82 FR 11045 - Karis Copper Delong: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 32 (February 17, 2017)

Page Range		11045-11046
FR Document		2017-03172

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.

Federal Register, Volume 82 Issue 32 (Friday, February 17, 2017)

[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11045-11046]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices 11045

request a hearing, providing him 30 availability of information in these 5630 Fishers Lane, Rm. 1061, Rockville,
days from the date of receipt of the letter submissions is governed by 21 CFR MD 20852.
in which to file the request, and advised 10.20. FOR FURTHER INFORMATION CONTACT:
him that failure to request a hearing Publicly available submissions will be Kenny Shade, Division of Enforcement,
constituted a waiver of the opportunity placed in the docket, and will be Office of Regulatory Affairs (ELEM–
for a hearing and of any contentions viewable at https://www.regulations.gov 4144), Food and Drug Administration,
concerning this action. The proposal or at the Division of Dockets 12420 Parklawn Dr., Rockville, MD
was received on October 31, 2016. Dr. Management (see ADDRESSES) between 9 20857, 301–796–4640.
Brown did not request a hearing and a.m. and 4 p.m., Monday through SUPPLEMENTARY INFORMATION:
has, therefore, waived his opportunity Friday.
for a hearing and any contentions Dated: February 13, 2017.
I. Background
concerning his debarment (21 CFR part Section 306(b)(2)(B)(i)(I) of the FD&C
Armando Zamora,
12). Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
Deputy Director, Office of Enforcement and
II. Findings and Order Import Operations, Office of Regulatory permits debarment of an individual if
Therefore, the Director, Office of Affairs. FDA finds that the individual has been
Enforcement and Import Operations, [FR Doc. 2017–03173 Filed 2–16–17; 8:45 am] convicted of a misdemeanor under
Office of Regulatory Affairs, under BILLING CODE 4164–01–P federal law for conduct relating to the
section 306(a)(2)(B) of the FD&C Act, regulation of drug products under the
under authority delegated to him (Staff FD&C Act, and if FDA finds that the
Manual Guide 1410.35), finds that Dr. DEPARTMENT OF HEALTH AND type of conduct that served as the basis
Raymond Sean Brown has been HUMAN SERVICES for the conviction undermines the
convicted of a felony under Federal law process for the regulation of drugs.
Food and Drug Administration On June 9, 2015, in the U.S. District
for conduct relating to the regulation of
a drug product under the FD&C Act. [Docket No. FDA–2016–N–1677] Court for the Eastern District of
Section 306(c)(2)(A)(ii) of the FD&C Act Washington, judgment was entered
requires that Dr. Brown’s debarment be Karis Copper Delong: Debarment against Ms. Delong after she entered a
permanent. Order plea of guilty to four counts of shipment
As a result of the foregoing finding, of misbranded drugs in interstate
AGENCY: Food and Drug Administration, commerce, in violation of section 301(a)
Dr. Raymond Sean Brown is
HHS. of the FD&C Act (21 U.S.C. 331(a)),
permanently debarred from providing
services in any capacity to a person with ACTION: Notice. which according to section 303(a)(1) of
an approved or pending drug product the FD&C Act (21 U.S.C. 333(a)(1))
SUMMARY: The Food and Drug constitutes a misdemeanor.
application under sections 505, 512, or Administration (FDA or Agency) is
802 of the FD&C Act (21 U.S.C. 355, FDA’s finding that debarment is
issuing an order under the Federal appropriate is based on the
360b, or 382), or under section 351 of Food, Drug, and Cosmetic Act (the
the Public Health Service Act (42 U.S.C. misdemeanor convictions referenced
FD&C Act) debarring Karis Copper herein. The factual basis for these
262), effective (see DATES) (see section Delong for a period of 12 years from
201(dd), 306(c)(1)(B), and convictions is as follows: Beginning as
providing services in any capacity to a early as April 2008, Ms. Delong assisted
306(c)(2)(A)(ii) of the FD&C Act (21 person that has an approved or pending
U.S.C. 321(dd), 335a(c)(1)(B), and Louis Daniel Smith and others in the
drug product application. FDA bases operation of Project Green Life (PGL).
335a(c)(2)(A)(ii)). Any person with an
this order on a finding that Ms. Delong PGL was a Nevada corporation with
approved or pending drug product
was convicted of four misdemeanor physical operations at various locations
application who knowingly employs or
counts under the FD&C Act for in Spokane, WA. PGL marketed and
retains as a consultant or contractor, or
introducing, delivering for introduction, sold various health-related products
otherwise uses the services of Dr.
and causing the introduction and over the Internet. PGL’s flagship product
Brown, in any capacity during his
delivery for introduction of a was the Miracle Mineral Solution
debarment, will be subject to civil
misbranded drug into interstate (MMS), a mixture of sodium chlorite
money penalties (section 307(a)(6) of the
commerce, which relates to the and water.
FD&C Act (21 U.S.C. 335b(a)(6))). If Dr.
regulation of drug products under the Although Ms. Delong acted primarily
Brown provides services in any capacity
FD&C Act. In addition, FDA determined at the direction of Louis Daniel Smith,
to a person with an approved or
that the type of conduct that served as she had access to PGL’s operations. On
pending drug product application
the basis for the conviction undermines various occasions, she handled shipping
during his period of debarment he will
the process for the regulation of drugs. for PGL, including the delivery of
be subject to civil money penalties
Ms. Delong was given notice of the packages containing MMS for shipment
(section 307(a)(7) of the FD&C Act). In
proposed debarment and an opportunity in interstate commerce to PGL
addition, FDA will not accept or review
to request a hearing within the customers nationwide and
any abbreviated new drug applications
timeframe prescribed by regulation. Ms. internationally. Although at times PGL
from Dr. Brown during his period of
Delong failed to request a hearing. Ms. marketed MMS as a water purification
debarment (section 306(c)(1)(B) of the
Delong’s failure to request a hearing product, Ms. Delong knew that MMS
FD&C Act).
Any application by Dr. Brown for constitutes a waiver of her right to a was also used by consumers to treat
mstockstill on DSK3G9T082PROD with NOTICES

