[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44907-44908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16062]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5969]
John Seil Lee: 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
John Seil Lee 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. Lee was convicted of one felony count under Federal
law for conspiracy to import merchandise contrary to law and to defraud
the United States and of one felony count under Federal law for
importing merchandise contrary to law. The factual basis supporting
both of Mr. Lee's convictions, as described below, is conduct relating
to the importation into the United States of a drug or controlled
substance. Mr. Lee 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 March 15, 2020 (30 days after receipt of the notice),
Mr. Lee had not responded. Mr. Lee'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, Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029), 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 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 August 20, 2019, Mr. Lee was convicted, as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S. 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
conspiracy to commit offense or to defraud the United States in
violation of 18 U.S.C. 371 and smuggling goods into
[[Page 44908]]
the United States; principals in violation of 18 U.S.C. 545 and 2(b).
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 count 1 of the information in Mr. Lee's
case, filed on January 7, 2019, to which Mr. Lee pleaded guilty,
between 2011 and 2017 Mr. Lee owned, controlled, and operated four
businesses for the purpose of manufacturing and distributing male
sexual enhancement pills that he marketed as herbal remedies but that
contained undisclosed tadalafil, a prescription drug product. Until
February 22, 2017, Mr. Lee conspired with others to import bulk
tadalafil, with labeling that was false and misleading, from suppliers
in China contrary to law. Mr. Lee had his Chinese suppliers ship the
bulk tadalafil under false labeling to commercial mailboxes that he
controlled in New Jersey and Pennsylvania. Mr. Lee then had the
commercial mailbox companies that received the Chinese shipment
repackage the tadalafil shipments and forward them to mailboxes Mr. Lee
controlled in California. After receiving the bulk tadalafil in
California, Mr. Lee caused it to be manufactured into at least 5 and a
half million pills that he sold to distributors across the United
States. The pills Mr. Lee manufactured contained levels of tadalafil
significantly higher than the levels in FDA-approved prescription drugs
such as Cialis. Mr. Lee sold at least $11 million worth of these pills
to distributors in packages with labeling that did not disclose the
presence of tadalafil. When, as on a number of occasions, FDA announced
that a brand of pills sold by one of Mr. Lee companies contained
undeclared tadalafil, he would establish a new company and/or begin
manufacturing identical pills with different brand names in an effort
to evade FDA regulators.
As contained in count 2 of the information in Mr. Lee's case, to
which Mr. Lee pleaded guilty, on or about February 9, 2017, Mr. Lee
fraudulently and knowingly, and contrary to law, imported two parcels
of the bulk drug tadalafil with labeling that was false and misleading
as to the parcels' contents, labels that did not contain accurate
statements of the quantity of the contents in terms of weight, measure,
and numerical count, and labeling that did not bear adequate directions
for use, contrary to sections 301(a) and 502(a)(1), (b), and (f) of the
FD&C Act (21 U.S.C. 331(a), 352(a)(1), (b), and (f)).
As a result of these convictions, FDA sent Mr. Lee, by certified
mail on February 10, 2020, a notice proposing to debar him for a 10-
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 Mr. Lee's felony conviction for one
felony count under Federal law for conspiracy to import merchandise
contrary to law and to defraud the United States was for conduct
relating to the importation into the United States of any drug or
controlled substance because he conspired to illegally import bulk
tadalafil and repackage it into pills that he resold across the United
States. The proposal was also based on a finding under section
306(b)(3)(C) of the FD&C Act that Mr. Lee's felony conviction for one
felony count under Federal law for importing merchandise contrary to
law was for conduct relating to the importation into the United States
of any drug or controlled substance because he also fraudulently and
knowingly imported two parcels of bulk drug tadalafil into the United
States contrary to sections 301(a) and 502(a)(1), (b), and (f) of the
FD&C Act.
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. Lee's offenses, and concluded that these felony
offenses warrant the imposition of a 10-year period of debarment.
The proposal informed Mr. Lee of the proposed debarment and offered
Mr. Lee 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. Lee received the proposal and notice of opportunity for a
hearing on February 14, 2020. Mr. Lee 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. John
Seil Lee 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 as provided by section 306(c)(2)(A)(iii)
of the FD&C Act. Under section 306(c)(2)(A) of the FD&C Act, in the
case of a person debarred for multiple offenses, FDA may 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 for which Mr. Lee was convicted will run
consecutively, resulting in a total debarment period of 10 years.
As a result of the foregoing finding, Mr. Lee 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, 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. Lee is a prohibited act.
Any application by Mr. Lee for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-5969 and sent to the Dockets Management Staff (see
ADDRESSSES). 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. 2020-16062 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P