Notice2025-21075
Nicole Shelby Randall: Final Debarment Order
Primary source
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Published
November 25, 2025
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 Nicole Shelby Randall 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 Ms. Randall was convicted of one felony count under Federal law for introduction of an adulterated drug into interstate commerce. The factual basis supporting Ms. Randall's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Randall was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of July 30, 2025 (30 days after receipt of the notice), Ms. Randall had not responded. Ms. Randall's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 90 Issue 225 (Tuesday, November 25, 2025)</title>
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[Federal Register Volume 90, Number 225 (Tuesday, November 25, 2025)]
[Notices]
[Pages 53327-53329]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1137]
Nicole Shelby Randall: 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 Nicole Shelby Randall 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 Ms. Randall was convicted of one
felony count under Federal law for introduction of an adulterated drug
into interstate commerce. The factual basis supporting Ms. Randall's
conviction, as described below, is conduct relating to the importation
into the United States of a drug or controlled substance. Ms. Randall
was given notice of the proposed debarment and was given an opportunity
to request a hearing to show why she should not be debarred. As of July
30, 2025 (30 days after receipt of the notice), Ms. Randall had not
responded. Ms. Randall's failure to respond and request a hearing
constitutes a waiver of her right to a hearing concerning this matter.
DATES: This order is applicable November 25, 2025.
ADDRESSES: Any application by Ms. Randall 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
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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-1137. 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#6c08090e0d1e010902181f2c0a080d4204041f420b031a"><span class="__cf_email__" data-cfemail="bedadbdcdfccd3dbd0cacdfed8dadf90d6d6cd90d9d1c8">[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 January 22, 2025, Ms. Randall was convicted as defined in
section 306(l)(1) of the FD&C Act, in the U.S. District Court for the
District of Oregon, when the court accepted her plea of guilty and
entered judgment against her for the felony offense of introduction of
an adulterated drug into interstate commerce in violation of sections
301(a) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)).
The underlying facts supporting the conviction are as follows: As
contained in the Information and Plea Agreement from her case,
beginning on or about February 2020, and continuing through on or about
May 2022, Ms. Randall along with co-conspirators operated a scheme to
import and distribute GS-441524, a new drug, within the United States.
This drug, GS-441524, has not been approved by FDA for human or animal
use. To mislead and defraud U.S. Customs and Border Protection (CBP)
officers, Ms. Randall imported GS-441524 from China and Hong Kong
disguised in boxes marked ``Facial Mask'' and ``Pet Shampoo'' and
declared to CBP as ``Beauty Essence Products,'' ``Cosmetics,''
``Essence Water,'' and ``Beauty Facial Masks.'' Through the private
Facebook Group, ``FIP Warriors 5.0,'' Ms. Randall marketed GS-441524.
Despite having no veterinary or prescriber licenses, Ms. Randall
defrauded and mislead her customers by ``diagnosing'' their cats and
kittens with Feline Infectious Peritonitis (FIP) and ``prescribing''
GS-441524 for the animal's consumption. On or about August 12, 2021,
and as part of an undercover law enforcement operations, Ms. Randall
``diagnosed'' a healthy cat with FIP and ``prescribed'' GS-441524 for
consumption. After receiving payment, Ms. Randall introduced GS-441524
into interstate commerce by mailing it to the undercover agents.
FDA sent Ms. Randall, by certified mail, on June 25, 2025, a notice
proposing to debar her 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 Ms. Randall's
felony conviction under Federal law for introduction of an adulterated
drug into interstate commerce in violation of sections 301(a) 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 Ms.
Randall illegally imported and introduced misbranded 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 Ms. Randall's offense and concluded
that the offense warranted the imposition of a 5-year period of
debarment.
The proposal informed Ms. Randall of the proposed debarment and
offered her an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Randall received the proposal and notice of opportunity for
a hearing on June 30, 2025. Ms. Randall failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived any contentions
concerning her 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, under
authority delegated to the Director, Division of Enforcement, finds
that Ms. Nicole Shelby Randall 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, Ms. Randall 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
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assistance of, or at the direction of Ms. Randall is a prohibited act.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-21075 Filed 11-24-25; 8:45 am]
BILLING CODE 4164-01-P
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