Insights on Longevity & Healthspan

The wellness and longevity industry is booming, and many brands are branching into supplements. The US Food and Drug Administration (FDA) and consumer class action lawyers judge your product the same way: What does it promise, and can you back that up? A lawsuit can arrive before the FDA ever does.

On September 18, the US Food and Drug Administration (FDA) issued a warning letter to Empower Pharmacy, a Houston-based compounding pharmacy that was producing GLP-1 weight-loss drugs (semaglutide and tirzepatide) at high volume.

In July 2025, the US Food and Drug Administration (FDA) issued a Warning Letter asserting that Whoop’s blood pressure estimation feature was a medical device requiring premarket clearance. In June 2026, the FDA issued a closeout letter resolving the matter.

The US Food and Drug Administration’s (FDA) enforcement machine does not take summer Fridays. On August 24, the agency’s Center for Drug Evaluation and Research (CDER) issued five Warning Letters to online peptide vendors.

Partner and Longevity & Healthspan Industry Group Co-Leader, Thorne Maginnis, will moderate the “Status, Wellness & the Evolving Consumer Economy” panel at Brand Forward, The Fashion Law’s annual conference, on September 17, 2026.

Longevity & Healthspan Industry Co-Leader Gayland Hethcoat was quoted in a segment airing on Germany’s national public radio about brain-computer interfaces (BCIs), an emerging technology for treating diseases and conditions with neurological causes.

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.

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 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.

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

Longevity & Healthspan Industry Group Co-Leader Gayland Hethcoat will moderate two panels exploring emerging trends in the preventative health and longevity spaces at the Alliance for Longevity Initiatives’ (A4LI) H-SPAN Summit in Washington, DC on June 29, 2026.

Partner James Westerlind was featured in a Q&A on the risk landscape for investors in the life settlement market.

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.

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.

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.

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.

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

The rapidly expanding consumer biomarker testing market — a major pillar of the longevity ecosystem — has produced its first major lawsuit between competitors.

ArentFox Schiff’s recently launched Longevity & Healthspan Industry Group and Group Leader Gayland O. Hethcoat II were featured by Longevity.Technology in an article about how the emergence of longevity-focused legal counsel is a maturity marker for the field.

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.