Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more
The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
On March 31, 2025, the U.S. District Court for the Southern District of Texas vacated the FDA’s Final Rule on laboratory-developed tests (LDTs), holding that the agency lacks authority to regulate LDTs as medical devices...more
The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more
In a seminal opinion, the United States Supreme Court held that a case removed on federal question grounds is properly remanded when the plaintiff amends his or her complaint and dismisses the federal claims. What is the...more
Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more
The U.S. Court of Appeals for the First Circuit recently upheld multiple misdemeanor convictions for two former medical device company executives under the Food, Drug and Cosmetic Act (FDCA). While the former executives...more
BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more
On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing...more
MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more
In its first occasion to interpret § 353b of the Federal Food, Drug, and Cosmetic Act (FDCA), the US Court of Appeals for the Ninth Circuit relied on the “implied preemption doctrine” to affirm a district court’s case...more
A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues. In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court...more
The US Court of Appeals for the First Circuit affirmed-in-part and vacated-in-part a district court ruling dismissing claims under the Lanham Act and Massachusetts consumer protection law based on statements on a website...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
Federal law expressly authorizes manufacturers of dietary supplements to make “structure/function” claims—that is, claims about the effect of particular nutrients on the structure or function of the human body. (Think:...more
Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more
In 2011, Perkins Coie’s winning defense in Turek v. General Mills led to the first published federal appellate decision on the scope of the preemption defense under the Nutrition Labeling and Education Act (NLEA)....more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and settlements affecting the agribusiness, food, beverage, and cosmetics industry. This month, cannabidiol (CBD) suits continue to...more
A recent Eleventh Circuit decision took a broad view of what type of economic injury is sufficient to confer Article III standing, concluding that two dietary supplement companies’ alleged violations of a federal statute...more