As federal regulators intensify scrutiny of compounded GLP-1 drugs and telehealth marketing practices, two developments in early March 2026 signal a turning point for the industry: a wave of FDA enforcement actions and a high-profile resolution between Hims & Hers Health and Novo Nordisk.
On March 3, 2026, the U.S. Food and Drug Administration (FDA or the “Agency”) publicly released a new batch of thirty Warning Letters directed at telehealth companies and online wellness clinics accused of making false or misleading claims about compounded versions of popular glucagon-like peptide-1 (GLP-1) receptor agonist medications. . Just days later, Novo Nordisk and Hims & Hers Health announced a partnership under which Hims & Hers will offer Novo Nordisk’s branded GLP-1 medications while ceasing most advertising and marketing of compounded alternatives.
Together, these developments signal the FDA’s most aggressive enforcement posture to date in this rapidly evolving area and carry significant implications for telehealth platforms, compounding pharmacies, and companies marketing GLP-1 therapies.
Background: The Rise and Regulation of Compounded GLP-1 Drugs
To appreciate the significance of the FDA’s latest action, some context is necessary. GLP-1 receptor agonists—most notably semaglutide (marketed by Novo Nordisk as Ozempic® and Wegovy®) and tirzepatide (marketed by Eli Lilly as Mounjaro® and Zepbound®)—have experienced extraordinary demand as treatments for type 2 diabetes and obesity. That demand has, at various times, outstripped supply. In 2022, the FDA placed tirzepatide on the national drug-shortage list, which under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) authorized compounding pharmacies to produce the medication to help meet patient needs.
Compounding, the practice of preparing customized medications tailored to an individual patient’s needs, serves a legitimate role in the pharmaceutical ecosystem. However, compounded drugs are not FDA-approved and have not undergone the rigorous clinical testing required for approval. They are intended to address specific gaps, such as meeting individual patient requirements or providing access during a verified drug shortage.
In late 2024, the FDA lifted the shortage designation for tirzepatide and directed compounders to cease production. Semaglutide had previously come off the shortage list as well. Despite these determinations, numerous telehealth platforms and online pharmacies continued to market and sell compounded versions of these drugs (often at a fraction of the branded products’ cost) using advertising that, in the FDA’s view, crossed into misleading territory.
The Warning Letters: Specific Allegations
The thirty Warning Letters which were sent on February 20, 2026 and made public on March 3, were signed by Matthew J. Lash, Acting Director of the Office of Compounding Quality and Compliance within the Center for Drug Evaluation and Research (CDER). They allege violations of FDCA Sections 502(a) and 502(bb) (codified at 21 U.S.C. §§ 352(a) and (bb)), which prohibit false or misleading labeling and advertising of drug products.
According to the FDA, the targeted companies engaged in several categories of problematic conduct. Many implied that their compounded products were equivalent to, or interchangeable with, FDA-approved branded medications (for example, suggesting that compounded GLP-1 drugs contained “the same ingredients” as branded products or had been “tested in clinical trials”). The Agency views such statements as materially misleading because compounded products have not been independently evaluated for safety and efficacy. The FDA also found that some companies obscured the compounded nature of their products or failed to adequately disclose the source of the compounded drug.
The letters require each recipient to respond within fifteen working days to CDER’s Office of Compliance, detailing corrective steps taken, including identifying compounding sources, providing product labeling samples, and removing misleading website claims. Recipients that fail to respond face the threat of further enforcement action “without further notice, including, without limitation, seizure and injunction.”
The Hims & Hers Episode: A Catalyst for the Crackdown
The latest round of Warning Letters did not emerge in a vacuum. They follow a high-profile confrontation between the FDA and Hims & Hers Health, Inc. (“Hims & Hers”), one of the most visible direct-to-consumer telehealth platforms in the United States.
In early 2026, Hims & Hers announced its intention to market a compounded version of Novo Nordisk’s oral semaglutide product. FDA Commissioner Marty Makary, M.D., publicly pledged to take “swift action” against companies that mass-market what he characterized as “illegal copycat drugs.” While Hims & Hers ultimately retreated from its plans in the face of mounting legal pressure, the episode served as a watershed moment, putting the industry on notice that the FDA intended to draw a firm line between legitimate compounding and unauthorized mass-market drug distribution.
In a significant turn of events, however, Novo Nordisk and Hims & Hers announced on March 9, 2026, that they had resolved their dispute and entered into a new partnership. Under the agreement, Hims & Hers will offer Novo Nordisk’s branded semaglutide products (Ozempic and Wegovy) on its telehealth platform, while ceasing its advertising and marketing of compounded GLP-1 drugs except where medically necessary. Novo Nordisk dismissed its patent infringement lawsuit against Hims & Hers, though it has reserved the right to refile. FDA Commissioner Makary publicly endorsed the deal, and the resolution may serve as a template for how other telehealth companies navigate the evolving regulatory landscape.
