Insights on Food, Drug, Medical Device & Cosmetic

On October 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments under the Physician Fee Schedule (PFS), effective on or after January 1, 2026.

The US Food and Drug Administration (FDA) regulates the products hospitals and health systems use, make, or study. As health system innovations increasingly leap quickly across service lines, regulatory obligations can shift in real time.

ArentFox Schiff has been awarded 62 top rankings in the 2026 edition of Best Law Firms®, which recognizes firms for professional excellence based on consistently positive ratings from clients and peers.

Last week’s jury convictions of Safe Chain Solutions’ co-owners in United States v. Brosius, No. 1:24-cr-20255 (S.D. Fla.) coupled with US Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enforcement make one conclusion unavoidable: The DSCSA is both a regulatory mandate and a criminal risk boundary.

Food, Drug, Medical Device & Cosmetic Partner Emily Cowley Leongini and International Trade & Investment Associate Mario Torrico will speak at SupplySide Global 2025.

On October 13, California took a significant step toward consumer transparency with the enactment of SB 68, the Allergen Disclosure for Dining Experiences Act. This legislation makes California the first state to mandate large restaurant chains to disclose major food allergens on their menus. The law is set to take effect on July 1, 2026.

Rather than waiting for the “ultra-processed food” (UPF) definition promised by the federal government’s Make America Healthy Again (MAHA) Commission, the California legislature has forged ahead to produce its own definition and to apply it to the state’s school meals program.

Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements.

Last month, the US Food and Drug Administration (FDA) announced that it would begin daily publication of adverse event data for drugs and biologics via the FDA Adverse Event Reporting System (FAERS).

FDA Practice Leader and Agriculture & AgTech Industry Leader Karen Carr will participate in a panel at the 2025 CERSA Genome-Edited Microbial Workshop.

On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with foreign regulators, and virtual inspections, to evaluate drug manufacturing facilities identified in pending marketing applications.

On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and Development Authority (BARDA).

ArentFox Schiff is pleased to announce that 132 attorneys have been recognized by The Best Lawyers in America 2026, with two attorneys highlighted as “Lawyers of the Year” and 66 attorneys listed as “Ones to Watch.”

Last month, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced that they are requesting data and information to help develop a uniform definition of ultra-processed foods (UPFs) for human food products. On the heels of this announcement, a former FDA commissioner has filed a petition asking the FDA to ban popular ingredients in UPFs entirely.

On July 30, the US Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT), a new science-based tool designed to screen and evaluate the safety or toxicity of chemicals in food.

On August 6, the US Food and Drug Administration (FDA) issued an update regarding the use of per- and polyfluoroalkyl substances (PFAS), specifically fluoropolymers such as polytetrafluoroethylene (PTFE), in medical devices. The FDA concluded that, based on current scientific evidence, there is no reason to restrict the continued use of fluoropolymers in medical devices.

The Trump Administration is moving aggressively to prevent foreign adversaries’ ownership of US agricultural land.

Food, Drug, Medical Device & Cosmetic Counsel Abha Kundi will deliver the opening presentation of the Healthcare Distribution Alliance’s (HDA) 2025 Traceability Seminar on August 5, 2025.

On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”

Partner Emily Cowley Leongini was quoted on Sarepta Therapeutics’ decision to pause sales of its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) following a request from the US Food and Drug Administration (FDA).

As artificial intelligence (AI) becomes increasingly embedded in health care, from diagnostics and clinical decision support to administrative automation, health care providers are increasingly reliant on AI vendors to deliver accurate, safe, and compliant solutions, subject to applicable regulatory requirements and standards of care.

Food, Drug, Medical Device & Cosmetic Partner Emily Cowley Leongini will give a presentation titled “Inspections: What to Do if the Government Shows Up at Your Door” at the American Conference Institute’s Food Law and Regulation Boot Camp on July 23.

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”

On June 18, the US Food and Drug Administration (FDA) released for public comment a proposed method for ranking chemicals present in the food supply to determine which should be prioritized for post-market safety assessments.

ArentFox Schiff is pleased to announce that Abha Kundi has joined the firm as Counsel in the Food, Drug, Medical Device & Cosmetic practice in Washington, DC.