Notice2021-16211
Matthew Hebert: Final Debarment Order
Primary source
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Published
July 30, 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 Matthew Hebert 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. Hebert 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. Hebert was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 5, 2021 (30 days after receipt of the notice), Mr. Hebert has not responded. Mr. Hebert'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 144 (Friday, July 30, 2021)</title>
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[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41042-41043]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16211]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2340]
Matthew Hebert: 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
Matthew Hebert 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. Hebert 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. Hebert was given notice of
the proposed debarment and an opportunity to request a hearing within
the timeframe prescribed by regulation. As of May 5, 2021 (30 days
after receipt of the notice), Mr. Hebert has not responded. Mr.
Hebert'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 July 30, 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 (ELEM-4029), Division
of Enforcement, 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#4125242320332c242f3532012725206f2929326f262e37"><span class="__cf_email__" data-cfemail="2b4f4e494a59464e455f586b4d4f4a05434358054c445d">[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 debarment of 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 December 11, 2020,
Mr. Hebert was convicted, as defined in section 306(l)(1)(A) of the
FD&C Act, in the U.S. District Court for the Northern
[[Page 41043]]
District of Texas-Dallas Division, when the court accepted Mr. Hebert's
plea of guilty and entered judgment against him for the offense of
introduction of misbranded food into interstate commerce with intent to
defraud and mislead, in violation of sections 301(a) and 303(a)(2) of
the FD&C Act (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 superseding indictment,
filed on January 5, 2016, Mr. Hebert was a co-owner of USP Labs with
primarily responsibilities over product packaging design. As contained
in the factual r[eacute]sum[eacute] submitted as part of Mr. Hebert's
plea agreement on March 11, 2019, and the factual resumes submitted as
part of plea agreements with his codefendants, one of Mr. Hebert's
codefendants 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' dietary
supplement products, using the false name ``cynanchum auriculatum root
extract.'' USP Labs sent false labels to retailers and wholesalers
listing ``cynanchum auriculatum (root) extract'' as an ingredient in
OxyElite Pro ``Advanced Formula'' (which went on sale in or around
August 2013), even though that ingredient was not present in the
product. Beginning in or around August 2013, Mr. Hebert, USP Labs, and
others working at USP Labs and S.K. Laboratories, did knowingly, and
with the intent to defraud and mislead, cause the shipment of a
misbranded food, namely the OxyElite Pro ``Advanced Formula'' dietary
supplement, in interstate commerce. Specifically, on or about October
4, 2013, with intent to defraud and mislead, Mr. Hebert caused the
shipment of misbranded OxyElite Pro ``Advanced Formula'' in interstate
commerce. The labeling for OxyElite Pro ``Advanced Formula'' falsely
declared cynanchum auriculatum (root) extract as an ingredient, when in
fact OxyElite Pro ``Advanced Formula'' contained imported cynanchum
auriculatum powder but no cynanchum auriculatum (root) extract.
As a result of this conviction, FDA sent Mr. Hebert, by certified
mail on March 29, 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. Hebert's felony
conviction of ``introduction of misbranded food into interstate
commerce with intent to defraud and mislead'' in violation of sections
301(a) and 303(a)(2) of the FD&C Act constitutes conduct relating to
the importation into the United States of an article of food because
Mr. Hebert caused the shipment of a misbranded food in interstate
commerce, and the food was misbranded because its labeling falsely
declared cynanchum auriculatum (root) extract as an ingredient, when in
fact the imported ingredient was cynanchum auriculatum powder, not
cynanchum auriculatum root extract.
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. Hebert should be subject to a 5-year period of debarment. The
proposal also offered Mr. Hebert an opportunity to request a hearing,
providing Mr. Hebert 30 days from the date of receipt of the letter in
which to file the request, and advised Mr. Hebert that failure to
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. Mr. Hebert 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.
Matthew Hebert 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. Hebert 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, 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 Matthew Hebert is a prohibited
act.
Any application by Mr. Hebert for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-2340 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: July 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16211 Filed 7-29-21; 8:45 am]
BILLING CODE 4164-01-P
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