Notice2026-02786
Jeremy Spencer Brown: Final Debarment Order
Primary source
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Published
February 12, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeremy Spencer Brown for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Brown was convicted of one felony count under Federal law for introduction of unapproved drugs into interstate commerce with intent to defraud or mislead. The factual basis supporting Mr. Brown's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Brown was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of May 21, 2025 (30 days after receipt of the notice), Mr. Brown had not responded. Mr. Brown'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 91 Issue 29 (Thursday, February 12, 2026)</title>
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[Federal Register Volume 91, Number 29 (Thursday, February 12, 2026)]
[Notices]
[Pages 6643-6645]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0435]
Jeremy Spencer Brown: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) debarring Jeremy Spencer Brown for a period of 5 years from
importing or offering for import any drug into the United States. FDA
bases this order on a finding that Mr. Brown was convicted of one
felony count under Federal law for introduction of unapproved drugs
into interstate commerce with intent to defraud or mislead. The factual
basis supporting Mr. Brown's conviction, as described below, is conduct
relating to the importation into the United States of a drug or
controlled substance. Mr. Brown was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. As of May 21, 2025 (30 days after receipt of
the notice), Mr. Brown had not responded. Mr. Brown'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 February 12, 2026.
ADDRESSES: Any application by Mr. Brown for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) 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-
2025-N-0435. Received applications will be
[[Page 6644]]
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. 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, 240-402-
8743, or <a href="/cdn-cgi/l/email-protection#88ecedeae9fae5ede6fcfbc8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="4024252221322d252e3433002624216e2828336e272f36">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act 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 February 3, 2025, Mr. Brown was convicted as defined in section
306(l)(1) of the FD&C Act, in the U.S. District Court for the District
of Vermont, when the court accepted his plea of guilty and entered
judgment against him for the felony offense of introduction of
unapproved drugs into interstate commerce with intent to defraud or
mislead in violation of 21 U.S.C. 331(d), 333(a)(2), and 355(a)
(sections 301(d), 303(a)(2), and 505(a) of the FD&C Act). The
underlying facts supporting the conviction are as follows:
As contained in the Information and in the Plea Agreement from his
case, Mr. Brown was the owner and operator of the company Warrior Labz
SARMs and its multiple websites. Beginning in March 2019 and until
December 2023, Mr. Brown owned and operated Warrior Labz SARMs and the
website warriorlabzarms (the ``Original SARMs Site''), which offered
certain drugs for sale. In January 2023, Mr. Brown created the website
<a href="http://warriorlabzvip.com">warriorlabzvip.com</a> (the ``VIP SARMs Site''), which required customers
to create a username and password.
Through his company's websites, Mr. Brown offered for sale drugs
such as numerous selective androgen receptor modulators (``SARMs''),
including Cardarine, Ostarine, Ligandrol, and YK-11. Mr. Brown also
offered for sale through his company's websites Viagra-Max Sildenafil
and Cialis-Max Tadalafil, which were unapproved versions of the
prescription drugs Viagra and Cialis. In addition, Mr. Brown also
offered for sale an unapproved version of drug products containing
semaglutide, the active pharmaceutical ingredient in the FDA approved
prescription drugs Ozempic, Wegovy, and Rybelsus. None of the drugs Mr.
Brown sold through his website was approved by FDA. Mr. Brown included
on his websites disclaimers that he knew were false and misleading,
including falsely stating the drugs offered for sale were for
``research purposes only'' and ``not for human consumption.''
Mr. Brown obtained the bulk of the drugs he sold through his
websites from China. Mr. Brown did not ask his Chinese suppliers about
the shipping or storage conditions of the drugs he obtained from them,
nor did he use a lab or other method to verify the contents of the
drugs he received from China. However, on one of Mr. Brown's company's
websites, he included assertions on the Original SARMs site that he
used only the highest quality pharmaceutical grade ingredients and U.S.
manufacturing practices; Mr. Brown knew that these assertions were
false. In addition, the labeling on the drugs Mr. Brown sold through
his website falsely stated that the drugs were made in the United
States; Mr. Brown also knew that these claims were false.
