Notice2021-16045
Jacobo Geissler: Final Debarment Order
Primary source
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Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40592-40593]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16045]
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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.
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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
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
<a href="/cdn-cgi/l/email-protection#1c78797e7d6e717972686f5c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="ef8b8a8d8e9d828a819b9caf898b8ec187879cc1888099">[email protected]</span></a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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