The U.S. Food and Drug Administration has issued warning letters to 25 telehealth companies for marketing false and misleading claims about compounded versions of Eli Lilly and Novo Nordisk's hugely popular weight-loss and diabetes drugs. The letters, posted on the health regulator's website on Tuesday, were sent to companies including Medica Weight Loss, Ready Med, Roen Health Inc., Maximus Health Inc., Clover Meds, and Altru Telehealth among others earlier this month.
The health regulator previously sent a series of warning letters to telehealth firms as part of its broader crackdown on compounded drugs. This latest wave marks the third major set of warning letters in less than a year, following approximately 80 warning letters and 40 untitled letters in September 2025, and 30 warning letters in March 2026.
False and Misleading Claims
Some telehealth companies claimed on their websites that their compounded versions of Lilly's tirzepatide and Novo's semaglutide were sourced from FDA-approved pharmacies or that the ingredients were clinically studied, the regulator said in the letters. For others, the agency noted that representations made by the telehealth firms regarding compounded semaglutide and tirzepatide products are false or misleading.
According to the FDA's warning letters, common violations include claims that compounded products are 'generic' versions of FDA-approved GLP-1 drugs, implied claims that FDA approved or reviewed the compounded products for safety and effectiveness, messaging implying the compounded product is 'clinically proven' to achieve the same results as an FDA-approved product, and claims that the product was obtained from an 'FDA-approved' or 'FDA-licensed' pharmacy.
In one warning letter to Altru Telehealth, the FDA cited claims including: 'Compounded semaglutide combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12,' and 'Compounded semaglutide & tirzepatide offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy.' The agency noted that compounded drug products are not FDA-approved and that such claims represent that the compounded drug products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
FDA's Escalating Crackdown
The FDA's action represents a significant escalation in enforcement against telehealth companies marketing compounded GLP-1 drugs. The agency has launched a dedicated webpage for telehealth companies that highlights common compliance pitfalls in promoting compounded drugs, alongside a separate webpage outlining the agency's specific concerns with compounded GLP-1 products.
Lilly's tirzepatide is the active ingredient in the obesity injection Zepbound and its diabetes drug Mounjaro, while semaglutide is used in the Danish drugmaker's diabetes drug Ozempic and weight-loss drug Wegovy. Pharmaceutical giants Novo Nordisk is the only drugmaker that holds FDA approval for semaglutide, while Lilly is the only manufacturer with FDA-approved tirzepatide.
Patient Safety Concerns
Compounded drugs are customized medicines made when a licensed pharmacist or physician combines, mixes or alters drug ingredients to meet the needs of an individual patient. They are not approved by the FDA and have not undergone the rigorous review for safety, efficacy, and manufacturing quality that is required for drugs approved through the new drug application pathway.
'Patients deserve to know what they're getting — compounded GLP-1 products have not been proven safe, effective, or of consistent quality like FDA-approved drugs,' said Michael Davis, acting director of the FDA's Center for Drug Evaluation and Research, in a social media post. 'We will continue holding companies accountable.'
The FDA's crackdown comes as the agency continues to grapple with the proliferation of compounded versions of popular weight-loss drugs. In April, the agency proposed excluding Novo Nordisk and Eli Lilly's weight-loss drugs from a key compounding list, potentially limiting large-scale production by outsourcing facilities. The 60-day negotiating period officially began on June 18 and is set to expire on August 17, when both sides hope to reach a permanent agreement.
