February 20, 2024: FDA warns companies selling unapproved semaglutide and tirzepatide

Major Stories

The U.S. FDA warned companies in New York and Florida to stop selling unapproved GLP-1 agonists. Europol’s Operation Shield IV removed $69 million in illicit medicine and doping substances from European markets.

The U.S. Food and Drug Administration (FDA) warned Synthetix Inc. and US Chem Labs to stop selling non-FDA approved semaglutide and tirzepatide, the active ingredients in the diabetes treatments Ozempic and Mounjaro. The letter to US Chem Labs also warned the company to stop selling thymalin, a peptide that it claims boosts immune systems and metabolisms. Both companies labeled the drugs as research chemicals that are “not for human consumption,” but their websites made it clear that they were selling the products to individuals.

Europol announced the results of Operation Shield IV, a six-month, 30-country effort targeting illegal sales of counterfeit and misused medicines and illicit doping substances in Europe. Between April and October 2023, authorities seized illegal medicines and raw pharmaceutical materials worth $69 million; dismantled four underground labs; initiated almost a thousand prosecutions and shut down 92 websites. In particular, Greek authorities disrupted a counterfeiting ring that trafficked counterfeit botox, vitamin acid preparations, falsified drugs and doping substances sourced from Turkey and Poland.

Helix Chemical Supply homepage as captured by the Wayback Machine on May 17, 2023.

Domestic News

A California man who smuggled and distributed tianeptine received a two-year sentence.

Stabile repacked illegally imported tianeptine for sale on his now-defunct website, SupplementsforWork.com (U.S. Attorney's Office, District of Massachusetts)

A federal judge in Massachusetts sentenced Ryan M. Stabile of Pasadena, California to serve two years in prison and to forfeit $1.8 million for smuggling and distributing tianeptine in the United States. Stabile smuggled between 10 and 15 kilograms of tianeptine from China each month, repackaged it and sold it on his company’s website, ultimately making at least $2.2 million in illegal tianeptine sales.

Casey Howard of Leeds, Massachusetts received a three-and-a-half to four year prison sentence after law enforcement caught him with a pill press and other items suggesting a drug distribution business in 2022.