Notice2021-16044
Justin Ash: Final Debarment Order
Primary source
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Published
July 28, 2021
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 Justin Ash 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. Ash was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Mr. Ash's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Ash was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of April 4, 2021 (30 days after receipt of the notice), Mr. Ash had not responded. Mr. Ash's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40579-40580]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2366]
Justin Ash: Final Debarment Order
AGENCY: Food and Drug Administration, Health and Human Services (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
Justin Ash 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. Ash was convicted of one felony count under Federal
law for conspiracy to commit offenses against the United States. The
factual basis supporting Mr. Ash's conviction, as described below, is
conduct relating to the importation into the United States of a drug or
controlled substance. Mr. Ash was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. As of April 4, 2021 (30 days after receipt
of the notice), Mr. Ash had not responded. Mr. Ash'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 28, 2021.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029), 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 <a href="/cdn-cgi/l/email-protection#1377767172617e767d6760537577723d7b7b603d747c65"><span class="__cf_email__" data-cfemail="3753525556455a5259434477515356195f5f4419505841">[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 November 24, 2020, Mr. Ash was convicted, as defined in section
306(l)(1) of FD&C Act, in the U. S. District Court for the Western
District of Pennsylvania, when the court entered judgment against him
for the offense of conspiracy to commit offenses against the United
States, in violation of 18 U.S.C. 371.
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 information in Mr. Ash's case, filed
December 10, 2019, to which he plead guilty, from on or about January
1, 2016, and continuing until May 8, 2018, he controlled an internet-
based business entity known as both DRC and Domestic RCS (hereinafter
DRC). During this time, Mr. Ash obtained bulk supplies of clonazolam,
diclazepam, flubromazolam, and etizolam (none of which have been
approved for use by FDA in the United States) from overseas sources,
including from suppliers in China. Mr. Ash caused his overseas
suppliers to ship these drugs in smaller quantities to multiple
addresses in the United States he controlled to draw less government
scrutiny. After receiving these bulk drugs, Mr. Ash caused his
employees to press them into pills and package them. Mr. Ash caused the
pill packaging to include disclaimers stating that the drugs were for
research purposes only, in part to evade detection by regulatory
authorities, including FDA. Mr. Ash then had the packages shipped to
customers throughout the United States who ordered the drugs through a
website he operated.
As a result of this conviction, FDA sent Mr. Ash, by certified
mail, on February 26, 2021, 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. Ash's felony conviction under
Federal law for conspiracy to commit offenses against the United
States, in violation of 18 U.S.C. 371, was for conduct relating to the
importation into the United States of any drug or controlled substance
because he illegally imported, manufactured, repackaged, and then
introduced unapproved clonazolam, diclazepam, flubromazolam, and
etizolam drug products into interstate commerce.
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. Ash's offense, and concluded that the offense
warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Ash 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. Ash received the proposal and notice of opportunity for a
hearing on March 5, 2021. Mr. Ash 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.
Justin Ash 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. Ash 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 (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Mr. Ash is a prohibited
act.
Any application by Mr. Ash for termination of debarment under
section 306(d)(1) of the FD&C Act should be
[[Page 40580]]
identified with Docket No. FDA-2020-N-2366 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: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16044 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
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