[Federal Register Volume 89, Number 158 (Thursday, August 15, 2024)]
[Notices]
[Pages 66413-66415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18268]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1090]


Ryan Stabile: 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 
Ryan Stabile 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. Stabile was convicted of three felony counts under 
Federal law: one count of conspiracy and two counts of introduction of 
misbranded drugs with intent to defraud/mislead. The factual basis 
supporting Mr. Stabile's conviction, as described below, is conduct 
relating to the importation into the United States of a drug or 
controlled substance. Mr. Stabile 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 June 7, 2024 (30 days after receipt of 
the notice), Mr. Stabile had not responded. Mr. Stabile'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 August 15, 2024.

ADDRESSES: Any application by Mr. Stabile 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

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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-
2024-N-1090. 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, 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 February 14, 2024, Mr. Stabile was convicted as defined in 
section 306(l)(1) of the FD&C Act in the U.S. District Court for the 
District of Massachusetts when the court accepted his plea of guilty 
and entered judgment against him for the offenses of conspiracy in 
violation of 18 U.S.C. 371, and two counts of introduction of 
misbranded drugs with intent to defraud/mislead in violation of 21 
U.S.C 331(a) and 333(a)(2) (sections 301(a) and 303(a)(2) of the FD&C 
Act). The underlying facts supporting the conviction are as follows: As 
contained in the indictment and plea agreement, Mr. Stabile owned the 
companies Ultra Vulgar Media, LLC and Supplements for Work (S4W). S4W 
sold nootropics, a class of drugs and supplements claiming to enhance 
mood and cognitive functioning. Tianeptine, when sold as a mood 
enhancer or as a nootropic, or when otherwise intended to treat or 
mitigate a disease or to affect the structure or any function of the 
human body, is a drug within the meaning of section 201(g)(1) of the 
FD&C Act (21 U.S.C. 321(g)(1)), and a prescription drug within the 
meaning of section 503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). A 
drug is misbranded under section 503(b)(1) of the FD&C Act if it is a 
prescription drug dispensed without the prescription of a practitioner 
licensed by law to administer such drugs. A drug is also misbranded 
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if its 
labeling does not bear adequate directions for use.
    Mr. Stabile and S4W operated several websites where Mr. Stabile 
knowingly sold various forms of tianeptine, which were not approved by 
the FDA. Although Mr. Stabile's websites displayed statements that the 
tianeptine being sold was for research purposes only, and not intended 
for human consumption, Mr. Stabile sold it to customers for those 
customers' personal use. Mr. Stabile sold tianeptine without requiring 
the prescription of a practitioner licensed by law to administer 
prescription drugs. In addition, the tianeptine Mr. Stabile sold was 
not labeled with adequate directions for use. Mr. Stabile and his 
coconspirators smuggled the tianeptine into the United States from a 
supplier in China and had the supplier send shipments to Mr. Stabile or 
his coconspirators at several post office boxes Mr. Stabile controlled. 
Mr. Stabile and his coconspirators gave his supplier in China 
instructions on steps they could take to mislabel packages of 
tianeptine in order to evade U.S. Customs and Border Protection (CBP) 
detection. Through Mr. Stabile's illegal smuggling and distribution of 
tianeptine, he earned at least $1,833,922.13.
    Beginning in December 2017, some of the packages of tianeptine Mr. 
Stabile and his coconspirators imported were intercepted and seized by 
CBP. In an effort to have CBP release the packages, Mr. Stabile and his 
coconspirators filed a petition to have a package of tianeptine 
released, which falsely represented that the package was mislabeled and 
that the tianeptine was for research and development only.
    FDA sent Mr. Stabile, by certified mail, on May 3, 2024, 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. Stabile's 
felony convictions under Federal law for conspiracy in violation of 18 
U.S.C. 371, and two counts of introduction of misbranded drugs with 
intent to defraud/mislead in violation of sections 301(a) and 303(a)(2) 
of the FD&C Act, were for conduct relating to the importation of any 
drug or controlled substance into the United States because Mr. Stabile 
illegally imported tianeptine from China and then distributed 
tianeptine in

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interstate commerce. 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. Stabile's offense and concluded that the 
offense warranted the imposition of a 15-year period of debarment.
    The proposal informed Mr. Stabile 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. Stabile received the proposal and notice of opportunity for 
a hearing on May 8, 2024. Mr. Stabile 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. Ryan 
Stabile 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 15 years as provided by section 306(c)(2)(A)(iii) 
of the FD&C Act.
    As a result of the foregoing finding, Mr. Stabile 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, the importing or offering for import into the United 
States of any drug by, with the assistance of, or at the direction of 
Mr. Stabile is a prohibited act.

    Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18268 Filed 8-14-24; 8:45 am]
BILLING CODE 4164-01-P