The U.S. Food and Drug Administration (FDA) has issued 30 warning letters to telehealth companies for their marketing of compounded GLP-1 products on their websites. The FDA accused these companies of making false or misleading claims about the safety and efficacy of the compounded drugs. In one case, manufacturing problems were found that posed health risks to patients taking a non-GLP-1 compounded medicine.
According to the FDA, three individuals were sent to the emergency room after using products containing nicotinamide adenine dinucleotide (NAD+) that were compounded by GenoGenix. The agency’s letter detailed that an unopened vial from the same lot was contaminated with excessive bacterial endotoxins.
Compounded GLP-1 medicines became more common as patients had trouble accessing or affording branded drugs from Novo Nordisk and Eli Lilly when these treatments first launched. Although supplies have improved and prices have decreased, compounded versions remain in use. Novo Nordisk reported that last year approximately one million people used a compounded GLP-1 medicine, which it considers a barrier to its business growth. The company has also questioned the quality of these unapproved alternatives since they are not reviewed premarket by the FDA.
Recently, the FDA increased scrutiny of compounding pharmacies and telehealth providers in this sector, including sending warnings to major firms such as Hims & Hers and MedisourceRx. On Tuesday, 30 additional warning letters went out to smaller telehealth companies.
The FDA stated that some telehealth companies implied their products were equivalent to approved medicines and obscured sourcing by branding drugs with their own names or trademarks without clarifying they are not original manufacturers.
In its investigation into GenoGenix, regulators said the pharmacy repackaged semaglutide (marketed as Ozempic and Wegovy by Novo Nordisk), tirzepatide (sold as Mounjaro and Zepbound by Eli Lilly), and retatrutide—a new GLP-1 drug under development at Lilly. Inspectors also noted GenoGenix made other compounds such as 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and NAD+, which do not qualify for exemptions allowing compounding under federal law when there is clinical need.
Further inspection revealed unsanitary conditions at GenoGenix’s facility, including inadequate disinfection practices among staff and facility design issues compromising cleanroom integrity. “The conditions created the risk that the products ‘could be contaminated with filth or rendered injurious to health,’” according to the FDA statement.
Operator errors included failure to disinfect materials properly during aseptic processing while exposing skin, raising further concerns about contamination risk. Inspectors also cited problems with written procedures at the plant.