Commissioner Makary’s public comments surrounding the FDA’s recent enforcement actions reflect the broader regulatory posture that likely helped drive this outcome. In announcing the March 3 release of the Warning Letters, Makary stated, “It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action. Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”
Viewed in this context, the Hims & Hers–Novo Nordisk partnership may illustrate how telehealth companies are beginning to adapt to this more aggressive enforcement environment, shifting away from widespread marketing of compounded GLP-1 products and toward collaboration with branded manufacturers.
Escalating Enforcement: A Pattern of Increasing Pressure
The Warning Letters are the latest step in a progressively intensifying enforcement campaign. In September 2025, the FDA sent approximately 100 cease-and-desist letters targeting deceptive direct-to-consumer advertising for compounded drugs. The Agency has also signaled its intent to scrutinize the broader landscape of direct-to-consumer pharmaceutical advertising, including commercials that may overstate benefits or obscure material information.
Taken together, these actions suggest a deliberate regulatory strategy: the FDA is building a record of escalating warnings before resorting to more consequential enforcement mechanisms. Companies that received cease-and-desist letters in September and have not adequately responded now face Warning Letters with explicit threats of seizure and injunction. This stepwise approach is characteristic of FDA enforcement practice, and companies would be well-advised to treat these letters as genuine precursors to litigation.
Industry Response and First Amendment Considerations
Not everyone in the industry views the FDA’s approach as unambiguously sound. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, expressed that he was “puzzled” by Commissioner Makary’s framing, particularly the suggestion that the scale of compounders’ marketing, rather than its truthfulness, was part of the problem. While acknowledging that enforcement against genuinely false or misleading marketing is within the FDA’s authority, Brunner cautioned that the Supreme Court has made clear that “lawful pharmacies cannot be broadly prohibited from communicating truthful information about their services.”
Brunner’s point raises a real and unresolved tension. Commercial speech enjoys First Amendment protection, and the Supreme Court’s decision in Thompson v. Western States Medical Center, 535 U.S. 357 (2002) has imposed meaningful limits on the government’s ability to restrict advertising by compounding pharmacies. Where legitimate informational advertising ends and misleading promotion begins will likely be tested further as this enforcement campaign progresses.
Practical Implications for Telehealth and Compounding Companies
For companies in the telehealth and compounding space, the immediate takeaways are consequential. Any company currently marketing compounded GLP-1 products should conduct an immediate review of all advertising and promotional materials (including website content, social media, and direct-to-consumer communications) to ensure that no claims imply FDA approval, equivalency with branded products, or clinical validation that does not exist. Companies should clearly disclose that their products are compounded, not FDA-approved, and have not been evaluated by the FDA for safety, efficacy, or quality.
Companies that received Warning Letters should respond promptly and substantively within the fifteen-day window, as a failure to do so materially increases the risk of injunctive action or product seizure. Engagement of experienced FDA regulatory counsel at this stage is not merely advisable, it is essential.
More broadly, the FDA’s actions send a clear signal that the regulatory environment for compounded drugs, particularly high-demand products like GLP-1 receptor agonists, has fundamentally shifted. The era in which compounders could market these products with aggressive, consumer-facing advertising and minimal regulatory scrutiny appears to be closing. Companies that fail to adapt to this new reality do so at considerable legal and commercial risk.
Conclusion
The FDA’s issuance of thirty Warning Letters targeting telehealth companies marketing compounded GLP-1 drugs marks a significant escalation in the Agency’s enforcement posture. Coming on the heels of the Hims & Hers confrontation and the September 2025 cease-and-desist campaign, these letters establish a clear trajectory: the FDA intends to use the full range of its enforcement authority to curtail what it views as misleading marketing of compounded drugs that circumvent the approval process. Notably, the subsequent settlement between Novo Nordisk and Hims & Hers (under which Hims & Hers will sell branded FDA-approved semaglutide products while ceasing its advertising of compounded alternatives) suggests that at least some market participants are already adapting to this new reality.
Whether this partnership model becomes a broader industry template remains to be seen, but it signals that the path forward for telehealth companies in the GLP-1 space will increasingly run through collaboration with branded manufacturers rather than competition via compounded alternatives. Companies operating in this space should take these developments seriously, review their compliance programs immediately, and prepare for a regulatory landscape that will only become more demanding in the months ahead.
How Frier Levitt Can Help
The attorneys at Frier Levitt represent compounding pharmacies, telehealth companies and other FDA-regulated companies in developing corrective and preventive action (CAPA) plans and responding effectively to Warning Letters. Our attorneys also assist with compliance strategy, label compliance, product classification, enforcement risk assessment, and engagement with the FDA, the FTC and state regulators. Companies facing regulatory scrutiny or evaluating their compliance posture should contact Frier Levitt to discuss strategies for mitigating risk and responding to government inquiries.
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