Insights on Food, Drug, Medical Device & Cosmetic

ArentFox Schiff’s Gayland Hethcoat on navigating the line between wellness and medical devices in the longevity era.

On April 29, the US Food and Drug Administration (FDA) published a Request for Information (RFI) seeking public comment on a proposed pilot program to test the use of artificial intelligence (AI) in early-stage clinical trials for drugs and biologics. Comments are due June 29.

Until recently, no state or federal law specifically governed ownership or rights in agricultural and livestock data. If ownership allocations were addressed at all, it was by contract.

Food, Drug, Medical Device & Cosmetic Counsel and Longevity & Healthspan Industry Group Co-Leader Abha Kundi will participate in a panel discussion examining the Drug Supply Chain Security Act (DSCSA) on May 21, 2026.

Last year, we reported that Nebraska senators introduced the Agriculture Data Privacy Act (LB525), a first-of-its-kind privacy bill specifically aimed at regulating agricultural-sector data.

Mail and telemedicine access to mifepristone — used together with misoprostol to end an early pregnancy — is in flux following a Fifth Circuit Court of Appeals ruling that restricts mail-order distribution of the medication nationwide, and the US Supreme Court’s subsequent administrative stay restoring the status quo ante on a temporary basis.

On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP-1 receptor agonists by 503B outsourcing facilities.

On April 23, Acting Attorney General Todd Blanche announced a final order reclassifying US Food and Drug Administration (FDA)-approved drug products containing “marijuana” and cannabis products regulated under qualifying state-issued medical marijuana licenses from Schedule I to Schedule III of the Controlled Substances Act (CSA), effective April 28. Critically, adult-use (recreational) cannabis remains in Schedule I.

Everyone is talking about peptides. Your doctor, your trainer, that guy at the dinner party who swears that BPC-157 rebuilt his knee — peptides have officially entered the zeitgeist. But for every breathless testimonial, there is a thicket of regulations that most market participants barely understand.

On April 18, President Trump signed an executive order (EO) directing multiple federal agencies to accelerate research and expand access to psychedelic drugs as potential treatments for serious mental health conditions. The EO represents a notable shift in federal policy toward psychedelic substances and their potential therapeutic use.

The US Food and Drug Administration (FDA) has now escalated its Drug Supply Chain Security Act (DSCSA) findings at Pure Indulgence Aesthetics from a Form FDA 483 (given to the company at the close of a December 2025 inspection) to a formal Warning Letter, issued on April 1.

Forget science fiction — the race to wire computers directly into the human brain is well underway, and it is moving fast.

ArentFox Schiff, in collaboration with Consilio, will host the 2026 Chicago Pharma Forum on May 6, 2026, bringing together pharmaceutical industry leaders and in‑house counsel in the Chicago area for a full day of discussion and networking.

As we continue to move through 2026, the life sciences landscape is shaped by a convergence of regulatory, enforcement, and market access developments that demand heightened attention from industry stakeholders.

The US Food and Drug Administration (FDA) issued a final rule on March 5 that will change National Drug Codes (NDCs) from several different 10‑digit formats to one standard 12‑digit format.

On February 19, the US Food and Drug Administration (FDA) announced a significant shift in its drug approval framework: A single adequate and well-controlled clinical trial, combined with confirmatory evidence, will now serve as the default standard for marketing authorization of new drugs.

As the beverage and food industry enters 2026, companies face a rapidly changing legal environment shaped by an expanding litigation landscape, evolving regulatory frameworks, and renewed transactional activity.

The Centers for Medicare & Medicaid Services (CMS) has released detailed payment amounts, performance targets, and reporting requirements for the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, applicable to care periods beginning July 5 through December 31, 2027.

On February 5, the US Food and Drug Administration (FDA) announced it will now allow food companies to use “no artificial colors” claims when foods do not contain any food, drug, and cosmetic (FD&C)-certified synthetic colors, shifting away from the historical view that such claims were only appropriate where no color was added at all.

The longevity ecosystem sits at the crossroads of health care, life sciences, consumer wellness, artificial intelligence (AI), and other emerging technologies.

FDA Counsel Emily Cowley Leongini will discuss FDA’s recent decision to withdraw a proposed rule that would have required standardized testing for asbestos in talc-containing cosmetics as part of the American Conference Institute’s FDA Regulatory Update Series for Cosmetics & Personal Care Products on February 9, 2026.

The US Food and Drug Administration (FDA) has approved a Phase 1 clinical trial from Life Biosciences that aims to help certain eye cells act younger and improve vision in glaucoma and related conditions.

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.

Per- and polyfluoroalkyl substances (PFAS) are used as intentionally added ingredients in some cosmetic formulations, primarily on account of their water- and oil-resistance and long-lasting properties, for conditioning and smoothing the skin and hair, or for modifying product consistency and texture.

On January 21, the US Food and Drug Administration (FDA) issued a draft guidance clarifying the agency’s authority to access and copy records related to cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Cosmetic companies should take care to ensure that their recordkeeping policies and procedures comply with these requirements.