Modernization of Cosmetics Regulation Act (MoCRA): New Regulatory Framework for Cosmetics
Enacted on December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)[1] applies more of a drug-like regulatory framework to cosmetics. The landmark legislation significantly overhauls the Food and Drug Administration’s (“FDA”) current regulatory framework for cosmetics, which has existed since 1938, and provides greater FDA enforcement authority in the form of mandatory recall authority, suspending facility registration, and access to records relating to products (i.e. inspection authority). Most of the act’s changes will go into effect on December 29, 2023.
MoCRA adds requirements for manufacturer (domestic and foreign) registration, premarket notification (but not approval), ingredient safety testing including ‘adequate safety substantiation’, product and ingredient listing, mandatory allergen labeling, Good Manufacturing Practices (“GMPs”), and Adverse Event reporting. Mandatory Adverse Event reporting includes 15 day reporting for serious events, and is limited to infections or “significant disfigurement,” such as “serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance, other than as intended, under conditions of use that are customary or usual.” Smaller companies may find certain requirements particularly burdensome, such as “adequate safety substantiation” using “tests, studies or other research”.
Manufacturers must be prepared to identify their fragrances or excipients as well as their sources for same. Companies should be aware that ingredient lists for their products would be publicly available unless protected by a trade secret exemption.
Since most of the changes will take effect on December 29, 2023, companies manufacturing and marketing these products need to prepare their compliance programs, registration, labeling, listing and policies & procedures, including adverse event reporting and manufacturing well in advance of that date. Relabelers and repackagers per se need not register with the FDA as a manufacturer of qualifying cosmetic products, but those that perform ‘packaging’ and ‘repackaging’ by filling a product container with a cosmetic product must, in fact, register.
Certain provisions of MoCRA cannot be implemented until FDA provides additional guidance, such as Current Good Manufacturing Practice (“cGMP”) requirements for manufacturing (FDA is required to develop a proposed rule within 2 years), or identification of which allergens FDA requires mentioned in labeling. The complexity of MoCRA could result in repercussions for both inadvertent noncompliance and intentional negligence. For example, safety substantiation will most likely be interpreted by the courts in product liability lawsuits. From a liability defense standpoint, robust safety data will be needed, which may be a burden for smaller companies that manufacture cosmetic products.
How Can Frier Levitt Help
Frier Levitt is actively reviewing the new cosmetic regulatory requirements and developing resources to assist companies in this space with compliance. Contact us if you have questions as to how the new legislation will affect your business or for guidance and legal support to assist with adjusting your policies & procedures accordingly for facility operations, manufacturing, and product safety. We offer comprehensive legal support to help our clients realize their goals while bringing novel cosmetic and cosmeceutical products to the market.
[1] P.L. 117-328 (2022).
