Notice2025-04031
John Warrington Kosolcharoen: Final Debarment Order
Primary source
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Published
March 13, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring John Warrington Kosolcharoen from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application (BLA). FDA bases this order on a finding that Mr. Kosolcharoen was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Kosolcharoen was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 26, 2024 (30 days after receipt of the notice), Mr. Kosolcharoen has not responded. Mr. Kosolcharoen's failure to respond and request a hearing constitutes a waiver of Mr. Kosolcharoen's right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 90 Issue 48 (Thursday, March 13, 2025)</title>
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[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11988-11990]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04031]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4887]
John Warrington Kosolcharoen: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently
debarring John Warrington Kosolcharoen from providing services in any
capacity to a person that has an approved or pending drug product
application including, but not limited to, a biologics license
application (BLA). FDA bases this order on a finding that Mr.
Kosolcharoen was convicted of a felony under Federal law for conduct
that relates to the regulation of a drug product under the FD&C Act.
Mr. Kosolcharoen was given notice of the proposed debarment and an
opportunity to request a hearing within the timeframe prescribed by
regulation. As of December 26, 2024 (30 days after receipt of the
notice), Mr. Kosolcharoen has not responded. Mr. Kosolcharoen's failure
to respond and request a hearing constitutes a waiver of Mr.
Kosolcharoen's right to a hearing concerning this matter.
DATES: This order is applicable March 13, 2025.
ADDRESSES: Any application by Mr. Kosolcharoen for special termination
of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted at any time as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2024-N-4887. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application.
[[Page 11989]]
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets
Management Staff. Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, at 240-
402-8743, or <a href="/cdn-cgi/l/email-protection#3357565152415e565d4740735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="ec88898e8d9e818982989fac8a888dc284849fc28b839a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application including, but not limited to, a BLA if FDA finds that the
individual has been convicted of a felony under Federal law for conduct
relating to the regulation of any drug product under the FD&C Act. On
September 30, 2024, Mr. Kosolcharoen was convicted as defined in
section 306(l)(1) of the FD&C Act in the United States District Court
for the Central District of California when the court accepted his plea
of guilty and entered judgment against him for the offense of
introducing an unapproved new drug into interstate commerce with intent
to defraud in violation of 21 U.S.C. 331(d), 333(a)(2), and 355(a). The
underlying facts supporting the conviction are as follows:
As described in the plea agreement from his case, Mr. Kosolcharoen
was the chief executive officer and sole owner of Liveyon, LLC
(Liveyon). Genetech, Inc. (Genetech) was a company incorporated by
another individual who described it as a ``research lab'' in the public
filing. Mr. Kosolcharoen directed that other person to operate Genetech
for the purpose of manufacturing ReGen, an injectable stem cell product
made from human umbilical cord blood, for exclusive distribution by
Liveyon to physicians to administer to patients to purportedly treat a
variety of human diseases and illnesses. Mr. Kosolcharoen knew that
Genetech and Liveyon were essentially formed and operated in concert
solely to manufacture and distribute ReGen.
Beginning around May 2016, and continuing through April 2019, Mr.
Kosolcharoen, together with others, fraudulently introduced ReGen and
other stem cell derived Liveyon products into interstate commerce.
Around July 2016, Mr. Kosolcharoen retained legal counsel and was
advised that ReGen could not be manufactured or distributed without
FDA's premarket approval. Nonetheless, Mr. Kosolcharoen sold ReGen and
other stem cell derived Liveyon products without premarket approval. In
November 2016, an FDA regulatory expert advised Mr. Kosolcharoen that
ReGen could only be distributed for research use or for specific
therapeutic applications that FDA had approved. Mr. Kosolcharoen then
directed Liveyon's purchase orders to falsely state that the stem cell
products were being sold ``for research purposes only for
investigational use.''
