The U.S. Food and Drug Administration announced on March 3, 2026 the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites.
Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.
Claims that imply that products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not are false or misleading and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)].
“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.”
This is the second group of warning letters sent to telehealth firms since the agency launched in September a crackdown on misleading direct-to-consumer pharmaceutical advertisements. Over the past six months, the agency has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads, more than had been sent over the entire preceding decade.
Primary violations identified in the letters included making claims implying sameness with FDA-approved products and obscuring product sourcing by advertising drug products branded with the telehealth firm’s name or trademark without qualification, implying they are the compounder.
Compounded drugs are not FDA-approved. This means the agency does not review their safety, effectiveness or quality before they are marketed. Compounded drugs are also not the same as generic drugs, which are FDA-approved.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
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