[UPDATE: On August 7, 2023, FDA issued a draft guidance for industry (“Draft Guidance”) for comment on cosmetic product facility registrations and product listings as mandated by MoCRA. As noted below, owners and operators of both domestic and foreign facilities that manufacture or process cosmetic products will be required to register and list their products with FDA beginning in October 2023 and no later than December 29, 2023. Exemptions exist for small businesses and for cosmetics facilities that are already subject to FDA’s drug and device registration requirements.
Per the Draft Guidance, registrations must include the name of the owner and/or operator of the facility; the facility’s name, physical address, email address, and telephone number; for foreign facilities, the name, phone number, and email (if available) of the facility’s U.S. agent; all brand names under which cosmetic products manufactured or processed in the facility are sold; the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility; the type of submission (initial, amended, biennial renewal, or abbreviated renewal); and the facility registration number. With respect to this last data point, FDA intends to use a facility’s FDA Establishment Identifier (FEI) as the facility registration number. Therefore, to facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. Relevant information from cosmetic product facility registrations and listings will be made available to the public, but FDA will not publish listing numbers or cosmetic brand names.
Cosmetic products subject to the new registration and listing requirements include the following categories: baby products (such as baby shampoos and baby wipes); bath products (including bath salts and bubble baths); cologne, perfume, and other fragrance products; hair products (including hair color and eyebrow and eyelash dyes); makeup products (including makeup products for children); manicure products (including nail polish, cuticle softeners, and nail creams); personal cleanliness products (including deodorants and douches); shaving preparations; skin care preparations (including depilatories and paste masks); mouthwash and breath fresheners; suntan preparations; and permanent and temporary tattoo inks.
Facilities that manufacture or process a cosmetic product that was marketed in the United States as of December 29, 2022, must register with FDA no later than December 29, 2023. Registrations are required to be renewed every two years; there is no fee for either the initial registration or any renewals. FDA will offer both an electronic submission portal and a paper form for the submission of registration and product listing information but strongly encourages electronic submissions over the paper form to facilitate the timeliness of data submission. To that end, FDA intends to make the new electronic submission portal available in October 2023.
Prior to launching the new electronic submission portal, FDA is soliciting applications from members of the cosmetic product industry to participate in a voluntary pilot program to test user acceptance of the new portal. FDA plans to accept up to nine participants for the pilot program. Interested parties should submit an electronic application to eRLC.testing@fda.hhs.gov by August 22, 2023. The pilot testing is scheduled to begin on or about September 15, 2023.
Comments on the Draft Guidance should be submitted by September 7, 2023. Electronic comments may be submitted to Regulations.gov. All written comments should be identified with the docket number FDA-2023-D-1716 and the title of the Draft Guidance (“Registration and Listing of Cosmetic Product Facilities and Products”). Epstein Becker Green is available to assist with drafting comments or with the application for the voluntary pilot program.]
* * * *
In the first major reform of cosmetics regulations since the Federal Food, Drug & Cosmetics Act (FDCA) became law in 1938, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expands the authority of the U.S. Food and Drug Administration (FDA) to oversee and regulate cosmetics.
Enacted on December 29, 2022, as part of the 2023 omnibus bill, MoCRA amends Chapter VI of the FDCA to include new provisions and requirements for cosmetic products similar to those already in place for other FDA-regulated products.
New Obligations for Cosmetics Companies
Under the FDA’s new cosmetics regulatory framework, manufacturers and processers of cosmetics will be subject to a number of new regulatory responsibilities, including the following:
- Facility Registration. Owners and operators of both domestic and foreign facilities that manufacture or process cosmetic products will be required to register with the FDA. (Notably, facilities whose activities solely relate to the labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products will not be required to register with the FDA.) Owners/operators will have one year from December 29, 2022, to register existing facilities, while new facilities must be registered either 60 days after they start manufacturing cosmetics or 60 days after the existing facility deadline, whichever is later. Registrations must be renewed biennially.
- Product Listing. “Responsible persons”—meaning manufacturers, packers, or distributors of a cosmetic product whose name appears on the label—will have one year from December 29, 2022, to list their cosmetic products with the FDA. (As with medical devices, listings for cosmetics will likely occur at the time of the facility registration.) Such listings must include the product’s ingredients and information about where the cosmetic product is manufactured.
- Mandatory Reporting of Adverse Events. Serious adverse events must be submitted to the FDA by the responsible person no later than 15 days after receiving the report, and responsible persons must maintain all records related to serious adverse events for a minimum of six years. “Serious adverse events” include death, a life-threatening experience, hospitalization, a persistent or significant disability, a congenital anomaly or birth defect, 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. (Currently, the FDA uses MedWatch for voluntary cosmetics adverse event reporting, and presumably will continue to do so for the new mandatory serious adverse event reporting.)
