Insights

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.

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 one of the most significant developments in product safety law over the past decade, Gree Electric Appliances Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co. Ltd., and Gree USA Inc. (the “Gree Companies”), an appliance manufacturer and two of its subsidiaries, have pled guilty to willfully failing to report to the Consumer Product Safety Commission (CPSC) under Section 15(b) of the Consumer Product Safety Act (CPSA). According to the U.S. Department of Justice (DOJ) and the CPSC, the Gree Companies knew their dehumidifiers were defective, failed to meet applicable safety standards, and could catch fire, but failed to timely report that information to the CPSC. Section 19 of the CPSA makes it unlawful to fail to furnish information required by Section 15(b), and such failures are subject to both civil and criminal penalties. While CPSC civil penalties have become fairly routine—the Gree Companies also paid a then-record $15.45 million civil penalty in 2016—this is the first corporate criminal enforcement action brought under the CPSA, according to the DOJ. 

Could the end of Section 6(b) of the Consumer Product Safety Act (CPSA) actually be near?  Time will tell.  But last week’s development on Capitol Hill in the saga of “Section 6(b)” is noteworthy, and, one day in the not-so-distant future, may be recognized as the beginning of the end for this controversial provision of the law.   

The Biden Administration has promised an across-the-government effort to combat climate change, consistent with policy priorities during the Obama Administration. While much speculation has focused on a climate infrastructure package or a possible revamp of the Clean Power Plan, appliance manufacturers should be prepared for a less publicized but similarly significant change in direction from the current administration: increased enforcement under the U.S. Department of Energy’s (DOE) appliance standards program.

This week, the FAA delivered on its promise to the drone industry that it would release a final rule of both Remote Identification of Unmanned Aircraft Systems (Remote ID) and Operations Over People before we all put 2020 in the rear view mirror. The release of the final rules is a major milestone for the drone industry; once fully implemented, the rules will enable routine, complex unmanned aircraft system (UAS or drone) operations, such as operations beyond visual line of sight (BVLOS) and operations over people, and will lay the groundwork for an Unmanned Traffic Management System that will allow for full integration of drones into the National Airspace System.

On Monday, more than a dozen states and major environmental and consumer organizations issued notices of intent (available here and here) to sue the Department of Energy (DOE) for alleged violations of the Energy Policy and Conservation Act (EPCA).

On June 15, the National Highway Traffic Safety Administration (NHTSA) announced its new Automated Vehicle Transparency and Engagement for Safe Testing initiative (AV TEST), a new online log that will track the status of Autonomous Vehicles’ (AVs) public roadway efforts nationwide. Specifically, the log will track submissions of state and federal AV activity as well as AV developer testing activities.

The U.S. Department of Energy (DOE) issued a Request for Information (RFI) last week soliciting comments no later than June 3, 2020, on possible revisions to the energy efficiency regulations for battery chargers. Understanding how both the existing regulatory regime and any proposed changes will impact a company’s battery chargers and related products is an essential but often overlooked component of company compliance programs, and compliance failures can result in substantial civil penalties.

The COVID-19 epidemic has led to a critical shortage in respiratory protective devices. An amendment to the Secretary of Health and Human Services’ declaration under the Public Readiness and Emergency Preparedness (PREP) Act, published today in the Federal Register, may promote and expedite the production and use of such devices by allowing them to automatically be considered “Covered Countermeasures” for the purposes of PREP Act immunity.

On April 8, 2020, Massachusetts Governor Charlie Baker exercised his powers as an “Authority Having Jurisdiction” to issue a directive designating specific activities to which Public Readiness and Emergency Preparedness (“PREP”) Act immunity will apply in Massachusetts. The PREP Act provides expansive immunity from liability for claims of loss related to designated “Covered Countermeasures,” and was recently activated with respect to medical countermeasures against COVID-19 pursuant to a declaration issued by the Secretary of the Department of Health and Human Services.  However, certain restrictions apply, and there is little precedent to provide guidance as to how PREP Act immunity may attach in practice.

