[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Notices]
[Page 71271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
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)(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, 
www.etizy.com, 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 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: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27056 Filed 12-14-21; 8:45 am]
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