US companies warned over unapproved obesity drugs

The US FDA has sent warning letters to two companies claiming to provide the active ingredients used in sought-after obesity therapies sold by Novo Nordisk and Eli Lilly under false pretences.

US Chem Labs and Synthetix (doing business as Helix Chemical Supply) offered semaglutide and tirzepatide – the active ingredients in Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, respectively – for “research purposes,” according to the regulator.

However, both companies made the drugs available with claims that they could treat illnesses, which is not allowed and means that they introduced “unapproved and misbranded semaglutide and tirzepatide products into interstate commerce,” said the FDA.

US Chem Labs sold the two drugs accompanied by claims such as weight loss, reducing the risk of stroke, heart attack, or heart disease, and has also been rapped for offering an unapproved product called “Thymalin” as a treatment for various conditions, such as immunosuppression after chemotherapy in cancer patients, including children.

Meanwhile, Helix Chemical Supply said semaglutide and tirzepatide they could be used to treat Alzheimer’s disease, lower blood sugar, and enhance insulin secretion.

Massive demand for semaglutide and tirzepatide has been driven by clinical trial data showing they can achieve significant weight loss, as well as stories about their effects on social media, and both manufacturers have struggled to keep up with demand.

That has almost inevitably resulted in the emergence of a black market for the injections which is often being supplied using counterfeit and otherwise illicit versions of the drugs, some of which have been shown to cause harm to patients.

Both companies have been asked to respond to the FDA within 15 working days with details of measures that will be taken to prevent a recurrence of the violations.