Notice2025-19163
Yong Sheng Jiao: Denial of Application for Termination of Debarment
Primary source
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Published
October 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is denying Yong Sheng Jiao's application for termination of debarment under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Mr. Jiao was given notice of the proposed denial of his application for termination of his debarment and was given an opportunity to request a hearing to show why his application for termination of debarment should be granted. As of June 16, 2025 (30 days after receipt of the notice), Mr. Jiao had not requested a hearing and through his attorney informed FDA he would not be requesting a hearing in this matter. Mr. Jiao's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 90 Issue 188 (Wednesday, October 1, 2025)</title>
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[Federal Register Volume 90, Number 188 (Wednesday, October 1, 2025)]
[Notices]
[Page 47312]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19163]
[[Page 47312]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0604]
Yong Sheng Jiao: Denial of Application for Termination of
Debarment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is denying Yong Sheng
Jiao's application for termination of debarment under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). Mr. Jiao was given notice of the
proposed denial of his application for termination of his debarment and
was given an opportunity to request a hearing to show why his
application for termination of debarment should be granted. As of June
16, 2025 (30 days after receipt of the notice), Mr. Jiao had not
requested a hearing and through his attorney informed FDA he would not
be requesting a hearing in this matter. Mr. Jiao's failure to respond
and request a hearing constitutes a waiver of his right to a hearing
concerning this matter.
DATES: This order is applicable October 1, 2025.
ADDRESSES: Submit comments electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Written comments may be submitted to the Dockets
Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, 240-402-
8743 or <a href="/cdn-cgi/l/email-protection#05616067647768606b7176456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="a6c2c3c4c7d4cbc3c8d2d5e6c0c2c788ceced588c1c9d0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any drug or controlled substance.
On January 24, 2023, Mr. Jiao, the owner and operator of Santec
Chemicals Corporation and Syntec Pharma Corporation, pled guilty to a
felony count of causing the delivery of misbranded drugs into
interstate commerce in violation of sections 301(a), 303(a)(2), and
502(a) of the FD&C Act (21 U.S.C. 331(a), 333(a)(2), and 352(a)). Then,
on January 8, 2024, the U.S. District Court for the Eastern District of
New York entered a judgment convicting and sentencing Mr. Jiao to 2
years of probation and fines. Mr. Jiao's conviction stemmed from
conduct, occurring on or about and between November 30, 2017, and April
30, 2020, relating to the importation of a drug, dipyrone, which is not
approved for use in the United States. Mr. Jiao imported dipyrone from
suppliers located in China into the United States, addressed to one of
his businesses, Santec Chemicals Corporation. The shipments of dipyrone
were misbranded in that they were either not labeled or they were
falsely labeled as sebacic acid. Mr. Jiao pled guilty to knowingly and
intentionally introducing into interstate commerce, with the intent to
defraud and mislead the Federal government, the misbranded drug
dipyrone.
By letter dated March 18, 2024, FDA's Office of Regulatory Affairs
(ORA) notified Mr. Jiao of its proposal to issue an order under section
306(b)(1)(D) of the FD&C Act debarring him for a period of 5 years from
importing or offering to import any drug into the United States. FDA's
proposal was based on a finding that Mr. Jiao was convicted, as defined
in section 306(l)(1) of the FD&C Act, for conduct relating to the
importation of any drug or controlled substance into the United States.
Mr. Jiao requested a hearing on the proposed debarment, and on January
8, 2025, FDA issued an order under section 306(b)(1) of the FD&C Act
denying the request for a hearing and debarring Mr. Jiao for 5 years
from importing or offering for import any drug into the United States.
On February 16, 2025, Mr. Jiao, through his attorney, submitted an
application for termination of debarment to FDA pursuant to section
306(d)(1) of the FD&C Act. Pursuant to 306(d)(3)(B)(ii), FDA will grant
an application to terminate a debarment if it finds that, as relevant
here, termination of that individual's debarment would ``serve[ ] the
interests of justice'' and ``adequately protect the integrity of the
drug approval process.'' Mr. Jiao's application did not assert or
provide a basis to conclude that termination is appropriate here.
By letter dated May 13, 2025, the Office of Inspections and
Investigations (OII) (formerly ORA) offered Mr. Jiao an opportunity for
a hearing, under 21 CFR part 12, on OII's proposal to deny his
application for termination of his debarment. The proposal reflected
OII's assessment that, considering all favorable and unfavorable
information in light of the remedial public health purposes underlying
debarment, terminating Mr. Jiao's debarment would not serve the
interests of justice or adequately protect the integrity of the drug
approval process.
OII sent Mr. Jiao the letter proposing to deny his application for
termination of his debarment, by certified mail, on May 14, 2025. In
addition to informing him about OII's proposal, the letter offered Mr.
Jiao an opportunity to request a hearing, providing him 30 days from
the date of receipt of the letter in which to file the request, and
advised him that failure to request a hearing constituted an election
not to use the opportunity for a hearing and a waiver of any
contentions concerning this action. Mr. Jiao received the proposal and
notice of opportunity for a hearing on May 15, 2025. On June 17, 2025,
Mr. Jiao's attorney informed FDA that Mr. Jiao was not requesting a
hearing in this matter. As such, Mr. Jiao failure to request a hearing
within the timeframe prescribed by regulation constitutes a waiver of
his opportunity for a hearing and any contentions concerning his
application for termination of debarment (21 CFR part 12).
II. Conclusion
Therefore, the Division of Field Enforcement, Office of Inspections
and Investigations, under section 306(d) of the FD&C Act, under
authority delegated to the Director, Division of Enforcement, denies
Mr. Jiao's application for termination of debarment. Mr. Jiao has
failed to request a hearing and has waived his right to have a hearing
on OII's proposal to deny his application for termination of his
debarment. Pursuant to section 301(cc) of the FD&C Act, the importing
or offering for import into the United States of any drug by, with the
assistance of, or at the direction of Mr. Jiao is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-19163 Filed 9-30-25; 8:45 am]
BILLING CODE 4164-01-P
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