Insights on Food, Drug, Medical Device & Cosmetic

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

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

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.

The National Environmental Policy Act (NEPA) is a federal statute that outlines how federal agencies must review the environmental impacts of their regulatory actions. The regulated community has often viewed NEPA as an obstacle to a broad range of federal actions in areas ranging from energy permitting to agriculture.

FDA Practice Group Leader Karen Carr was featured on The International Fresh Produce Association’s (IFPA) podcast, Fresh Takes on Tech, in its recent episode “Science and Policy: The Battle Shaping Ag Biotechnology.”

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease.

The Make America Healthy Again (MAHA) Commission, chaired by US Health and Human Services Secretary Robert F. Kennedy Jr., has released its long-anticipated report on childhood chronic disease drivers. Although the document is only an assessment and expressly contains no binding policy recommendations, it signals the contours of a federal strategy that officials will draft within 100 days.

On April 22, at the direction of US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., both the US Food and Drug Administration (FDA) and HHS published identical statements announcing the phase-out of so-called “petroleum-based” synthetic food dyes and their replacement with “natural alternatives.”

There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota.

Join Joy Marie Virga on a panel at the Food Policy Impact 2025 conference.

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

FDA Practice Leader and Agriculture & AgTech Industry Leader Karen Carr will participate in a panel titled “Navigating Regulatory Changes in Seed Treatment” at the 2025 CLA and RISE Regulatory Conference in Arlington, Virginia, on April 24.