Notice2025-09649
Michael Dominic Diaz: Final Debarment Order
Primary source
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Published
May 29, 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) debarring Michael Dominic Diaz 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. Diaz was convicted of one felony count under Federal law. The factual basis supporting Mr. Diaz's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Diaz 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 16, 2024 (30 days after receipt of the notice), Mr. Diaz had not responded. Mr. Diaz'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 90 Issue 102 (Thursday, May 29, 2025)</title>
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[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Notices]
[Pages 22732-22734]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09649]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5302]
Michael Dominic Diaz: 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) debarring
Michael Dominic Diaz 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. Diaz was convicted of one felony count under Federal
law. The factual basis supporting Mr. Diaz's conviction, as described
below, is conduct relating
[[Page 22733]]
to the importation into the United States of a drug or controlled
substance. Mr. Diaz 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 16, 2024 (30 days after receipt of the notice), Mr.
Diaz had not responded. Mr. Diaz'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 May 29, 2025.
ADDRESSES: Any application by Mr. Diaz 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-
2023-N-5302. 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#b8dcdddad9cad5ddd6cccbf8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="6703020506150a0209131427010306490f0f1449000811">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
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 November 27, 2023, Mr. Diaz was convicted as defined in section
306(l)(1) of the FD&C Act in the U.S. District Court for the Western
District of Texas-San Antonio Division when the court accepted his plea
of guilty and entered judgment against him for the felony offense of
Conspiracy to Defraud the United States and Violate 21 U.S.C. 331--
Introduction of Misbranded Drugs into Interstate Commerce in violation
of 18 U.S.C. 371. The underlying facts supporting the conviction are as
follows: As contained in the Information from his case, beginning no
later than August 2019 and continuing to on or about June 2022, Mr.
Diaz was involved in the operation of multiple businesses and
associated websites, including Proximo Research and Gulf Coast Chems.
The websites for these businesses allowed end consumers to place orders
for misbranded prescription drugs, which would be shipped to them via
the U.S. Postal Service and other common carriers. The websites offered
various drugs for sale, including Clonazolam, Flubromazolam,
Fluclotizolam, O-Desmethyl-cis-tramadol (ODSMT) and 2-Methyl-AP-237
(2MAP); these drugs are not approved by FDA for any use in the United
States and, during the time Mr. Diaz was involved in operating the
Proximo Research and Gulf Coast Chems websites, were not controlled
under the Controlled Substances Act. At least some of the drugs offered
on the websites for these businesses were purchased by Mr. Diaz, and
others, in bulk quantities from sellers located outside the United
States, primarily from China. Once orders were placed through the
websites, Mr. Diaz, assisted by others, would repackage the drugs into
consumer-size containers and ship them to customers at various
locations throughout the United States. Mr. Diaz did not require
evidence or submission of lawful prescriptions before accepting payment
for and shipping the drugs. Despite Mr. Diaz's awareness that
individuals were buying the drugs for personal use, he misbranded the
drugs being sold with disclaimers that they were ``for research
purposes only'' and ``not for human consumption'' in an attempt to
evade FDA's regulatory oversight and authority.
FDA sent Mr. Diaz, by certified mail, on April 10, 2024, 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. Diaz's
felony conviction under Federal law for conspiracy to defraud
[[Page 22734]]
the United States and Violate 21 U.S.C. 331--Introduction of Misbranded
Drugs into Interstate Commerce in violation of 18 U.S.C. 371, was for
conduct relating to the importation of any drug or controlled substance
into the United States because Mr. Diaz illegally imported unapproved
drugs from sellers located outside of the United States, including in
China, 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 it
considered applicable to Mr. Diaz's offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Diaz 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. Diaz received the proposal and notice of opportunity for a
hearing on April 16, 2024. Mr. Diaz 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, under
authority delegated to the Director, Division of Enforcement, finds
that Mr. Michael Dominic Diaz 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. Diaz 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. Diaz is a prohibited act.
Dated: May 22, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09649 Filed 5-28-25; 8:45 am]
BILLING CODE 4164-01-P
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