[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54456-54457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21375]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
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 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 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: 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


