[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40063-40064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15775]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2149]
Jonathan Doyle: 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
Jonathan Doyle for a period of 5 years from importing articles of food
or offering such articles for importation into the United States. FDA
bases this order on a finding that Mr. Doyle was convicted of a felony
count under Federal law for conduct relating to the importation into
the United States of an article of food. Mr. Doyle was given notice of
the proposed debarment and an opportunity to request a hearing within
the timeframe prescribed by regulation. As of April 8, 2021 (30 days
after receipt of the notice), Mr. Doyle has not responded. Mr. Doyle'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 July 26, 2021.
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 https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), 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)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) 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 food.
On October 15, 2020, Mr. Doyle was convicted as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S. District Court for the
Northern District of Texas-Dallas Division, when the court accepted Mr.
Doyle's plea of guilty and entered judgment against him for the offense
of conspiracy to introduce misbranded food into interstate commerce
with an intent to defraud and mislead in violation of 18 U.S.C. 371 (21
U.S.C. 331(a) and 21 U.S.C. 333(a)(2)).
FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: As contained in the factual
r[eacute]sum[eacute], dated February 15, 2019, in Mr. Doyle's case, he
was the President of USPlabs, LLC (USP Labs), and owned 45 percent of
the company. USP Labs sold dietary supplements. Beginning in or around
October 2008 and continuing until at least in or around August 2014,
Mr. Doyle engaged in a conspiracy with others to import and ship in
interstate commerce a variety of chemicals for use and prospective use
in dietary supplements with false labeling. To further this conspiracy,
Mr. Doyle's coconspirators ordered chemicals from Chinese chemical
sellers to be used as ingredients in dietary supplements and had them
labeled falsely as other food substances. USP Labs sold dietary
supplements called Jack3d and OxyElite Pro, both of which originally
contained a substance called 1,3-dimethylamylamine (DMAA), which is
also known as methylhexaneamine. USP Labs imported numerous substances
intended for human consumption, including DMAA, using false and
fraudulent Certificates of Analysis (COA) and other false and
fraudulent documentation and labeling. At least some of the false COAs
that USP Labs
[[Page 40064]]
caused to be created for their DMAA shipments stated falsely that the
substance in the shipments had been extracted from the geranium plant.
Further, on or about December 8, 2011, Mr. Doyle's coconspirator
instructed a Chinese chemical seller via email to misbrand a shipment
of nine different chemicals sent from China to USP Labs in Texas. One
of those synthetic chemicals was called ``aegeline.'' The first
aegeline-containing version of OxyElite Pro, which was called OxyElite
``New Formula,'' went on sale in December 2012. In summer 2013, USP
Labs reformulated the product again to contain aegeline and powder
derived from a Chinese herb called cynanchum auriculatum. On or about
June 15, 2013, Mr. Doyle's coconspirator instructed a Chinese chemical
seller to have two metric tons of ground cynanchum auriculatum root
powder shipped internationally to SK Laboratories in California for
inclusion in USP Labs' products, using the false name ``cynanchum
auriculatum root extract.'' USP Labs sent false labels listing
``cynanchum auriculatum (root) extract'' as an ingredient in its
OxyElite Pro ``Advanced Formula'' supplement, even though that
ingredient was not present in the product. The conspirators collected
millions in revenue that they would not have obtained, absent the
conspiracy.
As a result of this conviction FDA sent Mr. Doyle, by certified
mail on March 4, 2021, a notice proposing to debar him for a period of
5 years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Doyle's felony
conviction of conspiracy to introduce misbranded food into interstate
commerce with an intent to defraud and mislead in violation of 18
U.S.C. 371 (21 U.S.C. 331(a) and 21 U.S.C. 333(a)(2)), constitutes
conduct relating to the importation into the United States of an
article of food because the offense involved a conspiracy to import a
variety of chemicals with false labeling in order to either use those
chemicals in dietary supplements which would themselves also contain
false labeling or to determine whether those chemicals could be used in
new dietary supplements.
The proposal was also based on a determination, after consideration
of the relevant factors set forth in section 306(c)(3) of the FD&C Act,
that Mr. Doyle should be subject to a 5-year period of debarment. The
proposal also offered Mr. Doyle an opportunity to request a hearing,
providing Mr. Doyle 30 days from the date of receipt of the letter in
which to file the request, and advised Mr. Doyle that failure to
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. Mr. Doyle failed to
respond 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)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Jonathan Doyle has been convicted of a felony count under Federal law
for conduct relating to the importation into the United States of an
article of food and that he is subject to a 5-year period of debarment.
As a result of the foregoing finding, Mr. Doyle is debarred for a
period of 5 years from importing articles of food or offering such
articles for import into the United States, effective July 26, 2021.
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Jonathan
Doyle is a prohibited act.
Any application by Mr. Doyle for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-2149 and sent to the Dockets Management Staff (ADDRESSES).
The public availability of information in these submissions is governed
by 21 CFR 10.20.
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: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15775 Filed 7-23-21; 8:45 am]
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