Insights

Looking back at 2024, manufacturers were extremely busy navigating a high number of recalled products and corresponding litigation. A number of these 2024 litigation and class action trends appear to be carrying over into 2025.

Despite other sweeping changes to the federal government under the Trump administration, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed under former President Biden, remains good law. Below, we report on recent trends in FDA’s implementation and enforcement of MoCRA in the early months of Trump’s presidency.

For years, consumers have initiated legal actions against cosmetic companies alleging a causal relationship between the use of certain cosmetic products containing talc (such as baby powder) and the development of various cancers, commonly mesothelioma and ovarian cancer, with varied results. Below, we discuss a recent proposed rule from FDA proposing asbestos testing for cosmetics containing talc and potential impacts on ongoing and new consumer litigation.

On December 11, 2024, the Food and Drug Administration (FDA) released a final guidance concerning the Modernization of Cosmetics Regulation Act (“MoCRA”)’s facility registration and product listing submission requirements, which FDA began enforcing on July 1, 2024. This guidance includes key FDA recommendations and instructions, including the following:

On October 25, 2024, FDA issued final guidance to the tattoo industry on the preparation, packing and holding of tattoo inks aimed at preventing the risk of microbial contamination. FDA is getting involved because tattoo ink is considered a cosmetic product regulated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

On July 29, 2024, FDA announced that it added two new features to Cosmetics Direct, the electronic submission portal used for the facility registration and product listing requirements now in effect under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The portal now allows responsible persons to “discontinue” and “relist” cosmetic products.

A warning letter posted by the Food and Drug Administration (FDA) on June 18, 2024 offers a first glimpse into how FDA may enforce its new regulatory scheme for products that fall within the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)’s purview. While MoCRA was enacted in December 2022 and many of its provisions became enforceable on December 29, 2023, until now, many have wondered how FDA will exercise its new enforcement powers.

Talc is a mineral ingredient used in many cosmetic and personal care products, including baby powder, root touch-up products, and blush. Because both talc and asbestos are naturally occurring minerals that may be found in close proximity in underground deposits, there is risk for contamination of asbestos in talc-based products.

As we have previously discussed, in recent years, consumers have increasingly demanded “cleaner” beauty products and more transparency in product labeling. In addition to the FDA’s increased authority to regulate cosmetics under MoCRA, a number of states have now taken steps to regulate ingredients in cosmetics by limiting, and in some instances even banning, the use of certain ingredients that may be potentially harmful or toxic.

On January 8, 2024, the U.S. Food and Drug Administration (FDA) announced that SPL Xforms, a Structured Product Labeling authoring tool, is now available as an additional option for completing facility registration and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As a result, companies may submit their facility registration(s) and product listing(s) in one of four ways:

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.

On December 14, 2023, the FDA issued an update with further instructions on  serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable starting December 29, 2023.

Just over a month after the Food and Drug Administration (FDA) announced its intent to delay enforcement of facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Government Accountability Office (GAO) issued a report, “COSMETIC SAFETY: Better Planning Would Enhance FDA Efforts to Implement New Law,” with seven recommendations to strengthen FDA efforts to implement its new cosmetic oversight responsibilities.

On October 13, 2023 he FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. 

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.

In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration's authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA's provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.