On June 12, 2023, Mr. Brown received a Warning Letter from FDA. The
Warning Letter stated that FDA had reviewed the Original SARMs Site and
determined that the products the site offered for sale, including
Ostarine and Ligandrol, were unapproved new drugs sold in violation of
the FD&C Act. The Warning Letter also stated that even though the
products were marketed ``for research purpose only'' and ``not for
human consumption,'' evidence from his company's website established
the products were in fact intended for human use. The Warning Letter
advised Mr. Brown that FDA had safety concerns about products
containing SARMs, including possible life-threatening reactions and the
potential to increase the risk of heart attack and stroke. The Warning
Letter stated that Mr. Brown was responsible for investigating the
cause of any violations, preventing their reoccurrence, preventing the
occurrence of other violations, and ensuring Mr. Brown's company
complied with all requirements of Federal law, including FDA
regulations.
Despite reading and fully understanding the Warning Letter FDA sent
Mr. Brown, he continued operating the Original SARMs website, but he no
longer listed Viagra-Max Sildenafil, Cialis-Max Tadalafil, and
semaglutide for sale. However, Mr. Brown continued offering SARMs
through the Original SARMs site but removed certain claims about the
product from the site. Mr. Brown also continued operating his VIP SARMs
site in the same manner as before he received the Warning Letter,
including by continuing to offer for sale SARMs alongside claims that
they were intended to affect the structure and/or function of the human
body, except that he began directing customers of the Original SARMs
website to his VIP SARMs site. In response to FDA's Warning Letter, Mr.
Brown stated that he had taken corrective actions to address the
violations. Mr. Brown knew that this statement was misleading.
Between March 2023 and December 2023, Mr. Brown made numerous sales
to an FDA undercover investigator posing as a customer of the SARMs
websites. FDA laboratories tested the products obtained. Many tested
positive for substances not listed on the Warrior Labz SARMS product
labels; some were found not to contain the ingredients listed on those
labels. For instance, of the substances received from an August
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2023 undercover purchase, one drug was labeled as containing Ostarine
and another as containing Ligandrol though neither contained Ligandrol,
and both contained Ostarine and a substance not included on the label,
Clomiphene. Clomiphene is an unapproved version of a prescription drug
approved by FDA to treat infertility in women by inducing ovulation.
Between March 2019 and December 2023, Mr. Brown received at least
$1,183,985.60 from sales of unapproved new drugs through his websites.
FDA sent Mr. Brown, by certified mail, on April 16, 2025, a notice
proposing to debar him for a 5-year period from importing or offering
for import any drug into the United States. The proposal was based on a
finding under section 306(b)(3)(C) of the FD&C Act that Mr. Brown's
felony conviction under Federal law for introduction of unapproved
drugs into interstate commerce with intent to defraud or mislead in
violation of 21 U.S.C. 331(d), 333(a)(2), and 355(a) (sections 301(d),
303(a)(2), and 505(a) of the FD&C Act), was for conduct relating to the
importation of any drug or controlled substance into the United States
because Mr. Brown illegally imported and introduced misbranded
prescription drug products into interstate commerce. In proposing a
debarment period, FDA weighed the considerations set forth in section
306(c)(3) of the FD&C Act that the Agency considered applicable to Mr.
Brown's offense and concluded that the offense warranted the imposition
of a 5-year period of debarment.
The proposal informed Mr. Brown 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 the opportunity for a hearing and of any contentions concerning this
action. Mr. Brown received the proposal and notice of opportunity for a
hearing on April 21, 2025. Mr. Brown 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(b)(3)(C) of the FD&C
Act, under authority delegated to the Director, Division of
Enforcement, finds that Mr. Jeremy Spencer Brown has been convicted of
a felony under Federal law for conduct relating to the importation into
the United States of any drug or controlled substance. FDA finds that
the offense should be accorded a debarment period of 5 years as
provided by section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Brown is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug by, with the assistance of,
or at the direction of Mr. Brown is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-02786 Filed 2-11-26; 8:45 am]
BILLING CODE 4164-01-P
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