[Federal Register Volume 88, Number 240 (Friday, December 15, 2023)]
[Notices]
[Pages 86906-86907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3369]


Adam Michael Nagy: 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 (the FD&C Act) debarring 
Adam Michael Nagy for a period of 15 years from importing or offering 
for import any drug into the United States. FDA bases this order on a 
finding that Mr. Nagy was convicted of three relevant felony counts 
under Federal law. The factual basis supporting Mr. Nagy's conviction, 
as described below, is conduct relating to the importation into the 
United States of a drug or controlled substance. Mr. Nagy 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 October 
22, 2023 (30 days after receipt of the notice), Mr. Nagy had not 
responded. Mr. Nagy's failure to respond and request a hearing 
constitutes a waiver of his right to a hearing concerning this matter.

DATES: This order is effective December 15, 2023.

ADDRESSES: Any application by Mr. Nagy 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-
2023-N-3369. 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. 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 (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 May 1, 2023, Mr. Nagy was convicted, as defined in section 
306(l)(1) of FD&C Act, in the U.S. District Court for the Western 
District of Pennsylvania, when the court entered judgment against him 
for multiple

[[Page 86907]]

offenses he pled guilty to, including the offenses of: (1) importation 
into the United States a quantity of ethylone, a Schedule I Controlled 
Substance in violation of 21 U.S.C. 952(a) and 960(a)(1); (2) 
importation into the United States quantities of TURINABOL and 
DIANABOL, anabolic steroids, and Schedule III Controlled Substances in 
violation of 21 U.S.C. 952(b) and 960(a)(1); and (3) smuggling goods 
into the United States, that is, alpha-PVP ethylone, Schedule I 
Controlled Substances, and TURINBOL and DIANABOL, Schedule III 
Controlled Substances, 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 superseding indictment, filed on March 22, 
2018, the Defendant's motion for downward variance, filed on April 24, 
2023, and the Government's sentencing memorandum, filed April 24, 2023, 
from Mr. Nagy's case, Mr. Nagy was the owner and operator of 
Prescription Nutrition, Prescription Protein, and N.O.B. Industries 
located in Pennsylvania. From on or about June 2014 to on or about 
September 2014, Mr. Nagy imported various types of controlled 
substances which he then capsuled and distributed to clients. 
Specifically, from on or about June 2014 to on or about July 2014, Mr. 
Nagy illegally imported ethylone. In July 2014, he also illegally 
imported TURINABOL and DIANABOL. In addition, from June 2014 until on 
or about September 2014, Mr. Nagy illegally imported alpha-PVP, 
ethylone, TURINABOL, and DIANABOL. All the controlled substances Mr. 
Nagy imported and smuggled into the country came from China.
    As a result of this conviction, FDA sent Mr. Nagy, by certified 
mail, on September 20, 2023, a notice proposing to debar him for a 15-
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. Nagy's three felony convictions 
that included: (1) importation into the United States a quantity of 
ethylone, a Schedule I Controlled Substance in violation of 21 U.S.C. 
952(a) and 960(a)(1); (2) importation into the United States quantities 
of TURINABOL and DIANABOL, anabolic steroids and Schedule III 
Controlled Substances in violation of 21 U.S.C. 952(b) and 960(a)(1); 
and (3) smuggling goods into the United States, that is, alpha-PVP 
ethylone, Schedule I Controlled Substances, and TURINBOL, DIANABOL, 
Schedule III Controlled Substances in violation of 18 U.S.C. 545, were 
for conduct relating to the importation into the United States of any 
drug or controlled substance because he imported controlled substances 
into the United States in order to capsule portions of the drugs to 
sell to clients. 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. Nagy's offenses and concluded that each 
offense warranted the imposition of a 5-year period of debarment, to 
run consecutively, for a total of a 15-year period of debarment.
    The proposal informed Mr. Nagy 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. Nagy received the proposal and notice of opportunity for a 
hearing on September 22, 2023. Mr. Nagy 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 Adam 
Michael Nagy been convicted of three felonies 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 15 years as provided by section 306(c)(2)(A)(iii) 
of the FD&C Act.
    As a result of the foregoing finding, Mr. Nagy is debarred for a 
period of 15 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. Nagy is a prohibited act.

    Dated: December 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27557 Filed 12-14-23; 8:45 am]
BILLING CODE 4164-01-P