[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47565-47566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
     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

     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov 
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 [email protected].

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