[Federal Register Volume 90, Number 71 (Tuesday, April 15, 2025)]
[Notices]
[Pages 15720-15721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06352]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1377]
Certain Products Containing Tirzepatide and Products Purporting
To Contain Tirzepatide; Notice of Issuance of a General Exclusion
Order, a Limited Exclusion Order, and Cease and Desist Orders;
Termination of the Investigation
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that the U.S. International Trade
Commission (``Commission'') has determined to issue a general exclusion
order (``GEO'') prohibiting the importation of products containing
tirzepatide and products purporting to contain tirzepatide that
infringe U.S. Trademark No. 6,809,369 or include a false designation of
origin; a limited exclusion order (``LEO'') prohibiting the entry of
falsely advertised products containing tirzepatide and products
purporting to contain tirzepatide that are imported by or on behalf of
certain defaulting respondents; and cease and desist orders (``CDOs'')
directed against certain defaulting respondents. This investigation is
terminated.
FOR FURTHER INFORMATION CONTACT: Ronald A. Traud, Esq., Office of the
General Counsel, U.S. International Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202) 205-3427. Copies of non-
confidential documents filed in connection with this investigation may
be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email
[email protected]. General information concerning the Commission may
also be obtained by accessing its internet server at https://www.usitc.gov. Hearing-impaired persons are advised that information on
this matter can be obtained by contacting the Commission's TDD terminal
on (202) 205-1810.
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation
on November 27, 2023, based upon a complaint filed on behalf of Eli
Lilly and Company of Indianapolis, Indiana (``Lilly''). 88 FR 82914-15
(Nov. 27, 2023). The complaint, as supplemented, alleges violations of
section 337 based upon the importation into the United States, the sale
for importation, and the sale within the United States after
importation of certain products containing tirzepatide or purporting to
contain tirzepatide by reason of false designation of source and false
and misleading advertising, the threat or effect of which is to destroy
or substantially injure an industry in the United States, and by reason
of infringement of U.S. Trademark No. 6,809,369. Id. The complaint also
alleges that a domestic industry exists pursuant to subsection (a)(2)
of section 337. Id. The Commission's notice of investigation named as
respondents Arctic Peptides LLC of Akeny, Iowa (``Arctic Peptides'');
Audrey Beauty Co. of Hong Kong, China (``Audrey Beauty''); Biolabshop
Limited of Lancaster, United Kingdom (``Biolabshop''); Mew Mews Company
Limited of Hong Kong, China (``Mew Mews''); Strate Labs LLC of Spring,
Texas (``Strate Labs''); Steroide Kaufen of Bialystok, Poland
(``Steroide Kaufen''); Super Human Store of Barcelona, Spain (``SHS'');
Supopeptide of Cedar Grove, New Jersey (``Supopeptide''); Triggered
Supplements LLC (d/b/a The Triggered Brand) of Clearwater, Florida
(``Triggered Brand''); Unewlife of Cedar Grove, New Jersey
(``Unewlife''); and Xiamen Austronext Trading Co., Ltd. (d/b/a
AustroPeptide) (``AustroPeptide'') of Fujian, China. Id. at 82915. The
Office of Unfair Import Investigations (``OUII'') is also named as a
party in this investigation. Id.
On March 21, 2024, the investigation terminated in part with
respect to respondents Unewlife, Supopeptide, and Steroide Kaufen.
Order No. 8 (Mar. 7, 2024), unreviewed by Comm'n Notice (Mar. 21,
2024). On May 15, 2024, Arctic Peptides, Audrey Beauty, Biolabshop, Mew
Mews, Strate Labs, SHS, Triggered Brand, and AustroPeptide were found
in default. Order No. 10 (Mar. 26, 2024), unreviewed by Comm'n Notice
(Apr. 22, 2024). And on May 21, 2024, the complaint was amended to add
as respondents Total Compounding Pharmaceuticals of Australia and
Singularity Marketing Limited (d/b/a Swiss Chems) of Hong Kong, China
(``Swiss Chems''). Order No. 12 (Apr. 22, 2024), unreviewed by Comm'n
Notice (May 21, 2024). On June 13, 2024, the complaint was further
amended to add as a respondent Total Compounding Pharmaceuticals of
Australia. Order No. 16 (May 8, 2024), unreviewed by Comm'n Notice
(June 13, 2024).
