[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11045-11046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03172]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1677]


Karis Copper Delong: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
debarring Karis Copper Delong for a period of 12 years from providing 
services in any capacity to a person that has an approved or pending 
drug product application. FDA bases this order on a finding that Ms. 
Delong was convicted of four misdemeanor counts under the FD&C Act for 
introducing, delivering for introduction, and causing the introduction 
and delivery for introduction of a misbranded drug into interstate 
commerce, which relates to the regulation of drug products under the 
FD&C Act. In addition, FDA determined that the type of conduct that 
served as the basis for the conviction undermines the process for the 
regulation of drugs. Ms. Delong was given notice of the proposed 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. Ms. Delong failed to request a hearing. Ms. 
Delong's failure to request a hearing constitutes a waiver of her right 
to a hearing concerning this action.

DATES: This order is effective February 17, 2017.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement, 
Office of Regulatory Affairs (ELEM-4144), Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds 
that the individual has been convicted of a misdemeanor under federal 
law for conduct relating to the regulation of drug products under the 
FD&C Act, and if FDA finds that the type of conduct that served as the 
basis for the conviction undermines the process for the regulation of 
drugs.
    On June 9, 2015, in the U.S. District Court for the Eastern 
District of Washington, judgment was entered against Ms. Delong after 
she entered a plea of guilty to four counts of shipment of misbranded 
drugs in interstate commerce, in violation of section 301(a) of the 
FD&C Act (21 U.S.C. 331(a)), which according to section 303(a)(1) of 
the FD&C Act (21 U.S.C. 333(a)(1)) constitutes a misdemeanor.
    FDA's finding that debarment is appropriate is based on the 
misdemeanor convictions referenced herein. The factual basis for these 
convictions is as follows: Beginning as early as April 2008, Ms. Delong 
assisted Louis Daniel Smith and others in the operation of Project 
Green Life (PGL). PGL was a Nevada corporation with physical operations 
at various locations in Spokane, WA. PGL marketed and sold various 
health-related products over the Internet. PGL's flagship product was 
the Miracle Mineral Solution (MMS), a mixture of sodium chlorite and 
water.
    Although Ms. Delong acted primarily at the direction of Louis 
Daniel Smith, she had access to PGL's operations. On various occasions, 
she handled shipping for PGL, including the delivery of packages 
containing MMS for shipment in interstate commerce to PGL customers 
nationwide and internationally. Although at times PGL marketed MMS as a 
water purification product, Ms. Delong knew that MMS was also used by 
consumers to treat disease. At times, PGL provided instructions to 
consumers that directed consumers to mix MMS with a citric acid 
solution and consume orally to treat various diseases. Ms. Delong knew 
that PGL provided such instructions to consumers.

[[Page 11046]]

    At no time did Ms. Delong or anyone else employed by PGL register 
their MMS manufacturing facilities with FDA as required under section 
510 of the FD&C Act (21 U.S.C. 360). In addition, bottled MMS that PGL 
shipped to consumers did not bear labeling that bore the full place of 
business of the manufacturer.
    On or about November 1, 2010, November 12, 2010, November 16, 2010, 
and June 30, 2011, Ms. Delong or another person involved with PGL, 
delivered for introduction into interstate commerce a number of 
packages containing bottled MMS. These packages contained MMS that Ms. 
Delong knew was primarily intended as a treatment for disease.
    As a result of these convictions, FDA sent Ms. Delong by certified 
mail on October 12, 2016, a notice proposing to debar her for 12 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act, that Ms. 
Delong was convicted of misdemeanors under Federal law for conduct 
relating to the regulation of drug products under the FD&C Act, and 
that the type of conduct that served as the basis for the conviction 
undermines the process for the regulation of drugs.
    The proposal offered Ms. Delong an opportunity to request a 
hearing, providing her 30 days from the date of receipt of the letter 
in which to file the request, and advised her that failure to request a 
hearing constituted a waiver of the opportunity for a hearing and of 
any contentions concerning this action. Ms. Delong received the 
proposal on October 20, 2016. Ms. Delong did not request a hearing 
within the timeframe prescribed by regulation and has, therefore, 
waived her opportunity for a hearing and has waived any contentions 
concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 
306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the 
Director (Staff Manual Guide 1410.35), finds that Karis Copper Delong 
has been convicted of four misdemeanor counts under federal law for 
conduct relating to the regulation of drug products under the FD&C Act, 
and that the type of conduct that served as the basis for the 
conviction undermines the process for the regulation of drugs.
    Based on consideration of the factors under section 306(c)(3) of 
the FD&C Act, FDA finds that each offense be accorded a debarment 
period of 3 years. Under section 306(c)(2)(A) of the FD&C Act, in the 
case of a person debarred for multiple offenses, FDA shall determine 
whether the periods of debarment shall run concurrently or 
consecutively. FDA has concluded that the 3-year period of debarment 
for each of the four offenses of conviction need to be served 
consecutively, resulting in a total debarment period of 12 years.
    As a result of the foregoing finding, Karis Copper Delong is 
debarred for a period of 12 years from providing services in any 
capacity to a person with an approved or pending drug product 
application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 
355, 360b, or 382), or under section 351 of the Public Health Service 
Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B), 
(c)(3), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(3), 
and 321(dd))). Any person with an approved or pending drug product 
application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Karis Copper Delong, in 
any capacity during Ms. Delong's debarment, will be subject to civil 
money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 
335b(a)(6))). If Ms. Delong provides services in any capacity to a 
person with an approved or pending drug product application during her 
period of debarment she will be subject to civil money penalties 
(section 307(a)(7) of the FD&C Act). In addition, FDA will not accept 
or review any abbreviated new drug applications submitted by or with 
the assistance of Karis Copper Delong during her period of debarment 
(section 306(c)(1)(B) of the FD&C Act).
    Any application by Ms. Delong for termination of debarment under 
section 306(d)(4) of the FD&C Act should be identified with Docket No. 
FDA-2016-N-1677 and sent to the Division of Dockets Management (see 
ADDRESSES). All such submissions are to be filed in four copies. 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 Division of 
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs.
[FR Doc. 2017-03172 Filed 2-16-17; 8:45 am]
 BILLING CODE 4164-01-P