Everyone wants to help by providing necessary equipment to the COVID-19 frontline: hospitals, doctors, nurses, and other healthcare providers battling COVID-19 need ventilators, masks, gowns and other supplies.

With the rapid spread of COVID-19, federal, state and local governments have been scrambling to ensure that the country is equipped with adequate resources to help mitigate the spread of the virus and treat those who have fallen ill. The Public Readiness and Emergency Preparedness Act (PREP Act) was enacted in 2005 and serves as a means of incentivizing contributions of much-needed resources in such times of crisis. The PREP Act authorizes the Secretary of the Department of Health and Human Services to issue a Declaration immunizing individuals and entities from liability associated with the use of medical countermeasures. Specifically, “Covered Persons” cannot be held liable for any claim of loss “caused by, arising out of, relating to, or resulting from” the development, testing, manufacture, distribution, administration, or use of designated “Covered Countermeasures” within the Secretary’s specified period of emergency.

The U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) took its first leap toward removing unintentional regulatory roadblocks for autonomous vehicle (AV) developers. On March 17, NHTSA released a notice of proposed rulemaking (NPRM) to modernize numerous Federal Motor Vehicle Safety Standards (FMVSS), and clarify ambiguities in current occupant protection standards for vehicles equipped with automated driving systems (ADS) that are designed without traditional manual controls.

Notable for being its first IoT guidance published since the January 1, 2020, implementation of California’s law requiring all IoT devices to include “reasonable security features,” the National Institute of Standards and Technology (NIST) has updated its manufacturer-facing IoT cybersecurity guidelines, NISTIR 8259, Recommendations for IoT Device Manufacturers: Foundational Activities and Core Device Cybersecurity Capability Baseline. This second draft “contains the same main concepts” as the first but revises how these concepts are presented to “clarify the concepts and address other comments from the public.” The second draft describes “voluntary, recommended activities related to cybersecurity” that IoT device manufacturers can use to enhance the security profiles of IoT devices when they are ultimately deployed by consumers.

On October 28, 2019, the House and Senate circulated draft legislative text for three sections of an autonomous vehicle bill. The three address federal advisory committees, AV testing expansions, and exemptions to allow for vehicles with novel designs. House and Senate committee staff emphasize that this was only a first cut, indicating there would be more to follow.

The rapid growth of the Internet of Things (IoT) is creating new risks, vulnerabilities, and leadership opportunities for the private sector on a global scale. It is estimated 20 billion connected devices will be in operation by 2020 and IoT spending will total nearly $1.4 trillion by 2021.1 As IoT creates new, innovative opportunities for businesses worldwide, it also introduces new types of cybersecurity risks that will begin to evolve and grow. To continue the secure, innovative growth of the global IoT sector, the business community must find a sustainable solution that takes into account all connected IoT devices, the applications they run, and the networks they use to transmit information.

The United States Postal Service (USPS) announced last week that it will explore the use of Unmanned Aircraft Systems or “drones” to deliver mail and to collect data. Through a Request for Information (RFI) posted on FedBizOps, USPS is seeking input from interested drone operators and developers to inform a future solicitation for drone delivery and data collection services.

Last week, the University of Alaska, in partnership with Iris Automation, Skyfront, Echodyne, and Alyeska Pipeline Service Company, completed the first-ever beyond-visual-line-of sight (BVLOS) drone flight without a ground-based visual observer. This successful flight is a breakthrough in both regulatory and operational respects and could pave the way for expanded commercial drone operations in the United States for a variety of drone users, including the energy, agriculture, and insurance industries. The mission also illustrates the gathering momentum for complex BVLOS operations; the FAA’s approval for the University of Alaska comes just seven months after insurer State Farm became the first operator to receive FAA approval for nationwide BVLOS flights using a visual observer.

NIST has finalized Internet of Things (IoT) risk management guidance, which derived from a draft publication.  The guidance informs government agencies how to understand and manage IoT risks throughout device lifecycles.  Industry can anticipate government focus on three high-level goals: