Notice2025-18213
William Goldsmith: Final Debarment Order
Primary source
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Published
September 19, 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 (the FD&C Act) debarring William Goldsmith 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. Goldsmith was convicted of one felony count under Federal law for introducing misbranded drugs into interstate commerce. The factual basis supporting Mr. Goldsmith's conviction, as described below, is conduct relating to the importation of a drug into the United States. Mr. Goldsmith 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 August 19, 2025 (more than 30 days after receipt of the notice), Mr. Goldsmith had not responded. Mr. Goldsmith'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 180 (Friday, September 19, 2025)</title>
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[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Pages 45223-45225]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18213]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1873]
William Goldsmith: 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 (the FD&C Act) debarring
William Goldsmith 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. Goldsmith was convicted of one felony count under
Federal law for introducing misbranded drugs into interstate commerce.
The factual basis supporting Mr. Goldsmith's conviction, as described
below, is conduct relating to the importation of a drug into the United
States. Mr. Goldsmith 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 August 19, 2025 (more than 30 days after receipt of
the notice), Mr. Goldsmith had not responded. Mr. Goldsmith'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 19, 2025.
ADDRESSES: Any application by Mr. Goldsmith 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 45224]]
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-
2024-N-1873. 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#f5919097948798909b8186b5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="89edecebe8fbe4ece7fdfac9efede8a7e1e1faa7eee6ff">[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 March 18, 2024, Mr. Goldsmith was convicted in the United States
District Court for the Southern District of Illinois when the court
accepted his plea of guilty and entered judgment against him for the
offense of introducing misbranded drugs into interstate commerce in
violation of 21 U.S.C. 331(a) and 333(a)(2) (sections 301(a) and
303(a)(2) of the FD&C Act). The underlying facts supporting the
conviction are as follows: As contained in the Stipulation of Fact, Mr.
Goldsmith was the registered agent of Malosi Fitness Corporation
(Malosi) in Illinois. Through Malosi's website Mr. Goldsmith sold and
dispensed products labeled as ``Ma'Kava,'' ``Ma'Kava Private Stock,''
and ``Night Cap X,'' all of which were marketed as ``all natural'' male
sexual performance enhancement supplements to hundreds of purchasers
located throughout the United States. The labels of the products Mr.
Goldsmith sold claimed the products included only ``natural'' herbal
ingredients. In reality, the products Mr. Goldsmith sold contained
sildenafil citrate, which was not listed as an ingredient on the labels
of any of the products he sold. Sildenafil citrate is the active
pharmaceutical ingredient in Viagra, a prescription drug approved by
FDA for the treatment of erectile dysfunction. The Ma'Kava products Mr.
Goldsmith sold were drugs within the meaning of section 201(g)(1) of
the FD&C Act (21 U.S.C. 321(g)(1)) because they were intended to be
used to treat erectile dysfunction.
Mr. Goldsmith ordered and received raw sildenafil from companies in
China and India in one-kilogram packages. Mr. Goldsmith mixed the raw
sildenafil he received with other ingredients and placed the mixture
into empty capsules. Mr. Goldsmith packaged these capsules into small
bottles, printed with labels he made but which did not list sildenafil
citrate as an ingredient on the labels. Mr. Goldsmith shipped his
products containing the imported sildenafil citrate to customers across
the United States. The selling of sildenafil generated Mr. Goldsmith
more than $250,000 in gross proceeds.
FDA sent Mr. Goldsmith, by certified mail, on May 29, 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.
Goldsmith was convicted, within the meaning of section 306(l)(1) of the
FD&C Act, of a felony under federal law. This conviction for
introducing misbranded drugs into interstate commerce in violation of
21 U.S.C. 331(a) and 333(a)(2) (sections 301(a) and 303(a)(2) of the
FD&C Act) was for conduct relating to the importation of any drug or
controlled substance into the United States, as discussed above. 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. Goldsmith's offense and concluded that the offense warranted the
imposition of a 5-year period of debarment.
The proposal informed Mr. Goldsmith 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. Goldsmith received the proposal and notice of opportunity
for a hearing on
[[Page 45225]]
June 7, 2024. Mr. Goldsmith 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. William Goldsmith 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. Goldsmith 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. Goldsmith is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18213 Filed 9-18-25; 8:45 am]
BILLING CODE 4164-01-P
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