[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 
debarments@fda.hhs.gov.

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]
BILLING CODE 4164-01-P


