Jacobo Geissler: Final Debarment Order, 40592-40593 [2021-16045]
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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
Application No.
Drug
Applicant
ANDA 204464 ......................
Sodium Fluoride F–18 Injection, 10–200 millicurie/mL ...
ANDA 206177 ......................
Docetaxel Injection, 20 mg/mL (20 mg/mL), 80 mg/4
mL (20 mg/mL), and 200 mg/10 mL (20 mg/mL).
Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40
mg.
Decatur Memorial Hospital, 2300 North Edward St.,
Suite 100, Decatur, IL 62526.
DFB Oncology, LLC, 3909 Hulen St., Fort Worth, TX
76107.
Lupin Limited, U.S. Agent, Lupin Pharmaceuticals, Inc.,
111 South Calvert St., Harborplace Tower, 21st
Floor, Baltimore, MD 21202.
Jiangsu Hansoh Pharmaceutical Group Co., Ltd., U.S.
Agent, eVenus Pharmaceutical Laboratories Inc., 506
Carnegie Center, Suite 100, Princeton, NJ 08540.
ANDA 206631 ......................
ANDA 209399 ......................
Olanzapine Tablets, 2.5 mg, 5 mg, and 10 mg ..............
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of August 27,
2021. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on August 27, 2021
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16047 Filed 7–27–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2169]
Jacobo Geissler: Final Debarment
Order
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Jacobo Geissler for a period of 5 years
from importing articles of food or
offering such articles for importation
into the United States. FDA bases this
order on a finding that Mr. Geissler was
convicted of a felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food. Mr. Geissler was given
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:16 Jul 27, 2021
Jkt 253001
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of April 7, 2021 (30 days
after receipt of the notice), Mr. Geissler
has not responded. Mr. Geissler’s failure
to respond and request a hearing
constitutes a waiver of Mr. Geissler’s
right to a hearing concerning this
matter.
DATES: This order is applicable July 28,
2021.
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–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 debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) 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 food.
On October 13, 2020, Mr. Geissler was
convicted as defined in section
306(l)(1)(A) of the FD&C Act (21 U.S.C.
335a(l)(1)(A)), in the U.S. District Court
for the Northern District of Texas-Dallas
Division, when the court accepted his
plea of guilty and entered judgment
against him for the offense of conspiracy
to introduce misbranded food into
interstate commerce with an intent to
defraud and mislead in violation of 18
U.S.C. 371 (21 U.S.C. 331(a) and 21
U.S.C. 333(a)(2)).
FDA’s finding that the debarment is
appropriate is based on the felony
PO 00000
Frm 00149
Fmt 4703
Sfmt 4703
conviction referenced herein. The
factual basis for this conviction is as
follows: As contained in the Factual
Resume, dated February 24, 2019, in Mr.
Geissler’s case, he was the Chief
Executive Officer (CEO) and coowner of
USPlabs, LLC (USP Labs). USP Labs
sold dietary supplements. Beginning in
or around October 2008 and continuing
until at least around August 2014, Mr.
Geissler engaged in a conspiracy with
others to import a variety of chemicals
with false labeling in order to either use
those chemicals in dietary supplements
which would themselves also contain
false labeling, or to determine whether
those chemicals could be used in new
dietary supplements. To further this
conspiracy, Mr. Geissler’s
coconspirators ordered chemicals from a
Chinese company to be used as
ingredients in dietary supplements and
had them labeled falsely as other food
substances. USP Labs sold dietary
supplements called Jack3d and OxyElite
Pro, which originally contained a
substance called 1,3-dimethylamine
(DMAA), which is also known as
methylhexaneamine. USP Labs
imported the DMAA it used in its
products, Jack3d and OxyElite Pro, from
a Chinese chemical factory by using
false and fraudulent Certificate of
Analysis (COA) and other false and
fraudulent documentation and labeling.
At least some of the false COAs that
USP Labs caused to be created for their
DMAA shipments stated falsely that the
substance in the shipments had been
extracted from the geranium plant.
Further, as contained in the factual
resume and superseding indictment,
filed January 5, 2016, in December 2011,
Mr. Geissler instructed a Chinese
company via email to misbrand a
shipment of nine different chemicals
sent from China to USP Labs in Texas.
