[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38059-38060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12487]


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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.

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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

     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-
2022-N-3011. 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. 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: 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.

[[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 
[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 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