Notice2026-01296
Tyler Jordan Hall: Final Debarment Order
Primary source
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Published
January 23, 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 Tyler Jordan Hall 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. Hall was convicted of a felony under Federal law for introduction of unapproved drugs into interstate commerce. The factual basis supporting Mr. Hall's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Hall 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 September 2, 2025 (30 days after receipt of the notice), Mr. Hall had not responded. Mr. Hall'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 15 (Friday, January 23, 2026)</title>
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[Federal Register Volume 91, Number 15 (Friday, January 23, 2026)]
[Notices]
[Pages 2940-2942]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01296]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1331]
Tyler Jordan Hall: 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 Tyler Jordan Hall 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. Hall was convicted of a felony under
Federal law for introduction of unapproved drugs into interstate
commerce. The factual basis supporting Mr. Hall's conviction, as
described below, is conduct relating to the importation into the United
States of a drug or controlled substance. Mr. Hall 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 September 2, 2025
(30 days after receipt of the notice), Mr. Hall had not responded. Mr.
Hall'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 January 23, 2026.
ADDRESSES: Any application by Mr. Hall 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
[[Page 2941]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2025-N-1331. 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. 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#7216171013001f171c0601321416135c1a1a015c151d04"><span class="__cf_email__" data-cfemail="3256575053405f575c4641725456531c5a5a411c555d44">[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 (21 U.S.C. 335a(b)(3)(C)), 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 May 15, 2025, Mr. Hall was convicted as defined in section
306(l)(1) of the FD&C Act, in the U.S. District Court for the District
of Montana Missoula Division, 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 under 21
U.S.C. 331(d) and 333(a)(2) (sections 301(d) and 303(a)(2) 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, from on or about June 17, 2020, through on or about March 30,
2022, Mr. Hall operated a business known as Rat's Army, LLC (Rat's
Army) to, among other things, import, create, bottle, and label
misbranded drugs which he sold through the Rat's Army website to
customers throughout the United States. Specifically, Mr. Hall
primarily focused on selling selective estrogen receptor modulators
(SERMs) and other unapproved new drugs. SERMs are a class of
prescription drugs primarily intended to block the effects of estrogen
in breast tissue. Products containing SERMs are often marketed and sold
for bodybuilding purposes to reduce male breast enlargement, a commonly
occurring side effect of the use of anabolic steroids and other
synthetic chemicals. Examples of drugs Mr. Hall sold through Rat's
Army's website included Raloxifene, Tamoxifen, and Pramipexole. The FDA
approved version of Raloxifene Hydrochloride is indicated for the
treatment of osteoporosis. The FDA approved version of Tamoxifen
Citrate is indicated for the treatment of breast cancer. The FDA
approved version of Pramipexole Dihydrochloride is indicated for the
treatment of Parkinson's disease. All three of these FDA-approved drugs
are not safe for use except under the supervision of a practitioner
licensed by law to administer prescription drugs. The FDA-approved
labeling for Raloxifene Hydrochloride and Tamoxifen Citrate display a
boxed warning emphasizing serious potential side effects. Throughout
this period, Mr. Hall knowingly took steps to mislead the FDA about the
true nature of the products sold on the Rat's Army website. In order to
avoid seizure by United States Customs and Border Protection officers
of the materials that Mr. Hall shipped internationally, Mr. Hall
falsely claimed that they were supplements or vitamins. While Mr. Hall
represented his business as a ``pharmaceutical manufacturer'' he was
never a pharmacist, he did not employ a licensed pharmacist at Rat's
Army, and he never registered his business with the FDA as a
pharmaceutical manufacturing facility. Specifically, Mr. Hall attempted
to conceal the nature of his products by falsely portraying them as
``research chemicals'' and ``not for human consumption,'' despite
knowing and intending that the products were for ingestion by humans to
affect the structure and function of their bodies. Mr. Hall also took
steps to mislead and defraud the consumers to whom he was offering the
sale of the drugs he sold. Specifically, Mr. Hall posted misleading
Certificates of Analysis on the Rat's Army website to convince
consumers Rat's Army was manufacturing products which were legitimate
and safe to consume. Mr. Hall also falsely claimed that, ``you do not
need a prescription'' or ``access to a pharmacy or pharmacist'' to
obtain products through Rat's Army. Between on or about June 17, 2020,
through on or about March 30, 2022, Mr. Hall obtained proceeds from
Rat's Army of approximately $3,805,470.
FDA sent Mr. Hall, by certified mail, on July 28, 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 (21 U.S.C.
335a(b)(3)(C)) Act that Mr. Hall's felony conviction under Federal law
for introduction of unapproved drugs into interstate commerce under 21
U.S.C. 331(d) and 333(a)(2) (sections 301(d) and 303(a)(2) of the FD&C
Act), was for conduct relating to the importation of any drug or
controlled substance into the United States because Mr. Hall illegally
imported materials for use in developing his products and he introduced
these unapproved new 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. Hall's offense and concluded that the offense
warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Hall 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.
[[Page 2942]]
Hall received the proposal and notice of opportunity for a hearing on
August 2, 2025. Mr. Hall 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, Office of Inspections
and Investigations, under section 306(b)(3)(C) of the FD&C Act (21
U.S.C. 335a(b)(3)(C)), under authority delegated to the Director,
Division of Enforcement, finds that Mr. Tyler Jordan Hall 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. Hall 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, the importing or offering for import into the United
States of any drug by, with the assistance of, or at the direction of
Mr. Hall is a prohibited act.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-01296 Filed 1-22-26; 8:45 am]
BILLING CODE 4164-01-P
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