The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was officially enacted on December 29, 2022, as a part of a comprehensive appropriations bill aimed at funding the Federal government for the fiscal year 2023. This groundbreaking legislation signifies the first substantial enhancement of the U.S. Food & Drug Administration’s (“FDA” or the “Agency”) jurisdiction over cosmetics since the original Federal Food, Drug, and Cosmetic Act (“FD&C Act”) was put in place in 1938. The introduction of MOCRA came during a period of increased scrutiny and concern regarding the safety of cosmetic products, particularly in light of serious health concerns associated with ingredients such as talc and per- and polyfluoroalkyl substances (“PFAS”). This shift reflects a growing demand for safer cosmetic products among consumers and advocates alike.

The reforms introduced by MOCRA fundamentally adjust the regulatory landscape for cosmetics, aligning it more closely with the standards governing medical products. However, it is essential to note that MOCRA does not mandate a premarket government review and approval process, nor does it fully align U.S. regulations with those of the European Union (“EU”). Key components of MOCRA include new stipulations for facility registration, product listings, safety substantiation, comprehensive labeling, adverse event reporting, recordkeeping, and adherence to good manufacturing practices (GMPs) for responsible parties involved in the cosmetic supply chain. Furthermore, the act empowers the FDA to enforce stricter measures, including the suspension of facilities and mandatory product recalls when public health is at risk.

All responsible parties and facilities must gear up for compliance with the majority of MOCRA provisions, which are scheduled to be effective within one year, specifically on December 29, 2023. However, there are exceptions: the labeling requirements will come into effect in two years, and the FDA is allotted three years to finalize regulations governing Good Manufacturing Practices (GMPs). It is vital for responsible parties and facilities to stay informed about the FDA’s ongoing rulemaking and guidance initiatives regarding new obligations, especially concerning products containing talc and PFAS. Noncompliance with any of MOCRA’s mandates may lead to violations of the adulteration or misbranding sections of the FD&C Act, thereby constituting a separate prohibited act under the law.

The compliance timelines outlined in MOCRA presuppose that the FDA will have developed and instituted all necessary regulatory frameworks by the designated dates. However, there is a possibility that the FDA may require additional time, which could inadvertently extend the compliance deadlines for responsible parties. Stakeholders should remain vigilant and prepared for any adjustments to these timelines as the FDA navigates the implementation of these new regulations.

Below is a detailed summary of the significant provisions of MOCRA, along with a brief comparison to the cosmetic regulatory framework in the European Union. For those interested in the Food and Drug Omnibus Reform Act of 2022, which was also included in the same appropriations bill, we have published a concurrent client alert that you can access here.

1. Essential Facility Registration and Comprehensive Product Listing

Under the stipulations of MOCRA, every facility engaged in the manufacturing of cosmetic products is required to maintain an active registration with the FDA. Facilities already operational at the time of MOCRA’s enactment must complete their registration by December 29, 2023. For new facilities, registration must occur within 60 days of initiating manufacturing or processing operations for products intended for distribution in the U.S. Moreover, MOCRA clarifies that for contract manufacturers, either the facility or the responsible person whose products are being manufactured can submit the registration on behalf of the facility. This dual submission option aims to streamline compliance for various business models within the cosmetics industry.

In addition, responsible persons are mandated to maintain comprehensive listings of their cosmetic products with the FDA. This includes vital information such as the product name, type, full ingredient list (including any fragrances, flavors, or colors), and details regarding the manufacturing or processing facility. Responsible parties must submit their product listings for currently marketed items by December 29, 2023, and for any new cosmetic products within 120 days of their market introduction. This rigorous documentation process is designed to enhance product transparency and safety.

It is important to note that registration procedures operate on a per-facility basis, while product listings are managed on a per-responsible person basis. These processes will follow distinct timelines, with registration renewals required every two years and product listing updates mandated annually. This structured approach ensures that both the FDA and consumers receive up-to-date information regarding cosmetic products in the marketplace.

2. Ensuring Safety Through Adequate Substantiation

Responsible parties must guarantee the safety of their cosmetic products by maintaining thorough records that provide adequate substantiation of safety for each item. MOCRA defines adequate substantiation of safety as including tests, studies, research, analyses, or other data deemed sufficient by qualified experts in the field. This data must support the assertion that the product and its ingredients are “safe” when used in accordance with the labeling or customary use. This requirement emphasizes the importance of scientific validation in ensuring consumer safety and product efficacy.

