Notice2024-12356
Marina Sievert: Final Debarment Order
Primary source
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Published
June 6, 2024
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 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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 110 (Thursday, June 6, 2024)</title>
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[Federal Register Volume 89, Number 110 (Thursday, June 6, 2024)]
[Notices]
[Pages 48432-48434]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="/cdn-cgi/l/email-protection#9ffbfafdfeedf2faf1ebecdff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="45212027243728202b3136052321246b2d2d366b222a33">[email protected]</span></a>.
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 <a href="http://www.beautyforeverflorida.com">www.beautyforeverflorida.com</a> (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
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