special termination of debarment under hearing concerning this action. disease. At times, PGL provided
section 306(d)(4) of the FD&C Act DATES: This order is effective February instructions to consumers that directed
should be identified with Docket No. 17, 2017. consumers to mix MMS with a citric
FDA–2016–N–2191 and sent to the ADDRESSES: Submit applications for acid solution and consume orally to
Division of Dockets Management (see termination of debarment to the treat various diseases. Ms. Delong knew
ADDRESSES). All such submissions are to Division of Dockets Management (HFA– that PGL provided such instructions to
be filed in four copies. The public 305), Food and Drug Administration, consumers.

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11046 Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices

At no time did Ms. Delong or anyone FDA finds that each offense be accorded Dated: February 13, 2017.
else employed by PGL register their a debarment period of 3 years. Under Armando Zamora,
MMS manufacturing facilities with FDA section 306(c)(2)(A) of the FD&C Act, in Deputy Director, Office of Enforcement and
as required under section 510 of the the case of a person debarred for Import Operations, Office of Regulatory
FD&C Act (21 U.S.C. 360). In addition, multiple offenses, FDA shall determine Affairs.
bottled MMS that PGL shipped to whether the periods of debarment shall [FR Doc. 2017–03172 Filed 2–16–17; 8:45 am]
consumers did not bear labeling that run concurrently or consecutively. FDA BILLING CODE 4164–01–P
bore the full place of business of the has concluded that the 3-year period of
manufacturer. debarment for each of the four offenses
On or about November 1, 2010, DEPARTMENT OF HEALTH AND
of conviction need to be served
November 12, 2010, November 16, 2010, HUMAN SERVICES
and June 30, 2011, Ms. Delong or consecutively, resulting in a total
another person involved with PGL, debarment period of 12 years. Meeting of the Advisory Committee on
delivered for introduction into interstate As a result of the foregoing finding, Minority Health
commerce a number of packages Karis Copper Delong is debarred for a
AGENCY: Department of Health and
containing bottled MMS. These period of 12 years from providing
Human Services, Office of the Secretary,
packages contained MMS that Ms. services in any capacity to a person with Office of Minority Health.
Delong knew was primarily intended as an approved or pending drug product
a treatment for disease. ACTION: Notice of meeting.
application under sections 505, 512, or
As a result of these convictions, FDA 802 of the FD&C Act (21 U.S.C. 355, SUMMARY: As stipulated by the Federal
sent Ms. Delong by certified mail on 360b, or 382), or under section 351 of Advisory Committee Act, the
October 12, 2016, a notice proposing to the Public Health Service Act (42 U.S.C. Department of Health and Human
debar her for 12 years from providing
262), effective (see DATES) (see sections Services (DHHS) is hereby giving notice
services in any capacity to a person that
306(c)(1)(B), (c)(3), and 201(dd) of the that the Advisory Committee on
has an approved or pending drug
product application. The proposal was FD&C Act (21 U.S.C. 335a(c)(1)(B), Minority Health (ACMH) will hold a
based on a finding under section (c)(3), and 321(dd))). Any person with meeting. This meeting will be open to
306(b)(2)(B)(i)(I) of the FD&C Act, that an approved or pending drug product the public. Preregistration is required
Ms. Delong was convicted of application who knowingly employs or for both public attendance and
misdemeanors under Federal law for retains as a consultant or contractor, or comment. Any individual who wishes
conduct relating to the regulation of otherwise uses the services of Karis to attend the meetings and/or
drug products under the FD&C Act, and Copper Delong, in any capacity during participate in the public comment
that the type of conduct that served as Ms. Delong’s debarment, will be subject session should email OMH–ACMH@
