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[Federal Register Volume 90, Number 17 (Tuesday, January 28, 2025)]
[Notices]
[Pages 8299-8301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01785]

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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1377]

Certain Products Containing Tirzepatide and Products Purporting 
To Contain Tirzepatide; Notice of a Commission Determination Not To 
Review an Initial Determination Finding Respondents in Violation of 
Section 337; Request for Written Submissions on Remedy, the Public 
Interest, and Bonding

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 not to review an initial 
determination (``ID'') (Order No. 26) of the presiding administrative 
law judge (``ALJ''), partially granting a motion for summary 
determination on violation of section 337. The Commission requests 
written submissions from the parties, interested government agencies, 
and other interested persons on the issues of remedy, the public 
interest, and bonding, under the schedule set forth below.

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, 
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

[[Page 8300]]

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: (1) Arctic Peptides LLC of Akeny, 
Iowa (``Arctic Peptides''); (2) Audrey Beauty Co. of Hong Kong, China 
(``Audrey Beauty''); (3) Biolabshop Limited of Lancaster, United 
Kingdom (``Biolabshop''); (4) Mew Mews Company Limited of Hong Kong, 
China (``Mew Mews''); (5) Strate Labs LLC of Spring, Texas (``Strate 
Labs''); (6) Steroide Kaufen of Bialystok, Poland (``Steroide 
Kaufen''); (7) Super Human Store of Barcelona, Spain (``SHS''); (8) 
Supopeptide of Cedar Grove, New Jersey (``Supopeptide''); (9) Triggered 
Supplements LLC (d/b/a The Triggered Brand) of Clearwater, Florida 
(``Triggered Brand''); (10) Unewlife of Cedar Grove, New Jersey 
(``Unewlife''); and (11) Xiamen Austronext Trading Co., Ltd. (d/b/a 
AustroPeptide) of Fujian, China (``AustroPeptide''). 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, based on 
withdrawal of the related allegations in the complaint, as 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, the Commission found Arctic Peptides, Audrey 
Beauty, Biolabshop, Mew Mews, Strate Labs, SHS, Triggered Brand, and 
AustroPeptide in default. Order No. 13 (Apr. 22, 2024), unreviewed by 
Comm'n Notice (May 15, 2024).
    On May 21, 2024, the complaint was amended to add as respondents 
Fibonacci Sequence LLC (d/b/a GenX Peptides) of Houston, Texas (``GenX 
Peptides''); and Paradigm Peptides of Michigan City, Indiana 
(``Paradigm Peptides''). Order No. 12 (Apr. 22, 2024), unreviewed by 
Comm'n Notice (May 21, 2024), available at 89 FR 46159, 46159-60 (May 
28, 2024).
    On June 13, 2024, the complaint was further amended to add as a 
respondent Total Compounding Pharmaceuticals of Australia (``Total 
Compounding''). Order No. 16 (May 8, 2024), unreviewed by Comm'n Notice 
(June 13, 2024), available at 89 FR 5149, 51549-50 (June 18, 2024).
    On October 16, 2024, the Commission found GenX Peptides in default. 
Order No. 23 (Aug. 27, 2024), unreviewed by Comm'n Notice (Oct. 16, 
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 the subject ID, which partially 
granted the motion. Order No. 26 (Dec. 6, 2024). The ID 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. 
E.g., ID at 134 (including n.61). The ID 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. E.g., id. (including n. 62). And the ID granted Lilly's 
motion as to false advertising as to respondents SHS, AustroPeptide, 
and Arctic Peptides. E.g., id. The ID additionally found that Lilly is 
entitled to summary determination as to the domestic industry 
requirement. E.g., id. No petitions for review of the ID were filed.
    The subject ID included the ALJ's Preliminary Recommended 
Determination on Remedy and Bond (``RD''), should a violation be found. 
The RD recommended: (1) a general exclusion order directed to certain 
products containing tirzepatide and products purporting to contain 
tirzepatide imported, sold for importation, and/or sold after 
importation for the asserted trademark infringement and false 
designation of origin allegations; (2) in the alternative to a general 
exclusion order for the asserted trademark infringement and false 
designation of origin allegations, limited exclusion orders directed to 
Audrey Beauty, Mew Mews, SHS, Triggered Brand, Strate Labs, and 
AustroPeptide; (3) limited exclusion orders directed to SHS and 
AustroPeptide for the false advertising allegations; and (4) in 
addition to either a general exclusion order or limited exclusion 
orders, cease and desist orders directed to Arctic Peptides, Triggered 
Brand, and Strate Labs. The Commission notes that only the portions of 
Order No. 26 that correspond to a grant of a summary determination of 
violation for a particular respondent and claim are ripe for review at 
this time.
    Having reviewed the record of the investigation, including the ID 
and the parties' submissions to the ALJ, the Commission has determined 
not to review the ID.
    In connection with the final disposition of this investigation, the 
statute authorizes issuance of, inter alia, (1) an exclusion order that 
could result in the exclusion of the subject articles from entry into 
the United States; and/or (2) cease and desist orders that could result 
in the respondents being required to cease and desist from engaging in 
unfair acts in the importation and sale of such articles. Accordingly, 
the Commission is interested in receiving written submissions that 
address the form of remedy, if any, that should be ordered. If a party 
seeks exclusion of an article from entry into the United States for 
purposes other than entry for consumption, the party should so indicate 
and provide information establishing that activities involving other 
types of entry either are adversely affecting it or likely to do so. 
For background, see Certain Devices for Connecting Computers via 
Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op. 
at 7-10 (Dec. 1994).
    The statute requires the Commission to consider the effects of that 
remedy upon the public interest. The public interest factors the 
Commission will consider include the effect that an exclusion order and 
cease and desist orders would have on: (1) the public health and 
welfare, (2) competitive conditions in the U.S. economy, (3) U.S. 
production of articles that are like or directly competitive with those 
that are subject to investigation, and (4) U.S. consumers. The 
Commission is therefore interested in receiving written submissions 
that address the aforementioned public interest factors in the context 
of this investigation.
    If the Commission orders some form of remedy, the U.S. Trade 
Representative, as delegated by the President, has 60 days to approve, 
disapprove, or take no action on the Commission's determination. See 
Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). 
During this period, the subject articles would be entitled to enter the 
United States under bond, in an amount determined by the Commission and 
prescribed by the Secretary of the Treasury. The Commission is 
therefore interested in receiving submissions concerning the amount of 
the bond that should be imposed if a remedy is ordered.

