GLP-1s: Litigation, Enforcement, and Marketing Watchpoints

Previously on the blog, we focused on the regulatory and compliance risks surrounding compounded GLP‑1 products, particularly misbranding, quality concerns, and how quickly the enforcement landscape has evolved. Continuing this discussion, we broaden the lens to the developing litigation environment and additional regulatory scrutiny that can affect manufacturers, pharmacies, telehealth providers, and other stakeholders across the GLP‑1 ecosystem.

Refresher: Why GLP‑1s Remain a Legal Flashpoint

GLP‑1 receptor agonists continue to sit at the center of heavy public attention, evolving litigation, and increasingly assertive regulatory oversight. That combination has contributed to (1) expanding personal‑injury allegations against manufacturers, (2) ongoing scrutiny of compounded alternatives, and (3) increased attention to promotional practices, including direct‑to‑consumer advertising and influencer marketing.

Current Federal Litigation Landscape

There are two multidistrict litigation (MDL) proceedings centralized in the Eastern District of Pennsylvania for coordinated pretrial proceedings. Although still in their early stages, these MDLs may shape discovery expectations, warning-adequacy debates, and emerging injury theories across the industry. 

• MDL No. 3094 — Gastrointestinal (GI) Injury Allegations

MDL 3094 consolidates claims alleging that certain GLP‑1 receptor agonists (and related incretin therapies) caused or contributed to gastrointestinal injuries such as gastroparesis, ileus/intestinal obstruction, and gallbladder‑related events. The case is in coordinated pretrial proceedings, with core case‑management orders addressing issues such as preservation, protective orders, ESI protocols, and plaintiff fact sheets. Although the litigation is early, the court’s approach to general causation, warnings, and expert issues may influence future filings. 

• MDL No. 3163 — NAION (vision‑loss) Allegations

A separate proceeding, MDL 3163, addresses claims that GLP‑1 therapies caused non‑arteritic anterior ischemic optic neuropathy (NAION), a condition associated with sudden vision loss. The Judicial Panel on Multidistrict Litigation kept NAION claims separate from the GI‑injury MDL reflecting the different scientific questions and causation analyses.

Compounded Products and Supply‑Chain Enforcement

Our prior article described the legal boundaries for compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). Those frameworks remain central, particularly as the FDA repeatedly emphasizes that compounded drugs cannot be “essentially a copy” of an FDA‑approved drug outside narrow exceptions. 

In February 2026, the FDA publicly announced its intent to take action targeting mass-marketed, non-FDA-approved compounded GLP‑1 products, emphasizing that promotional claims implying equivalence to FDA‑approved drugs can trigger enforcement risk. 

In March 2026, the FDA announced it issued warning letters to 30 telehealth companies for false or misleading claims about compounded GLP‑1 products offered on their websites. The FDA identified concerns including claims implying “sameness” with FDA‑approved products and practices that obscure product sourcing, such as branding that could suggest the telehealth company is the compounder. The FDA also reiterated that compounded drugs are not FDA‑approved and are not the same as generic drugs.

Taken as a whole, practical watchpoints for compounded products may include: (1) avoiding “same as” or “equivalent to” messaging; (2) clearly disclosing product sourcing and the identity of the compounder; and (3) using careful language that does not imply FDA review or approval for compounded products. Similarly, supply‑chain risk indicators may include broad consumer‑facing sales without individualized prescriptions, weak cold‑chain controls for injectables, unclear sourcing of active ingredients, and labeling or advertising that overstates safety, efficacy, or “generic” status.

Promotional Practices and Advertising Scrutiny

In addition to product‑liability claims and compounding enforcement, promotional practices are a growing source of legal and regulatory exposure in the GLP‑1 space, especially as these therapies remain high‑visibility and are frequently marketed through telehealth, subscription programs, and direct‑to‑consumer channels. Regulators have emphasized familiar compliance fundamentals in this context: clear disclosures of total cost and material terms, substantiation for “typical results” claims, and truthful, non‑manipulated testimonials and reviews with appropriate disclosure of material connections. Enforcement activity in this area can affect not only manufacturers, but also platforms, marketers, and affiliated vendors involved in creating or disseminating promotional content.

• Federal Trade Commission (FTC) Enforcement: Pricing, Testimonials, and Subscription Practices

One recent example is the FTC’s NextMed action, which illustrates how telehealth weight‑loss programs tied to GLP‑1 access can draw scrutiny based on how programs are marketed, billed, and administered. The order addresses issues including cost representations, claims substantiation, review/testimonial integrity, and subscription cancellation and refund practices.

• FDA, Office of Prescription Drug Promotion Advertising Oversight

The FDA has also signaled ongoing attention to consumer‑facing promotion of GLP‑1 products. When advertisements suggest superiority or benefits that are not supported by evidence, or fail to present risk information appropriately, the FDA may take the position that the promotion is “false or misleading” underscoring the importance of balanced presentations and appropriate contextualization of safety information. 

• Digital Media and Influencer Marketing

Some academic commentary has raised interesting questions about short-form digital promotions—particularly celebrity- or influencer-driven content— including whether they consistently or adequately include risk information in ways that consumers can readily understand. Commentators also note that many high‑visibility mentions are informal rather than clearly sponsored endorsements, which can complicate how disclosure and risk‑communication expectations translate in practice on short‑form platforms. 

Given strong consumer interest in GLP‑1 therapies, companies using digital or social-media marketing may want to consider substantiation, balanced messaging, and clear disclosure of material connections.

Looking Ahead: Risk Management Takeaways for Insureds

For life‑science and healthcare stakeholders, the GLP‑1 landscape rewards disciplined compliance and documentation. A few practical steps that can help reduce risk include:

1. Strengthen promotional review controls (including influencer and social‑media content) and document substantiation for claims.
2. For subscription or membership programs, present total costs and key terms plainly (medication, labs, consults, cancellation, and recurring billing).
3. For compounding or distribution models, prioritize supply‑chain verification, cold‑chain integrity, and clear differentiation from FDA‑approved products.
4. Monitor MDL developments for emerging injury theories, pleading trends, and any court rulings that may influence warning, causation, or preemption arguments.

The GLP‑1 landscape remains dynamic, with active MDL proceedings and ongoing FDA and FTC scrutiny of compounding and promotional practices. Companies that invest in strong documentation, substantiation, and compliant marketing-review processes will be better positioned to respond as litigation theories and regulatory priorities develop.

This post is for general informational purposes only and is not intended as legal or other professional advice.

Authored by Amily Farraj, Berkley Life Sciences Legal Intern