Notice2021-27056
Julia Fees: Final Debarment Order
Primary source
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Published
December 15, 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 Julia Fees 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 Ms. Fees was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Ms. Fees' conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Fees was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of September 12, 2021 (30 days after receipt of the notice), Ms. Fees had not responded. Ms. Fees' failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 86 Issue 238 (Wednesday, December 15, 2021)</title>
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[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Notices]
[Page 71271]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27056]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0505]
Julia Fees: 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
Julia Fees 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 Ms. Fees was convicted of one felony count under Federal
law for conspiracy to commit offenses against the United States. The
factual basis supporting Ms. Fees' conviction, as described below, is
conduct relating to the importation into the United States of a drug or
controlled substance. Ms. Fees was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
she should not be debarred. As of September 12, 2021 (30 days after
receipt of the notice), Ms. Fees had not responded. Ms. Fees' failure
to respond and request a hearing constitutes a waiver of her right to a
hearing concerning this matter.
DATES: This order is applicable December 15, 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, 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#187c7d7a796a757d766c6b587e7c793670706b367f776e"><span class="__cf_email__" data-cfemail="3e5a5b5c5f4c535b504a4d7e585a5f1056564d10595148">[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 5, 2021, Ms. Fees 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 her
for the offense of conspiracy to commit offenses against the United
States, in violation of 18 U.S.C. 2 and 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 indictment in Ms. Fees' case, filed August 22, 2017, to which
she plead guilty, from on or about April 2015 and continuing until May
2017, Ms. Fees was involved in the operation of a website,
<a href="http://www.etizy.com">www.etizy.com</a>, through which she sold and distributed a drug known as
etizolam to consumers throughout the United States. Etizolam is a drug
known as thienodiazepine, which is chemically similar to
benzodiazepines and carries risks of dependency, toxicity, and the
possibility of fatal overdose. Etizolam is not FDA-approved in the
United States. Ms. Fees and her co-conspirator illegally bought
etizolam from an overseas supplier in India, which she then arranged to
have smuggled into the United States through the use of multiple post
office boxes controlled by her and her co-conspirator. To avoid Federal
regulators, she used false and misleading labeling and generally
misrepresented the nature of the products sold on the website she
operated. Ms. Fees reshipped the misbranded etizolam to customers
located in the United States.
As a result of this conviction, FDA sent Ms. Fees, by certified
mail, on August 3, 2021, a notice proposing to debar her 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 Ms. Fees' 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 she illegally
imported, relabeled, and then introduced unapproved etizolam 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 Ms. Fees' offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.
The proposal informed Ms. Fees of the proposed debarment and
offered her an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Fees received the proposal and notice of opportunity for a
hearing on August 13, 2021. Ms. Fees failed to request a hearing within
the timeframe prescribed by regulation and has, therefore, waived her
opportunity for a hearing and waived any contentions concerning her
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 Ms. Julia
Fees 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, Ms. Fees 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 Ms. Fees is a prohibited
act.
Any application by Ms. Fees for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0505 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: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27056 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P
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