Insights on Food, Drug, Medical Device & Cosmetic

On June 17, the US Food and Drug Administration (FDA) formally denied a citizen petition requesting that the agency establish temporary tolerance levels and action levels for per- and polyfluoroalkyl substances (PFAS) in certain foods.

“Whether ‘tis nobler to deviate from the RLD and rely on established data, or take arms against a sea of troubles with a bioequivalent product that conforms to the sameness requirement — that is the question.” That might have been Shakespeare’s opening to Hamlet, had the Bard traded quills for regulatory submissions and Denmark for the District of Delaware or New Jersey.

ArentFox Schiff is pleased to announce that 125 attorneys have been recognized by The Best Lawyers in America 2027, with two attorneys highlighted as “Lawyers of the Year” and 36 attorneys listed as “Ones to Watch.”

Longevity & Healthspan Industry Co-Leader Abha Kundi, a former US Food and Drug Association (FDA) regulator, was quoted on the complexities surrounding an FDA advisory committee recommending six peptides to be added to the Section 503A Bulks List.

On August 6, the US Food and Drug Administration (FDA) announced it is extending an existing Drug Supply Chain Security Act (DSCSA) exemption for small dispensers until November 27, 2027, as the FDA begins its small dispenser assessment.

At the midpoint of 2026, the agriculture industry is navigating a complex and ever-changing legal landscape shaped by the evolution of artificial intelligence (AI), trade and capital-market uncertainty, regulatory reform, and other policy issues.

Longevity & Healthspan Industry Co-Leader Abha Kundi, a former US Food and Drug Association (FDA) regulatory counsel, was quoted on a recent vote from an FDA advisory committee that recommended six (out of seven) peptide substances for lawful compounding.

On June 17, the Council of the European Union (EU) and the European Parliament formally adopted the long-debated regulation for plants developed using certain new genomic techniques (NGTs).

On July 14, the US Food and Drug Administration (FDA) announced final guidance regarding clinical investigations of psychedelic drugs.

The Pharmacy Compounding Advisory Committee (PCAC) is a 14-member US Food and Drug Administration (FDA) advisory panel of pharmacists, physicians, and other experts. It reviews the scientific and safety record for bulk drug substances nominated for compounding and votes on non-binding recommendations to the FDA.

On July 13, the US Food and Drug Administration (FDA) proposed a new rule that would fundamentally change how certain drug manufacturers register their facilities and list their products with the agency.

Peptides remain one of the hottest topics in the drug industry, and many therapeutic peptides offered for sale today have been compounded.

On June 10, the US Food and Drug Administration (FDA) issued a final administrative order adding bemotrizinol to the list of permissible sunscreen active ingredients in the United States – the first new sunscreen active added in 26 years.

On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”

On June 8, the California State Senate adopted Senate Resolution (SR) 104, a measure expressing support for targeting the biological mechanisms of aging as a strategy to prevent and delay chronic disease.

On June 3, the US Food and Drug Administration (FDA) released a revised draft guidance on what drug and device manufacturers can say to health insurers, pharmacy benefit managers (PBMs), formulary committees, and similar organizations about their products.

On June 4, the US Supreme Court issued a unanimous decision authored by Justice Ketanji Brown Jackson in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24–889, delivering a significant win for generic pharmaceutical manufacturers seeking US Food and Drug Administration (FDA) approval for drugs with multiple indications.

Forget science fiction — the race to connect computers directly to the human brain is already underway, and it is accelerating. In recent months, neurotechnology companies have expanded human clinical trials and attracted substantial investment.

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.