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Deadline Approaching: U.S. FDA’s Enforcement for Facility Registration and Product Listing Begins on July 1, 2024

Starting July 1, 2024, all cosmetic companies wishing to enter the U.S. market must complete the mandatory FDA registration, including facility registration and product listing. Cosmetic stakeholders are urged to complete the necessary submissions promptly.

On December 29, 2022, U.S. President Joe Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) into law, which marks the first major overhaul of the Federal Food, Drug, and Cosmetic Act (FD&C Act) since its passage in 1938. The new legislation grants the Food and Drug Administration (FDA) expanded enforcement authority over cosmetics, and imposes several new compliance requirements on cosmetic manufacturers and distributors, including facility registration and product listing.

Key Requirements

Facility Registration

All entities engaged in the manufacture or processing of cosmetic products for the U.S. market, whether domestic or overseas, must register their facilities with the FDA. The registrations must be updated within 60 days of any changes and renewed biennially. Foreign facilities, in particular, shall designate a U.S. agent during registration for effective communication with the FDA.

Product Listing

The responsible person for cosmetics intended for distribution in the U.S., namely, manufacturer, packer, and distributor of a cosmetic product whose name appears on the label, must list each marketed cosmetic product with the FDA. Product listing must be renewed annually. Notably, a single listing submission can encompass multiple products with identical formulations, or formulations that only have minor variations in color, fragrance, flavor, and/or quantity.

MoCRA provides exemptions for certain small businesses and drug-related businesses from facility registration and product listing. Small businesses are defined as those with less than $1 million in average gross annual cosmetics sales in the U.S. over the past three years, provided their products do not include high-risk cosmetics such as injection, those regularly contact the mucous membrane of the eye, those for internal use, or those with other specific characteristics.

Drug-related businesses mainly refer to enterprises whose product categories satisfy the definitions of both cosmetics and drugs. However, if these enterprises concurrently produce products solely categorized as cosmetics, this exemption is not applicable.

Upcoming Enforcement Time

The original statutory deadline for facility registration and product listing under MoCRA was December 29, 2023. However, the FDA issued guidance (Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing) on November 8, 2023, postponing the enforcement deadline by six months to July 1, 2024, to give the industry additional preparation time.

As the July 1st deadline nears, cosmetic stakeholders are urged to complete the necessary submissions promptly to avoid disruptions to their operations in the U.S. market. For more detailed guidance and resources on MoCRA updates, please refer to the following:

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With extensive experience in MoCRA compliance, ChemLinked’s parent company REACH24H Consulting Group offers compliance solutions to assist overseas cosmetic enterprises entering into the United States. Welcome to contact us at contact@chemlinked.com for more advice.

Our services:

  • Facility registration (including FEI application), amendment, and renewal.

  • INCI Name Application

  • Cosmetics Formula and Packaging Review

  • Product Listing and Annual Renewal

  • Cosmetic Safety Substantiation

  • Technical and Regulatory Consulting

  • U.S. Local Agent Service

Tags : USMoCRA
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