U.S. manufacturers face a multitude of cybersecurity challenges that threaten their operations, reduce productivity, and jeopardize their intellectual property and data. For the past two years, the manufacturing sector has been the most targeted industry for ransomware attacks,1 with manufacturers spending an average of US$1.82 million per attack in 2023, not including any ransom payments.2 These cybersecurity challenges and risks are exacerbated by the simple reality that manufacturing operations often rely on various intertwined systems not designed with cybersecurity in mind. Retrofitt ..read more

Intellectual property protection is essential for emerging companies in the healthy food and beverage (“F&B”) space to attract investors and stand out from competitors. To gain a competitive edge, companies should understand and be intentional about building their intellectual property portfolio, which can include patents, trademarks, copyrights and trade secrets. A robust – or lackluster – IP portfolio can make or break an emerging company.  Trademarks A trademark is any word, phrase, symbol, or design that identifies the source of a product. Trademarks are typically used in the hea ..read more

On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (guidance). This guidance updates previous guidance issued during the COVID-19 pandemic and is meant to provide clarity on current enforcement policies now that the public health emergency is declared over. Limited Modifications to Indications or Functionality. In its guidance, FDA announced that the administration does not intend to object to limited modifications to the indications o ..read more

Happy Halloween! In honor of the holiday, we are taking our compliance message in a bit of a . . . spooky direction. But our message remains the same: International transactions are inherently high-risk; they require constant attention and oversight for your compliance to be effective; and it is always better to put your resources into compliance than to spend them on investigations. Speaking of Halloween, here are some interesting facts about Edgar Allan Poe: Poe ruined a promising start to an army career at West Point by spending his time writing mocking poems about his instructors rat ..read more

On September 20, 2023, the Consumer Product Safety Commission (CPSC) issued a Federal Register Notice and Request for Information1 asking for public comment about the use and presence of per- and polyfluoroalkyl substances (PFAS) in “consumer products” under its jurisdiction (the “Request for Information”). By issuing this Request for Information, CPSC has signaled its interest in joining the Environmental Protection Agency, U.S. Food and Drug Administration, and U.S. Department of Agriculture, along with several state and municipal jurisdictions, in studying and potentially regulating PF ..read more

Companies operating in the food and beverage industry are dealing with PFAS-related issues on a daily basis. So far, twelve states have passed legislation regulating PFAS, and each of those twelve states explicitly targets the food industry.1 On the federal level, the Environmental Protection Agency issued a final rule restricting the use of certain long-chain PFAS in food packaging. The same is true in PFAS litigation—the plaintiffs’ bar has asserted PFAS-based fraud and misrepresentation claims against a number of food and beverage manufacturers and packagers.  This is th ..read more

Sales of consumer products through online marketplaces have been commonplace for years and account for a significant portion of the total consumer products marketplace.  Sellers of industrial products such as replacement parts for industrial or heavy equipment are enthusiastically taking advantage of these online marketplaces to gain access to a huge population of potential industrial equipment consumers. A review of online marketplaces such as Amazon, Walmart, eBay, and AliExpress shows that these marketplaces are quickly becoming an increasingly popular market for the promotion and sale ..read more

On October 4, 2023, U.S. producers of aluminum extrusions filed antidumping duty (AD) and countervailing duty (CVD) petitions with the U.S. Department of Commerce (DOC) and the U.S. International Trade Commission (ITC), seeking to impose extra tariffs on imports of aluminum extrusions and products made from them. The number of countries involved is unusually large, with separate AD cases on: Colombia The Dominican Republic Ecuador India Indonesia Italy Malaysia Mexico China South Korea Taiwan Turkey The United Arab Emirates Vietnam In addition, the U.S. producers also are seeking the initiat ..read more

The United States Department of Justice (DOJ) actively enforces the Sherman Act within the U.S. and internationally. Generally described, the Sherman Act is a powerful statutory scheme designed to prohibit anti-competitive behavior, which applies both domestically and internationally. The DOJ’s ability to enforce the Sherman Act is constrained by a separate statute, the Foreign Trade Antitrust Improvements Act (FTAIA). The language of the FTAIA statute is complicated, so the focus of this article is on the Sherman Act’s application to conduct outside the U.S., recent FTAIA enforcement actions ..read more

In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence, the Internet of Things (IoT), blockchain, and the like, manufacturers continue to optimize production, increase efficiency, and drive innovation. However, this digital revolution brings with it complex cybersecurity risks and threats, creating significant implications for manufacturers. In this white paper, jointly authored by Foley & Lardner and the Cybersecurity Manuf ..read more