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Although cosmetics were brought under the purview of the landmark 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act), which comprehensively reformed the U.S. Food and Drug Administration's (FDA) regulation of food and drugs and granted it regulatory authority over cosmetics, the FDA's regulatory power over cosmetics expanded relatively limitedly between 1938 and 2022, with the 1967 Fair Packaging and Labelling Act being a significant exception.

This means that the FDA has fewer tools to protect public health and ensure the safety of cosmetics compared to other products regulated by the FDA. For example, while cosmetic companies and their marketers have a responsibility to ensure the safety of their products, they were not previously required to register their cosmetic manufacturing facilities with the FDA, list cosmetic product information, or report serious adverse events like other FDA-regulated industries.

MoCRA expands FDA's regulatory powers over cosmetics

This situation changed on December 29, 2022. After more than a decade of bipartisan efforts, the U.S. Congress passed the Cosmetic Regulatory Modernization Act of 2022 (MoCRA), which significantly expanded the FDA's regulatory authority over cosmetics and established a number of new compliance requirements for companies and related responsible persons selling cosmetics in the U.S. market.

MoCRA has granted the FDA new powers, including the authority to mandate recalls and access records. Entities responsible for these recalls are now required to report serious adverse events to the FDA and retain documentation demonstrating the safety of their cosmetics. The FDA has also been tasked with developing regulations regarding fragrance allergen labeling and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics.

MoCRA also mandates that cosmetic manufacturing and processing companies register their facilities, and the responsible entities must submit product filings for cosmetics already on the market to the FDA, including product ingredient information. Furthermore, the FDA is required to establish Good Manufacturing Practices (GMP) for cosmetic manufacturing and processing facilities. However, MoCRA offers exemptions for certain small businesses regarding facility registration, product filings, and GMP requirements.

Extensive achievements of MoCRA over the past three years

Over the past three years, the FDA has primarily relied on existing resources to continuously advance the implementation of MoCRA regulations, achieving several results, including:

• The FDA has issued multiple guidance documents on the registration of cosmetic manufacturing facilities and product filings, and developed tools to assist the industry in completing the relevant processes. As of March 2025, the FDA has begun regularly publishing aggregated data on the number of cosmetic facility registrations and product filings.

• Cosmetics Direct electronic submission portal is launched, while also offering an electronic submission gateway (ESG NextGen) and paper submission options.

• Update tools and applications to support companies in submitting mandatory reports of serious adverse events related to cosmetics.

• A draft guidance document was released to further clarify the FDA's authority regarding mandatory recalls and record-keeping for cosmetic products.

• Online hearings were held to engage with cosmetics manufacturers (including SMEs and contract manufacturers) and consumer organizations to support the development of GMP regulations.

New information has a positive impact on public health.

The new regulatory authority granted to the FDA by MoCRA has begun to have beneficial public health effects.

For example, prior to the implementation of MoCRA, the number of adverse event reports from the industry was very limited because reporting was voluntary. After implementation, the number of adverse events reported by companies to the FDA more than tripled. Furthermore, this data is now publicly available through the FDA Adverse Event Monitoring System, a unified, simplified, and user-friendly platform for viewing all adverse event reports submitted to the FDA. The FDA anticipates that this increased transparency will encourage consumers, healthcare professionals, and the public to submit more detailed and complete reports.

Furthermore, there are currently over 15,000 independent and active cosmetic manufacturing facilities registered, and over 1 million independent and active cosmetic product filings. Prior to the implementation of MoCRA, the FDA received only 5,176 business registrations and 35,102 product filings through its voluntary cosmetic registration program. Today, facility registrations have nearly tripled, and product filings have increased approximately thirtyfold, highlighting the size of the cosmetic market and illustrating the importance of mandatory registration and filing for effective regulation.

Facility registration allows the FDA to know who is manufacturing or processing cosmetics and where that manufacturing takes place, while product registration provides detailed information about cosmetics and their ingredients on the market. Together, these two are important resources for the FDA to effectively monitor the cosmetics market.

PFAS assessment and other regulatory developments

MoCRA also requires the FDA to assess the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics and the evidence for their safety, including potential risks. In December 2025, the FDA released a report evaluating the safety of the 25 most commonly used PFAS in the U.S. market. This PFAS information was derived from new mandatory product registration data. As of August 2024, cosmetics containing PFAS accounted for approximately 0.41% of all registered products.

Ongoing regulatory work under the FD&C Act and the Fair Packaging and Labelling Act

In addition to the MoCRA, the FDA continues to regulate cosmetics in accordance with existing regulations. For example:

• Final guidance has been released to help tattoo ink manufacturers and distributors identify potential microbial contamination of their products.

• In 2025, a consumer alert was issued, pointing out that some gel nail polish removers contain dichloromethane, an ingredient that is prohibited in cosmetics.

At the same time, the FDA's Office of Cosmetics and Colors also completed an organizational restructuring. In 2024, the office moved from the Center for Food Safety and Applied Nutrition to the Office of the Chief Scientist to better align with its core responsibilities.

The FDA will continue to release information on the safety of cosmetics and their ingredients, including product recalls and test results, through its official website and social media. The FDA will also continue to regularly update the public on its regulatory activities and the progress of the MoCRA implementation.