US trade commission opens investigation into imported tirzepatide products

The U.S. International Trade Commission voted to open an investigation into imported products that contain tirzepatide, and products that claim to contain it, after a complaint by Eli Lilly and Company ^[2]. The agency announced the vote on November 21, 2023 ^[2]. The notice of institution was published in the Federal Register on November 27, 2023, at 88 FR 82914 ^[1].

The case is Investigation No. 337-TA-1377, brought under section 337 of the Tariff Act of 1930 ^[1]. The Commission ordered the investigation instituted on November 20, 2023 ^[1]. Lilly filed the complaint on October 19, 2023, and filed a supplement on November 10, 2023 ^[1][2].

Lilly alleges that importing the products, selling them for import, and selling them in the United States after import violates section 337 by infringing U.S. Trademark Registration No. 6,809,369 ^[1]. The complaint also alleges false designation of source and false and misleading advertising, and says those practices threaten to destroy or substantially injure a U.S. industry ^[1][2]. Lilly asked the Commission to issue a general exclusion order or, as an alternative, a limited exclusion order, along with cease and desist orders ^[1][2].

The Commission named 11 respondents in the investigation ^[2]:

• Arctic Peptides LLC of Ankeny, Iowa
• Audrey Beauty Co. of Hong Kong
• Biolabshop Limited of Lancaster, United Kingdom
• Mew Mews Company Limited of Hong Kong
• Steroide Kaufen of Bialystok, Poland
• Strate Labs LLC of Spring, Texas
• Super Human Store of Barcelona, Spain
• Supopeptide of Cedar Grove, New Jersey
• Triggered Supplements LLC, doing business as The Triggered Brand, of Clearwater, Florida
• Unewlife of Cedar Grove, New Jersey
• Xiamen Austronext Trading Co., Ltd., doing business as AustroPeptide, of Fujian, China

By instituting the investigation, the Commission has not made any decision on the merits of the case ^[2].

Why it matters for patients

The case is about where tirzepatide products come from and how they are labeled and sold, not about whether tirzepatide works. It centers on imports sold by companies other than the one that filed the complaint ^[1][2]. If the Commission issues an exclusion order, the affected products could be kept out of the U.S. market ^[1][2].

The title of the case separates products "containing tirzepatide" from products "purporting to contain tirzepatide," wording that leaves open whether every product at issue actually holds the drug ^[1]. The notice does not say whether any products were tested, or what testing found. Whether the case will change the supply, price, or availability of compounded or imported tirzepatide has not been reported ^[1][2]. The investigation is separate from FDA review of new drugs, and the notice makes no finding about the safety or effectiveness of any product ^[1]. It also does not say whether sellers who were not named as respondents could be affected later ^[2].

What happens next

Within 45 days after institution, the Commission will set a target date for completing the investigation ^[2]. The Commission's chief administrative law judge will assign the case to an administrative law judge, who will schedule and hold an evidentiary hearing and issue an initial determination on whether section 337 was violated. That determination is subject to review by the Commission ^[2].

The Commission will make a final determination "at the earliest practicable time," the agency says ^[2]. Remedial orders in section 337 cases take effect when issued and become final 60 days later, unless the U.S. Trade Representative disapproves them for policy reasons within that period ^[2]. The notice does not state a target date or a hearing date ^[2].