Legal Status This site displays a prototype of a “Web 2.0” version of the daily
Federal Register. It is not an official legal edition of the Federal
Register, and does not replace the official print version or the official
electronic version on GPO’s govinfo.gov.

The documents posted on this site are XML renditions of published Federal
Register documents. Each document posted on the site includes a link to the
corresponding official PDF file on govinfo.gov. This prototype edition of the
daily Federal Register on FederalRegister.gov will remain an unofficial
informational resource until the Administrative Committee of the Federal
Register (ACFR) issues a regulation granting it official legal status.
For complete information about, and access to, our official publications
and services, go to About the Federal Register on NARA's archives.gov.

The OFR/GPO partnership is committed to presenting accurate and reliable
regulatory information on FederalRegister.gov with the objective of
establishing the XML-based Federal Register as an ACFR-sanctioned
publication in the future. While every effort has been made to ensure that
the material on FederalRegister.gov is accurately displayed, consistent with
the official SGML-based PDF version on govinfo.gov, those relying on it for
legal research should verify their results against an official edition of
the Federal Register. Until the ACFR grants it official status, the XML
rendition of the daily Federal Register on FederalRegister.gov does not
provide legal notice to the public or judicial notice to the courts.

Legal Status

Notice

John Warrington Kosolcharoen: Final Debarment Order

A Notice by the Food and Drug Administration on 03/13/2025

• 1.

1.
Comments on this document are being accepted at Regulations.gov. Submit a public comment

Thank you for taking the time to create a comment. Your input is important.

Once you have filled in the required fields below you can preview and/or submit your comment to the Health and Human Services Department for review. All comments are considered public and will be posted online once the Health and Human Services Department has reviewed them.

You can view alternative ways to comment or you may also comment via Regulations.gov at https://www.regulations.gov/commenton/FDA-2024-N-4887-0002.

It appears that you have attempted to comment on this document before
so we've restored your progress.
Start over.
1.
2. Comment * What is your comment about? Upload File(s) Note: You can attach your comment as a file and/or attach supporting
documents to your comment. Attachment Requirements.

Email this will NOT be posted on regulations.gov

Opt to receive email confirmation of submission and tracking number? Tell us about yourself! I am... * An Individual An Organization Anonymous First Name * Last Name * City Region State Alabama Alaska American Samoa Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Guam Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virgin Islands Virginia Washington West Virginia Wisconsin Wyoming Zip Country Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Côte d'Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People's Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macao Macedonia, the Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia, Federated States of Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan, Province of China Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Viet Nam Virgin Islands, British Virgin Islands, U.S. Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Phone Organization Type * Company Organization Federal State Local Tribal Regional Foreign U.S. House of Representatives U.S. Senate Organization Name * You are filing a document into an official docket. Any personal
information included in your comment text and/or uploaded
attachment(s) may be publicly viewable on the web. I read and understand the statement above.

2. Preview Comment Please review the Regulations.gov privacy notice and user notice.
3. Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2024-N-4887 Document Citation 90 FR 11988 Document Number 2025-04031 Document Type Notice Pages 11988-11990 (3 pages) Publication Date 03/13/2025 Published Content - Document Details

• PDF Official Content
  • View printed version (PDF) Official Content
• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2024-N-4887 Document Citation 90 FR 11988 Document Number 2025-04031 Document Type Notice Pages 11988-11990 (3 pages) Publication Date 03/13/2025 Published Content - Document Details
• Document Dates Published Content - Document Dates Dates Text This order is applicable March 13, 2025. Published Content - Document Dates

• Table of Contents Enhanced Content - Table of Contents This table of contents is a navigational tool, processed from the
  headings within the legal text of Federal Register documents.
  This repetition of headings to form internal navigation links
  has no substantive legal effect.

  • AGENCY:
  • ACTION:
  • SUMMARY:
  • DATES:
  • ADDRESSES:
  • FOR FURTHER INFORMATION CONTACT:
  • SUPPLEMENTARY INFORMATION:
  • I. Background
  • II. Findings and Order Enhanced Content - Table of Contents

• Public Comments Enhanced Content - Public Comments Comments are being accepted - Submit a public comment.

Enhanced Content - Public Comments
- Regulations.gov Data Enhanced Content - Regulations.gov Data

FederalRegister.gov retrieves relevant information about this document
from Regulations.gov to provide users with additional context. This
information is not part of the official Federal Register document.

NOOH Proposal to Debar John W. Kosolcharoen

Docket ID FDA-2024-N-4887 Supporting Documents No supporting documents available Enhanced Content - Regulations.gov Data

- Sharing Enhanced Content - Sharing Shorter Document URL https://www.federalregister.gov/d/2025-04031 Email Email this document to a friend Enhanced Content - Sharing

• Print Enhanced Content - Print
  • Print this document Enhanced Content - Print
• Document Statistics Enhanced Content - Document Statistics Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.

Page views 1,092
as of
04/06/2026 at 10:15 am EDT Enhanced Content - Document Statistics
- Other Formats Enhanced Content - Other Formats This document is also available in the following formats:

JSON Normalized attributes and metadata XML Original full text XML MODS Government Publishing Office metadata More information and documentation can be found in our developer tools pages.

Enhanced Content - Other Formats
- Public Inspection Public Inspection This PDF is FR Doc. 2025-04031 as it appeared on Public Inspection on
03/12/2025 at 8:45 am.

It was viewed
12
times while on Public Inspection.

If you are using public inspection listings for legal research, you
should verify the contents of the documents against a final, official
edition of the Federal Register. Only official editions of the
Federal Register provide legal notice of publication to the public and judicial notice
to the courts under 44 U.S.C. 1503 & 1507. Learn more here.

Public Inspection
Published Document: 2025-04031 (90 FR 11988) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Document Headings Document headings vary by document type but may contain
the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details.

Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2024-N-4887]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
• 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

• 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.

• 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• 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. ( printed page 11989) The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. 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: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.
  Docket: For access to the docket, go to https://www.regulations.gov 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 debarments@fda.hhs.gov.

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 ( printed 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

Published Document: 2025-04031 (90 FR 11988)