Lilly asks trade panel to block imports of unapproved tirzepatide sold online

Eli Lilly filed a complaint with the U.S. International Trade Commission on Oct. 19, 2023, asking the agency to stop 11 online pharmacies from importing, selling and distributing products that purport to contain tirzepatide, the active ingredient in its diabetes drug Mounjaro ^[1]. Lilly said the case is aimed at blocking the shipments and removing the products from the market ^[1].

Five of the named businesses are based in the United States: Artic Peptides, Strate Labs, Supopeptide, The Triggered Brand and Unewlife. The complaint also names Biolabshop of Britain, Super Human Store of Spain, Steroide Kaufen in Poland, and Audrey Beauty, Mew Mews Company and AustroPeptide ^[1].

The commission can impose import bans on products that violate certain parts of U.S. trade law and can take those products off the market after they arrive in the country ^[1].

Lilly's complaint accuses the sellers of infringing its Mounjaro trademark, presenting themselves as connected to Lilly and to FDA-approved tirzepatide when they are not, and making false or misleading advertising claims about tirzepatide ^[1]. In the filing, the company called the products it is targeting "dangerous research chemicals that are not approved for human consumption" with "no connection to Eli Lilly or Mounjaro" ^[1]. Those are Lilly's allegations; the commission has not ruled on them.

Lilly said its testing of AustroPeptide's product, which was marketed as containing tirzepatide, found it was "nothing more than sugar alcohol" ^[1].

Lilly is the only company with U.S. Food and Drug Administration approval to sell tirzepatide products ^[1]. At the time of the filing, Mounjaro was cleared to treat diabetes and was expected to win approval for weight loss later in 2023 ^[1].

The trade complaint followed two earlier enforcement steps. One month before, Lilly sued 10 U.S. medical spas, wellness centers and compounding pharmacies over products claiming to contain tirzepatide, in federal courts in Arizona, Florida, Georgia, Minnesota, South Carolina and Utah ^[1]. The week before the trade filing, the FDA published letters telling two online vendors to stop selling unapproved versions of tirzepatide and semaglutide, the active ingredient in Novo Nordisk's Wegovy ^[1].

Why it matters for patients

The complaint reaches a supply route the earlier lawsuits did not. The medical spa and compounding cases involved U.S. businesses; this one covers sellers that ship from other countries, which are outside the FDA's approval process for tirzepatide ^[1]. A product bought from one of these sellers does not come with the same assurance about what is inside it that an FDA-approved product carries. For at least one product named in the complaint, testing cited by Lilly turned up sugar alcohol rather than tirzepatide ^[1].

Nothing in the complaint has been proven, and the commission has not decided whether to take the case. Whether anyone other than Lilly tested the products named, and how any of the 11 defendants responded, has not been reported. Even if the commission acts, its tools are trade measures — an import ban or removal from the market — rather than a recall or a criminal charge ^[1]. The prices the named sellers charged, and whether any of them are still shipping, has not been disclosed.

The practical distinction the filing highlights is the route a product takes to a buyer: an FDA-approved medicine, or an unapproved version sold by an importer ^[1].

What happens next

• After the complaint is published in the Federal Register, the commission has 30 days to accept or decline it ^[1].
• No date has been set for a ruling, and the outcome of Lilly's earlier suits against U.S. spas and compounding pharmacies has not been reported ^[1].
• The FDA warning letters to two online vendors were issued in the week before the trade complaint was filed ^[1].