- Substantiation of Safety. Under MoCRA, businesses must now maintain records, including tests, analyses, research, and other evidence sufficient to demonstrate to a “reasonable certainty” that a cosmetic product is safe. MoCRA clarifies that a cosmetic is deemed to be “safe” if it “is not injurious to users under the conditions of use prescribed in the [product’s] labeling” or under conditions of customary or usual use.
- Cosmetics Labeling Changes: Professional Use Only; Allergens; Contact Information. Cosmetic product labels will now be required to identify all fragrance allergens. The FDA will issue a list of such allergens no later than July 1, 2024. Manufacturers, packers, or distributors must also update their cosmetic product labels to include contact information in order to receive adverse event reports from consumers. Finally, cosmetic products intended for use solely by licensed professionals such as estheticians, cosmetologists, or hair/nail salons must be clearly labeled “For Professional Use Only.” As noted above, such products will also be required to include additional contact information and identify any fragrance allergens.
Enhanced FDA Oversight
MoCRA also provides the FDA with new enforcement tools that authorize the agency to take timely action to help protect the public.
- Access to Records. MoCRA permits the FDA to access a company’s records related to a cosmetic product if the agency reasonably believes the product and/or its ingredients are adulterated, such that they present a risk of serious adverse health consequences or death. The FDA may also request a list of ingredients in a product’s fragrance or flavor if it believes these components contributed to a consumer’s serious adverse event, and access records as needed to enforce the good manufacturing practice (GMP) rules, adverse event reporting rules, and other new requirements detailed above. The FDA will not have access to a company’s records related to formulas/recipes, financial data, or research data unrelated to safety substantiation.
- Mandatory Recalls. Effective December 29, 2023, the FDA will have the authority to issue cosmetic product recalls. The FDA must provide the responsible person the opportunity to voluntarily recall and halt distribution of the product before issuing a mandatory recall.
- Suspension of Registration. MoCRA gives the FDA the authority to suspend a facility’s registration if it determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences and other products manufactured by the facility may be similarly affected. Once suspended, a facility may not introduce any cosmetic products into commerce until its registration is reinstated. This authority is similar to the FDA’s authority to suspend food facility registrations for safety violations.
Forthcoming FDA Action
As summarized below, MoCRA requires the FDA to issue three new rules subject to notice-and-comment rulemaking. Although Congress set forth various dates by which the FDA must issue proposed and final rules with respect to these topics, industry should continue to monitor these developments, as the public will have an opportunity to review and provide comments on these proposed rules.
- Current Good Manufacturing Practices. MoCRA directs the FDA to establish GMP regulations consistent with national and international standards. FDA must issue a proposed rule within two years after the December 29, 2022, enactment and a final rule no later than three years after MoCRA’s enactment. If a cosmetic product has been manufactured or processed under conditions that do not meet these regulations, it will be deemed adulterated under the FDCA.
- Talc-Containing Products. By December 29, 2023, the FDA must issue a proposed rule to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products and must finalize the rule 180 days thereafter.
- PFAS in Cosmetic Products. MoCRA directs the FDA to assess the scientific evidence regarding the safety of, and risks associated with, the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. The FDA is also required to issue a report within three years of MoCRA’s enactment summarizing the results of its assessment.
Exemptions and Limitations of Application
We note that MoCRA exempts cosmetic/drug and cosmetic/device combination products from certain requirements related to adverse event reporting, GMPs, registration/listing, safety substantiation, recordkeeping, and mandatory recall authority. FDA’s oversight for such combination products will presumably be handled under the agency’s drug or device authorities. However, the foregoing exemptions are not applicable to facilities that manufacture both combination products and cosmetics.
In addition, owners/operators of “small businesses,” which are defined as those whose average gross annual sales of cosmetic products in the United States for the previous three-year period is less than $1,000,000, and who do not engage in the manufacturing or processing of certain types of cosmetic products (such as injectables), are exempt from the GMP and registration/listing requirements.
Looking Forward
Although many of the new MoCRA requirements do not become effective until later this year (i.e., one year after the law was enacted), it is important for cosmetics manufacturers and processers to proactively think about these requirements to ensure they have robust compliance programs in place to comply with these new obligations. We expect that the FDA will issue guidance for industry concerning the new requirements, and state laws may also change in response once the full extent of the FDA requirements become known. Such changes may also spur manufacturers to rethink their contracts with raw material/ingredient suppliers in order to comply with the new requirements and shift the burden for such compliance to suppliers where possible.
* * * *
This Insight was authored by Tracey T. Gonzalez. If you have any questions regarding the new MoCRA requirements, please contact the author or the Epstein Becker Green attorney who regularly handles your legal matters.
