[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41042-41043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
https://www.regulations.gov.

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 
[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 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 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 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