Notice2022-26012
Jennings Ryan Staley: Final Debarment Order
Primary source
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Published
November 29, 2022
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 Jennings Ryan Staley 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. Staley was convicted of one felony count under Federal law for Importation Contrary to Law. The factual basis supporting Mr. Staley's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Staley was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. Mr. Staley provided notice to FDA that he acquiesced to the debarment; FDA received that notice on October 6, 2022. As such, his debarment commenced on the date FDA was notified of acquiescence.
Full Text
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<title>Federal Register, Volume 87 Issue 228 (Tuesday, November 29, 2022)</title>
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[Federal Register Volume 87, Number 228 (Tuesday, November 29, 2022)]
[Notices]
[Pages 73315-73316]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26012]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1129]
Jennings Ryan Staley: 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
Jennings Ryan Staley 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. Staley was convicted of one felony count under Federal
law for Importation Contrary to Law. The factual basis supporting Mr.
Staley's conviction, as described below, is conduct relating to the
importation into the United States of a drug or controlled substance.
Mr. Staley was given notice of the proposed debarment and was given an
opportunity to request a hearing to show why he should not be debarred.
Mr. Staley provided notice to FDA that he acquiesced to the debarment;
FDA received that notice on October 6, 2022. As such, his debarment
commenced on the date FDA was notified of acquiescence.
DATES: This order is applicable October 6, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
<a href="http://www.regulations.gov">www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4144), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at
<a href="/cdn-cgi/l/email-protection#a9cdcccbc8dbc4ccc7dddae9cfcdc887c1c1da87cec6df"><span class="__cf_email__" data-cfemail="a1c5c4c3c0d3ccc4cfd5d2e1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>.
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, 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 May 27, 2022, Mr. Staley was convicted, as defined in section
306(l)(1) of FD&C Act, in the U.S. District Court for the Southern
District of California, when the court accepted his plea of guilty and
entered judgment against him for the offense Importation Contrary to
Law, in violation of 18 U.S.C. 545 and 2. FDA's finding that debarment
is appropriate is based on the felony conviction referenced herein. The
factual basis for this conviction is as follows: As contained in the
Plea Agreement in Mr. Staley's case, filed July 16, 2021, as a licensed
medical doctor and the proprietor of Skinny Beach Med Spa, Mr. Staley
sold ``treatment packs'' for COVID-19 to members of the public in March
and April 2020 in Southern California. Mr. Staley marketed these
treatment packs by making statements about the efficacy of the drugs
the packs included. For example, Mr. Staley told an undercover agent
from the Federal Bureau of Investigation, who posed as a prospective
patient, that hydroxychloroquine and mefloquine would cure COVID-19
``one hundred percent'' and would provide at least 6 weeks of immunity.
Mr. Staley also stated that hydroxychloroquine was a ``magic bullet,''
an ``amazing weapon,'' ``almost too good to be true,'' an ``amazing
cure,'' and a ``miracle cure'' for COVID-19.
To obtain hydroxychloroquine for use in his COVID-19 treatment
packs, Mr. Staley contacted merchants in China who could purportedly
supply bulk quantities of the drug, including one merchant who could
supposedly import kilogram quantities of hydroxychloroquine powder. In
Mr. Staley's correspondence with this merchant, he agreed that the
merchant would deliberately mislabel the shipment of hydroxychloroquine
powder as ``yam extract'' to fool U.S. Customs and Border Protection
(CBP) agents and ensure that the shipment would not be rejected or
delayed. In Mr. Staley's plea agreement, he admitted that by
mislabeling what he believed to be 12 kilograms of hydroxychloroquine
powder as yam extract in violation of 18 U.S.C. 541, he knowingly and
willfully intended to deceive CBP and cause the importation of
merchandise into the United States upon a false classification of its
quality or value. It is immaterial under 18 U.S.C. 541 that the
shipment ultimately contained baking soda rather than
hydroxychloroquine.
As a result of this conviction, FDA sent Mr. Staley, by certified
mail, on September 8, 2022, 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. Staley's felony conviction under
Federal law for Importation Contrary to Law, in violation of 18 U.S.C.
545 and 2, was for conduct relating to the importation into the United
States of a drug or controlled substance because, in order to defraud
CBP, he knowingly and willfully intended to cause the mislabeling and
importation of 12 kilograms of what Mr. Staley believed to be
hydroxychloroquine powder upon a false classification of its quality or
value in violation of 18 U.S.C. 541.
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. Staley's offense and concluded that the offense
warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Staley 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. Staley received the proposal and notice of opportunity for
a hearing. Through his attorney, Mr. Staley sent a memorandum to FDA,
dated September 26, 2022, wherein he stated that he acquiesced to the
proposed debarment. FDA received the memorandum on October 6, 2022. In
accordance with section 306(c)(2)(B) of the FD&C Act, Mr. Staley's
period of debarment shall commence on the date FDA received notice he
acquiesced to the debarment, which was October 6, 2022 (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.
Jennings Ryan Staley 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. Staley is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective October 6, 2022. Pursuant to section
301(cc) of the FD&C Act (21
[[Page 73316]]
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. Staley is a prohibited act.
Any application by Mr. Staley for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2022-N-1129 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
Publicly available submissions will be placed in the docket and
will be viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26012 Filed 11-28-22; 8:45 am]
BILLING CODE 4164-01-P
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