[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