Insights on Food, Drug, Medical Device & Cosmetic

FDA Practice Leader and Agriculture & AgTech Industry Leader Karen Carr will present to the Plant Agriculture & Pesticide Regulations policy committee at the 2026 National Association of State Departments of Agriculture (NASDA) Winter Policy Conference on February 3, 2026.

The US Food and Drug Administration (FDA) issued an inspectional observation (Form FDA 483) to a Texas med spa, Pure Indulgence Aesthetics, citing Drug Supply Chain Security Act (DSCSA) violations for dispensers.

Last month, the US Food and Drug Administration (FDA) issued a draft guidance explaining how it intends to implement the mandatory recall authority established under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Last month, a federal court in Maine halted the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program in its tracks — a mere four days before it was to go into effect.

For the first time in 26 years, the US Food and Drug Administration (FDA) has proposed adding a new active ingredient to the list of permissible sunscreen actives in the United States.

On December 18, President Trump issued an executive order (EO) directing the Attorney General to complete rulemaking to reschedule “marijuana” from Schedule I to Schedule III under the Controlled Substances Act (CSA) and to expand federal research and policy development on medical marijuana and hemp derived cannabinoids.

Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.

Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care.

The US Food and Drug Administration (FDA) has withdrawn its proposed rule on standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics, almost exactly one year after publication.

A putative class action against Whoop, the wearable technology company, uses the US Food and Drug Administration’s (FDA) July 2025 warning letter regarding its new blood pressure product feature as a litigation springboard. The case shows how misalignment with regulators’ expectations can quickly cascade from agency scrutiny to consumer litigation.

The New Mexico Environment Department (NMED) recently proposed broadly applicable labeling requirements for all products (including consumer products) that contain intentionally added per- or polyfluoroalkyl substances (PFAS) — the first such requirements in the nation.

On November 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments for hospital outpatient services under the Hospital Outpatient Prospective Payment System (HOPPS).

After issuing the Physician Fee Schedule (PFS) on October 31, the Centers for Medicare & Medicaid Services (CMS) has now published templates for manufacturers to utilize when complying with new requirements regarding the submission of reasonable assumptions related to their average sales price (ASP) calculations. CMS also mandates that manufacturers submit Bona Fide Service Fee (BFSF) certification or warranty letters for new or renewal contracts dated January 1, 2026, or later that contain BFSFs with quarterly ASP.

US Congress tucked a big change into the latest government spending bill: a federal crackdown on intoxicating hemp-derived products.

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.