[Federal Register Volume 89, Number 110 (Thursday, June 6, 2024)]
[Notices]
[Pages 48432-48434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5324]


Marina Sievert: 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 
Marina Sievert for a period of 10 years from importing or offering for 
import any drug into the United States. FDA bases this order on a 
finding that Ms. Sievert was convicted of one felony count under 
Federal law for mail fraud and one felony count under Federal law

[[Page 48433]]

for introduction of an unapproved new drug into interstate commerce. 
The factual basis supporting Ms. Sievert's conviction, as described 
below, is conduct relating to the importation into the United States of 
a drug or controlled substance. Ms. Sievert 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 March 10, 2024 (30 days 
after receipt of the notice), Ms. Sievert had not responded. Ms. 
Sievert'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 June 6, 2024.

ADDRESSES: Any application by Ms. Sievert 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-5324. 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 October 31, 2023, Ms. Sievert was convicted as defined in 
section 306(l)(1) of the FD&C Act in the United States District Court 
for the Middle District of Florida-Tampa Division when the court 
accepted her plea of guilty and entered judgment against her for two 
felony offenses, mail fraud in violation of 18 U.S.C. 1341 and 
introduction of an unapproved new drug into interstate commerce in 
violation of 21 U.S.C. 331(d), 355(a), and 333(a)(2). The underlying 
facts supporting the conviction are as follows: as contained in the 
Indictment and the Plea Agreement from her case, beginning in or about 
July 2019, and continuing through in or about April 2022, Ms. Sievert 
served as the registered agent, president, and director of Beauty 
Forever Florida, Inc. (BFF). In addition, Ms. Sievert operated the 
website www.beautyforeverflorida.com (the BFF website) on behalf of 
BFF. Through the BFF website Ms. Sievert sold a variety of foreign 
unapproved beauty and skin care products, including botulinum toxin 
type A drugs, to customers across the United States. On BFF's website 
Ms. Sievert promoted and sold a Korean pharmaceutical company's 
products, Innotox Medytox and Meditoxin. Innotox Medytox and Meditoxin 
were injectable botulinum toxin type A products that Ms. Sievert 
advertised would temporarily improve moderate to severe wrinkle lines 
and/or procerus muscle activity in adults. FDA-approved drug products 
containing botulinum toxin type A are only available pursuant to a 
prescription from a licensed prescriber. Innotox Medytox and Meditoxin 
lacked required FDA approval and were unapproved new drugs. Ms. Sievert 
ordered, purchased, imported, and received Innotox Medytox and 
Meditoxin from a foreign pharmaceutical retailer for the purpose of 
redistributing them to BFF's customers in the United States. The BFF 
website's online store used false and fraudulent pretenses and 
representations, including false and misleading claims that BFF's 
products were ``FDA approved,'' had ``cleared customs,'' and had 
``guaranteed authenticity.''
    On or about March 13, 2020, FDA agents advised Ms. Sievert that 
receiving foreign unapproved new drugs, including specifically foreign 
toxins, in interstate commerce and delivering or offering to deliver 
those drugs to others was a violation of Federal law. FDA agents warned 
Ms. Sievert that the foreign unapproved new

[[Page 48434]]

drugs that she was selling online through the BFF website were not 
``FDA approved.'' Despite these warnings, Ms. Sievert continued 
operating BFF and the BFF website in the same manner as she had prior 
to the FDA's warnings.
    On or about March 29, 2021, an FDA Office of Criminal 
Investigations agent conducted an online undercover purchase from the 
BFF website. The agent purchased five units of injectable botulinum 
type A labeled as ``Innotox 100U. Korea'' and five units of injectable 
botulinum type A labeled as ``Meditoxin 200U-Botulinum A Toxin.'' On or 
about March 30, 2021, the agent received the undercover purchase made 
from the BFF website. The ``Innotox Medytox'' and ``Meditoxin'' labeled 
products were tested by FDA. Both products tested positive for the 
presence of botulinum toxin type A. Between July 2019 and April 2022 
Ms. Sievert derived more than $1,500,000 from her illegal sales of 
foreign unapproved new drugs.
    FDA sent Ms. Sievert, by certified mail, on November 30, 2023, a 
notice proposing to debar her for a 10-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. 
Sievert's felony convictions under Federal law for mail fraud in 
violation of 18 U.S.C. 1341 and introduction of an unapproved new drug 
into interstate commerce in violation of 21 U.S.C. 331(d), 355(a), and 
333(a)(2) was for conduct relating to the importation into the United 
States of any drug or controlled substance because Ms. Sievert 
illegally imported unapproved new drugs containing botulinum toxin type 
A and sold those products to her company's customers throughout the 
United States. 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. Sievert's offenses and concluded that the 
offenses warranted the imposition of a 10-year period of debarment.
    The proposal informed Ms. Sievert 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. Sievert received the proposal and notice of opportunity for 
a hearing on February 9, 2024. Ms. Sievert 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. 
Marina Sievert has been convicted of two felonies under Federal law for 
conduct relating to the importation into the United States of any drug 
or controlled substance. FDA finds that the offenses should each be 
accorded a debarment period of 5 years, to run consecutively for a 
total debarment period of 10 years as provided by section 
306(c)(2)(A)(iii) of the FD&C Act.
    As a result of the foregoing finding, Ms. Sievert is debarred for a 
period of 10 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 Ms. Sievert is a prohibited act.

    Dated: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12356 Filed 6-5-24; 8:45 am]
BILLING CODE 4164-01-P