Highlights
- The U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) have announced a broad initiative to "rein in misleading direct-to-consumer pharmaceutical advertisements."
- Notably, in addition to drug companies, the FDA issued warning letters to telehealth providers and companies, including several glucagon-like peptide-1 (GLP-1) telehealth providers.
The U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) on Sept. 9, 2025, announced a broad initiative to "rein in misleading direct-to-consumer pharmaceutical advertisements." In its press release, the FDA said it was "sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads."
The FDA published these letters on its Warning Letter database last week. Notably, in addition to drug companies, the FDA issued warning letters to telehealth providers and companies, including several glucagon-like peptide-1 (GLP-1) telehealth providers. The FDA claimed that due to what it deems misleading advertisements, these products are misbranded and, therefore, cannot be lawfully introduced into the U.S. market. Some of the GLP-1-related claims that the FDA specifically flagged as concerning were:
- "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy"
- "Clinically proven ingredients"
- "Semaglutide (the same ingredient in Wegovy & Ozempic)"
- "Tirzepatide (the same ingredient in Zepbound & Mounjaro)"
- "SEMAGLUTIDE (GENERIC OZEMPIC/WEGOVY)"
- "TIRZEPATIDE (GENERIC MOUNJARO)"
- "Is Semaglutide the same as Wegovy and Ozempic? Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective ..."
- "Your healthcare provider will help you find the right dose of GLP-1 Medication including Semaglutide (same active ingredient as Wegovy, and Ozempic), to achieve healthy weight loss."
- "Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective for members whose insurance deny coverage of brand name medication like Wegovy or who are uninsured."
The telehealth industry saw and participated in the emergence and drastic growth of the GLP-1 marketplace while Semaglutide and Tirzepatide were on the FDA's drug shortage list. While Semaglutide and Tirzepatide were in shortage, compounding pharmacies operating under the authority of Section 503A or 503B of the Food, Drug, and Cosmetic Act were permitted to compound the active ingredients with fewer regulatory constraints. As a result, the burden associated with patient access and market entry was significantly reduced.
Takeaways and Considerations
Semaglutide and Tirzepatide are now off the drug shortage list, and the standard 503A and 503B pharmacy rules apply. At this time, 503A pharmacies are the only entities that can compound Semaglutide and Tirzepatide and, when doing so, must ensure the drugs are compounded with valid patient-specific prescriptions and that they comply with other legal and regulatory requirements.
Significantly, the FDA's issuance of these warning letters is the first time we have seen FDA regulators specifically call out telehealth providers and the advertising associated with compounded products, signaling that future enforcement actions against telehealth providers is likely and, as a result, telehealth providers should closely evaluate their compliance with FDA requirements and other applicable laws.
Specifically, telehealth companies and providers, even those outside of the GLP-1 space, should ensure their marketing materials, websites and statements about the products and services offered are truthful, not misleading and can be substantiated. Though the FDA's misbranding laws and regulations traditionally fell within a gray area when applied to compound pharmacies, this latest action appears to show the FDA's intent to enforce the rigorous advertising and marketing standards that apply to pharmaceutical manufacturers. These entities should also understand and appreciate the broader risks for compounding these drugs, including the applicability of state practice of medicine and pharmacy laws, including corporate practice of medicine, scope of practice, freedom of choice of pharmacy, and prescriptive authority requirements and restrictions.
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