[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76490-76492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27091]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0521]
David J. Kempema: 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
David J. Kempema 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. Kempema was convicted of one felony count under
Federal law which FDA has determined is for conduct relating to the
importation into the United States of a drug or controlled substance.
The factual basis supporting Mr. Kempema's conviction is described in
further detail below. Mr. Kempema 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 September 14, 2022 (30 days after
receipt of the notice), Mr. Kempema had not responded. Mr. Kempema'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 December 14, 2022.
[[Page 76491]]
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-4144), 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 March 15, 2022, Mr. Kempema was convicted, as defined in section
306(l)(1) of FD&C Act, in the U.S. District Court for Northern District
of Iowa, when the court entered judgment against him for the offense of
Introduction into Interstate Commerce of Misbranded Drugs with Intent
to Defraud After Having Been Previously Convicted of an Offense under
21 U.S.C. 331 and 333 in violation of sections 301(a), 301(k), and
303(a)(2) of the FD&C Act (21 U.S.C. 331(a), 331(k), and 333(a)(2)).
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows: As contained in the Information, filed on October 4, 2021,
and in the Plea Agreement from Mr. Kempema's case, Mr. Kempema was
previously convicted, on February 8, 2012, of one count of introducing
and causing the introduction of misbranded drugs into interstate
commerce, and causing the misbranding of drugs held for sale after
shipment in interstate commerce with intent to defraud or mislead, in
violation of sections 301(a), 301(k), and 303(a)(2) of the FD&C Act in
U.S. v. David Kempema, No. 5:11-cr-04140-MWB (N.D. Iowa). In that case,
between October 2009 and July 2011, Mr. Kempema ordered pills from
India that contained the same active ingredients as Viagra and Cialis,
but that had not been approved by FDA for sale in the United States.
Mr. Kempema then sold the non-FDA approved pills to U.S. consumers as
Viagra and Cialis.
Subsequently, from about February 2014 through about December 2018,
Mr. Kempema was the owner and operator of Canned Ads, a business
located in Iowa. During that time, he obtained Silditop, Aurogra, and
Tadalista pills from India and/or Germany. Mr. Kempema found suppliers
by searching the internet for generic Viagra and Cialis. He then
purchased the drugs online from vendors overseas and received the
products at the location of his business Canned Ads in Iowa. Both
Silditop and Aurogra were new drugs that contained sildenafil, the
active ingredient in Viagra, while Tadalista was a new drug that
contained tadalafil, the active ingredient in Cialis. Silditop,
Aurogra, and Tadalista had not been approved by FDA for sale or
distribution in the United States. FDA approved drugs containing the
active ingredients sildenafil and tadalafil are only available by
prescription, and the labeling for those products includes numerous
warnings, including a warning that those drugs can cause blood pressure
to drop suddenly to an unsafe level if taken with certain other
medications.
Mr. Kempema placed advertisements that made claims about male
enhancement dietary supplements in men's restrooms in businesses in
Iowa, in truck stops along the Interstate 29 corridor, and other
locations. If a customer placed an order with Mr. Kempema for male
enhancement dietary supplements, he would supply the customer with
Silditop, Aurogra, and/or Tadalista. Mr. Kempema did not identify the
drugs he sold as Silditop, Aurogra, and/or Tadalista. Instead, Mr.
Kempema offered the drugs for sale under the names of other drugs, such
as ``All Natural Male.'' Mr. Kempema shipped the drugs to customers
both inside and outside of the State of Iowa. The labeling on the drugs
he shipped customers did not contain adequate directions for use and
Mr. Kempema dispensed these prescription drugs without the prescription
of a practitioner licensed by law to administer the drugs. During the
course of this offense, Mr. Kempema obtained and attempted to obtain at
least 4,059 pills for resale.
An undercover FDA agent made 3 controlled purchases from Mr.
Kempema over a period of time for a product Mr. Kempema characterized
as a dietary supplement called ``All Natural Male'' which came in the
form of tablets in a pack of 10 at a cost of $5 per tablet. During the
first controlled purchase, the agent purchased $50 worth of tablets
from Mr. Kempema, which he shipped to the agent. FDA testing later
revealed that the tablets the undercover FDA agent purchased contained
sildenafil, an undeclared erectile dysfunction drug. After the FDA
undercover agent made the second controlled purchase, Mr. Kempema
shipped the agent two 10-count blister packs of Silditop 100 Sildenafil
Citrate tablets IP 100mg. The labeling for the products indicated they
had been manufactured in India by Centurion Remedies PVT.LTD, for
Healing Pharma, and FDA confirmed the products were not approved for
sale or distribution in the United States. After the third controlled
purchase, Mr. Kempema shipped the undercover FDA agent two 10-count
blister packets with labeling that indicated the products were
``Aurogra 100'' Sildenafil Tablets 100mg. The labeling listed the
manufacturer as ``Aurochem Pharmaceuticals'' of India, and FDA
confirmed the products were not approved for sale or distribution in
United States.
As a result of this conviction, FDA sent Mr. Kempema, by certified
mail, on August 9, 2022, 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. Kempema's felony conviction under Federal law
for Introduction into Interstate Commerce of Misbranded Drugs with
Intent to Defraud After Having Been Previously Convicted of an Offense
under sections 301(a), 301(k), and 303(a)(2) of the FD&C Act was for
conduct relating to the importation into the United States of any drug
or controlled substance because he illegally imported and introduced
misbranded prescription drug products 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. Kempema's offense and concluded that the offense warranted the
imposition of a 5-year period of debarment.
The proposal informed Mr. Kempema of the proposed debarment and
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. Kempema received the proposal and notice of opportunity for
a hearing on August 15, 2022. Mr. Kempema failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived his opportunity for a
[[Page 76492]]
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. David
J. Kempema has been convicted of a felony under Federal law for conduct
relating to the importation into the United States of any drug or
controlled substance. FDA finds that the offense 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. Kempema is debarred for a
period of 5 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 by, with the assistance of,
or at the direction of Mr. Kempema is a prohibited act.
Any application by Mr. Kempema for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2022-N-0521 and sent to the Dockets Management Staff (see
ADDRESSES). 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: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27091 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P