Get Ready for the Modernization of Cosmetics Regulation Act

Introduction

Signed into law in December 2022, the Modernization of Cosmetics Regulation Act of 2022  ("MoCRA" for short) represents the most significant expansion of the FDA's authority to regulate cosmetics (domestic and imported) since the enactment of the 1938 Federal Food, Drug, and Cosmetic (FD&C) Act.

MoCRA's primary goal is to ensure the safety of cosmetic products, used by American consumers an average of six to 12 times per day. Cosmetics span a broad range of personal care and beauty products, such as (but not limited to) makeup, nail polish, personal fragrance, shaving cream and other grooming products, perfume, baby care and wipes, face and body cleansers, bath products, hair care products, moisturizers, and other skincare products.

Let's dive into what this potentially means for you.

What You Need to Know Now

The law imposes new requirements on cosmetics manufacturers (i.e., formulators and fillers), including:

• Registration. Manufacturers and processors must register each facility with the FDA by July 1, 2024, and renew every two years unless subject to certain exclusions for this requirement (e.g., they manufacture or contract pack for several brands/companies). Companies with average gross annual sales in the U.S. of less than $1,000,000 for the previous 3-year period (adjusted for inflation) and who do not sell products that are injected, for the eye, for internal use, or 24-hour-plus appearance-altering products are exempt from registration and product listing.
• Product Listing. The responsible person (i.e., manufacturer, packer, or distributor of a cosmetic product whose name appears on the label) must list each marketed cosmetic product with the FDA by July 1, 2024, including product ingredients, and provide any updates annually. New cosmetic products must be listed within 120 days of marketing.
• Labeling. Effective December 29, 2024, cosmetic product labels must include contact information (domestic address and domestic phone number, or electronic contact information, e.g., a website URL or email) through which the responsible person can receive adverse event reports.
• Adverse Event Reporting and Recordkeeping. The responsible person is required to report serious adverse events (e.g., death, life-threatening event, inpatient hospitalization, infection, etc.) associated with the use of cosmetic products in the U.S. to the FDA within 15 business days. The report must include a copy of the label on or within the retail packaging of such cosmetic products. Companies must keep records of serious adverse events for at least 6 years and maintain safety records for such cosmetic products.
• Substantiation of Safety. Effective December 29, 2024, the responsible person shall ensure and maintain records supporting that there is adequate substantiation of safety (e.g., tests or studies, research, analyses, or other evidence and information that is considered by qualified experts) to support a reasonable certainty that a cosmetic product is safe.
• Mandatory Recall Authority. If the FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, the agency can order a mandatory recall if the responsible person refuses to do so voluntarily.
• Records Access. Under specific circumstances, the FDA can access and copy certain records related to a cosmetic product, including safety records.