Notice2024-12064
Shanif Abdul Punjani: Final Debarment Order
Primary source
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Published
June 3, 2024
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 Shanif Abdul Punjani 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. Punjani was convicted of one felony count under Federal law for Conspiracy to Defraud the United States. The factual basis supporting Mr. Punjani's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Punjani 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 March 6, 2024 (30 days after receipt of the notice), Mr. Punjani had not responded. Mr. Punjani'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 89 Issue 107 (Monday, June 3, 2024)</title>
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[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47565-47566]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5023]
Shanif Abdul Punjani: 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
Shanif Abdul Punjani 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. Punjani was convicted of one felony count under
Federal law for Conspiracy to Defraud the United States. The factual
basis supporting Mr. Punjani's conviction, as described below, is
conduct relating to the importation into the United States of a drug or
controlled substance. Mr. Punjani 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 March 6, 2024 (30 days after receipt
of the notice), Mr. Punjani had not responded. Mr. Punjani'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 June 3, 2024.
ADDRESSES: Any application by Mr. Punjani 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 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-
2023-N-5023. 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 Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743,
or <a href="/cdn-cgi/l/email-protection#94f0f1f6f5e6f9f1fae0e7d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="25414047445748404b5156654341440b4d4d560b424a53">[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 16, 2023, Mr. Punjani 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 Georgia-Atlanta Division, when the court accepted his plea
of guilty and entered judgment against him for the offense of
Conspiracy to Defraud the United States in violation of 18 U.S.C. 371.
The underlying facts supporting the conviction are as follows: As
contained in the Information and the Government's Sentencing Statement
from Mr. Punjani's case, in or about March 2019, and continuing until
February 2021, he imported thousands of Aurogra 100mg Sildenafil
tablets, which were male enhancement pills manufactured in India, but
not authorized for sale in the United States. Sildenafil is the same
active pharmaceutical ingredient (API) as that in the prescription drug
Viagra. The FDA approved drugs containing the active ingredient
sildenafil are only
[[Page 47566]]
available by prescription, and may cause serious side effects for those
suffering from cardiovascular disease, hypertension, bleeding
disorders, and other related health conditions. The drugs Mr. Punjani
imported and resold had not been approved by the FDA meaning that they
did not have the same assurance of safety or efficacy as FDA approved
drugs. Mr. Punjani would use commercial shippers to ship the tablets
from India to his home where Mr. Punjani would organize them in order
to resell them to wholesale businesses and convenience stores in
Georgia. The labeling on the drugs Mr. Punjani resold did not contain
adequate directions for use and he dispensed these prescription drugs
without the prescription of a practitioner licensed by law to
administer the drugs. At one point, Customs and Border Patrol (CBP)
sent Mr. Punjani a notice warning him that pills he had offered for
import had been seized because they were in violation of the FD&C Act.
Mr. Punjani ignored this notice and others CBP and FDA later sent him.
Ultimately Mr. Punjani imported thousands of illegal pills over several
years.
As a result of this conviction, FDA sent Mr. Punjani, by certified
mail, on January 30, 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. Punjani's felony conviction under Federal law
for Conspiracy to Defraud the United States in violation of 18 U.S.C.
371, was for conduct relating to the importation into the United States
of any drug or controlled substance because Mr. Punjani illegally
imported and introduced unapproved and misbranded prescription 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. Punjani's offense and
concluded that the offense warranted the imposition of a 5-year period
of debarment.
The proposal informed Mr. Punjani 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. Punjani received the proposal and notice of opportunity for
a hearing on February 5, 2024. Mr. Punjani 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 Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Shanif Abdul Punjani 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. Punjani 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. Punjani is a prohibited act.
Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12064 Filed 5-31-24; 8:45 am]
BILLING CODE 4164-01-P
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