Drugs

30 Warning Letters to Telehealth Companies Over GLP-1 Marketing

FDA has issued 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on their Web sites. “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,” FDA commissioner Marty Makary is quoted in a release as saying. “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.”

Makary says the latest salvo of letters is part of FDA’s ongoing crackdown on misleading direct-to-consumer pharmaceutical advertising, launched 9/2025. Over the past six months, the agency says has sent thousands of letters to pharmaceutical and telehealth firms, surpassing the total number of such warnings issued in the previous decade.

The agency identified key violations in the latest letters, including:

Claims implying compounded GLP-1 products are equivalent to FDA-approved drugs
Advertising drug products under the telehealth company’s own brand or trademark without clarifying the source, giving the impression the company is the compounder

FDA emphasizes that compounded drugs are not FDA-approved, meaning their safety, effectiveness, and quality are not reviewed before marketing. Compounded drugs also differ from generic drugs, which do undergo FDA approval.

This latest action underscores the agency’s increasing scrutiny of telehealth and digital marketing practices as compounded drugs gain popularity among patients seeking treatments like GLP-1 receptor agonists for weight loss or diabetes management.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome