[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12174-12175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04484]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0665]


George Kuiper: 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 
George Kuiper 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 Mr. Kuiper was convicted of multiple felony offenses: One 
count of smuggling, one count of conspiracy to smuggle goods into the 
United States and to introduce into interstate commerce unapproved 
drugs, and one count of introduction into interstate commerce of 
unapproved drugs. The factual basis supporting Mr. Kuiper's 
convictions, as described below, is conduct relating to the importation 
into the United States of a drug or controlled substance. Mr. Kuiper 
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 
December 8, 2021 (30 days after receipt of the notice), Mr. Kuiper had 
not responded. Mr. Kuiper'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 March 3, 2022.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, 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 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 May 26, 2021, Mr. Kuiper was convicted, as defined in section 
306(l)(1) of FD&C Act, in the U.S. District Court for the District of 
New Hampshire, when the court entered judgment against him for one 
count of smuggling in violation of 18 U.S.C. 545; one count of 
conspiracy to smuggle goods into the United States and to introduce 
into interstate commerce unapproved drugs in violation of 18 U.S.C. 371 
and 545 and sections 301(d) and 303(a)(2) of the FD&C Act (21 U.S.C. 
331(d) and 333(a)(2)); and one count of introduction into interstate 
commerce of unapproved drugs in violation of sections 301(d) and 
303(a)(2) of the FD&C Act. 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 in Mr. Kuiper's case, filed on December 21, 2020, 
from as early as 2006, and until June 2020, Mr. Kuiper operated an 
internet pharmacy through several websites which changed over the 
years. Specifically, Mr. Kuiper operated the website nubrain.com until 
February 2015, when the registration for the website was revoked after 
FDA notified the domain name registrar that the website was selling 
products in violation of section 301 of the FD&C Act). Mr. Kuiper then 
immediately re-established his operations on a new website, 
healthclown.com. On both these websites, Mr. Kuiper offered for sale 
over 100 types of products, including prescription drugs and controlled 
substances.
    Mr. Kuiper's best-selling product through these websites was 
modafinil, a new prescription drug, and a Schedule IV controlled 
substance. FDA-approved modafinil, sold under the trade name PROVIGIL, 
is indicated to improve wakefulness in patients with excessive daytime 
sleepiness associated with narcolepsy, and it is only available by 
prescription. The version of modafinil Mr. Kuiper sold was not approved 
by the FDA, and it is therefore an unapproved new drug. FDA's Office of 
Criminal Investigations (OCI) conducted a number of controlled buys of 
unapproved modafinil and other unapproved prescription drugs from Mr. 
Kuiper's websites over approximately 11 years. On most occasions, the 
drugs were either received by OCI directly from shippers in foreign 
countries or had packaging indicating that they were manufactured in 
foreign countries. During subsequent interviews, Mr. Kuiper admitted to 
investigators that he caused unapproved modafinil to be shipped 
directly to customers from his overseas suppliers. OCI's purchases from 
Mr. Kuiper's websites never required a prescription.
    As a result of his convictions, FDA sent Mr. Kuiper, by certified 
mail on October 28, 2021, a notice proposing to debar him 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 Mr. Kuiper's convictions for three felony counts 
under Federal law, specifically for one count of smuggling, one count 
of conspiracy to smuggle goods into the United States and to introduce 
into interstate commerce unapproved drugs, and one count of 
introduction into interstate commerce of unapproved drugs, were for 
conduct relating to the importation into the United States of any drug 
or controlled substance, because he knowingly conspired to illegally 
smuggle modafinil, an unapproved drug and controlled substance, into 
the United States on multiple occasions and then caused it to be 
introduced into interstate commerce.
    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. Kuiper's offenses and concluded that each felony 
offense warranted the imposition of a 5-year period of debarment. 
However, FDA placed significant weight on the cooperation Mr. Kuiper 
provided to law enforcement. Specifically, upon the execution of a 
search warrant by FDA's OCI, Mr. Kuiper immediately began to cooperate 
meaningfully with Federal agents and ceased his own operations.
    In light of Mr. Kuiper's assistance, FDA determined that the 5-year 
debarment periods for each conviction should run concurrently. The 
proposal informed Mr. Kuiper of the proposed debarment, offered him 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. Kuiper

[[Page 12175]]

received the proposal and notice of opportunity for a hearing on 
November 8, 2021. Mr. Kuiper 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. 
George Kuiper has been convicted of felonies under Federal law for 
conduct relating to the importation into the United States of any drug 
or controlled substance. FDA finds that the offenses 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, Mr. Kuiper is debarred for a 
period of 5 years from importing or offering for import any drug into 
the United States, applicable (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. Kuiper is a 
prohibited act.
    Any application by Mr. Kuiper for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2021-N-0665 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 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: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04484 Filed 3-2-22; 8:45 am]
BILLING CODE 4146-01-P