[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44904-44905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16085]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4829]
Jin Su Park: 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 Jin
Su Park for a period of 10 years from importing or offering for import
any drug into the United States. FDA bases this order on a finding that
Mr. Park was convicted of one felony count under Federal law for
Importing Merchandise Contrary to Law, Causing an Act to be Done and of
one felony count of introducing Misbranded Drugs into Interstate
Commerce, causing an Act to be Done. The factual basis supporting both
of Mr. Park's convictions, as described below, is conduct relating to
the importation into the United States of a drug or controlled
substance. Mr. Park 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 January 19, 2019 (30 days after receipt of the notice),
Mr. Park had not responded. Mr. Park'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 24, 2020.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, 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 the 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 March 25, 2019, Mr. Park was convicted, as defined in section
306(l)(1)(B) of the FD&C Act, in the United States District Court for
the Central District of California, when the court accepted his plea of
guilty and entered judgment against him for the felony offenses of
Importing Merchandise Contrary to Law, Causing an Act to be Done in
violation of 18 U.S.C. 545, 2(b) and of Introducing Misbranded Drugs
into Interstate Commerce, causing an Act to be Done in violation of 21
U.S.C. 331(a), 352, and 333(a)(2) (sections 301(a), 502, and 303(a)(2)
of the FD&C Act).
The FDA's finding that debarment is appropriate is based on the
felony convictions referenced herein. The factual basis for these
convictions is as follows: As contained in the Plea Agreement, filed on
February 7, 2019, Mr. Park did, no later than 2015, begin providing
minor assistance to his long-time friend ``J.L.'' who owned and
operated several companies that manufactured and distributed misbranded
male sexual enhancement pills across the United States. In February
2017, J.L.'s operation was shut down after the FDA and Department of
Homeland Security executed a search warrant at J.L.'s pill business as
part of an investigation into J.L.'s smuggling of Tadalafil into the
United States from China. Mr. Park knew that J.L. had been unlawfully
selling misbranded pills containing Tadalafil and other active
pharmaceutical ingredients smuggled from China. Mr. Park took
approximately 14,000 male sexual enhancement pills, all containing
undisclosed Tadalafil, from J.L.'s business, and stored them at Mr.
Park's home. Mr. Park then set up a new company, RNG Global Management
and Trading Group, Inc. (RNG). Mr. Park repackaged the 14,000 pills
with new labeling that failed to disclose the presence of Tadalafil and
he commenced selling the misbranded pills to various customers
throughout the United States.
Furthermore, in April 2018, Mr. Park ordered, and subsequently paid
for, five kilograms of Dapoxetine and five kilograms of Rhodiola rosea
from suppliers in China. Mr. Park had the Chinese supplier ship five
kilograms of Dapoxetine to him, through a Korean intermediary, in a
parcel mislabeled as containing, ``Glass Colour Sample (Zinc Sulfide)''
to a commercial mailbox Mr. Park controlled in Michigan. Mr. Park
subsequently had the same Chinese supplier ship to his Michigan mailbox
the five kilograms of Rhodiola rosea, through the same Korean
intermediary, in a parcel mislabeled as containing, ``Glass Colour
(Zinc Sulfide) Sample.'' Mr. Park intended to use both the Dapoxetine
and Rhodiola rosea in the male sexual enhancement pills he would sell.
As a result of this conviction, FDA sent Mr. Park by certified mail
on December 16, 2019, a notice proposing
[[Page 44905]]
to debar him for two consecutive 5-year periods (10 years) 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. Park's felony convictions for introducing misbranded drugs
into interstate commerce and importing merchandise contrary to law were
for conduct relating to the importation into the United States of any
drug or controlled substance because he knew that the 14,000 pills
containing Tadalafil were illegally imported, yet Mr. Park decided to
repackage them and sell them to U.S. consumers. In addition, he did in
fact illegally import Dapoxetine and Rhodiola rosea and intended to
sell them to consumers in the United States.
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. Park's offenses, and concluded that each of these
felony offenses independently warranted a 5-year period of debarment,
and proposed that these debarment periods be served consecutively under
section 306(c)(2)(A)(iii).
The proposal informed Mr. Park of the proposed debarment and
offered Mr. Park 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. Park received the proposal and notice of
opportunity for a hearing on December 20, 2019. Mr. Park 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. Park
has been convicted of two felony counts under Federal law for conduct
relating to the importation into the United States of any drug or
controlled substance. FDA finds that each offense should be accorded a
debarment period of 5 years. Under section 306(c)(2)(A)(iii) of the
FD&C Act, in the case of a person debarred for multiple offenses, FDA
shall determine whether the periods of debarment shall run concurrently
or consecutively. FDA has concluded that the 5-year period of debarment
for each of the two offenses of conviction will be served
consecutively, resulting in a total debarment period of 10 years.
As a result of the foregoing finding, Mr. Park is debarred for a
period of 10 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. Park is a prohibited
act.
Any application by Mr. Park for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-4829 and sent to the Dockets Management Staff (see
ADDRESSSES). All such submissions are to be filed in four copies. 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 http://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16085 Filed 7-23-20; 8:45 am]
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