The FDA has increased scrutiny of misleading advertising of compounded drug products. On March 3, 2026, the FDA announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. This latest enforcement action represents the second group of warning letters sent to telehealth companies since the agency heightened its focus on misleading direct-to-consumer pharmaceutical advertisements in September 2025. The FDA stated that over the past six months alone, thousands of warning letters have been sent to pharmaceutical and telehealth firms for the removal of misleading ads, more than had been sent over the entire preceding decade.
As FDA Commissioner Marty Makary, M.D., M.P.H., 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.”
Key Violations Triggering FDA Enforcement
The FDA has identified specific advertising practices that are drawing regulatory scrutiny. The primary violations cited in the recent warning letters include:
- Implying Compounded Drug Products are the same as FDA-approved products. In the warning letters, the FDA cited telehealth companies for making claims implying their compounded products were generic equivalents of branded products, or had been tested in clinical trials, when in reality compounded drug products are not FDA-approved, thus the FDA does not review their safety or effectiveness.
- Unclear Sourcing of Compounded Products. In multiple warning letters, the FDA took issue with advertising compounded drug products seemingly branded with the telehealth firm’s name or trademark, implying the telehealth company was the compounder. This practice misleads consumers about the actual source of the compounded medication and creates the false impression that the telehealth company itself prepared the compounded medication.
What the FDA Is Requiring
In response to these violations, the recipients of the warning letters are required to provide written responses explaining how they plan to address the cited violations and prevent future occurrences. Specifically, the FDA has requested that companies:
- Identify the entities that produced the compounded drug products
- Provide a representative sample of labeling for the compounded drug products
- Remove safety and efficacy claims about compounded drug products
- Address the basis for other website claims that could be construed as false or misleading and demonstrate that such claims have been modified or removed
Telehealth companies targeted in the warning letters have only 15 days to address the FDA’s concerns. If the FDA does not receive a timely response, the companies may face “legal action without further notice, including, without limitation, seizure and injunction.”
Beyond FDA Compliance: Avoiding the Unlicensed Practice of Pharmacy
As the FDA increases its scrutiny of telehealth websites, it is critical that these companies be more transparent about the arrangements they have with compounding pharmacies. This is not simply a matter of federal regulatory compliance, it implicates state Pharmacy Practice Acts as well.
When a telehealth company’s marketing materials suggest that the company itself compounded the medication, the company risks more than FDA enforcement. Such representations may create the impression that the telehealth company is engaging in the unlicensed practice of pharmacy. Specifically, telehealth companies may violate state Pharmacy Practice Acts by including images of the compounded drug product with their trademark. This practice may create the impression that the telehealth company prepared the compounded drug product or otherwise repackaged the medication prepared by a compounding pharmacy.
Telehealth companies and affiliated medical practices must carefully structure their relationships with compounding pharmacies to ensure clear separation between the administrative functions (performed by the telehealth company), the treatment and prescribing functions (performed by licensed healthcare providers), and the compounding and dispensing functions (performed by licensed pharmacies). Frequently, marketing materials and website content are not transparent as to this separation, and while there may be room for certain “bundling” in the context of services made available, content must not be false or misleading.
How Frier Levitt Can Help
While the FDA has selectively focused on certain areas of enforcement, its latest round of warning letters indicates its intent to continue to pursue misleading advertising and inappropriate compounding practices related to GLP-1 medications. Telehealth companies, medical practices, and pharmacies that fail to bring their advertising into compliance face both federal enforcement action and disciplinary actions by state licensing boards.
Contact us today to speak with an experienced healthcare attorney. Our team has extensive experience advising telehealth companies on compliance with federal and state laws, and the unique challenges that arise at the intersection of digital health and pharmaceutical regulation. Frier Levitt offers comprehensive compliance reviews to assess your website content and marketing materials in light of current FDA guidance and offers guidance and assistance to implement corrective measures to address deficiencies that may attract regulatory attention. Our attorneys can also assist with drafting patient consent and privacy policies to align with state and federal privacy rules.
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