McDermott Will & Schulte, a global law firm

On June 16, 2026, the US Food and Drug Administration (FDA) issued 25 warning letters to various telehealth companies alleging that their websites contained false or misleading claims about compounded semaglutide, tirzepatide, and, in one case, liraglutide products.

These warning letters follow a wave of similar FDA enforcement activity in late 2025 when the agency issued more than 40 warning letters to telehealth-based compounding pharmacies, targeting advertising claims that implied compounded glucagon-like peptide-1 (GLP-1) products were equivalent to their FDA-approved counterparts.

This set of warning letters marks a continuation of FDA’s growing crackdown on compounded drugs and related promotional practices. Each of the warning letters includes at least one of the three following alleged violations:

• The compounded products displayed on the company’s website identified the company on the pictured label, suggesting that the company was the compounder of drugs despite that not being the case.
• The company’s website contained a claim (or claims) representing that the compounded drug products it offers have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
• The company’s website included claims that the compounding pharmacy or outsourcing facility from which the company sources its compounded drug products is “FDA-approved” or “FDA-licensed,” implying a formal authorization that FDA does not grant to such entities or their compounded products.

According to the warning letters, these alleged violations cause the compounded drug products to be misbranded under Sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and their introduction into interstate commerce therefore constitutes a prohibited act under Section 301(a) of the FD&C Act. The warning letters conclude by outlining the steps companies should take to address the identified issues, including:

• Identify the entities that produce the compounded drug products offered on their website
• Provide a representative sample of labeling for such drug products
• Address other website claims that contain false or misleading representations about their compounded drug products or demonstrate that such claims have been modified or removed in light of FD&C Act Sections 502(a) and 502(bb).

Companies are expected to send a written response within 15 business days of receipt of the letter to the FDA’s Office of Compounding Quality and Compliance within the Center for Drug Evaluation and Research Office of Compliance at compoundinginspections@fda.hhs.gov.

We will continue to monitor FDA’s evolving enforcement approach to compounded drugs and associated promotional claims. If you have any questions about how these developments may affect your business, please contact the authors.