[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16215-16216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06036]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov.

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 
[email protected].

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 https://www.regulations.gov 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