Major Update to US Cosmetic Regulations: The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) - Introduction to Key Terms and Regulations

Every day, most American consumers use cosmetic products. These products include makeup, perfumes, face and body cleaners, hair products and other skincare or grooming products. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant reform of cosmetic laws in U.S. MoCRA expands the U.S. FDA regulatory authority over the cosmetic industry since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will ensure the safety use of cosmetic products.

In April 2023, the FDA hosted a webinar titled “Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions”. The webinar introduced an overview of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA); also outlined the requirements mandated by the act as well as updated on the information of good manufacturing practices (GMPs) and the Voluntary Cosmetic Reporting Program.

Proregulations listed some essential key changes. If you need to know more detail, please refer to the following link: Modernization of Cosmetics Regulation Act of 2022

1. Cosmetic Facility Registration

Any manufacturers and processes of cosmetic products (including an establishment of an importer) distributed in the United States mandatory register their facilities with FDA and renew their registration every two years.

2. Cosmetic product listing

Manufacturers and processors must product listing to FDA for each marketed cosmetic products, and update annually. FDA issued draft guidance below on registration and product listing for cosmetic products.

• Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
• FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products

3. Cosmetic Good Manufacturing Practices (GMP)

This document provides guidance to help industry to meet the product’s quality of standards. However, on May 3, 2023, as required by the The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA intends to reissue or withdraw and reissue this draft guidance. For more information please refer to:

• Public Meeting: Good Manufacturing Practices for Cosmetic Products - 06/01/2023
• Draft Guidance for Industry: Cosmetic Good Manufacturing Practices

4. Adverse Event Reporting

If a serious adverse event occurs with the use of cosmetic products in the U.S., the responsible person must submit the report accompanied by a copy of the label or within the retail packaging of the cosmetic product to the FDA within no later than 15 business days after the report is received. Within 1 year of the initial report, the responsible party must also provide certain additional information to FDA. The FDA will also obtain adverse event reports during inspections.

The FDA is developing a process for filing mandatory adverse event reports for cosmetic products.

5. Safety substantiation

Cosmetic companies or manufacturers are required to maintain records for supporting adequate safety substantiation of their products. All data used to support the safety must derive from scientifically robust methods.

6. Records Access

MoCRA provides authority to FDA to access and copy certain records (including safety records) related to cosmetic products if there is a reasonable belief that a product lead to a threat of serious adverse health result or death.

7. Mandatory Recall Authority

FDA has the authority to order a mandatory recall if the responsible party refuses to do so voluntarily and the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and that use of or exposure to the cosmetic will cause serious adverse health consequences or death.

8. New Cosmetic Labeling Requirements

MoCRA also requires that industry comply with the following labeling requirements:

• Requires the label of cosmetic products that contain fragrance allergen
• Requires certain labeling of cosmetic products that indicate a clear statement that used only by licensed professionals.
• Requires product labels must includes a domestic address, domestic phone number or electronic contact information include a website where a responsible person can receive adverse event reports.
• Require that FDA establish for Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

Exemptions:
MoCRA exempts certain small businesses from GMP, registration, and product listing requirements. However, such exemptions do not apply to manufacturers or facilities that manufacture or process cosmetics product that:

• Products that regularly come into contact with the mucous membranes of the eyes under customary or usual conditions of use.
• Injected products.
• Products for internal use.
• Products intended to change their appearance for more than 24 hours under customary or usual conditions of use and removed by the consumer are not part of such conditions of use.

Related Service

US FDA Cosmetics Registration