Notice2024-07271
Robert Lance Shuffert: Final Debarment Order
Primary source
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Published
April 5, 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 (FD&C Act) debarring Robert Lance Shuffert 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. Shuffert was convicted of one felony count under Federal law for, with the intent to defraud and mislead, causing a drug to be misbranded while it was held for sale after shipment in interstate commerce. The factual basis supporting Mr. Shuffert's conviction, as described below, is conduct relating to the importation into the United States of any drug or controlled substance. Mr. Shuffert was given notice of the proposed debarment and an opportunity to request a hearing to show why he should not be debarred. As of March 4, 2024 (30 days after receipt of the notice), Mr. Shuffert had not responded. Mr. Shuffert'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 67 (Friday, April 5, 2024)</title>
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[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Pages 24013-24015]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07271]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5257]
Robert Lance Shuffert: 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
Robert Lance Shuffert 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. Shuffert was convicted of one felony count
under Federal law for, with the intent to defraud and mislead, causing
a drug to be misbranded while it was held for sale after shipment in
interstate commerce. The factual basis supporting Mr. Shuffert's
conviction, as described below, is conduct relating to
[[Page 24014]]
the importation into the United States of any drug or controlled
substance. Mr. Shuffert was given notice of the proposed debarment and
an opportunity to request a hearing to show why he should not be
debarred. As of March 4, 2024 (30 days after receipt of the notice),
Mr. Shuffert had not responded. Mr. Shuffert'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 April 5, 2024.
ADDRESSES: Any application by Mr. Shuffert for termination of debarment
under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) 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 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-
2023-N-5257. 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,
<a href="/cdn-cgi/l/email-protection#8eeaebeceffce3ebe0fafdcee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="7f1b1a1d1e0d121a110b0c3f191b1e5117170c51181009">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act permits FDA to debar a person
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 October 26, 2023, Robert Lance Shuffert was convicted as defined
in section 306(l)(1) of the FD&C Act, in the U.S. District Court for
the Southern District of Texas when the court accepted his plea of
guilty and entered judgment against him for the offense of importing,
causing misbranding, and distribution for sale a misbranded drug in
violation of 21 U.S.C. 331(k) and 333(a)(2) (sections 301(k) and
303(a)(2) of the FD&C Act). The underlying facts supporting the
conviction are as follows:
As contained in the Information from his case, Mr. Shuffert worked
for Science Production Products LLC (SPP); although, in SPP's corporate
filings with the Texas Secretary of State, he was listed as SPP's owner
and operator, and someone else owned SPP and directed Mr. Shuffert's
activities. SPP imported, created, marketed, and distributed for sale
purported bodybuilding and dietary supplements, including, but not
limited to, Selective Androgen Receptor Modulators (SARMs). SARMs are
synthetic chemicals designed to mimic the effects of testosterone and
other anabolic steroids. At the direction of SPP's owner, Mr. Shuffert
operated SPP and SPP manufactured, marketed, and sold a SARM product
called Ostarine MK-2866. This product was misbranded because it was
labeled as a ``Research Product'' but was in fact intended to be used
by humans as a drug to increase lean muscle mass and lose unwanted fat.
Mr. Shuffert worked with others to import SARMs from China. Mr.
Shuffert then would use the imported SARMs as components of a drug
(Ostarine MK-2866) that he and others caused to become misbranded and
then distributed for sale such misbranded drugs in the United States.
Mr. Shuffert knowingly took steps to mislead and defraud the Government
and consumers in the sale of SARMs, including Ostarine MK-2866.
FDA sent Mr. Shuffert, by certified mail, on January 30, 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 FDA's finding under section 306(b)(3)(C) of the FD&C Act that
Mr. Shuffert's felony conviction under Federal law for importing,
causing misbranding, and distribution for sale a misbranded drug in
violation of 21 U.S.C. 331(k) and 333(a)(2), was for conduct relating
to the importation of any drug or controlled substance into the United
States because Mr. Shuffert illegally imported SARMs from China, which
he would use as components of a drug (Ostarine MK-2866) that he caused
to become misbranded and then distributed for sale in the United
States. Mr. Shuffert
[[Page 24015]]
knowingly took steps to mislead and defraud the Government and
consumers in the sale of SARMs, including Ostarine MK-2866. 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. Shuffert's offense and concluded that the offense warranted the
imposition of a 5-year period of debarment.
The proposal informed Mr. Shuffert 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. Shuffert received the proposal and notice of opportunity
for a hearing on February 3, 2024. Mr. Shuffert 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.
Shuffert 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.
As a result of the foregoing finding, Mr. Shuffert 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. Shuffert is a prohibited act.
Dated: April 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07271 Filed 4-4-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 5, 2024.
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