Notice2025-19162
Jason Oppenheimer: Final Debarment Order
Primary source
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Published
October 1, 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 Jason Oppenheimer 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. Oppenheimer was convicted of one felony count under Federal law for the offense of possession with intent to distribute Tapentadol. The factual basis supporting Mr. Oppenheimer's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Oppenheimer 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 July 17, 2025 (30 days after receipt of the notice), Mr. Oppenheimer had not responded. Mr. Oppenheimer'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 188 (Wednesday, October 1, 2025)</title>
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[Federal Register Volume 90, Number 188 (Wednesday, October 1, 2025)]
[Notices]
[Pages 47310-47311]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19162]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1114]
Jason Oppenheimer: 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
Jason Oppenheimer 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. Oppenheimer was convicted of one felony count under
Federal law for the offense of possession with intent to distribute
Tapentadol. The factual basis supporting Mr. Oppenheimer's conviction,
as described below, is conduct relating to the importation into the
United States of a drug or controlled substance. Mr. Oppenheimer 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 July 17,
2025 (30 days after receipt of the notice), Mr. Oppenheimer had not
responded. Mr. Oppenheimer'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 October 1, 2025.
ADDRESSES: Any application by Mr. Oppenheimer 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
[[Page 47311]]
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-1114. 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, <a href="/cdn-cgi/l/email-protection#6d09080f0c1f000803191e2d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="dcb8b9bebdaeb1b9b2a8af9cbab8bdf2b4b4aff2bbb3aa">[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 March 17, 2025, Mr. Oppenheimer was convicted as defined in
section 306(l)(1) of the FD&C Act, in the U.S. District Court for the
Northern District of California when the court accepted his plea of
guilty and entered judgment against him for the offense of possession
with intent to distribute Tapentadol in violation of 21 U.S.C.
841(a)(1) and 841(b)(1)(C). The underlying facts supporting the
conviction are as follows: As contained in the Indictment from Mr.
Oppenheimer's case, to which he pleaded guilty, in return for payment
from others he received prescription drugs from foreign countries and
held them at his residence. Mr. Oppenheimer made videos showing himself
unpacking boxes of the controlled substances in order to confirm
receipt of the drugs to others. Mr. Oppenheimer then would receive
order information from others and used that information to repack the
misbranded drugs and ship them to the customers in the United States
who placed the orders.
FDA sent Mr. Oppenheimer, by certified mail, on June 12, 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.
Oppenheimer's felony conviction under Federal law for possession with
intent to distribute Tapentadol, was for conduct relating to the
importation of any drug or controlled substance into the United States
because Mr. Oppenheimer received illegally imported misbranded drugs
and then stored them before he repackaged and mailed them in violation
of 21 U.S.C. 841(a)(1) and 841(b)(1)(C). 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. Oppenheimer's
offense and concluded that the offense warranted the imposition of a 5-
year period of debarment.
The proposal informed Mr. Oppenheimer 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. Oppenheimer received the proposal and notice of opportunity
for a hearing on June 17, 2025. Mr. Oppenheimer 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. Jason Oppenheimer 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. Oppenheimer 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. Oppenheimer is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-19162 Filed 9-30-25; 8:45 am]
BILLING CODE 4164-01-P
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