[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Pages 16226-16227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1682]


Ursula Wing: 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 
Ursula Wing 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. Wing was convicted of one felony count under Federal 
law for conspiracy to defraud the United States. Ms. Wing was given 
notice of the proposed debarment and an opportunity to request a 
hearing to show why she should not be debarred within the timeframe 
prescribed by regulation. Ms. Wing failed to request a hearing. Ms. 
Wing's failure to respond and request a hearing constitutes a waiver of 
her right to a hearing concerning this matter.

DATES: This order is applicable March 26, 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 July 10, 2020, 
Ms. Wing was convicted, as defined in section 306(l)(1) of the FD&C 
Act, in the U.S. District Court for the Western District of Wisconsin, 
when the court accepted her plea of guilty and entered judgment against 
her for the felony offense of conspiracy to defraud the United States 
in violation of 18 U.S.C. 371.
    FDA's finding that debarment is appropriate is based on this felony 
conviction referenced herein. The factual basis for this conviction is 
as follows: As contained in count 1 of the indictment in Ms. Wing's 
case, filed on June 26, 2019, to which she pleaded guilty, from in or 
about June 2016 and continuing to on or about June 21, 2018, she 
operated a blog under the name ``the Macrobiotic Stoner'' and a fake 
jewelry business under the name ``Morocco International Inc.'' Ms. Wing 
used both entities to sell unapproved and misbranded prescription drugs 
to consumers in the United States and around the world and to process 
payments for those drugs. Throughout the course of this conspiracy Ms. 
Wing did not possess a valid wholesale drug distribution license, 
pharmacy license, or a license to prescribe prescription drugs. She was 
also not registered under section 510 of the FD&C Act (21 U.S.C. 360) 
as a person who owns or operates an establishment engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
drug.
    As part of this conspiracy, Ms. Wing imported foreign-sourced 
prescription drugs in wholesale quantities from India into the United 
States. The imported drugs contained U.S. Customs Declaration Forms 
falsely stating that the contents were ``personal supply medication'' 
and did not contain any dangerous articles or articles prohibited by 
postal or customs regulations. The drugs Ms. Wing imported were foreign 
versions of mifepristone and misoprostol. There are two 200 mg 
mifepristone tablets that are FDA-

[[Page 16227]]

approved for use in a regimen with misoprostol for the medical 
termination of early pregnancy. There are no approved drug applications 
pursuant to section 505 of the FD&C Act (21 U.S.C. 355) in effect for 
the mifepristone and misoprostol Ms. Wing imported and sold via her 
website. In addition to being unapproved, the drugs sold via Ms. Wing's 
website were also misbranded because they failed to bear adequate 
directions for their intended use (see 21 U.S.C. 352(f)(1) and 21 CFR 
201.5) and are prescription medications that were dispensed without a 
prescription from a practitioner licensed by law to administer such 
drugs (21 U.S.C. 353(b)(1) and 331(k)).
    Ms. Wing broke down the bulk shipments of unapproved and misbranded 
drugs she received from India and repackaged them into retail 
quantities which she then shipped to customers in the United States and 
around the world via U.S. mail. To disguise her sales, Ms. Wing created 
a fake company called ``Fatima's Bread Basket,'' which she listed as 
the shipper on the envelope going to the customer. Ms. Wing then 
inserted a piece of jewelry in the shipping envelope to serve as the 
cover piece of merchandise being mailed to the customer. She packaged 
the unapproved and misbranded prescription drugs in a smaller packet 
that was in a hidden panel and taped to the inside of the shipping 
envelope. Ms. Wing disguised the nature of the item being purchased by 
listing on the invoice alternate jewelry product names, each of which 
had a code to indicate the actual item (unapproved and misbranded 
drug(s)) being ordered.
    As a result of this conviction, FDA sent Ms. Wing, by certified 
mail on October 15, 2020, 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. Wing's conviction for one felony count under 
Federal law, for conspiracy to defraud the United States, was for 
conduct relating to the importation into the United States of any drug 
or controlled substance because she illegally smuggled unapproved and 
misbranded prescription drugs from India into the United States and 
then distributed those misbranded and unapproved drugs to consumers 
both in the United States and abroad.
    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. Wing's offense, and concluded that this felony 
offense warranted the imposition of a 5-year period of debarment. The 
proposal informed Ms. Wing 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. Wing received the proposal and notice of opportunity for a 
hearing on October 19, 2020. Ms. Wing 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. 
Ursula Wing 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. Wing 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. Wing is a prohibited 
act.
    Any application by Ms. Wing for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2020-N-1682 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: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06258 Filed 3-25-21; 8:45 am]
BILLING CODE 4164-01-P