Notice2026-02337
Paul Zachary Lamberty: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 6, 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 Paul Zachary Lamberty for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lamberty was convicted of two felonies under Federal law; one felony count for conspiracy and one felony count for introduction of misbranded drugs with intent to defraud and mislead. The factual basis supporting Mr. Lamberty's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lamberty 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 8, 2025 (30 days after receipt of the notice), Mr. Lamberty had not responded. Mr. Lamberty's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 25 (Friday, February 6, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Notices]
[Pages 5489-5491]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02337]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1655]
Paul Zachary Lamberty: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Paul Zachary Lamberty for a period of 10 years from
importing or offering for import any drug into the United States. FDA
bases this order on a finding that Mr. Lamberty was convicted of two
felonies under Federal law; one felony count for conspiracy and one
felony count for introduction of misbranded drugs with intent to
defraud and mislead. The factual basis supporting Mr. Lamberty's
conviction, as described below, is conduct relating to the importation
into the United States of a drug or controlled substance. Mr. Lamberty
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 8, 2025 (30 days after receipt of the notice), Mr. Lamberty
had not responded. Mr. Lamberty'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 February 6, 2026.
ADDRESSES: Any application by Mr. Lamberty 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
[[Page 5490]]
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-
2025-N-1655. 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#2642434447544b4348525566404247084e4e5508414950"><span class="__cf_email__" data-cfemail="3652535457445b5358424576505257185e5e4518515940">[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 May 30, 2025, Mr. Lamberty was convicted as defined in section
306(l)(1) of the FD&C Act in the U.S. District Court for District of
Massachusetts when the court accepted his plea of guilty and entered
judgment against him for the felony offenses of one felony count for
conspiracy in violation of 18 U.S.C. 371 and one felony count for
introduction of misbranded drugs with intent to defraud and mislead in
violation of 21 U.S.C. 331(a) (section 301(a) 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 February 2017, through on or about August 2021,
Mr. Lamberty operated the websites, <a href="http://www.encern.com">www.encern.com</a> and <a href="http://www.ohmod.com">www.ohmod.com</a>.
Through these websites Mr. Lamberty advertised and sold etizolam.
Etizolam is a drug known as a thienodiazepine. Thienodiazepines are a
class of drug chemically related to benzodiazepines. Benzodiazepines
are a class of drug that produces central nervous system depression. In
the United States, practitioners can prescribe FDA approved products
containing benzodiazepines to treat insomnia and anxiety. However,
benzodiazepines carry a risk of dependency, toxicity, and even fatal
overdose particularly when combined with other central nervous system
depressants. Thienodiazepines carry similar health risks as
benzodiazepines. FDA has not approved any drugs containing etizolam.
The websites Mr. Lamberty operated included disclaimers stating the
products he was selling were for ``For Research Purposes Only'' and
``Not for Human Use.'' However, despite these disclaimers, Mr. Lamberty
knew and intended that the products he sold would be used by humans as
drugs intended to affect the structure or any function of the human
body. Mr. Lamberty obtained the etizolam he sold from suppliers in
China. Mr. Lamberty mislabeled the etizolam before and during
importation into the United States to avoid detection by Customs and
Border Protection (CBP) and he knew he imported the etizolam contrary
to the law. In addition, Mr. Lamberty received the etizolam he
purchased from China at multiple addresses and post office boxes as a
tactic to avoid CBP detection. After Mr. Lamberty received the etizolam
he imported, he sold his drug product to customers in the United States
who had ordered them on the websites he operated. Mr. Lamberty sent the
etizolam to his customers with false labeling stating that the product
was sold ``For Research Purposes Only'' and ``Not for Human
Consumption.'' Despite the disclaimers on the products themselves, Mr.
Lamberty knew the etizolam products he sold would be used by humans as
drugs. The etizolam products Mr. Lamberty sold through his website were
misbranded because their labeling was false and misleading and because
their labeling failed to bear adequate directions for use.
FDA sent Mr. Lamberty, by certified mail, on July 29, 2025, a
notice proposing to debar him for a 10-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.
Lamberty's felony conviction under Federal law for conspiracy in
violation of 18 U.S.C. 371 and one felony count for introduction of
misbranded drugs with intent to defraud and mislead in violation of 21
U.S.C. 331(a) (section 301(a) of the FD&C Act), was for conduct
relating to the
[[Page 5491]]
importation of any drug or controlled substance into the United States
because Mr. Lamberty illegally imported the unapproved drug etizolam
and sold it to customers in the United States. 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. Lamberty's
offense and concluded that the offense warranted the imposition of a
10-year period of debarment.
The proposal informed Mr. Lamberty 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. Lamberty received the proposal and notice of opportunity
for a hearing on August 8, 2025. Mr. Lamberty 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 Director, 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. Paul Zachary Lamberty has been convicted of
felonies under Federal law for conduct relating to the importation into
the United States of any drug or controlled substance. FDA finds that
the offenses should be accorded a debarment period of 10 years as
provided by section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Lamberty is debarred for
a period of 10 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. Lamberty is a prohibited act.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-02337 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 6, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.