In a move that some may not have seen coming, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. The MCRA significantly strengthens the U.S. Food and Drug Administration (FDA) authority over cosmetic products. Key impacts are summarized below.

Background

On April 16, 2021, the Performance Enhancement Reform Act was introduced to the House of Representatives by Representative Gerald E. Connolly (D-VA). The summary states that the “…bill revises provisions regarding agency reporting of performance goals.” The bill was swept up into the Omnibus Appropriations bill passed by the House on September 28, 2021, and by the Senate on November 15, 2022. President Biden signed it into law on December 29, 2022, where it is now cited as the Consolidated Appropriations Act, 2023.

Highlights of the major changes include the following:

• Introduction and amendments to definitions. This includes “cosmetic product,” “adverse event,” “serious adverse event,” and “facility”;

• The addition of serious adverse event submissions;

• Introduction of good manufacturing practices (GMP) for facilities;

• Introduction of facility registration and product listing;

• Introduction of safety substantiation for cosmetic products, including record retention;

• Expansion of labeling requirements;

• Expansion on enforcement, mandatory recalls, recordkeeping, and record inspection;

• New ingredient-specific requirements for talc-containing cosmetic products; and

• New requirements to assess the use, safety, and risks of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.

A more detailed discussion of especially significant measures follows.

Facility Registration -- The immediate impact to cosmetic product manufacturers and importers is the mandatory requirement to register the facility at which cosmetics are manufactured and to provide product details. This requirement enters into force one year after the date of the enactment of this Act for existing facilities. This means that “[e]very person that, on the date of enactment of the MCRA, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary…” The initial registration is within one year, with a requirement for biennial renewal. The term “facility” is defined as “…any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.” Certain entities and operations not included in the definition of facility include beauty shops, salons, retailers, hospitals, hotels, airlines, trade shows, research facilities, and establishments that only label, relabel, pack, repack, hold, or distribute. Packing and repacking does not appear to include filling.

The facility registration includes identification of the responsible party, providing all brand names manufactured or processed at the facility, the product category, and cosmetic product listing. The cosmetic product listing includes the facility registration number of each facility where the cosmetic product is manufactured or processed, contact details for the responsible person, the applicable cosmetic category, and a list of ingredients including any fragrances, flavors, or colors. The list of ingredients shall use the nomenclature currently specified in 21 C.F.R. Section 701.3. Mandatory timeframes for updates are provided, in addition to requirements for new facilities and products.

GMPs -- One of the most notable inclusions in the Act is the requirement that FDA must issue a proposed rule no later than two years from the date of enactment intended to establish regulations for GMP for facilities. The regulation must be issued in final no later than three years from the date of enactment. The proposed GMP requirements should align with appropriate national and international standards and are meant to “…ensure that cosmetic products are not adulterated.” GMP will also result in records that will provide insight for inspectors to demonstrate compliance.

Adverse Event Reporting -- The Act includes mandatory adverse event submissions within specific timeframes. Serious adverse events must be reported no later than 15 business days after the report is received by the responsible person. Serious adverse events include death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, an infection, significant disfigurement (e.g., serious rashes, second- or third-degree burns, significant hair loss, or alternation of appearance), or requires a medical or surgical intervention to prevent an outcome noted. Records related to adverse events must be kept for six years. The Act notes that if a fragrance or flavor is suspected as being the cause of the serious adverse event, a list of these ingredients must be provided within 30 days after receiving the request.

Cosmetic Safety Substantiation -- The MCRA requires safety substantiation for cosmetic products. The details requested are that “…a responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.” The term “safe” is defined to mean “…that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.” Adequate substantiation is defined to mean “…tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.” The requirement is assumed to be enacted within one year as it is not stipulated otherwise.

Voluntary Cease Distribution/Recall of Adulterated Cosmetics -- TheMCRAstates that if there is a reasonable probability that a cosmetic is adulterated, and the use will result in a serious adverse health consequence, FDA is authorized to offer the responsible party the option of voluntarily recalling the product, including no longer selling or distributing the product. If the responsible party refuses or fails to act within a time and manor determined, FDA will by order require the immediate recall of the product. Public notification is included in these requirements.

Labeling -- Labeling changes include provisions related to the addition of contact details for adverse event reporting, additional consideration for fragrance allergens, and additional clarification of cosmetic products for professional use. Labeling requirements are required to take effect two years after the date of enactment.

Talc Regulations -- The Act states that talc-containing products require the establishment of regulations and standards test methods for detection and identification of asbestos. The Act establishes a timeline of one year for the proposed regulation, and no later than 180 days after the comment period closes for the final regulations.

PFAS -- Finally, the MCRA states that FDA is required to assess the use, safety, and risks associated with PFAS in cosmetics no later than three years from the enactment of the Act. FDA is also required to publish a report on its website with the results of the assessment.

Commentary

Enactment of the MCRA is consequential. Cosmetic product stakeholders will need to monitor and engage in the many initiatives the new law requires FDA to complete. FDA currently requires facility registration for other products under its jurisdiction. FDA currently has a voluntary cosmetic registration program that could serve to assist in the development of process. The timing of registration and implementation of the MCRA’s provisions will be problematic as cosmetic product manufacturers, importers, and FDA will need to develop implementation mechanisms and tools this year to meet the deadlines.

The addition of GMP through a new rulemaking initiative introduces significant uncertainty for cosmetic product manufacturers, and perhaps cosmetic ingredient manufacturers. FDA’s definition of adulterated is somewhat basic and has served as a mechanism for FDA to address issues that result from deficient manufacturing quality. It is unclear how cosmetic products, in all cases, can comply with whatever GMP FDA develops. GMP exists within the FDA framework, but it is defined differently depending on the use (i.e., drug, device, food, food contact substance).

It is not surprising to see the inclusion of serious adverse event reporting and mandatory recalls among the MCRA’s provisions. These concepts are core to FDA regulations, and the agency’s extension of authority in these areas to include cosmetics is, according to some, long overdue. That said, how FDA will implement these new authorities is unclear. It is possible FDA will utilize existing tools developed for food to address this space as well.

We hope the FDA website will soon host a copy of the MCRA, which is quite lengthy and complicated. Greater visibility will enable stakeholders to better assist FDA in undertaking the challenges implementation of the law invites.