[Federal Register Volume 90, Number 103 (Friday, May 30, 2025)]
[Notices]
[Pages 23057-23059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09797]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5281]
Evan Asher Field: 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
Evan Asher Field 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. Field was convicted of one felony count under Federal
law. The factual basis supporting Mr. Field's conviction, as described
below, is conduct relating to the importation into the United States of
a drug or controlled substance. Mr. Field 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 April 25, 2024 (30 days after
receipt of the notice), Mr. Field had not responded. Mr. Field'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 30, 2025.
ADDRESSES: Any application by Mr. Field 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
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
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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
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-
2023-N-5281. 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. 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, 240-402-
8743, or [email protected].
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 9, 2023, Mr. Field was convicted as defined in section
306(l)(1) of the FD&C Act (21 U.S.C. 335a(l)(1)), 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
September 2021, Mr. Field operated multiple businesses and associated
websites, including Proximo Research. The website for Proximo Research
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 website 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. Field operated the Proximo Research website, were not controlled
under the Controlled Substances Act. At least some of the drugs offered
on Mr. Field's website was purchased by him, and others, in bulk
quantities from sellers located outside the United States, primarily
from China. Once orders were placed through his website, Mr. Field,
assisted by others, would repackage the drugs into consumer-size
containers and ship them to customers at various locations throughout
the United States. Mr. Field did not require evidence or submission of
lawful prescriptions before accepting payment for and shipping the
drugs. Despite his awareness that individuals were buying the drugs for
personal use, Mr. Field 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. Field, by certified mail, on March 18, 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. Field's
felony conviction under Federal law for 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, was for
conduct relating to the importation of any drug or controlled substance
into the United States because Mr. Field 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. Field's offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Field 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. Field received the proposal and notice of opportunity for a
hearing on March 26, 2024. Mr. Field 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. Evan Asher Field has been convicted of a felony under Federal
law for conduct relating to the importation into the United States of
any drug or controlled
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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. Field 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. Field is a prohibited act.
Dated: May 27, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09797 Filed 5-29-25; 8:45 am]
BILLING CODE 4164-01-P