the basis for the conviction undermines to civil money penalties (section hhs.gov.
the process for the regulation of drugs. 307(a)(6) of the FD&C Act (21 U.S.C. DATES: The meeting will be held on
The proposal offered Ms. Delong an 335b(a)(6))). If Ms. Delong provides Thursday, March 23, 2017, from 9:00
opportunity to request a hearing, services in any capacity to a person with a.m. to 5:00 p.m. and Friday, March 24,
providing her 30 days from the date of an approved or pending drug product 2017, from 9:00 a.m. to 1:00 p.m.
receipt of the letter in which to file the application during her period of ADDRESSES: The meeting will be held at
request, and advised her that failure to debarment she will be subject to civil the 5600 Fishers Lane Building, Room
request a hearing constituted a waiver of money penalties (section 307(a)(7) of the 05N76, 5600 Fishers Lane, Rockville,
the opportunity for a hearing and of any FD&C Act). In addition, FDA will not Maryland 20857.
contentions concerning this action. Ms. accept or review any abbreviated new FOR FURTHER INFORMATION CONTACT: Dr.
Delong received the proposal on drug applications submitted by or with Minh Wendt, Designated Federal
October 20, 2016. Ms. Delong did not Officer, ACMH; Tower Building, 1101
the assistance of Karis Copper Delong
request a hearing within the timeframe Wootton Parkway, Suite 600, Rockville,
during her period of debarment (section
prescribed by regulation and has, Maryland 20852. Phone: 240–453–8222,
therefore, waived her opportunity for a 306(c)(1)(B) of the FD&C Act).
Fax: 240–453–8223; OMH–ACMH@
hearing and has waived any contentions Any application by Ms. Delong for
hhs.gov.
concerning her debarment (21 CFR part termination of debarment under section
12). 306(d)(4) of the FD&C Act should be SUPPLEMENTARY INFORMATION: In
identified with Docket No. FDA–2016– accordance with Public Law 105–392,
II. Findings and Order the ACMH was established to provide
N–1677 and sent to the Division of
Therefore, the Director, Office of Dockets Management (see ADDRESSES). advice to the Deputy Assistant Secretary
Enforcement and Import Operations, All such submissions are to be filed in for Minority Health in improving the
Office of Regulatory Affairs, under four copies. The public availability of health of each racial and ethnic
section 306(b)(2)(B)(i)(I) of the FD&C information in these submissions is minority group and on the development
Act, under authority delegated to the of goals and specific program activities
governed by 21 CFR 10.20(j).
Director (Staff Manual Guide 1410.35), of the Office of Minority Health.
finds that Karis Copper Delong has been Publicly available submissions will be Topics to be discussed during this
convicted of four misdemeanor counts placed in the docket, and will be meeting will include strategies to
under federal law for conduct relating to viewable at https://www.regulations.gov improve the health of racial and ethnic
mstockstill on DSK3G9T082PROD with NOTICES

the regulation of drug products under or at the Division of Dockets minority populations through the
the FD&C Act, and that the type of Management (see ADDRESSES) between 9 development of health policies and
conduct that served as the basis for the a.m. and 4 p.m., Monday through programs that will help eliminate health
conviction undermines the process for Friday. disparities, as well as other related
the regulation of drugs. issues.
Based on consideration of the factors Public attendance at this meeting is
under section 306(c)(3) of the FD&C Act, limited to space available. Individuals

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Document Created: 2017-02-17 00:28:39
Document Modified: 2017-02-17 00:28:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is effective February 17, 2017.
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.
FR Citation		82 FR 11045

82 FR 11045 - Karis Copper Delong: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 32 (February 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration