Insights

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.

The number of medical devices with wireless and network-connected capabilities continues to grow. At the same time, by some reports the number of ransomware attacks on health care facilities has more than doubled in recent years.[1] Recent cyberattacks and/or ransomware attacks on healthcare systems have resulted in stolen patient data, emergency room closures, diversion of ambulances, and cancellation of surgeries and other appointments. Given the potential disruptions in patient care in connection with these incidents, the cybersecurity of medical devices with wireless and network-connected capabilities becomes increasingly important to avoid and mitigate these possible impacts.

Artificial intelligence (AI) and machine learning (ML) have become ubiquitous across industries, and the pharmaceutical industry is no exception. AI and ML are already influencing drug development and manufacturing, but these innovations present unique regulatory challenges. For example, if a ML algorithm can change a CGMP-compliant manufacturing process on its own to increase efficiency, how does the drug manufacturer ensure that the updated, machine-created process is CGMP-compliant? If researchers use AI to identify ideal candidates to participate in a drug trial, how do they account for biases in the data underlying the AI’s decision-making? FDA recently released a discussion paper[1] requesting input from pharmaceutical industry stakeholders on how to tackle such issues. Stakeholders should seize this opportunity to provide input to FDA as the agency develops the applicable regulatory landscape.

Many medical device companies are accustomed to defending product liability litigation, and the applicability of product liability law to traditional medical devices is not usually questioned. But as an increasing number of medical devices are themselves software or include some software-based function – from clinical decision support tools to robotic surgery machines – an important question becomes: is medical device software a “product” within the meaning of product liability law? This threshold issue has the potential to be claim or even case dispositive for defendants facing allegations of defective device software.

On March 30, 2023, the FDA authorized marketing of Happiest Baby’s SNOO Smart Sleeper, an over-the-counter infant sleep system intended to keep infants on their back throughout sleep. This marks the first time we are aware of that the FDA has given de novo marketing authorization to a product designed to keep sleeping babies positioned on their backs,[1] and signals a potential expansion of what the FDA considers to be a “medical device” within its regulatory purview.

In Brown v. GlaxoSmithKline, LLC and Providence Health System – Oregon, 323 Or. App. 214 (Ct. App. Or. 2022), the Oregon Court of Appeals recently found that a hospital could be a “seller” of pharmaceutical drugs under Oregon law, subjecting it to strict products liability for alleged drug defects.  This decision contravenes—and thus threatens to upset—the overwhelming consensus among U.S. courts that hospitals are not strictly liable for allegedly defective drugs or medical devices used in the course of providing medical care to patients. 

On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The guidance clarifies the agency’s scope of oversight and regulation of clinical decision support software based on the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also describes the criteria used to assess whether software functions do not meet the definition of a device.

Cyberattacks have become an omnipresent threat in our society, affecting every industry. On Friday, July 2, the biggest ransomware attack on record hit thousands of victims in at least 17 countries, including at least 200 companies in the United States. Hackers demanded $70 million in cryptocurrency to provide a decryption key. This attack followed on the heels of two high-profile ransomware attacks on U.S. infrastructure: the May Colonial Pipeline attack and the June attack on JBS, the world’s largest meat processing company.

Counterfeit medical devices—medical devices that are falsely represented to be produced, packed, or distributed by another device manufacturer, packer, or distributer—are reportedly increasing in volume and sophistication. Recent reports of counterfeit diagnostic COVID-19 tests and N-95 masks demonstrate that the demands associated with the COVID-19 pandemic have only exacerbated supply chain vulnerability to counterfeit medical devices. In addition to putting patients at risk, counterfeit medical devices harm manufacturers and distributors of genuine devices in myriad ways: by damaging the reputation of the genuine devices, imposing costs to remove counterfeit product from market, and even posing potential product liability risks under certain circumstances.

On May 20, 2019, the U.S. Supreme Court announced that application of “impossibility” preemption to bar failure to warn claims against drug manufacturers presents a question of law to be decided by trial courts, not juries. While the Justice Breyer-authored decision resolved a decade of disagreement among the lower courts and settled the issue of whose decision governs (judge or jury), concurring opinions by Justices Thomas and Alito demonstrate that this decision raises even more challenging questions as to the scope and availability of impossibility preemption. These issues will be, for now, left to the lower courts to work out. Their resolution will likely determine the ongoing viability of this defense.

In this issue:

On March 9, 2017, the Fairness in Class Action Litigation Act of 2017 passed the House 220-201.  According to the Act itself, this aggressive legislation would sweepingly address “abuses in class action and mass tort litigation” with the intent of “ensuring Federal court consideration of interstate controversies of national importance consistent with diversity jurisdiction principles.” 

On March 21, 2016, a federal judge in the Northern District of Texas denied Michaels Stores, Inc. (Michaels) motion to dismiss an enforcement action brought by the U.S. Department of Justice (DOJ) on behalf of the U.S. Consumer Product Safety Commission (CPSC). The enforcement action seeks civil penalties and injunctive relief based on Michaels’ alleged failure to timely report hazardous glass vases that it imported and sold in its retail stores. U.S. v. Michaels Stores, Inc., No. 3:15-cv-01203, 2016 WL 1090666 (N.D. Tex. Mar. 21, 2016). The court’s short opinion rejected Michaels’ argument that the government’s action was time barred and agreed with the government that Michaels’ failure to report under Sec. 15(b) continued until it adequately informed the Commission. The court did not directly address the applicability of the discovery rule and Gabelli v. S.E.C., 133 S.Ct. 1216 (2013) to CPSC enforcement actions.