[Federal Register Volume 87, Number 228 (Tuesday, November 29, 2022)]
[Notices]
[Pages 73315-73316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
www.regulations.gov.

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 
[email protected].

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

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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 https://www.regulations.gov 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


