Notice2026-19655
Jeffrey Thies: Final Debarment Order
Primary source
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Published
September 25, 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 Jeffrey Thies 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. Thies was convicted of two felony counts under Federal law for trafficking in counterfeit goods and aiding and abetting. The factual basis supporting Mr. Thies's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Thies 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 13, 2026 (more than 30 days after receipt of the notice), Mr. Thies had not responded. Mr. Thies'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 91 Issue 185 (Friday, September 25, 2026)</title>
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[Federal Register Volume 91, Number 185 (Friday, September 25, 2026)]
[Notices]
[Pages 60970-60972]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19655]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6692]
Jeffrey Thies: 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 Jeffrey Thies 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. Thies was convicted of two felony counts
under Federal law for trafficking in counterfeit goods and aiding and
abetting. The factual basis supporting Mr. Thies's conviction, as
described below, is conduct relating to the importation into the United
States of a drug or controlled substance. Mr. Thies 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 13, 2026
(more than 30 days after receipt of the notice), Mr. Thies had not
responded. Mr. Thies'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 September 25, 2026.
ADDRESSES: Any application by Mr. Thies 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,
[[Page 60971]]
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-6692. 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. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' 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#0763626566756a6269737447616366296f6f7429606871"><span class="__cf_email__" data-cfemail="4f2b2a2d2e3d222a213b3c0f292b2e6127273c61282039">[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 August 6, 2025, Mr. Thies was convicted as defined in section
306(l)(1) of the FD&C Act, in the U.S. District Court for the Eastern
District of Pennsylvania, when the court accepted his plea of guilty
and entered judgment against him on two counts for the felony offenses
of trafficking in counterfeit goods in violation of 18 U.S.C.
2320(a)(1) and aiding and abetting in violation of 18 U.S.C. 2. The
underlying facts supporting the conviction are as follows:
As contained in the Indictment and in the Government's Change of
Plea Memorandum, from in or around 2020 through in or around January
2023, Mr. Thies operated websites, including ``<a href="http://sexpillshop.com">sexpillshop.com</a>,''
through which he trafficked counterfeit ``sex pills.'' In order to
obtain and manufacture the counterfeit pills, Mr. Thies smuggled
counterfeit Viagra and Cialis pills and packaging and the active
ingredients sildenafil and tadalafil into the United States from
foreign suppliers in China and India. Viagra and Cialis are
prescription drug products that are approved by FDA for distribution
within the United States for certain medical conditions. Under Federal
law, and in order to ensure public health safety, genuine prescription
drug products must be manufactured and distributed under strict quality
control standards and may be dispensed only upon a doctor's
prescription and by a licensed pharmacist.
On or about December 16, 2020, a federal agent acting in an
undercover capacity visited a website controlled by Mr. Thies. The
website advertised for sale a large number of pills listed as ``male
enhancement products,'' which were available for purchase in various
quantities and packages. The agent placed an order for two packs of
``sex pills'': ``80 Pill Steal Variety Pack'' and ``50 Pill All Imports
Variety Pack.'' The agent paid a total of $99.98 to an account
controlled by Mr. Thies. Two days later, on December 18, 2020, the
agent received an email from <a href="/cdn-cgi/l/email-protection#d4a7b1aca4bdb8b8a7bcbba494b3b9b5bdb8fab7bbb9"><span class="__cf_email__" data-cfemail="5221372a223b3e3e213a3d2212353f333b3e7c313d3f">[email protected]</span></a> that confirmed the
pills were shipped by U.S. mail, provided a tracking number, and
offered a cell phone number registered to Mr. Thies for any additional
assistance. When the agent sent a follow-up email, Mr. Thies responded
and apologized for the delay.
On or about January 13, 2021, the agent received a parcel with his
order of pill packs in an undercover mailbox. The parcel sent by Mr.
Thies contained a variety of pills. Some pills were in unmarked blister
packs; others were in capsules and packaging with names including
``Superman,'' ``Black Mamba,'' and ``Blue Rhino.'' Much of the wording
on the packaging was in a foreign language. The parcel also included a
blue and silver box labeled ``U.S.A. Viagra'' with a glass vial labeled
``U.S.A. Viagra,'' which contained 10 blue almond-shaped tablets
imprinted with ``USA'' on each side. Law enforcement identified
fingerprints on the parcel and its contents that matched Mr. Thies's
fingerprints. The Viagra packaging and pills were counterfeit.
