On December 20, 2022, the US Senate unveiled the long-awaited Consolidated Appropriations Act, 2023. The US House of Representatives passed the bill three days later, and it is now awaiting President Biden’s signature.

Among the spending bill’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MCRA), which significantly expands the US Food and Drug Administration’s (FDA) regulation of cosmetic products in the United States.

The MCRA imposes extensive new requirements related to cosmetic products, including:

• Adverse event reporting and recordkeeping;

• Good manufacturing practices for cosmetic facilities;

• Establishment registration and product listing;

• Maintenance of records documenting product safety;

• Identification of fragrance allergens on product labels; and

• Specific labeling for products intended for professional use.

Small businesses are exempt from the requirements pertaining to (1) good manufacturing practices and (2) establishment registration and product listing. This exemption does not apply to small businesses that manufacture or process certain products, including cosmetics that (1) are injected, (2) intended for internal use, (3) alter appearance for more than 24 hours under normal use, or (4) come into contact with the mucus membrane of the eye.

The MCRA also gives FDA mandatory recall authority for situations in which (1) FDA determines that there is “a reasonable probability” that a cosmetic product is adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act, (2) FDA determines that the use of or exposure to the cosmetic product “will cause serious adverse health consequences or death,” and (3) the responsible entity has refused to voluntarily cease distribution and/or recall the violative cosmetic product.

Further, the MCRA requires FDA to:

• Issue proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing products; and

• Assess and issue a report regarding use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and the scientific evidence regarding the safety of and any risks associated with such use.

While the MCRA contains no actual requirement on the following issue, it further provides that “[i]t is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.”

Importantly, the MCRA contains a preemption clause that specifies that no state or political subdivision of a state may establish requirements regarding cosmetic product establishment registration and product listing, good manufacturing practices, records, recalls, adverse event reporting, or safety substantiation that differ from the MCRA. But notably, the preemption clause does not prevent states from (1) prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or (2) continuing in effect a requirement of any state that is in effect at the time of enactment of the MCRA for the reporting to the state of an ingredient in a cosmetic product.

We will continue to monitor developments, including FDA’s implementation of the MCRA’s new requirements.