Notice2022-06036
Shiba I. Momin: Final Debarment Order
Primary source
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Published
March 22, 2022
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 Shiba I. Momin 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 Ms. Momin was convicted of one felony count under Federal law for Conspiracy. The factual basis supporting Ms. Momin's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Momin was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of December 26, 2021 (30 days after receipt of the notice), Ms. Momin had not responded. Ms. Momin's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 87 Issue 55 (Tuesday, March 22, 2022)</title>
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[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16215-16216]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06036]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0417]
Shiba I. Momin: Final Debarment Order
AGENCY: Food and Drug Administration, Department of Health and Human
Services (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
Shiba I. Momin 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 Ms. Momin was convicted of one felony count under Federal
law for Conspiracy. The factual basis supporting Ms. Momin's
conviction, as described below, is conduct relating to the importation
into the United States of a drug or controlled substance. Ms. Momin was
given notice of the proposed debarment and was given an opportunity to
request a hearing to show why she should not be debarred. As of
December 26, 2021 (30 days after receipt of the notice), Ms. Momin had
not responded. Ms. Momin's failure to respond and request a hearing
constitutes a waiver of her right to a hearing concerning this matter.
DATES: This order is applicable March 22, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at
<a href="/cdn-cgi/l/email-protection#593d3c3b382b343c372d2a193f3d387731312a773e362f"><span class="__cf_email__" data-cfemail="1e7a7b7c7f6c737b706a6d5e787a7f3076766d30797168">[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 February 12, 2021, Ms. Momin was convicted, as defined in
section 306(l)(1) of the FD&C Act, in the U.S. District Court for the
District of Georgia, Rome Division, when the court entered judgment
against her for the offense of conspiracy, in violation of 18 U.S.C.
371.
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows:
As contained in the Information in Ms. Momin's case, filed on
September 23, 2020, to which she pleaded guilty, between August 2014
and November 2018, Ms. Momin along with her co-conspirators, illegally
imported misbranded drugs from China that she marketed for male
enhancement under names such as ``Black Ant King,'' ``Bull,'' ``Rhino
7,'' ``Super Hard,'' ``Herb Viagra,'' ``Jack Rabbit,'' ``Zhen Gongfu,''
``Stree Overlord,'' ``Pro Power Max,'' ``A Traditional Chinese
Medicine-Kidney Reinforcing Pallet,'' ``Libigrow,'' ``Red Mamba,''
``Rhino 69,'' ``Krazzy Rhino,'' ``Rhino 25,'' Hard Steel,'' and ``Black
Mamba.'' These products contained sildenafil, the active pharmaceutical
ingredient in Pfizer, Inc.'s FDA-approved erectile dysfunction drug,
VIAGRA, and/or tadalafil, the active pharmaceutical ingredient in Eli
Lilly & Company's FDA-approved erectile dysfunction drug, CIALIS. Both
VIAGRA and CIALIS can be obtained in the United States only with a
prescription from a practitioner licensed by law to administer such
drug pursuant to section 503(b) of the FD&C Act (21 U.S.C. 353(b)). In
order to evade U.S. import restrictions, Ms. Momin illegally imported
misbranded drugs into the United States from China. As per the
conspiracy Ms. Momin was involved in, the U.S. Customs declarations on
the boxes containing the misbranded drugs falsely declared the contents
of the boxes to be something other than misbranded drugs, such as
beauty products and health products, to make it appear that the boxes
contained items that could legally be imported into the United States
Ms. Momin then introduced and delivered for introduction into
interstate commerce these misbranded drugs containing undeclared
sildenafil and tadalafil, in violation of sections 301(a), 301(c),
303(a)(2), 502(a), and 502(f) of the FD&C Act (21 U.S.C. 331(a),
331(c), 333(a)(2), 352(a) and 352(f)).
As a result of this conviction, FDA sent Ms. Momin, by certified
mail, on November 19, 2021, a notice proposing to debar her 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 Ms. Momin's felony conviction under
Federal law for conspiracy, 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 she illegally imported and then
introduced misbranded tadalafil and sildenafil 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 Ms. Momin's offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.
[[Page 16216]]
The proposal informed Ms. Momin of the proposed debarment and
offered her an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Momin received the proposal and notice of opportunity for a
hearing at her residence on November 26, 2021. Ms. Momin failed to
request a hearing within the timeframe prescribed by regulation and
has, therefore, waived her opportunity for a hearing and waived any
contentions concerning her 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 Ms. Shiba
I. Momin 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, Ms. Momin 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 or controlled substance by,
with the assistance of, or at the direction of Ms. Momin is a
prohibited act.
Any application by Ms. Momin for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0417 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
Publicly available submissions will be placed in the docket and
will be viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06036 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P
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