On December 29, 2022, US President Joe Biden signed the Consolidated Appropriations Act, 2023 into law, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This new cosmetic legislation establishes a federal standard for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more.
For years, the US Food and Drug Administration (FDA) had relatively loose regulations on cosmetics. Cosmetics business registration and product listing are voluntary rather than mandatory. FDA can issue a warning letter to cosmetic products or companies involved in violations and deny the entry of such products at ports. Still, FDA has no right to order a mandatory recall of unqualified cosmetics.
Focusing on product safety, MoCRA sets out a number of key provisions and new requirements to amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) and increase FDA’s oversight over cosmetics and ingredients thereof. It marks the first significant reform to the US cosmetics regulation since the enactment of the FD&C Act in 1938.
Key Provisions of MoCRA
Some of the key points of MoCRA are summarized below:
1.Mandatory Facility Registration and Product Listing
MoCRA stipulates that one year after MoCRA is formally promulgated, “responsible persons” (i.e., manufacturers, packers, and distributors of a cosmetic product whose name appears on the product label) will be subject to mandatory facility registration and product listing requirements.
Specifically, all existing US domestic and foreign facilities that manufacture or process cosmetic products for sale in the United States must register with FDA within one year after MoCRA’s enactment. All facility registrations must be renewed every two years. Notably, facilities engaged solely in the labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products are not required to register.
Regarding listing, responsible persons shall list each cosmetic product with FDA, including its ingredients and where the cosmetic product is manufactured. The product listings shall be updated annually. It is worth noting that a single listing submission may include multiple cosmetic products with identical formulations or formulations that differ only in colors, fragrances, flavors, or quantity of contents.
2. Cosmetic Safety Substantiation
MoCRA requires responsible persons to ensure and maintain records supporting “adequate substantiation” that shows that a cosmetic product is safe, and establishes a safety standard that products must meet to be marketed in the US. Cosmetic products without adequate safety substantiation will be considered adulterated.
3.Updated Cosmetic Labeling Requirements
MoCRA updates the labeling requirements for cosmetics, including:
- The requirement to include contact information through which the responsible person can receive adverse event reports on cosmetic product labels, which will be effective two years after the date of enactment of MoCRA;
- The requirement to include a notice that only licensed professionals may use the product on the labels of cosmetics products for professional use, which will be effective one year after the date of enactment of MoCRA;
- The requirement for disclosure of fragrance allergens on product labels. The disclosed information shall be consistent with FDA’s new regulations.
4.Mandatory Adverse Event Reporting
MoCRA requires that responsible persons submit reports of serious adverse events to FDA no later than 15 days after learning the issue, and maintain all records related to health-related adverse events associated with the use of its product for six years. Exceptionally, small businesses need only maintain such records for three years.
Besides, MoCRA expands the definition of “serious adverse event” to include infections or “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual.”
5.FDA’s Increased Oversight
In addition to the above new requirements for cosmetic manufacturers, packers, and distributors, MoCRA greatly expands FDA’s rulemaking and enforcement authority over cosmetics. It mandates FDA to issue good manufacturing practices (GMPs) regulations and develop regulations that establish and require standardized testing methods for asbestos in cosmetics. It also grants FDA’s mandatory recall authority for a cosmetic product and expands FDA’s access to certain records.
Latest Updates
The implementation and enforcement of MoCRA’s detailed legislation may take years for the FDA, as it will need to develop necessary regulations. Over the next 2-3 years, the FDA will dedicate efforts towards developing necessary implementing regulations, including mandatory GMP regulations for cosmetic manufacturers.
Recently, FDA held a virtual public listening session on good manufacturing practices, seeking input and expertise from stakeholders to inform the development of GMP regulations for the cosmetics industry. The regulations will be formulated with reference to suggestions and opinions put forward by enterprises at the listening session.
Representatives from various organizations and businesses presented public comments, sharing perspectives and suggestions on GMP for cosmetic products. Key themes and concerns emerged, highlighting the importance of addressing safety, quality, and consistency in GMPs regulations to protect consumers and support industry growth.
- Safety and Quality Assurance: Many speakers emphasized the necessity for robust GMPs to ensure the safety and quality of cosmetic products. They called for comprehensive guidelines encompassing manufacturing processes, ingredient safety, labeling requirements, and product testing;
- Compliance and Enforcement: Effective compliance mechanisms and enforcement actions were highlighted as crucial for ensuring adherence to GMPs. Suggestions included regular inspections, mandatory reporting of adverse events, and appropriate penalties for non-compliance;
- Small Business Considerations: Representatives from small cosmetics businesses emphasized the need for adaptable and feasible GMP guidelines tailored to smaller enterprises. They stressed the significance of providing sufficient support, resources, and education to facilitate compliance without burdening small businesses excessively;
- Ingredient Transparency: Speakers advocated for clearer labeling requirements, including the disclosure of potential allergens, fragrance components, and other potentially harmful substances;
- International Harmonization: Participants stressed the importance of aligning GMP regulations with international standards to facilitate global trade and ensure consistency in quality and safety measures.
The listening session fostered an open and inclusive discussion on the development of GMP regulations for the cosmetics industry. It emphasized the significance of ensuring safety, quality, and transparency in cosmetic manufacturing processes while considering the diverse needs of different stakeholders, including small businesses.
The FDA will utilize the insights and recommendations shared during the session to develop GMP regulations that prioritize public health and promote responsible manufacturing practices in the cosmetics industry.
ChemLinked Comments
MoCRA’s passage is set to have a significant and far-reaching impact on the cosmetics industry. For example, it will require US and foreign facilities that manufacture or process cosmetic products for US distribution to register with the FDA. This mandatory registration must be renewed every two years, adding complexity to proceedings. While major manufacturers may not have an issue with this, smaller manufacturers could face challenges.
Previously, the US had different regulations from other countries, with the Voluntary Cosmetic Registration Program (VCRP) in place. However, this non-mandatory registration system for cosmetic products was decommissioned in March. Each product will require separate registration, creating a bigger burden for brands with a wide range of products.
Stakeholders interested in entering the US market should carefully study the regulatory changes and comply with the corresponding deadlines. Facility registration and product listing will take effect one year after MoCRA’s enactment. Adequate preparations in advance can mitigate compliance risks and increase the chances of successful market entry.
Further Reading
- Decoding U.S. Modernization of Cosmetics Regulations Act of 2022 (MoCRA)
- US FDA Stops the VCRP System and Will Launch a New System for Facility Registrations and Product Listings
- Explanation of MoCRA Regulation (Video)
ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.
We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com
Author
Winnie Xu
ChemLinked Regulatory Analyst, REACH24H Consulting Group
Winnie Xu is an experienced cosmetic regulatory analyst in the ChemLinked team tasked with tracking, analyzing and interpreting the latest regulatory and market changes in China, Japan, and the rest of the Asia Pacific area. She has published a number of news and articles on cosmetic regulatory compliance and involved in various industry conferences.
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