Notice2023-12487
Luis Anarbol Moran: 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
June 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Luis Anarbol Moran 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. Moran was convicted of one felony count under Federal law for smuggling goods into the United States. The factual basis supporting Mr. Moran's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Moran 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 March 30, 2023 (30 days after receipt of the notice), Mr. Moran had not responded. Mr. Moran'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 88 Issue 112 (Monday, June 12, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38059-38060]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-3011]
Luis Anarbol Moran: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
debarring Luis Anarbol Moran 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. Moran was convicted of one felony count
under Federal law for smuggling goods into the United States. The
factual basis supporting Mr. Moran's conviction, as described below, is
conduct relating to the importation into the United States of a drug or
controlled substance. Mr. Moran 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 March 30, 2023 (30 days after receipt
of the notice), Mr. Moran had not responded. Mr. Moran'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 June 12, 2023.
ADDRESSES: Any application by Mr. Moran for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted 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-
2022-N-3011. 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. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' 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.
[[Page 38060]]
and 4 p.m., Monday through Friday. 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, 240-402-8743, or
<a href="/cdn-cgi/l/email-protection#dbbfbeb9baa9b6beb5afa89bbdbfbaf5b3b3a8f5bcb4ad"><span class="__cf_email__" data-cfemail="5b3f3e393a29363e352f281b3d3f3a75333328753c342d">[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 July 22, 2022, Mr. Moran 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
his plea of guilty and entered judgment against him 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 October 6, 2021, and the plea agreement,
filed on April 14, 2022, in Mr. Moran's case, Jhanna 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 1 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.
During the search of Ms. Novikov's residence, agents seized her
cell phone and subsequently conducted a computer forensic examination
of the phone. The examination revealed that, from August 10, 2016
through June 26, 2018, Mr. Moran exchanged messages with Ms. Novikov
about the products he sold her, referring to them as ``botox,'' ``bx,''
and ``tox.'' In some cases, Mr. Moran's messages discussed sending
packages to Ms. Novikov from outside the United States. For example, in
response to Ms. Novikov's October 3, 2016, inquiry about a package, Mr.
Moran replied that ``[i]t was in customs.'' In another instance on
April 18, 2017, Ms. Novikov wrote to Mr. Moran that a package had been
``opened at customs'' but ``all fine[.]'' In response, Mr. Moran stated
he had ``put it as anti dandruff.'' In another exchange, on June 22,
2018, Ms. Novikov messaged Mr. Moran, ``I need bx'' and agreed to pay
$1,200, plus $100 shipping. Ms. Novikov sent Mr. Moran a photograph of
a deposit slip on June 25, 2018, indicating that $1,300 had been
deposited into a bank account. That same day, Mr. Moran sent Ms.
Novikov a photograph of a shipping confirmation for a package he
shipped to her from Mexico. On June 26, 2018, Ms. Novikov sent Mr.
Moran a message asking, ``Why Caspis? They like Neuroxin better.'' Mr.
Moran replied, ``is for customs . . . issues'' and offered to send Ms.
Novikov ``Neuroxin labels'' and ``boxes and stickers[,]'' but she
declined.
As a result of this conviction, FDA sent Mr. Moran, by certified
mail, on February 9, 2023, 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. Moran's felony conviction under Federal law
for smuggling goods into the United States, in violation of 18 U.S.C.
545, was for conduct relating to the importation into the United States
of any drug or controlled substance because he illegally imported
unapproved new drugs containing botulinum toxin for use in treatments
conducted by others 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 Mr. Moran's offense and concluded
that the offense warranted the imposition of a 5-year period of
debarment.
The proposal informed Mr. Moran 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. Moran received the proposal and notice of opportunity for a
hearing at his residence on February 28, 2023. Mr. Moran 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).
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. Luis
Anarbol Moran 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. Moran 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 by, with the assistance of,
or at the direction of Mr. Moran is a prohibited act.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12487 Filed 6-9-23; 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 June 12, 2023.
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.