Notice2022-04484
George Kuiper: Final Debarment Order
Primary source
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Published
March 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 42 (Thursday, March 3, 2022)</title>
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[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12174-12175]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
<a href="/cdn-cgi/l/email-protection#ec88898e8d9e818982989fac8a888dc284849fc28b839a"><span class="__cf_email__" data-cfemail="4226272023302f272c3631022426236c2a2a316c252d34">[email protected]</span></a>.
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 <a href="http://nubrain.com">nubrain.com</a> 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,
<a href="http://healthclown.com">healthclown.com</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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