How MoCRA’s Implementation Shapes Regulatory Strategies

The Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022, introduced new cosmetics legislation requirements in the USA (1). This legislation mandated safety standards, US Food and Drug Administration (US FDA) oversight, and accountability for cosmetic manufacturers including safety data management records that could be auditable by the FDA, for example, in a case of a reported consumer safety use issue. However, while MoCRA sets comprehensive safety standards, it does not impose restrictions on specific ingredients. The US FDA announced it would delay enforcement of certain MoCRA requirements until July 1, 2024, to give companies leeway to transition to the new regulations. Despite this grace period, a recent analysis by Registrar Corp found that “48% of companies selling imported cosmetics at America's top 25 retailers are non-compliant with the U.S. Food and Drug Administration's (FDA) new cosmetics regulations” (2). Now that the deadline has passed, non-compliant companies with MoCRA can be subject to penalties. These include fines, product seizure and recall, suspension, and in some cases, criminal prosecution (3).

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MoCRA sets clear requirements like mandatory product registration, adverse event reporting, and substantiation of product safety. Nonetheless, some challenges do arise such as:

• Overlapping regulations: At times, MoCRA requirements intersect with federal-state laws.
• Resource strain: Smaller companies, in particular, need help meeting the demands for comprehensive ingredient data, safety testing, and compliance reporting.
• Supply chain accountability: MoCRA places a strong emphasis on ensuring transparency throughout the entire supply chain, particularly concerning Good Manufacturing Practice (GMP).

Our SmartSafety solution addresses MoCRA challenges with:

• Automated support of risk assessment: Efficiently evaluating ingredient safety using the largest amount of data;
• Centralized documentation: Streamlining access to safety substantiation records, including Safety Data Sheets;
• Real-time tracking: Supporting compliance with federal and state regulations on an ongoing basis (e.g., best practices in data integrity and record keeping supporting versioned reporting).

The FDA Modernization Act (4). encourages companies to use New Approach Methodologies (NAMs ) whenever possible. One example of this is the integration of Integrated Approaches to Testing and Assessment (IATA) results from the SaferSkin application (5). into the SmartSafety application for the risk assessment of formulations and ingredients (6). The SaferSkin app aids in assessing skin sensitization risks without the need for animal testing. This innovative tool demonstrates how technology supports safer, more efficient product testing. Beyond federal regulations, individual states also impose their cosmetic laws, often complicating compliance. For example, New York has enacted legislation banning formaldehyde and certain PFAS chemicals. Some challenges are:

• Reformulation needs: Companies may need to remove and replace banned substances while ensuring that the products still perform effectively
• Label updates: Adapting labels to comply with state-specific transparency requirements.

Similarly, California, often the first U.S. state to adopt regulations in line with emerging standards, is set to implement even stricter cosmetic laws. In October 2023, California lawmakers passed a bill that will “ban 26 ingredients linked to health risks like burns, cancers, reproductive issues, and birth defects and more… they are among 1,600 that already have been banned in the European Union, but not in the United States” (7). The new law, authored by Assembly Member Laura Friedman, a Democrat from Burbank, will take effect on January 1, 2027, to give companies time to eliminate those ingredients from their products.

As of December 2024, MoCRA is still in the process of being implemented by the FDA. Its adoption has sparked global interest, as many other countries are considering or have already implemented their regulatory frameworks for cosmetics. For example, the European Union (EU), China, Canada, Japan, South Korea, Australia, and Brazil have proactive policies supporting cosmetics product safety. For instance, South Korea’s Ministry of Food and Drug Safety (MFDS) has implemented stringent safety and labeling requirements and has proactively banned animal testing for cosmetics. In January 2021, South Korea introduced a new certification mechanism that inspects raw materials instead of the final products (8).

On December 11, 2024, the FDA finalized its guidance on cosmetic facility registration under MoCRA and issued three new draft FAQs for public comment by January 13, 2025. Some key updates include requiring foreign establishments to designate a U.S. agent for communication and inspections, allowing multiple buildings within three miles to share an FDA Establishment Identifier (FEI), and mandating product listings for free samples or gifts, except those used solely for industry research. (9). MoCRA’s success hinges on industry collaboration and innovative solutions. Tools like SaferSkin and SmartSafety empower companies to meet compliance requirements efficiently, enhancing transparency and consumer safety. By staying proactive, businesses can maintain trust, meet regulatory demands, and innovate.

References:

1. 1. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
2. 2. https://www.prnewswire.com/news-releases/cosmetic-industry-faces-significant-non-compliance-under-new-fda-regulations-302303037.html
3. 3. https://www.oberk.com/packaging-crash-course/MoCRA
4. 4. https://www.congress.gov/bill/117th-congress/senate-bill/5002 
5. 5. https://saferworldbydesign.com/saferskin/in-silico/skin-sensitization-app/app/ 
6. 6. https://smartsafety.edelweissconnect.com/ 
7. 7. https://calmatters.org/economy/2023/10/california-cosmetics-ban/
8. 8. https://criticalcatalyst.com/regulatory-framework-cosmetic-products-south-korea/
9. 9. https://www.cov.com/en/news-and-insights/insights/2024/12/fda-finalizes-mocra-registration-and-listing-faqs-and-issues-new-draft-faqs