The recent Food and Drug Omnibus Reform Act (FDORA) has instituted a new set of rules for cosmetic businesses. These regulations include registration, product listing, ingredient disclosure, adverse event reporting, safety substantiation, and adherence to good manufacturing practices (GMPs). FDORA, embedded within the Consolidated Appropriations Act, 2023, enhances the Federal Food, Drug, and Cosmetics Act (FDCA), granting the Food and Drug Administration (FDA) more supervisory powers over the cosmetics industry. The enhancement of the FDA’s jurisdiction is encapsulated in the “Modernization of Cosmetics Regulation Act of 2022” (MoCRA).
MoCRA presents the most extensive boost to the FDA’s regulatory powers over cosmetics since the inception of the FDCA in 1938. Under these fresh rules, cosmetic businesses will face increased obligations and heightened scrutiny, both regulatory and legal. As such, these changes necessitate early preparation from companies.
Facility Registration and Product Listing Obligations
Under the new rules, the proprietor or operator of a facility manufacturing or processing cosmetic products for the American market, regardless of its location, must register with the FDA. This process involves sharing detailed information with the FDA, including all brand names under which the facility’s cosmetic products are sold, the product category, and the identity of the “responsible person” associated with each product made at the facility.
A facility is required to submit a single registration, irrespective of whether it manufactures or processes cosmetic products on behalf of multiple responsible persons.
These requirements exclude certain beauty shops, salons, and retailers. Furthermore, establishments involved in activities such as labeling, relabeling, packaging, repackaging, holding, and distributing cosmetic products are not required to register.
Different deadlines apply to existing and new facilities. Existing facilities must register by December 29, 2023. New facilities are required to register within 60 days of their initial production of cosmetic products or by December 29, 2023, whichever comes later. Registration information must be updated within 60 days of any changes.
The FDA is developing a new system for these mandatory submissions, and any previous information submitted to its Voluntary Cosmetic Registration Program (VCRP) will not be carried over for registration and listing under MoCRA.
In addition to the facility registration obligation, each responsible person must list each cosmetic product intended for sale in the United States with the FDA and provide updates as necessary. This listing will require extensive product information. Companies might need to disclose fragrance ingredients deemed allergens by the FDA, raising potential trade secret issues.
Product listing pertains to formulas rather than brand names. Thus, a single formula sold under different brand names only needs to be listed once. Furthermore, minor variations in a formula such as color, fragrance, flavor, or quantity can be covered by a single listing.
Deadlines for product listing depend on when the product was marketed. Products marketed on December 29, 2022, need to be listed by December 29, 2023. Products marketed after that date need to be listed within 120 days of their introduction to the market. Thereafter, updates must be submitted annually.
Expanded Adherence to Adverse Event Reporting and Recordkeeping
MoCRA imposes stringent recordkeeping responsibilities concerning product safety and reporting, documentation, and follow-up of serious adverse events. New labeling requirements for reporting adverse events have also been introduced. Responsible persons must report serious adverse events associated with their cosmetic products within 15 business days of receiving such a report. They must also provide additional information to the FDA within one year of the initial report.
The definition of a “serious adverse event” under MoCRA is broader than that applied to dietary supplements and other products, as it includes infections and significant disfigurement. Companies should therefore be prepared to receive and report adverse events from consumers, and all adverse event records must be accessible for FDA inspection.
New GMP Regulations
The FDA must set GMP rules for manufacturers and processors. Upon their implementation, these rules will be the first federal regulations mandating GMP adherence by cosmetic companies. Manufacturing a cosmetic product that doesn’t meet these GMPs will be considered adulteration.
The proposed GMP rule must be published by December 29, 2024, and the final rule by December 29, 2025.
Exemptions and Safety Substantiation
MoCRA offers certain exemptions for small businesses from GMP, registration, and product listing requirements. However, these exemptions do not extend to manufacturers or facilities dealing with specific types of cosmetic products.
The responsible person for a cosmetic product must ensure and keep records supporting the safety of their products by December 29, 2023.
MoCRA also mandates the FDA to establish testing methods for asbestos in talc-containing cosmetic products. Additionally, the FDA will issue a report on the safety of the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics by December 29, 2025.
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