[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Notices]
[Pages 22734-22735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09646]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5056]
Justin Cole Henry: 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 (FD&C Act) debarring
Justin Cole Henry 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. Henry was convicted of a felony under Federal law for
possession with intent to distribute a Schedule III controlled
substance. The factual basis supporting Mr. Henry's conviction, as
described below, is conduct relating to the importation into the United
States of a drug or controlled substance. Mr. Henry 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 February 24, 2025
(30 days after receipt of the notice), Mr. Henry had not responded. Mr.
Henry'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 May 29, 2025.
ADDRESSES: Any application by Mr. Henry 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 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-5056. 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,
[[Page 22735]]
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 Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, 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 (21 U.S.C. 335a(b)(3)(C)), 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 August 23, 2024, Mr. Henry was convicted as defined in section
306(l)(1) of the FD&C Act (21 U.S.C. 335a(l)(1)), in the U.S. District
Court for the Middle District of Tennessee when the court accepted his
plea of guilty and entered judgment against him for the offense of
Possession with Intent to Distribute a Schedule III Controlled
Substance in violation of 21 U.S.C. 841(a)(1). The underlying facts
supporting the conviction are as follows: As contained in the
Information, and in the Plea Agreement from his case, Mr. Henry owned
and operated a gym called Power Athletics. In 2022 Mr. Henry purchased
large volumes of anabolic steroids, including testosterone (17[beta]-
hydroxyandrost-4-en-3-one), a Schedule III controlled substance, from
mostly overseas wholesale vendors. Mr. Henry then repackaged the drugs
and sold them to customers under his own label, American Muscle Labs.
On October 21, 2022, law enforcement officers executed a search warrant
at Mr. Henry's gym, which included a hidden room housing his steroid
laboratory. Mr. Henry admitted that on October 21, 2022, he possessed
more than 60,000 units of Schedule III controlled substances, including
testosterone (17[beta]-hydroxyandrost-4-en-3-one), which he intended to
use himself and sell to his customers.
FDA sent Mr. Henry, by certified mail, on January 2, 2025, 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 (21 U.S.C.
335a(b)(3)(C)) that Mr. Henry's felony conviction under Federal law for
Possession with Intent to Distribute a Schedule III Controlled
Substance in violation of 21 U.S.C. 841(a)(1) was for conduct relating
to the importation of any drug or controlled substance into the United
States because you illegally imported the controlled substances at
issue, including testosterone (17[beta]-hydroxyandrost-4-en-3-one), and
sold them to customers. In proposing a debarment period, FDA weighed
the considerations set forth in section 306(c)(3) of the FD&C Act (21
U.S.C. 335a(c)(3)) that it considered applicable to Mr. Henry's offense
and concluded that the offense warranted the imposition of a 5-year
period of debarment.
The proposal informed Mr. Henry 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. Henry received the proposal and notice of opportunity for a
hearing on January 24, 2025. Mr. Henry 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 Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(b)(3)(C) of the FD&C
Act (21 U.S.C. 335a(b)(3)(C)), under authority delegated to the
Director, Division of Enforcement, finds that Mr. Justin Cole Henry 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 (21 U.S.C. 335a(c)(2)(A)(iii)).
As a result of the foregoing finding, Mr. Henry 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. Henry is a prohibited act.
Dated: May 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09646 Filed 5-28-25; 8:45 am]
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