3. Enhanced Labeling Requirements for Consumer Safety

Existing FDA regulations necessitate that cosmetic products carry specific labeling elements, including ingredient lists, a clear statement of identity, net quantity of contents, and the name and location of the manufacturer, packer, or distributor. MOCRA expands these requirements by mandating that responsible parties include additional information on each product label. This includes their domestic address, phone number, or electronic contact details for adverse event reporting, acknowledgment of any “fragrance allergens” included in the formulation, and a clear statement that products intended for “professional use” should only be administered by licensed professionals such as cosmetologists, nail technicians, barbers, or estheticians. This enhanced labeling is designed to improve consumer awareness and safety.

4. Comprehensive Adverse Event Reporting and Recordkeeping

For the first time, MOCRA mandates cosmetic companies to report serious adverse events. Responsible parties must notify the FDA within 15 business days of receiving relevant information regarding any known serious adverse event (“SAE”) linked to the use of their cosmetic products in the U.S. An SAE is defined as an adverse event that results in death, a life-threatening situation, hospitalization, significant disability or incapacity, congenital anomalies, infections, significant disfigurement, or necessitates medical or surgical intervention to avoid such outcomes. This reporting framework is designed to enhance consumer safety by ensuring prompt communication of potential risks associated with cosmetic products.

In addition to reporting, responsible parties must receive, maintain, and retain records of adverse events linked to their cosmetic products for FDA inspection. If the FDA suspects that an ingredient in a fragrance or flavor has contributed to an SAE, they can request a list of ingredients, and the responsible party must provide this information within 30 days. This proactive approach to monitoring adverse events aims to improve overall product safety and accountability within the cosmetics industry.

5. Implementation of Good Manufacturing Practices for Safety

Historically, the FD&C Act and FDA regulations did not impose GMP requirements specifically for cosmetics. However, the FDA has consistently emphasized that adherence to GMPs is crucial for minimizing the risks of adulteration or misbranding of cosmetic products. Traditionally, the industry has looked to the international standard for cosmetics GMPs, known as ISO 22716, for guidance.

With the enactment of MOCRA, there is now a legal requirement for manufacturing facilities to comply with FDA-issued GMPs. MOCRA instructs the FDA to develop GMPs that align with both national and international standards, ensuring that cosmetic products remain free from adulteration. These regulations will take into account the size and operations of facilities and the public health risks associated with the cosmetics they produce. The FDA is tasked with issuing a proposed rule for these GMPs by December 29, 2024, and a final rule by December 29, 2025. This timeline reflects the agency’s commitment to enhancing the safety and quality of cosmetic products.

It is anticipated that the GMP regulations will closely mirror the standards set forth in ISO 22716. This expectation is based on previous recommendations by the FDA for manufacturers to adopt ISO 22716 and the industry’s voluntary compliance with these standards. Furthermore, the FDA recognizes the importance of harmonizing regulatory requirements on an international scale. Congress has mandated the FDA to develop GMPs that reflect international standards, which will ultimately facilitate compliance for manufacturers operating in both the U.S. and international markets.

6. Strengthened Authority for Facility Suspensions and Mandatory Recalls

Under MOCRA, the FDA is granted explicit authority to suspend the registration of a facility if it is determined that the facility produces or processes cosmetic products that pose a reasonable probability of causing serious adverse health effects or fatalities. Additionally, if the FDA has reason to believe that other products from the same facility may also be implicated due to widespread issues, they can initiate a suspension. This provision empowers the FDA to prevent potentially harmful cosmetic products from entering the market until the facility rectifies the identified violations and has its registration reinstated.

Moreover, MOCRA grants the FDA the authority to order responsible parties to cease distribution or recall cosmetic products if it is determined that there is a substantial risk of adulteration or misbranding, and such use could lead to serious health consequences or death. If a responsible party refuses to voluntarily recall or halt distribution as directed, the FDA will take the necessary steps to notify the public and ensure compliance. This enhanced enforcement capability reflects the FDA’s commitment to safeguarding public health and consumer safety.

7. Understanding Exemptions from MOCRA Regulations

MOCRA includes specific exemptions for various categories of responsible parties and facilities, relieving certain entities from compliance with its requirements. Notably, it excludes certain establishments from the definition of “facility,” which means they are not obligated to adhere to facility-related requirements. This includes cosmetic product retailers selling directly to consumers, hospitals, and physicians’ offices, as well as any entities engaged solely in labeling, relabeling, packaging, repackaging, holding, or distributing functions. Such exclusions aim to ease the regulatory burden on smaller businesses and streamline compliance efforts.

