A recent article published by MedTech, “Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern,” quotes a Crowell client alert and Crowell attorney, Robbie Jost, on this development. According to the client alert, “To the extent the FDA considers the SNOO a medical device based on its intended impact on infant sleep position, many

On May 5, 2023, the U.S. Consumer Product Safety Commission (“CPSC”) announced that it agreed to a civil penalty settlement with Generac Power Systems, Inc., (“Generac”) to resolve charges that Generac failed to report immediately to the CPSC under Section 15(b) of the Consumer Product Safety Act (“CPSA”). Specifically, the CPSC alleged that certain models of Generac’s portable generators contained a defect that could create a substantial product hazard and unreasonable risk of serious injury to consumers. This settlement includes a $15,800,000 civil penalty, and requirements that Generac (1) implement and maintain a compliance program and system of internal controls and procedures designed to ensure compliance with the CPSA; and (2) file annual reports with the agency for the next three years regarding the Company’s compliance program, internal controls and procedures, internal audits of the effectiveness of the new compliance program and internal controls.Continue Reading CPSC and Company Reach Agreement on $15.8 Million Civil Penalty for Failure to Report

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.Continue Reading The FDA Appears to Expand Its Definition of a “Medical Device” to Include CPSC-Regulated Infant Sleep Products

Last Thursday, April 6, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) sued SunSetter Products LP (SunSetter) in a Massachusetts federal court in a rare civil penalty lawsuit. SunSetter manufactures motorized retractable awnings for outdoor use. The Government alleges in its complaint that SunSetter knowingly failed to timely report under Section 15(b) of the Consumer Product Safety Act (CPSA) a hazardous defect related to vinyl covers for its retractable awnings. The complaint seeks permanent injunctive relief, including a third-party monitorship over the company, and civil penalties.Continue Reading CPSC Seeks Civil Penalty Against SunSetter in Rare Federal Court Action

In December 2022, the U.S. District Court for the Eastern District of Michigan dismissed a putative class action against FCA US LLC on prudential mootness grounds because FCA announced a voluntary safety recall shortly after plaintiffs filed suit. Earlier this year, LG Energy Solution Michigan (“LG”) showed, yet again, how a voluntary recall can prove an effective defense to pending litigation.Continue Reading Recall Litigation Report: LG Energy Solution Michigan Reaps the Benefit of a Quick and Comprehensive Recall

After a pause in 2022, there has been much talk of the continuation, or resumption, of a wave of retail bankruptcy cases as we begin 2023.  2022 was highlighted by Revlon’s filing (discussed here: Revlon May Signal Another Wave of Retail Bankruptcies | Retail & Consumer Products Law Observer (retailconsumerproductslaw.com)).  Revlon pointed to a number of issues that led to its filing, including most prominently, supply chain issues. Severe impediments in the supply chain – whether the inability to source product or the costs and delays in received goods — have been cited by many debtors since Revlon since as a leading cause of their distress.  And it may get much worse before it gets better, particularly for companies that source, directly or indirectly, from China.Continue Reading Continued Pain in the Retail Sector:  Coming Enforcement of Forced Labor Laws

On Wednesday afternoon, CPSC Chairman Alexander Hoehn-Saric addressed the annual conference of the International Consumer Product Health and Safety Organization (ICPHSO) for the second time as chairman. In his remarks, Hoehn-Saric looked back on his first year as chairman, including the recent controversy over gas stoves, and shared some of the agency’s priorities moving forward. But the central theme of Hoehn-Saric’s remarks could not have been clearer— consumers are first in everything the agency does.  Continue Reading CPSC Chairman Addresses Gas Stoves and Other Issues at ICPHSO Conference

Key Takeaways

  1. In 2023, the Department of Energy is likely to increase enforcement of its energy and water conservation standards.
  2. The penalties associated with violating energy and water conservation standards can exceed $500 per violation and result in multi-million-dollar penalties.
  3. Manufacturers and importers of appliances and other consumer and industrial products can mitigate enforcement risk by refamiliarizing themselves with the energy and water efficiency regime and conducting internal compliance audits.

As the Biden Administration enters its third year, now with a party split in Congress, it seems likely that the Administration will redouble its focus on executive branch regulatory tools that can be used to achieve energy-related policy objectives, including with respect to energy efficiency and reducing carbon emissions. For manufacturers and importers of appliances and certain other consumer, lighting, plumbing and commercial and industrial products, that means the potential for additional scrutiny of their products’ compliance with the Department of Energy’s (DOE) conservation standards for energy and water efficiency. It also likely means a commensurate increase in DOE enforcement activity for non-compliance with the applicable efficiency standards or the associated test procedures required to demonstrate compliance, as well as registration and labeling requirements. Given the magnitude of the penalties associated with violating efficiency standards, currently $503 per violation, which can quickly run into multiple millions of dollars across noncompliant units, manufacturers and importers should consider refamiliarizing themselves with DOE’s conservation standards regime.Continue Reading Appliance Manufacturers and Importers Should Prepare for Increased DOE Enforcement Activity in 2023

The U.S. Supreme Court is poised to clarify the extraterritorial reach of the Lanham Act for the first time in seventy years.  The decision will impact corporations’ ability to seek damages for international trademark infringement, and may resolve a circuit split on the applicability of the Lanham Act on foreign defendants’ foreign conduct.  The Court will review the Tenth Circuit’s decision in Abitron Austria GmbH et al. v. Hetronic International Inc. (“Hetronic”) and the extraterritoriality of the Lanham Act, seemingly the Court’s desired outcome after requesting the United States weigh in on Abitron Austria GmbH’s (“Abitron”) certiorari petition filed in January 2022. Continue Reading U.S. Supreme Court to Decide the Extraterritorial Application of the Lanham Act

Companies take note: over the past month or so, the U.S. Consumer Product Safety Commission (CPSC) has issued four unilateral press releases instructing consumers to stop using a product. Since May of this year, that number rises to seven. If that number does not seem high, consider this: between 2011 and 2019—a nine-year period—the agency issued two. So, what exactly is a “unilateral press release” and what does the agency’s issuance of four over recent weeks mean for you?Continue Reading CPSC Enforcement Trend: Unilateral Press Releases