Lilly seeks import ban on 11 online sellers of products labeled tirzepatide

Eli Lilly asked the U.S. International Trade Commission to block 11 online sellers from importing and distributing products marketed as containing tirzepatide, the active ingredient in the company's diabetes drug Mounjaro, Reuters reported on October 20, 2023 ^[1]. The complaint was filed with the ITC, the agency that handles certain import disputes ^[1].

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

Lilly said lab testing of a product sold by AustroPeptide that was described as containing tirzepatide found it was "nothing more than sugar alcohol" ^[1]. In the filing, the company called the goods at issue "dangerous research chemicals that are not approved for human consumption" and said they "have no connection to Eli Lilly or Mounjaro" ^[1]. The report does not say whether products from the other 10 sellers were tested ^[1].

Lilly's claims include that the sellers infringed its Mounjaro trademark, falsely suggested a link to Lilly and its FDA-approved tirzepatide, and made false or misleading statements about tirzepatide in advertising ^[1]. According to the report, Lilly is the only company with FDA approval to sell tirzepatide products ^[1].

The ITC can issue import bans on goods that violate parts of U.S. trade law and can take them off the market once they have entered the country ^[1]. After a complaint is published in the Federal Register, the commission has 30 days to decide whether to accept it ^[1]. The report does not state when publication occurred ^[1].

The ITC action came a month after Lilly sued 10 U.S. medical spas, wellness centers and compounding pharmacies in federal courts in Arizona, Florida, Georgia, Minnesota, South Carolina and Utah, also over products claimed to contain tirzepatide ^[1]. In the week before the trade complaint, the FDA published warning 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

A product sold online under a GLP-1 label is not necessarily what the label says. The one item tested in this case contained no tirzepatide at all, per the report; it was sugar alcohol ^[1]. No test results for the other sellers' products were described ^[1].

The complaint is aimed at sellers, not at people who bought from them. Nothing in the report indicates that patients are targets of the case ^[1].

Several practical questions are left open. The report does not say how many U.S. consumers bought these products, what they paid, or whether any of them reported harm. Those figures have not been disclosed ^[1].

The report also does not address compounded tirzepatide as a category. It describes goods that Lilly says were falsely tied to the company and its approved brand ^[1]. At the time of the report, Mounjaro was approved for type 2 diabetes, with an approval for weight loss expected later that year; the report does not specify what that later approval covered ^[1].

One more limit is timing. The filing described here dates to October 2023, and no update to it has been reported since ^[1].

What happens next

The 30-day window for the commission to accept or decline the complaint begins when the complaint is published in the Federal Register ^[1]. Whether that publication happened has not been reported ^[1].

It also has not been reported whether the ITC accepted the case, whether any import ban was issued, or how the matter ended ^[1]. The outcome of the earlier suits against the clinics and compounding pharmacies has not been reported either ^[1].