Mr. Kosolcharoen began selling ReGen around November 2016. From
November 2016 until October 2017, Mr. Kosolcharoen manufactured and
distributed more than $5,000,000 worth of ReGen. However, Liveyon did
not file its required annual registration with FDA until on or about
October 9, 2017. In that registration submission Mr. Kosolcharoen
caused a Liveyon employee to include numerous false statements to
mislead FDA. These false statements included that Liveyon was not a
labeling product, that Liveyon products were not human cells, tissues,
or cellular or tissue-based products (HCT/Ps) ``regulated as drugs or
biological drugs,'' that Liveyon was distributing HCT/Ps that met
certain criteria that exempted them from FDA pre-market approval
requirements, and that Liveyon was engaged in ``satellite distribution
only'' of human umbilical cord blood products for allogenic use. In
fact, Liveyon was the sole distributor of ReGen, which Genetech
manufactured exclusively for Liveyon to be distributed to Liveyon's
clinician-customers for treatment of their patients. Around September
12, 2018, Mr. Kosolcharoen introduced and delivered for introduction
into interstate commerce, ReGen, an unapproved new drug, for non-
research, clinical use for commercial profit, with a purchase order
that falsely stated ``Liveyon cells are sold for research purposes
only.'' This conduct was undertaken knowingly and with intent to
defraud as to material matters.
Mr. Kosolcharoen and others misrepresented in marketing materials
that ReGen was suitable for the treatment of a variety of conditions,
such as lung and heart diseases, autoimmune disorders, Alzheimer's
disease, Parkinson's disease and other conditions. Liveyon marketed the
products throughout the United States until about April 2019, using
advertising materials that contained multiple false and misleading
statements about their purported safety and effectiveness. Mr.
Kosolcharoen and others fraudulently induced Liveyon customers into
purchasing other stem cell derived Liveyon products that were ReGen's
successors, by falsely reporting and concealing material facts
regarding the outcome of an FDA inspection of Liveyon and nationwide
recall of ReGen, by misleading the public about the severity and cause
of adverse events suffered by Liveyon patients who were administered
ReGen, and by hosting seminars to promote ReGen's successor products
that were functionally identical to ReGen and that also were not FDA
approved.
ReGen was administered to well more than 10 patients to whom Mr.
Kosolcharoen and others mass marketed via internet and social media
advertisements that falsely claimed ReGen was a safe and effective,
cheaper, and less invasive treatment alternative to surgery or other
procedures for severe, serious, and chronic diseases and disorders that
had left patients feeling they had no options.
As a result of this conviction, FDA sent Mr. Kosolcharoen, by
certified mail, on November 20, 2024, a notice proposing to permanently
debar him from providing services in any capacity to a person that has
an approved or pending drug product application including, but not
limited to, a BLA. The proposal was based on a finding, under section
306(a)(2)(B), that Mr. Kosolcharoen was convicted of a felony under
Federal law for conduct relating to the regulation of a drug product
under the FD&C Act. The proposal informed Mr. Kosolcharoen of the
proposed debarment and offered him 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 a waiver of
[[Page 11990]]
the opportunity for a hearing and of any contentions concerning this
action. Mr. Kosolcharoen received the proposal and notice of
opportunity for a hearing on November 26, 2024. Mr. Kosolcharoen failed
to request a hearing within the timeframe prescribed by regulation and
has, therefore, waived his opportunity for a hearing and waived any
contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(a)(2)(B) of the FD&C
Act, under authority delegated to the Director, Division of Enforcement
finds that Mr. John Warrington Kosolcharoen has been convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product under the FD&C Act.
As a result of the foregoing finding, Mr. Kosolcharoen is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application including,
but not limited to, a BLA, effective (see DATES) (see sections
306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C.
335a(a)(2)(B) and 335a(c)(2)(A)(ii))). Any person with an approved or
pending drug product application including, but not limited to, a BLA,
who knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Mr. Kosolcharoen during
his debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Kosolcharoen
provides services in any capacity to a person with an approved or
pending drug product application including, but not limited to, a BLA
during his period of debarment he will be subject to civil money
penalties (section 307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7))).
In addition, FDA will not accept or review any abbreviated new drug
application from Mr. Kosolcharoen during his period of debarment, other
than in connection with an audit under section 306 of the FD&C Act
(section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B))). Note
that, for purposes of sections 306 and 307 of the FD&C Act (21 U.S.C.
335a and 335b), a ``drug product'' is defined as a ``drug subject to
regulation under section 505, 512, or 802 of this FD&C Act [(21 U.S.C.
355, 360b, 382)] or under section 351 of the Public Health Service Act
[(42 U.S.C. 262)]'' (section 201(dd) of the FD&C Act (21 U.S.C.
321(dd))).
Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04031 Filed 3-12-25; 8:45 am]
BILLING CODE 4164-01-P
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