One of those synthetic chemicals was
called ‘‘aegeline.’’ The first aegeline
containing version of OxyElite Pro,
which was called OxyElite ‘‘New
Formula’’, went on sale in December
2012, but did not sell as well as the
DMAA-containing version. Therefore, in
the summer 2013, USP Labs began using
E:\FR\FM\28JYN1.SGM
28JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
pulverized roots of cynanchum
auriculatum, in addition to aegeline, in
its OxyElite Pro ‘‘Advanced Formula’’
supplement. The cynanchum
auriculatum-containing product was
called OxyElite Pro ‘‘Advanced
Formula.’’ On or about June 15, 2013,
Mr. Geissler’s coconspirator instructed a
Chinese chemical seller to have two
metric tons of ground cynanchum
auriculatum root powder, rather than an
extract, shipped internationally to
laboratories in California for inclusion
in USP Labs’ products, using the false
name ‘‘cynanchum auriculatum root
extract.’’ USP Labs then used the
substance in its OxyElite Pro
‘‘Advanced Formula’’ supplement
which it shipped to retailers and
wholesalers using false labels. When
there was a liver-injury outbreak, USP
Labs put out a misleading press release
stating that the ingredients in OxyElite
Pro had been studied and showed ‘‘no
negative liver issues,’’ but USP Labs
knew that a study had shown ‘‘liver
issues’’ related to cynanchum
auriculatum. Mr. Geissler did, with
intent to defraud and mislead, cause the
shipment of misbranded OxyElite Pro
‘‘Advanced Formula’’ to be shipped in
interstate commerce. The conspirators
collected millions in revenue.
As a result of this conviction FDA
sent Mr. Geissler, by certified mail on
March 4, 2021, a notice proposing to
debar him for a period of 5 years from
importing articles of food or offering
such articles for import into the United
States. The proposal was based on a
finding under section 306(b)(1)(C) of the
FD&C Act that Mr. Geissler’s felony
conviction of conspiracy to introduce
misbranded food into interstate
commerce with an intent to defraud and
mislead in violation of 18 U.S.C. 371 (21
U.S.C. 331(a) and 21 U.S.C. 333(a)(2)),
constitutes conduct relating to the
importation of an article of food into the
United States because the offense
involved a conspiracy with others to
import a variety of chemicals with false
labeling in order to either use those
chemicals in dietary supplements which
would themselves also contain false
labeling or to determine whether those
chemicals could be used in new dietary
supplements.
The proposal was also based on a
determination, after consideration of the
relevant factors set forth in section
306(c)(3) of the FD&C Act, that Mr.
Geissler should be subject to a 5-year
period of debarment. The proposal also
offered Mr. Geissler 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
Mr. Geissler that failure to request a
VerDate Sep<11>2014
17:16 Jul 27, 2021
Jkt 253001
hearing constituted a waiver of the
opportunity for a hearing and of any
contentions concerning this action. Mr.
Geissler failed to respond 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)(1)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Jacobo
Geissler has been convicted of a felony
count under Federal law for conduct
relating to the importation into the
United States of an article of food and
that he is subject to a 5-year period of
debarment.
As a result of the foregoing finding,
Mr. Geissler is debarred for a period of
5 years from importing articles of food
or offering such articles for import into
the United States, effective July 28,
2021. 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 an article of food by,
with the assistance of, or at the direction
of Jacobo Geissler is a prohibited act.
Any application by Mr. Geissler for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2020–
N–2169 and sent to the Dockets
Management Staff (ADDRESSSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20.
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: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16045 Filed 7–27–21; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
40593
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6730]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Reporting
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by August 27,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0437. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Device Reporting—21 CFR Part
803
OMB Control Number 0910–0437—
Extension
This information collection supports
FDA regulations and FDA’s Medical
Device Reporting program. Section
519(a), (b), and (c) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(a), (b), and (c)) requires user
facilities, manufacturers, importers, and
distributors of medical devices to report
adverse events involving medical
Frm 00150
Fmt 4703
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E:\FR\FM\28JYN1.SGM
28JYN1
Agencies
[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40592-40593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16045]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2169]
Jacobo Geissler: Final Debarment Order
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Jacobo Geissler for a period of 5 years from importing articles of food
or offering such articles for importation into the United States. FDA
bases this order on a finding that Mr. Geissler was convicted of a
felony count under Federal law for conduct relating to the importation
into the United States of an article of food. Mr. Geissler was given
notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of April 7,
2021 (30 days after receipt of the notice), Mr. Geissler has not
responded. Mr. Geissler's failure to respond and request a hearing
constitutes a waiver of Mr. Geissler's right to a hearing concerning
this matter.
DATES: This order is applicable July 28, 2021.
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-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
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) 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 food.
On October 13, 2020, Mr. Geissler was convicted as defined in
section 306(l)(1)(A) of the FD&C Act (21 U.S.C. 335a(l)(1)(A)), in the
U.S. District Court for the Northern District of Texas-Dallas Division,
when the court accepted his plea of guilty and entered judgment against
him for the offense of conspiracy to introduce misbranded food into
interstate commerce with an intent to defraud and mislead in violation
of 18 U.S.C. 371 (21 U.S.C. 331(a) and 21 U.S.C. 333(a)(2)).
FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: As contained in the Factual Resume, dated
February 24, 2019, in Mr. Geissler's case, he was the Chief Executive
Officer (CEO) and coowner of USPlabs, LLC (USP Labs). USP Labs sold
dietary supplements. Beginning in or around October 2008 and continuing
until at least around August 2014, Mr. Geissler engaged in a conspiracy
with others to import a variety of chemicals with false labeling in
order to either use those chemicals in dietary supplements which would
themselves also contain false labeling, or to determine whether those
chemicals could be used in new dietary supplements. To further this
conspiracy, Mr. Geissler's coconspirators ordered chemicals from a
Chinese company to be used as ingredients in dietary supplements and
had them labeled falsely as other food substances. USP Labs sold
dietary supplements called Jack3d and OxyElite Pro, which originally
contained a substance called 1,3-dimethylamine (DMAA), which is also
known as methylhexaneamine. USP Labs imported the DMAA it used in its
products, Jack3d and OxyElite Pro, from a Chinese chemical factory by
using false and fraudulent Certificate of Analysis (COA) and other
false and fraudulent documentation and labeling. At least some of the
false COAs that USP Labs caused to be created for their DMAA shipments
stated falsely that the substance in the shipments had been extracted
from the geranium plant.
Further, as contained in the factual resume and superseding
indictment, filed January 5, 2016, in December 2011, Mr. Geissler
instructed a Chinese company via email to misbrand a shipment of nine
different chemicals sent from China to USP Labs in Texas. One of those
synthetic chemicals was called ``aegeline.'' The first aegeline
containing version of OxyElite Pro, which was called OxyElite ``New
Formula'', went on sale in December 2012, but did not sell as well as
the DMAA-containing version. Therefore, in the summer 2013, USP Labs
began using
[[Page 40593]]
pulverized roots of cynanchum auriculatum, in addition to aegeline, in
its OxyElite Pro ``Advanced Formula'' supplement. The cynanchum
auriculatum-containing product was called OxyElite Pro ``Advanced
Formula.'' On or about June 15, 2013, Mr. Geissler's coconspirator
instructed a Chinese chemical seller to have two metric tons of ground
cynanchum auriculatum root powder, rather than an extract, shipped
internationally to laboratories in California for inclusion in USP
Labs' products, using the false name ``cynanchum auriculatum root
extract.'' USP Labs then used the substance in its OxyElite Pro
``Advanced Formula'' supplement which it shipped to retailers and
wholesalers using false labels. When there was a liver-injury outbreak,
USP Labs put out a misleading press release stating that the
ingredients in OxyElite Pro had been studied and showed ``no negative
liver issues,'' but USP Labs knew that a study had shown ``liver
issues'' related to cynanchum auriculatum. Mr. Geissler did, with
intent to defraud and mislead, cause the shipment of misbranded
OxyElite Pro ``Advanced Formula'' to be shipped in interstate commerce.
The conspirators collected millions in revenue.
As a result of this conviction FDA sent Mr. Geissler, by certified
mail on March 4, 2021, a notice proposing to debar him for a period of
5 years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Geissler's felony
conviction of conspiracy to introduce misbranded food into interstate
commerce with an intent to defraud and mislead in violation of 18
U.S.C. 371 (21 U.S.C. 331(a) and 21 U.S.C. 333(a)(2)), constitutes
conduct relating to the importation of an article of food into the
United States because the offense involved a conspiracy with others to
import a variety of chemicals with false labeling in order to either
use those chemicals in dietary supplements which would themselves also
contain false labeling or to determine whether those chemicals could be
used in new dietary supplements.
The proposal was also based on a determination, after consideration
of the relevant factors set forth in section 306(c)(3) of the FD&C Act,
that Mr. Geissler should be subject to a 5-year period of debarment.
The proposal also offered Mr. Geissler 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 Mr. Geissler that failure to
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. Mr. Geissler failed to
respond 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)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Jacobo Geissler has been convicted of a felony count under Federal law
for conduct relating to the importation into the United States of an
article of food and that he is subject to a 5-year period of debarment.
As a result of the foregoing finding, Mr. Geissler is debarred for
a period of 5 years from importing articles of food or offering such
articles for import into the United States, effective July 28, 2021.
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 an article
of food by, with the assistance of, or at the direction of Jacobo
Geissler is a prohibited act.
Any application by Mr. Geissler for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-2169 and sent to the Dockets Management Staff (ADDRESSSES).
The public availability of information in these submissions is governed
by 21 CFR 10.20.
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: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16045 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P