[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]


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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.

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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 
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