Notice2024-18268
Ryan Stabile: Final Debarment Order
Primary source
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Published
August 15, 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 (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.
Full Text
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<title>Federal Register, Volume 89 Issue 158 (Thursday, August 15, 2024)</title>
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[Federal Register Volume 89, Number 158 (Thursday, August 15, 2024)]
[Notices]
[Pages 66413-66415]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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
[[Page 66414]]
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-
2024-N-1090. 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, 240-402-8743, or
<a href="/cdn-cgi/l/email-protection#ed89888f8c9f808883999ead8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="7115141310031c141f0502311715105f1919025f161e07">[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 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
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