[[Page 8301]]

    Written Submissions: Parties to the investigation, interested 
government agencies, and any other interested parties are encouraged to 
file written submissions on the issues of remedy, the public interest, 
and bonding. Such submissions should address the recommended 
determination by the ALJ on remedy and bonding.
    In its initial submission, Complainant is also requested to 
identify the remedy sought and Complainant and OUII are requested to 
submit proposed remedial orders for the Commission's consideration. 
Complainant is further to provide the HTSUS subheadings under which the 
accused products are imported, and to supply the identification 
information for all known importers of the products at issue in this 
investigation. The initial written submissions and proposed remedial 
orders must be filed no later than close of business on February 5, 
2025. Reply submissions must be filed no later than the close of 
business on February 12, 2025. No further submissions on these issues 
will be permitted unless otherwise ordered by the Commission. No 
further submissions on any of these issues will be permitted unless 
otherwise ordered by the Commission.
    Persons filing written submissions must file the original document 
electronically on or before the deadlines stated above. The 
Commission's paper filing requirements in 19 CFR 210.4(f) are currently 
waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the 
investigation number (Inv. No. 337-TA-1377) in a prominent place on the 
cover page and/or the first page. (See Handbook for Electronic Filing 
Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). Persons with questions regarding 
filing should contact the Secretary, (202) 205-2000.
    Any person desiring to submit a document to the Commission in 
confidence must request confidential treatment by marking each document 
with a header indicating that the document contains confidential 
information. This marking will be deemed to satisfy the request 
procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) 
& 210.5(e)(2)). Documents for which confidential treatment by the 
Commission is properly sought will be treated accordingly. Any non-
party wishing to submit comments containing confidential information 
must serve those comments on the parties to the investigation pursuant 
to the applicable Administrative Protective Order. A redacted non-
confidential version of the document must also be filed with the 
Commission and served on any parties to the investigation within two 
business days of any confidential filing. All information, including 
confidential business information and documents for which confidential 
treatment is properly sought, submitted to the Commission for purposes 
of this investigation may be disclosed to and used: (i) by the 
Commission, its employees and Offices, and contract personnel (a) for 
developing or maintaining the records of this or a related proceeding, 
or (b) in internal investigations, audits, reviews, and evaluations 
relating to the programs, personnel, and operations of the Commission 
including under 5 U.S.C. appendix 3; or (ii) by U.S. Government 
employees and contract personnel, solely for cybersecurity purposes. 
All contract personnel will sign appropriate nondisclosure agreements. 
All nonconfidential written submissions will be available for public 
inspection on EDIS.
    The Commission vote for this determination took place on January 
22, 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: January 22, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-01785 Filed 1-27-25; 8:45 am]
BILLING CODE 7020-02-P
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