Additionally, MOCRA provides exemptions for “small businesses” from GMP, facility registration, and product listing obligations. “Small businesses” are defined as those that have generated an average of $1,000,000 (adjusted for inflation) in gross annual sales over the past three years, provided they do not manufacture or process cosmetic products that frequently come into contact with sensitive areas of the body, such as the eyes or products intended for internal use. This provision encourages smaller enterprises to thrive while ensuring that consumer safety remains a priority.

8. Addressing Talc and PFAS Safety Concerns

MOCRA directs the FDA to develop regulations that establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics. The FDA is required to propose a rule by December 29, 2023, and must issue a final rule within 180 days following the public comment period. This directive marks a significant shift in the regulatory approach towards ingredients known to pose health risks, particularly in light of the well-documented dangers of asbestos exposure.

This mandate represents a departure from the FDA’s previous limited sampling and analysis practices for detecting asbestos in talc-containing products. The agency has conducted studies in 2009-2010, 2019, 2021, and 2022, revealing the presence of asbestos, a known carcinogen. Moreover, in December 2022, the FDA announced intentions to issue nonbinding guidance for industry regarding asbestos testing in talc-containing cosmetics, reflecting a proactive stance on consumer safety. Additionally, MOCRA instructs the FDA to evaluate the safety of PFAS in cosmetic products and to publicly disclose findings by December 29, 2025, further addressing consumer health concerns.

9. Regulatory Stance on Animal Testing in Cosmetics

While MOCRA introduces robust regulations surrounding cosmetic safety, it notably lacks provisions that specifically regulate animal testing practices in the cosmetics industry. Instead, it includes a “sense of Congress” statement, which emphasizes the recommendation that animal testing should not be employed for safety testing of cosmetics and advocates for its gradual elimination. This reflects the growing ethical considerations within the industry regarding the use of animals in product testing.

10. Understanding the Preemption Clause in MOCRA

In exchange for these comprehensive new regulations, MOCRA includes an express preemption provision that prohibits states from enacting or maintaining any laws or regulations that differ from or add to the requirements established by MOCRA regarding facility registration, product listing, GMPs, recordkeeping, recalls, adverse event reporting, or safety substantiation. However, this provision permits states to regulate cosmetic ingredients, including the ability to prohibit or limit certain substances, and continues to uphold existing statutes such as Proposition 65 in California. Furthermore, the savings clause affirms that MOCRA does not preempt product liability and damages claims under state law, allowing consumers to seek recourse through established legal channels.

Comparison with European Union Cosmetic Regulations

The EU Cosmetics Regulation, adopted nearly 15 years ago, imposes stringent regulations on cosmetic products, placing various obligations on the designated “responsible person” (typically the EU manufacturer or importer). These obligations encompass compliance with GMPs, labeling requirements, reporting of serious undesirable effects, and the creation of a “product information file” (PIF) before marketing, along with notification to a central European database. When comparing MOCRA to the EU framework:

i. The PIF must include extensive documentation, such as safety reports and proof of claimed effects. Manufacturers compliant with the PIF requirements will likely also fulfill MOCRA’s adequate substantiation of safety, potentially exempting them from additional testing in both regions.

ii. The EU mandates compliance with GMP standards. It is anticipated that the upcoming FDA regulations will align closely with the international GMP standards set forth in the EU, facilitating easier compliance for manufacturers operating in both markets.

iii. Current labeling requirements in the EU do not necessitate allergen information disclosures, though discussions are ongoing regarding this aspect.

iv. The EU does not require manufacturing facilities to register; however, some member states, such as France, impose separate registration obligations.

v. The EU maintains comprehensive lists of prohibited or restricted ingredients, which surpass the lists maintained by the FDA.

vi. The EU explicitly prohibits animal testing for cosmetic products and ingredients, as well as the marketing of any products tested on animals.

Overall, manufacturers already adhering to the EU Cosmetics Regulation, particularly those compliant with ISO 22716, may find it easier to transition to MOCRA compared to those solely producing for the U.S. market.

¹Consolidated Appropriations Act of 2023, Pub. L. No. 117-328, 117th Cong. § 3501 et seq. (2022) (Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”)).

²See 21 U.S.C. §§ 361–363.

³See Food and Drug Administration Safety and Landmark Advancements Act of 2022, S. 4348, 117th Cong. § 801 et seq. (2022).

⁴See U.S. Food & Drug Admin., Talc (updated Dec. 7, 2022), https://www.fda.gov/cosmetics/cosmetic-ingredients/talc; U.S. Food & Drug Admin., Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics (updated Feb. 25, 2022), https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics.

⁵MOCRA § 3502 (to be codified at FD&C Act §§ 605 (adverse event reporting and recordkeeping), 606 (good manufacturing practices), 607