Modernization of Cosmetics Regulation Act - What Companies Need to Know
Beginning on December 29, 2023, the Modernization of Cosmetics Regulation Act (MOCRA) became effective. Signed into law on December 29, 2022, MoCRA significantly expands the U.S. Food and Drug Administration’s (FDA) authority to regulate cosmetic products and related businesses by adding section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Companies should ensure compliance with MOCRA, which represents the first major reform of cosmetic product regulation in over 80 years.
MOCRA applies to “cosmetic products,” defined broadly as a “preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” MOCRA includes the following requirements:
Owners or operators of facilities that manufacture and process a cosmetic product for distribution in the United States, unless subject to the small business exemption, must register the facility with FDA by December 29, 2023 and then every two years. They must also update content within 60 days of any changes.
FDA has been refining its facility registration protocol for online and paper submissions and issued several relevant notices in the fall of 2023. Most recently, FDA announced on December 18, 2023, that the new electronic submissions portal, Cosmetics Direct, is available for submitting product registration and cosmetic product listings.
A responsible person must list each marketed cosmetic product with FDA by December 29, 2023, including product ingredients, and provide annual updates. MOCRA defines “responsible person” as “a manufacturer, packer, or distributor whose name, U.S. address, telephone number, and electronic information appear on the label and who will serve as the point of contact with the FDA.” Therefore, foreign entities will need to have a United States contact.
Serious Adverse Event Reporting
MOCRA requires manufacturers, packers, and distributors to report “serious adverse events” (defined to include serious medical conditions including death) to FDA within 15 business days after the report is received by the responsible person. There are also follow-up information that must be reported to FDA.
Adverse Event Recordkeeping
Manufacturers, packers, and distributors must maintain a record of adverse events associated with use of their cosmetic products for a prescribed period of time depending on whether they qualify for the small business exemption.
Each cosmetic product must bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, to which the responsible person can receive adverse event reports with respect to the cosmetic product.
A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is “adequate substantiation of safety” of the cosmetic products.
Good Manufacturing Practices
FDA will propose rules on good manufacturing practices that companies must follow.
Increased FDA Enforcement Authority
New enforcement mechanisms provide FDA with broad authority to regulate cosmetic companies and their products. For example, MOCRA authorizes FDA to access a company’s records relating to a cosmetic product or any ingredients that the FDA reasonably believes are tainted and create a threat of death or serious adverse health consequences. FDA can also access a company’s adverse health event records. MOCRA also vests FDA with mandatory recall authority of any cosmetic product that FDA determines is adultered, misbranded, or the cause of death or serious health consequences. Finally, the FDA can suspend a facility’s registration, effectively prohibiting a facility from selling or distributing a cosmetic product in the United States.
Companies had until December 29, 2023 to comply with MOCRA. However, despite the December 29th compliance deadline, on November 8, 2023, FDA issued a compliance policy stating that it does not intend to enforce the requirements pertaining to cosmetic product facility registration and cosmetic product listing until July 1, 2024. This six-month reprieve is an acknowledgment of FDA’s failure to have clearly defined protocols for compliance and to provide companies with additional time to comply with the requirements.
Importantly, the enforcement moratorium only applies to the facility registration and product listing requirements. Therefore, companies needed to comply with the other MOCRA requirements as of December 29, 2023. Companies that do not have a compliance plan in place should create one immediately to ensure compliance with MOCRA’s many nuances because non-compliance could result in adverse consequences including enforcement actions.