Insights

Washington – August 17, 2023: The 2024 edition of The Best Lawyers in America® has recognized 47 firm lawyers as "Best Lawyers" and 41 lawyers as “Ones to Watch.”

Washington – June 1, 2023: Crowell & Moring earned 82 rankings for 68 lawyers across 48 categories, as well as 37 national and statewide practice area rankings, in the Chambers USA 2023 guide. The rankings are driven by independent interviews of clients and lawyers at peer firms.

Washington – August 18, 2022: The 2023 edition of The Best Lawyers in America® has recognized 54 firm lawyers as "Best Lawyers" and 32 lawyers as “Ones to Watch.”

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. 

A failure to meet safety compliance and regulatory obligations can undo the herculean efforts to surmount supply chain challenges and get products into the US. Our Products Liability and Regulatory Compliance lawyers will discuss the impacts of current efforts by regulators to police product safety at the ports, the expectations of federal safety regulators at the ports and how to use compliance documentation to speed the process when products have been stopped for inspection. Our discussion will cover activities at CPSC, NHTSA, EPA and FDA. The panel will also discuss the challenge of counterfeit products and parts and how safety can be a lever to stop counterfeits. Given the increased costs of shipping, downstream recovery opportunities may help alleviate some of the monetary pressures and our panel will discuss these opportunities as well as the contract clauses that can allocate risks appropriately when things do go wrong.

The regulation of connected devices is an ongoing process at the federal and state level, and manufacturers have to contend with a variety of stringent regulations. For example, California’s IoT cybersecurity law went into effect at the beginning of 2020 and requires the manufacturer of a connected device include “a reasonable security feature or features that are…[d]esigned to protect the device and any information contained therein from unauthorized access, destruction, use, modification, or disclosure.” A number of other states, including Illinois, Maryland, Massachusetts, New York, and Oregon, have passed, or are considering similar laws. The federal government is also very interested in this area, and multiple U.S. federal agencies have authority over different aspects of IoT devices.