On December 29, 2022, as part of the 2023 Consolidated Appropriations Act, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law. With its enactment comes the first major shift to the cosmetics regulatory framework since the Federal Food Drug and Cosmetics Act (FFDCA) was enacted in 1938 and includes enhancements to the oversight authority currently afforded to the U.S. Food and Drug Administration (FDA).
With certain exceptions, MoCRA expressly preempts certain requirements under the FFDCA and prohibits states from establishing conflicting laws, regulations, referendums, or orders. Key provisions of MoCRA, such as those surrounding the addition of facility registration and product listing requirements, good manufacturing practices (GMP) requirements, and labeling requirements are outlined below.
Adverse Event Reporting
A “responsible person,” defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label, must submit to FDA any “serious adverse event” associated with the domestic use of a cosmetic product manufactured, packed or distributed by such person. The submittance of the serious adverse event, along with a copy of the label on or within the retail packaging, must occur within 15 business days after an adverse event report is received.
If it is believed that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a “serious adverse event,” FDA may also request a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product, of which must be provided within 30 days. Additionally, for one year following the initial submission of the report, all new and material medical information related to the “serious adverse event” must also be submitted within 15 days of receipt by the “responsible person.”
A “serious adverse event” is defined as an adverse event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement. A “serious adverse event” can also mean an adverse event that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent such outcomes.
Good Manufacturing Practices
Under MoCRA, by December 29, 2026, FDA is required to establish GMPs, consistent with national and international standards, for facilities that manufacture and process cosmetics. These GMPs can include an allowance for the inspection of records necessary to demonstrate compliance with such GMPs.
Overall, these GMPs must focus on protecting public health and ensuring that cosmetic products are not adulterated. Therefore, when creating such GMPs, FDA is required to consider the size and scope of the businesses engaged in the manufacture of cosmetics and the risks to public health posed by such cosmetics. Additionally, FDA must provide sufficient flexibility to be practicable for all sizes and types of facilities to which the GMPs will apply. This can include providing simplified GMPs or longer compliance times for smaller businesses to avoid undue economic hardship.
Registration and Product Listing
All domestic and foreign entities that meet the definition of “facilities” (i.e., engage in manufacturing or processing of a cosmetic product for distribution in the U.S.) must register with FDA and renew such registration every two years. Facility registration must be completed within one year of enactment of MoCRA, or within 60 days of initiating manufacturing or processing operations. To ensure all registration information is current, should any changes to the information within the registration occur, FDA must be notified within 60 days.
Notably, certain establishments are exemption from the term “facility,” and thus the registration requirement. This includes establishments that manufacture or process cosmetic products solely for use in research or evaluation (i.e., not offered for retail sale) and establishments that solely perform labeling, relabeling, packaging, or repackaging (not including filling a product container with a cosmetic product) of cosmetic products distributed in the U.S.
Each cosmetic product, including its ingredients, must also be listed with FDA, as part of a facility registration or separately, within 1 year if such product is marketed at the time of enactment of MoCRA, or within 120 days if marketed after enactment. Unlike the facility registration, however, if there are changes or updates to a product listing, such changes are to be submitted annually.
Registration of a facility, and thus the ability to sell such cosmetic product, can be suspended should it be determined that a cosmetic product has a reasonable probability of causing serious adverse health consequences or death to humans, and there is a reasonable belief that other products manufactured or processed by the facility may be similarly affected. Prior to such suspension, a registrant must be provided notice and be given five (5) business days to provide a plan for addressing the reasons for such suspension. Once this notice has occurred, an order of suspension will be issued that then provides a registrant the opportunity for an informal hearing to be held no later than five (5) business days, unless otherwise agreed.
A responsible person for each cosmetic product must ensure and maintain records of support for “adequate substantiation of safety” for each product. “Adequate substantiation of safety” has been defined to include tests or studies, research, analyses, or other qualifying evidence or information sufficient to support a reasonable certainty that a cosmetic product is safe. A product will be deemed safe if it is not injurious to users under customary or usual conditions or the conditions of use prescribed in the labeling.
All fragrance allergens, to be determined by regulation, will be required to be identified and disclosed on the label of a cosmetic product. The regulations pertaining to this allergen disclosure requirement must be proposed within 18 months after the enactment of MoCRA, with the final rule no later than 180 days after the close of the public comment period.
Labels are also to include a domestic address, domestic phone number, or electronic contact information through which adverse event reports can be received.
Records Access and Maintenance
All records related to adverse events, serious of otherwise, associated with the domestic use of a cosmetic product must be kept and available for inspection for six (6) years, or if an eligible small business, three (3) years. A “small business” is defined as responsible persons, and owners and operators of facilities, whose average gross annual domestic sales for the previous 3-year period is less than $1,000,000 and who do not engage in the manufacturing or processing of the certain cosmetic products (e.g., cosmetic products that are injected or cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual).
If there is a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, presents a threat of serious adverse health consequences or death to humans, a manufacturer must also allow FDA to access and copy all relevant records relating to such cosmetic product. Relevant records do not extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this Act), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
If there is a reasonable probability that the product is adulterated or misbranded, and the use of or exposure to the product will cause serious adverse health consequences or death, the responsible person must voluntarily cease distribution and recall all such affected products. FDA may also order a mandatory recall and issue a press release to include an image of the product subject to the recall, after providing the responsible person an opportunity for an informal hearing.
Like other regulations pertaining to recalls, FDA may require a notice to cease distribution or notification of a recall to be sent to affected persons such as consumers, distributors, and others who manufacture, distribute, import, or offer the product.
Talc-Containing Cosmetics and PFAS Use
Within one year of enactment of MoCRA, FDA is required to issue a proposed rule to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This rule must be finalized no later than 180 days after the public comment period for the proposed rule has closed.
Within three years of enactment, FDA must also issue a public report that assesses the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, and the scientific evidence regarding the safety of such use in these products.
For the purposes of safety testing on cosmetic products, MoCRA explicitly states that animal testing should not be used and should be phased out with the exception of appropriate allowances. The “specific allowances” are yet to be identified.
If your company needs help navigating the MoCRA and determining how it may impact your company, Buchanan’s experienced regulatory team is here to help. Please reach out to the authors or to our FDA Practice Group with any questions.