Such is the demand for new anti-obesity drugs that several online companies have begun trying to sell the latest “must-have” meds—but without approval or prescription, and that has irked the FDA.
Semaglutide serves as the active ingredient in both Novo Nordisk's weight loss drug Wegovy and its diabetes franchise. Likewise, tirzepatide is the active ingredient in Eli Lilly's diabetes drug Mounjaro, which is also aiming for a weight-loss indication.
In the two letters sent out this month to both companies, the FDA warns of the “inherent risks to consumers” who are buying drugs online without a prescription, adding that unapproved new drugs “do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.”
The FDA is demanding that the companies “cease offering any unapproved and misbranded drugs for sale to U.S. consumers,” something it says is “critical to protect the public from harm.”
In the letters, the FDA requested that both companies review their labeling, promotional materials and websites to make certain they aren't "misleadingly representing" that the products are "safe and effective."
The companies have until the end of the month to explain themselves; if not, the FDA can start legal action, including seizure and injunction.
This comes amid a major upsurge in demand for the approved versions of these drugs for weight loss, coming after celebrity endorsements from the likes of X owner Elon Musk and others, who have said they have used the drugs to help them lose weight.
Lilly is yet to gain any approval for Mounjaro as an anti-obesity therapy but could nab an FDA green light by year-end.
Novo, meanwhile, has been holding back marketing for Wegovy amid a surge in demand that put pressure on its manufacturing services for the drug.