Notice2022-06052
Irfanali Nisarali Momin: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
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 Irfanali Nisarali 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 Mr. Momin was convicted of one felony count under Federal law for conspiracy. The factual basis supporting Mr. Momin's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Momin 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 December 26, 2021 (30 days after receipt of the notice), Mr. Momin had not responded. Mr. Momin's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 55 (Tuesday, March 22, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16214-16215]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06052]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0415]
Irfanali Nisarali Momin: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Irfanali Nisarali 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 Mr. Momin was convicted of one felony count
under Federal law for conspiracy. The factual basis supporting Mr.
Momin's conviction, as described below, is conduct relating to the
importation into the United States of a drug or controlled substance.
Mr. Momin 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 December 26, 2021 (30 days after receipt of the notice), Mr.
Momin had not responded. Mr. Momin'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 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#91f5f4f3f0e3fcf4ffe5e2d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="395d5c5b584b545c574d4a795f5d581751514a175e564f">[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, Mr. 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 him 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 Mr. Momin's case, filed on September
23, 2020, to which he plead guilty, between August 2014 and November
2018, Mr. Momin along with his co-conspirators, illegally imported
misbranded drugs from China that he 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
drugs pursuant to section 503(b) of the FD&C Act (21 U.S.C. 353(b)). In
order to evade U.S. import restrictions, Mr. Momin illegally imported
misbranded drugs into the United States from China. As per the
conspiracy Mr. 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.
Mr. 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 Mr. Momin, by certified
mail, on November 19, 2021, 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. 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 he 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 Mr. Momin's offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Momin 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. Momin received the proposal and notice of opportunity for a
hearing at his residence on November 26, 2021. Mr. Momin 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).
[[Page 16215]]
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.
Irfanali 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, Mr. 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 Mr. Momin is a
prohibited act.
Any application by Mr. Momin for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0415 and sent to the Division of Dockets Management Staff
(see ADDRESSSES). 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. 2022-06052 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 22, 2022.
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.