[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40579-40580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
https://www.regulations.gov.

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 [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 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 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. 2021-16044 Filed 7-27-21; 8:45 am]
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