Robert Lance Shuffert: Final Debarment Order, 24013-24015 [2024-07271]
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Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Request for Nominations for Voting
Members for the Patient Engagement
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
requesting nominations for voting
members, excluding consumer and
industry representatives, to serve on the
Patient Engagement Advisory
Committee (the Committee) in the
Center for Devices and Radiological
Health. Nominations will be accepted
for upcoming vacancies effective with
this notice. FDA seeks to include the
views of members of all gender groups,
members of all racial and ethnic groups,
and individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before June 4, 2024, will be given first
consideration for membership on the
Committee. Nominations received after
June 4, 2024, will be considered for
nomination to the Committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be submitted
electronically, by logging into the FDA
Advisory Committee Membership
Nomination Portal (https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm) and
selecting Academician/Practitioner from
the dropdown menu (regardless of
whether Academician/Practitioner
accurately describes the nominee), or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
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SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Letise Williams, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5407, Silver Spring,
MD 20993–0002, 301–796–8398, email:
Letise.Williams@fda.hhs.gov.
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16:44 Apr 04, 2024
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FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the Patient Engagement Advisory
Committee. This notice does not include
consumer and industry representative
nominations. The Agency will publish
two separate notices announcing the
vacancy of a representative of consumer
interests and vacancy of representatives
of interests of the device manufacturing
industry.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. General Description of the Committee
Duties
The Committee provides relevant
skills and perspectives to improve
communication of benefits, risks, and
clinical outcomes, and increase
integration of patient perspectives into
the regulatory process for medical
devices. The Committee performs its
duties by identifying new approaches,
promoting innovation, recognizing
unforeseen risks or barriers, and
identifying unintended consequences
that could result from FDA policy. The
Committee provides advice on complex
scientific issues related to medical
devices, the regulation of devices, and
their use by patients. Agency guidance
and policies, clinical trial or registry
design, patient preference study design,
benefit-risk determinations, device
labeling, unmet clinical needs, available
alternatives, patient-reported outcomes,
device-related quality of life measures,
or health status issues are among the
topics that may be considered by the
Committee.
II. Criteria for Voting Members
The Committee consists of a core of
nine voting members, including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities who
are knowledgeable in areas such as
clinical research, patient or caregiver
experience, healthcare needs of patient
groups in the United States, or are
experienced in the work of patient and
health professional organizations,
scientific methodologies for patientreported outcomes and other clinical
outcome assessments, scientific
methodologies for eliciting patient
preferences, and strategies for
communicating benefits, risks, and
clinical outcomes to patients and
research subjects, as well as other
relevant areas. Members will be invited
to serve for overlapping terms of up to
4 years. Prospective members should
also have an understanding of the broad
spectrum of patients in a particular
disease area. Almost all non-Federal
members of this Committee serve as
Special Government Employees, with
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24013
the exception of the representatives
from industry.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the Committee. Selfnominations are also accepted.
Nominations must include a cover
letter; a current, complete re´sume´ or
curriculum vitae for each nominee,
including current business and/or home
address, telephone number, and email
address if available; and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must specify the advisory
committee for which the nominee is
recommended. Nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14,
relating to advisory committees.
Dated: April 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–07254 Filed 4–4–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
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.
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:
ADDRESSES:
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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–
5257. Received applications will be
placed in the docket and, except for
VerDate Sep<11>2014
16:44 Apr 04, 2024
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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-201509-18/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,
debarments@fda.hhs.gov.
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
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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
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05APN1
Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
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
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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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1157]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments—General Topic
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on May
22, 2024, from 10 a.m. to 3:45 p.m.
Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–1157.
The docket will close May 21, 2024.
Please note that late, untimely filed
comments will not be considered. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of May 21, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Comments received on or before May
8, 2024, will be provided to the
Committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
SUMMARY:
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24015
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment 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
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• 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 written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–1157 for ‘‘Pediatric Oncology
Subcommittee of the Oncologic Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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 a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
E:\FR\FM\05APN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Pages 24013-24015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07271]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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-
2023-N-5257. 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,
[email protected].
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
