[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