[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.

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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


