[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47576-47578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5345]


Michael Terry Little: 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 
Michael Terry Little 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. Little was convicted of one felony count under Federal 
law for introduction of unapproved new drugs in interstate commerce. 
The factual basis supporting Mr. Little's conviction, as described 
below, is conduct relating to the importation into the United States of 
a drug or controlled substance. Mr. Little 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 13, 2024 (30 days after 
receipt of the notice), Mr. Little had not responded. Mr. Little'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 3, 2024.

ADDRESSES: Any application by Mr. Little 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

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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-5345. 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 November 7, 2023, Mr. Little was convicted as defined in section 
306(l)(1) of the FD&C Act, in the U. S. District Court for the District 
of Idaho when the court accepted his plea of guilty and entered 
judgment against him for the offense of Introduction of Unapproved New 
Drugs in Interstate Commerce in violation of 21 U.S.C. 331(d) and 
333(a)(2) (sections 301(d) and 303(a)(2) of the FD&C Act). The 
underlying facts supporting the conviction are as follows: as charged 
in the Information and stated in the Plea Agreement, beginning in or 
about March 2018, and continuing to on or about January 2022, Mr. 
Little ran a business selling Selective Androgen Receptor Modulators 
(SARMs). SARMs are synthetic chemicals designed to mimic the effects of 
testosterone and other anabolic steroids. SARMs are new drugs under the 
FD&C Act that have not been reviewed by FDA for safety and 
effectiveness and have not been approved for marketing in the United 
States. Mr. Little primarily sold his SARM products via the website 
https://sarm.tech, under the name SARMTECH. Mr. Little imported the 
bulk ingredients from China which he then processed at his business 
location in Idaho. At Mr. Little's business location he used the 
imported bulk ingredients to manufacture the SARM products and he 
encapsulated, bottled, and prepared the products for shipment to his 
customers. To avoid government seizures of SARMs shipped to other 
countries, Mr. Little offered a stealth shipping option for an 
additional fee that intentionally mispackaged and falsely declared 
SARMs shipments as vitamins and supplements. Mr. Little sold at least 
$4,499,197.46 worth of SARMs between March 2018 and January 2022.
    FDA sent Mr. Little, by certified mail, on February 5, 2024, 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. 
Little's felony conviction under Federal law for Introduction of 
Unapproved New Drugs in Interstate Commerce in violation of 21 U.S.C. 
331(d) and 333(a)(2), was for conduct relating to the importation of 
any drug or controlled substance into the United States because Mr. 
Little illegally imported bulk ingredients for SARMs from China which 
he used as components to manufacture unapproved new drugs that he then 
distributed for sale to his customers. 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. Little's offense and 
concluded that the offense warranted the imposition of a 5-year period 
of debarment.
    The proposal informed Mr. Little 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. Little received the proposal and notice of opportunity for 
a hearing on February 12, 2024. Mr. Little 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. 
Michael Terry Little 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

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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. Little 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, the importing or offering for import into the United 
States of any drug by, with the assistance of, or at the direction of 
Mr. Little is a prohibited act.

    Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12066 Filed 5-31-24; 8:45 am]
BILLING CODE 4164-01-P