On January 11, 2023, law enforcement executed a federal search
warrant at Mr. Thies's home in Philadelphia, Pennsylvania. In his
residence, agents found a pill laboratory in the basement work area
where Mr. Thies manufactured, packaged, and prepared to ship
counterfeit pills to consumers. Agents seized his computers, phones,
and other items consistent with the trafficking of counterfeit pills,
such as pill bottles, pill presses, baking flour, various packages of
male enhancement pills, other packaging and shipping materials, empty
capsules, and counterfeit Viagra and Cialis pills. Most of these items
were found on and
[[Page 60972]]
around a dirty, non-sterile bench area in the basement laboratory where
multiple house cats also lingered. Specifically, agents seized from Mr.
Thies's residence 90 tablets purporting to be Viagra and 90 tablets
purporting to be Cialis. The Viagra and Cialis packaging and pills were
counterfeit. The counterfeit marks and trade names, ``Viagra'' and
``Cialis,'' used by Mr. Thies were identical or substantially
indistinguishable from the genuine marks owned by Pfizer, Inc./Viatris,
Inc. and Eli Lilly & Company, and Mr. Thies used the marks in
connection with purported ``sex pills,'' which were likely to confuse
or deceive consumers into believing that the product was made by the
genuine owner of the trademark. Mr. Thies was present at his residence
at the time of the search.
During the search, Mr. Thies admitted to law enforcement that he
sold male enhancement pills on his websites, including on
<a href="http://sexpillshop.com">sexpillshop.com</a>, sometimes receiving up to three orders a day. On
January 13, 2023, Mr. Thies met with law enforcement agents and again
admitted that he sold male enhancement pills on his websites for years.
He also stated he previously sold pills on eBay and social media
platforms, but that his accounts were closed upon being told that he
could not sell counterfeit products on those platforms.
Law enforcement searched and reviewed the email accounts Mr. Thies
operated, including <a href="/cdn-cgi/l/email-protection#85f6e0fdf5ece9e9f6edeaf5c5e2e8e4ece9abe6eae8"><span class="__cf_email__" data-cfemail="97e4f2efe7fefbfbe4fff8e7d7f0faf6fefbb9f4f8fa">[email protected]</span></a> and <a href="/cdn-cgi/l/email-protection#ef858a8989828a9b9b87868a9caf88828e8683c18c8082"><span class="__cf_email__" data-cfemail="b0dad5d6d6ddd5c4c4d8d9d5c3f0d7ddd1d9dc9ed3dfdd">[email protected]</span></a>.
These email accounts contained lengthy correspondence between Mr. Thies
and foreign suppliers of male enhancement pills, ingredients, and
packaging, including suppliers from China and India, and customers who
purchased pills from his website. At times, Mr. Thies faced impediments
to importing counterfeit pills and packaging from foreign countries.
When his shipments were seized or took longer to arrive, Mr. Thies
would direct his foreign suppliers to use different names and different
shipping addresses, in order to disguise or conceal the destination of
the shipments. In an email on April 28, 2021, for example, Mr. Thies
told a supplier, ``CHANGE IT TO [an alias name] AND MAKE IT APARTMENT
#3 INSTEAD OF #1.'' On June 7, 2021, Mr. Thies was made aware through
an email from a global shipping company that his package had been
detained by United States Customs and Border Protection. Mr. Thies
responded by stating, ``I have 2 options[,] contesting isn't one of
them.'' In other emails, Mr. Thies was told by foreign suppliers that
they were disguising or concealing the contents of shipments to avoid
policies that prohibited the sale of certain drugs. For example, Mr.
Thies received an email from a Chinese supplier stating, ``[s]ince
Alibaba [a Chinese e-commerce marketplace] forbids the sale of
sildenafil [the active ingredient in Viagra], we drafted the credit
order under the name of NMN, and the real goods are sildenafil.'' Mr.
Thies sold over $90,000 worth of pills to consumers throughout the
United States during the relevant time period.
FDA sent Mr. Thies, by certified mail, on June 8, 2026, 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. Thies's
felony convictions under Federal law for trafficking in counterfeit
goods in violation of 18 U.S.C. 2320(a)(1) and aiding and abetting in
violation of 18 U.S.C. 2 were for conduct relating to the importation
of any drug or controlled substance into the United States because Mr.
Thies illegally smuggled and trafficked counterfeit prescription drug
products into the United States. In proposing a debarment period, FDA
weighed the considerations set forth in section 306(c)(3) of the FD&C
that the Agency considered applicable to Mr. Thies's offenses and
concluded that the offenses warranted the imposition of a 10-year
period of debarment, consisting of two 5-year debarment periods for
each felony count to run consecutively.
The proposal informed Mr. Thies 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. Thies received the proposal and notice of opportunity for a
hearing on June 11, 2026. Mr. Thies 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. Jeffrey Thies 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,
consisting of two consecutive 5-year debarment periods as provided by
section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Thies 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 (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. Thies during his period of debarment is a
prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19655 Filed 9-24-26; 8:45 am]
BILLING CODE 4164-01-P
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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.