, color, and flavor. Any change to the formula requires a new listing.
  • Product Categories: The classification of the product (e.g., "skin care," "hair color," "makeup").
  • Responsible Person: The manufacturer, packer, or distributor named on the label.

How to Handle Fixed Field Changes (The Two-Step Process)

If a change is necessary for any of the four fixed fields above, the Responsible Person must follow a specific, mandatory two-step procedure:

1. Submit a New (INITIAL) Cosmetic Product Listing:

A brand-new listing must be submitted to the FDA reflecting the updated information (e.g., new product name or new cosmetic ingredients). A new listing number will be assigned for this revised product.

2. Discontinue the Previous Listing:

The original listing number for the superseded product must be discontinued from the FDA database, but only when appropriate.

Important: Discontinuing Your Previous Product Listing

The timing for discontinuing the previous listing depends entirely on the inventory status of the original product:

Product Still on the Market:

If the original version (formulation, name, etc.) is still being distributed or sold in the U.S., the previous product listing cannot be discontinued. The old listing must remain active until all stock of that specific version is off the market.

Product No Longer on the Market:

If the original product is no longer being marketed or distributed in the U.S., the Responsible Person can discontinue the previous listing.

This new MoCRA regulation ensures the FDA maintains accurate product listing data that precisely reflects the versions of cosmetic products currently or previously available to consumers, especially concerning ingredients and product safety.

FDA Cosmetic Registration and Listing Assistance

LMG assists with FDA MoCRA regulations, FDA cosmetic facility registration, cosmetic product listing, and US FDA agent service to cosmetic facilities. Please contact us for more information.