Notice2021-21375
Sitesh Bansi Patel: Final Debarment Order
Primary source
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Published
October 1, 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 Sitesh Bansi Patel 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. Patel 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. Patel was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 8, 2021 (30 days after receipt of the notice), Mr. Patel has not responded. Mr. Patel's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 86 Issue 188 (Friday, October 1, 2021)</title>
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54456-54457]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21375]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0269]
Sitesh Bansi Patel: 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
Sitesh Bansi Patel 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. Patel 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. Patel was given
notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of July 8,
2021 (30 days after receipt of the notice), Mr. Patel has not
responded. Mr. Patel'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 October 1, 2021.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff (HFA-305), 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#ee8a8b8c8f9c838b809a9dae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="5632333437243b3338222516303237783e3e2578313920">[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 February 19, 2020, Mr. Patel was convicted as defined in section
306(l)(1)(A) of the FD&C Act, in the U. S. District Court for the
Northern District of Texas-Dallas Division, when the court accepted Mr.
Patel's 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 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 22, 2019, Mr. Patel was the Vice
President of S.K. Laboratories, LLC, and in that role did business with
USP Labs. Beginning in or around October 2008 and continuing until at
least in or around August 2014, Mr. Patel and others working at USP
Labs and S.K. Laboratories engaged in a plan to import a variety of
compounds for use and prospective use in dietary supplements with false
labeling. To further this plan, Mr. Patel and his co-conspirators
ordered a variety of potential dietary compounds from a Chinese company
as prospective and actual ingredients for use in dietary supplements,
and instructed and agreed to have those powders labeled falsely as
other food substances. USP Labs sold dietary supplements called Jack3d
and OxyElite Pro, both of which originally contained a substance called
1,3-dimethylamylamine (DMAA), which is also known as methylhexaneamine.
The DMAA used in Jack3d and OxyElite Pro was a synthetic stimulant
manufactured in China. Mr. Patel and his co-conspirators came to
understand that importing and selling purported natural, plant-based
substances would be easier than selling synthetic stimulants. USP Labs
imported DMAA using false and fraudulent Certificates of Analysis
(COAs) and other false and fraudulent documentation and labeling. Some
of the false COAs that USP Labs caused to be created for DMAA shipments
stated falsely that the substance in the shipments had been extracted
from the geranium plant.
In a September 2008 email, Mr. Patel instructed one of his co-
conspirators, ``Have your supplier create a COA like this.'' In an
email exchange from May
[[Page 54457]]
2009, discussing the DMAA in USP Labs' products, Mr. Patel told two of
his co-conspirators, ``lol stuff is completely 100% synthethic [sic].''
From at least 2008 until at least 2013, USP Labs frequently imported
other potential dietary compounds from China, under false labeling, to
determine if they could be used in new dietary supplements. One of
those synthetic compounds was called ``aegeline.'' The first aegeline-
containing version of OxyElite Pro, which was called OxyElite ``New
Formula,'' went on sale in November 2012. USP Labs reformulated the
DMAA product in the summer of 2013 to contain aegeline and powder
derived from a Chinese herb called cynanchum auriculatum. On or about
June 15, 2013, one of Mr. Patel's co-conspirators at USP Labs
instructed a Chinese company to have 2 metric tons of ground cynanchum
auriculatum root powder shipped internationally to S.K. Laboratories in
California for inclusion in USP Labs' products, using the false name
``cynanchum auriculatum root extract.'' USP Labs sent false labels
listing ``cynanchum auriculatum (root) extract'' as an ingredient in
its OxyElite Pro ``Advanced Formula'' supplement to retailers and
wholesalers. On or about October 4, 2013, Mr. Patel and his co-
conspirators shipped and caused the shipment of misbranded OxyElite Pro
``Advanced Formula'' into interstate commerce. The food was misbranded
because its labeling falsely declared cynanchum auriculatum (root)
extract as an ingredient even though it was not contained in the
product.
As a result of this conviction FDA sent Mr. Patel, by certified
mail on May 27, 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. Patel'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 333(a)(2)) constitutes conduct
relating to the importation into the United States of an article of
food because Mr. Patel was engaged in a conspiracy with others to
import a variety of potential dietary compounds from a Chinese company
as prospective and actual ingredients for use in dietary supplements,
and instructed and agreed to have those powders labeled falsely as
other food substances. 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. Patel should be subject to a 5-year
period of debarment. The proposal also offered Mr. Patel an opportunity
to request a hearing, providing Mr. Patel 30 days from the date of
receipt of the letter in which to file the request, and advised Mr.
Patel that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Mr. Patel 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.
Sitesh Bansi Patel 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. Patel is debarred for a
period of 5 years from importing articles of food or offering such
articles for import 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 an article
of food by, with the assistance of, or at the direction of Mr. Sitesh
Bansi Patel is a prohibited act.
Any application by Mr. Patel for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0269 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 <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: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21375 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
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