[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]


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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

     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