Insights on Food, Drug, Medical Device & Cosmetic

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.

ArentFox Schiff is pleased to announce the additions of Partner Nichole D. Shustack, Counsel Michael Rudy, Senior Associate Isabelle R. Cunningham, and Director Helen C. Plunkett to its Food, Drug, Medical Device & Cosmetic Practice with a focus on the alcohol beverage industry. Nichole and Helen join in Washington, DC, with Michael and Isabelle joining in Boston and New York, respectively. Nichole and Isabelle are both recognized in Chambers USA 2025 and join ArentFox Schiff from a Chambers‑ranked team.

ArentFox Schiff is pleased to announce the launch of its Longevity & Healthspan Industry Group, a cross-sector initiative supporting the rapidly expanding ecosystem of companies advancing anti-aging innovation, wellness, and preventive health.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) just issued a joint statement outlining 10 “Guiding Principles” for using artificial intelligence (AI) in drug development.

With 2026 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.

On January 6, the US Food and Drug Administration (FDA) released two significant updates potentially important for companies operating in the consumer health technology space.

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.