On July 12, 2024, Lilly moved for summary determination on
violation based on allegations of trademark infringement, false
designation of origin, and/or false advertising against (1) Arctic
Peptides, (2) Audrey Beauty, (3) Biolabshop, (4) Mew Mews, (5) Strate
Labs, (6) SHS, (7) Triggered Brand, (8) AustroPeptide, (9) GenX
Peptides, (10) Paradigm Peptides, and (11) Total Compounding. On
December 6, 2024, the ALJ issued Order No. 26, which partially granted
the motion. See Order No. 26 (Dec. 6, 2024). Order No. 26 granted
Lilly's motion regarding trademark infringement as to respondents
Audrey Beauty, Mew Mews, SHS, and Triggered Brand, but denied the
motion as to GenX Peptides, Total Compounding, Paradigm Peptides, and
Strate Labs. That order also granted Lilly's motion regarding false
designation of origin as to respondents Audrey Beauty, Mew Mews, SHS,
Triggered Brand, and Strate Labs, but denied the motion as to GenX
Peptides, Total Compounding, Paradigm Peptides, and Biolabshop. The
order further
[[Page 15721]]
granted Lilly's motion as to false advertising as to respondents SHS,
AustroPeptide, and Arctic Peptides, but denied the motion as to Total
Compounding. The order additionally found that Lilly is entitled to
summary determination as to the domestic industry requirement.
Order No. 26 also included a preliminary recommendation on remedy
and bonding (``RD''), should a violation be found. The RD recommended:
(1) as to Lilly's trademark infringement and false designation of
origin allegations, a GEO directed to certain products containing
tirzepatide and products purporting to contain tirzepatide imported,
sold for importation, and/or sold after importation; (2) also as to
Lilly's trademark infringement and false designation of origin
allegations and in the alternative to a GEO, an LEO directed to certain
products containing tirzepatide and products purporting to contain
tirzepatide imported, sold for importation, and/or sold after
importation by Audrey Beauty, Mew Mews, SHS, Triggered Brand, Strate
Labs, and AustroPeptide; (3) as to Lilly's false advertising
allegations, an LEO directed to certain products containing tirzepatide
and products purporting to contain tirzepatide imported, sold for
importation, and/or sold after importation by AustroPeptide and SHS;
and (4) in addition to either a GEO order or LEOs, CDOs directed to
Arctic Peptides, Triggered Brand, and Strate Labs. The RD also
recommended that the Commission set the bond during the Presidential
review period at one hundred percent (100%) of entered value.
On January 22, 2025, the Commission determined not to review Order
No. 26. Comm'n Notice (Jan. 22, 2025).
Because Lilly's motion for summary determination was not granted as
to all issues, the ALJ sought a submission from the parties regarding
any further necessary proceedings. See Order No. 27 (Dec. 6, 2024),
unreviewed by Comm'n Notice (Jan. 6, 2025). In response, the parties
provided a joint submission in which Lilly indicated that it would seek
to terminate all claims on which summary determination was not granted.
Then, on December 19, 2024, Lilly moved to withdraw the allegations
remaining before the ALJ as to GenX Peptides, Paradigm Peptides, Total
Compounding, Biolabshop, and Strate Labs. On January 10, 2025, the ALJ
issued an initial determination granting Lilly's motion. See Order No.
29 (Jan. 10, 2025), unreviewed by Comm'n Notice (Jan. 31, 2025).
The Commission issued a notice soliciting comments regarding any
public interest concerns raised by the recommend relief in the RD. See
89 FR 101048 (Dec. 13, 2024). The Commission's notice received two
responses in support of the recommended relief. Additionally, Lilly
filed a statement on public interest pursuant to Commission Rule
210.50(a)(4), 19 CFR 210.50(a)(4).
The Commission requested briefing on remedy, bonding, and the
public interest. Comm'n Notice (Jan. 22, 2024). On February 5, 2025,
Lilly and OUII filed opening submissions. On February 12, 2025, OUII
filed a responsive submission. No other party filed a submission before
the Commission.
Having reviewed the record of the investigation, including the RD
and the parties' submissions, the Commission has determined that the
appropriate remedy is: (1) a GEO prohibiting the importation of
products containing tirzepatide and products purporting to contain
tirzepatide that infringe U.S. Trademark No. 6,809,369 and/or include a
false designation of origin; (2) an LEO prohibiting prohibiting the
entry of falsely advertised products containing tirzepatide and
products purporting to contain tirzepatide that are imported by or on
behalf of SHS, AustroPeptide, and Arctic Peptides; and (3) CDOs
directed to Arctic Peptides, Triggered Brand, and Strate Labs.
The Commission has further determined that the public interest
factors enumerated in subsections (d)(l) and (g)(1) (19 U.S.C.
1337(d)(l), (g)(1)) do not preclude issuance of the above referenced
remedial orders. Additionally, the Commission has determined to impose
a bond of 100% of entered value of the covered products during the
period of Presidential review (19 U.S.C. 1337(j)).
This investigation is terminated.
The Commission vote for this determination took place on April 9,
2025.
The authority for the Commission's determination is contained in
section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and
in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR
part 210).
By order of the Commission.
Issued: April 9, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-06352 Filed 4-14-25; 8:45 am]
BILLING CODE 7020-02-P