[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15191-15192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05443]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3474]
Zhang Xiao Dong: 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
Zhang Xiao Dong for a period of 5 years from importing articles of food
(including dietary supplements) or offering such articles for
importation into the United States. FDA bases this order on a finding
that Mr. Dong was convicted, as defined in the FD&C Act, of a felony
count under Federal law for conduct relating to the importation into
the United States of an article of food. Mr. Dong was given notice of
the proposed permanent debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of November
19, 2019 (30 days after receipt of the notice), Mr. Dong has not
responded. Mr. Dong'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 March 17, 2020.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, 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 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 December 20, 2018, Mr. Dong was convicted as defined in section
[[Page 15192]]
306(l)(1)(A) of the FD&C Act, in the United States District Court for
the Northern District of Texas Dallas Division, when the court entered
judgment against him for the offense of Mail Fraud in violation of 18
U.S.C. 1343.
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 in his
case, filed on March 12, 2018, Mr. Dong, along with other employees of
his employer Genabolix USA, Inc. and Shanghai Yongyi Biotechnology Co.,
Ltd. (Genabolix), did in or around February 2017, agree to sell
synthetic stimulant ingredients, including 1,4 Dimethylamylamine (1,4-
DMAA), to a purported dietary supplement manufacturer. That
manufacturer told Mr. Dong that the ingredients supplied by Mr. Dong
would not be accurately listed on the labels of the finished dietary
supplements produced with those ingredients. As Mr. Dong knew, the
synthetic stimulant ingredients would be omitted from the ingredient
label of the dietary supplements so that American retailers would sell
the product. Mr. Dong then sent unlabeled shipments of these
ingredients to a third party in the United States. Subsequently, on
June 8, 2017, Mr. Dong (along with others) caused 50kg of 1,3
Dimethylamylamine (1,3-DMAA) to be shipped via commercial carrier in
interstate commerce in the United States.
As a result of this conviction, FDA sent Mr. Dong, by certified
mail on October 18, 2019, 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. Dong's felony
conviction for Mail Fraud in violation of 18 U.S.C. 1343, constitutes
conduct relating to the importation into the United States of an
article of food because Mr. Dong unlawfully imported synthetic
stimulant ingredients which Mr. Dong then caused to be shipped in
interstate commerce and ultimately used in dietary supplements that did
not list the synthetic stimulants as an ingredient.
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. Dong should be subject to a 5-year period of debarment. The
proposal also offered Mr. Dong 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 him that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Mr. Dong 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. Dong
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. Dong 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. Dong is
a prohibited act.
Any application by Mr. Dong for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-3474 and sent to the Dockets Management Staff (see
ADDRESSES). All such submissions are to be filed in four copies. 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 http://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05443 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P