[Federal Register Volume 87, Number 129 (Thursday, July 7, 2022)]
[Notices]
[Pages 40539-40540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1358]


Jhanna Novikov: 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 
Jhanna Novikov 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. Novikov was convicted of one felony count under 
Federal law for smuggling goods into the United States. The factual 
basis supporting Ms. Novikov's conviction, as described below, is 
conduct relating to the importation into the United States of a drug or 
controlled substance. Ms. Novikov 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 April 8, 2022 (30 days after receipt 
of the notice), Ms. Novikov had not responded. Ms. Novikov's failure to 
respond and request a hearing within the prescribed timeframe 
constitutes a waiver of her right to a hearing concerning this matter.

DATES: This order is applicable July 7, 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 
<a href="/cdn-cgi/l/email-protection#ff9b9a9d9e8d929a918b8cbf999b9ed197978cd1989089"><span class="__cf_email__" data-cfemail="6e0a0b0c0f1c030b001a1d2e080a0f4006061d40090118">[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 the 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 December 9, 2021, Ms. Novikov was convicted, as defined in 
section 306(l)(1) of FD&C Act, in the U.S. District Court for the 
Southern District of Florida-West Palm Beach Division, when the court 
accepted her guilty plea and entered judgment against her for the 
offense of smuggling goods into the United States, in violation of 18 
U.S.C. 545. 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 indictment, filed on July 
28, 2021, and the plea agreement, filed on September 30, 2021, both 
from Ms. Novikov's case, on July 25, 2018, Ms. Novikov agreed to treat 
the facial wrinkles of an individual who was an undercover investigator 
with the Florida Department of Health with ``fillers'' for $600 and 
``BOTOX'' for $300. BOTOX, or botulinum neurotoxin Type A, is the most 
well-known neurotoxin approved by FDA to treat facial wrinkles. On 
August 10, 2018, the investigator returned to Ms. Novikov's residence 
for her ``BOTOX'' treatment, and as Ms. Novikov made preparations and 
drew a liquid into a syringe, agents from FDA's Office of Criminal 
Investigations (OCI) entered and took control of her residence. After 
obtaining a warrant, OCI agents searched Ms. Novikov's home. Agents 
seized various vials of white powder from Ms. Novikov's residence, 
including two labeled ``NEUROXIN Botulinum Toxin Type A,'' 14 labeled 
``CASPIS,'' and one with no label. Analysis by the FDA Forensic 
Chemistry Center determined that the two Neuroxin vials, a sample of 
four of the Caspis vials, and the unlabeled vial all contained 
botulinum toxin, the active ingredient in BOTOX; however, a search of 
FDA records revealed that these drugs had not been approved by FDA and 
were unapproved new drugs as well as misbranded drugs. Agents did not 
find any BOTOX or other FDA-approved drugs containing botulinum toxin 
in Ms. Novikov's home. A subsequent forensic examination of Ms. 
Novikov's cell phone, which had been seized by OCI agents, revealed 
that she had imported these unapproved new drugs from Mexico, in 
violation of the FD&C Act, and Ms. Novikov had been importing such 
drugs since 2016.
    As a result of this conviction, FDA sent Ms. Novikov, by certified 
mail, on March 1, 2022, 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. Novikov's felony conviction under Federal law 
for smuggling goods into the United States, in violation of 18

[[Page 40540]]

U.S.C. 545, was for conduct relating to the importation into the United 
States of any drug or controlled substance because she illegally 
imported unapproved new drugs containing botulinum toxin to use in 
treatments she conducted on individuals for money. 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. 
Novikov's offense and concluded that the offense warranted the 
imposition of a 5-year period of debarment.
    The proposal informed Ms. Novikov of the proposed debarment, 
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. Novikov received the proposal and notice of opportunity for 
a hearing at her residence on March 9, 2022. Ms. Novikov 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. 
Jhanna Novikov 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. Novikov 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. Novikov is a 
prohibited act.
    Any application by Ms. Novikov for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2021-N-1358 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: June 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14433 Filed 7-6-22; 8:45 am]
BILLING CODE 4164-01-P


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