[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76583-76585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26250]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1255]


Tuan Anh Tran: 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 
Tuan Anh Tran for a period of 5 years from importing or offering for 
import any drug into the United States. FDA bases this order on a 
finding that Mr. Tran engaged in a pattern of importing or offering for 
import misbranded drugs (i.e., in an amount, frequency, or dosage that 
is inconsistent with his personal or household use) that are not 
designated in an authorized electronic data interchange system as 
products

[[Page 76584]]

regulated by FDA. Mr. Tran was given notice of the proposed debarment 
and an opportunity to request a hearing to show why he should not be 
debarred. As of September 14, 2020 (30 days after receipt of the 
notice), Mr. Tran had not responded. Mr. Trans'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 November 30, 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, 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)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) 
permits debarment of an individual from importing or offering for 
import any drug into the United States if FDA finds, as required by 
section 306(b)(3)(D) of the FD&C Act, that the individual has engaged 
in a pattern of importing or offering for import misbranded drugs 
(i.e., in an amount, frequency, or dosage that is inconsistent with 
personal or household use by the importer), and the shipments are not 
designated in an entry in an authorized electronic data exchange system 
as products regulated by FDA.
    After an investigation, FDA discovered that Mr. Tran has engaged in 
numerous instances of importing or offering for import misbranded 
drugs; all the parcels containing the misbranded drugs serving as the 
basis for this action were intercepted by FDA at the John F. Kennedy 
International Mail Facility and were addressed to Mr. Tran at one of 
two addresses connected to him.
    On or about April 12, 2019, Mr. Tran offered for import three 
parcels. The product contained in the first parcel was 210 packets 
(pieces) of Kamagra Sildenafil Oral Jelly and was a misbranded drug 
because the product was a prescription drug product that failed to 
contain the ``Rx-only'' symbol on its label. The product was refused 
entry on May 17, 2019. The product contained in the second parcel was 
245 packets (pieces) of Kamagra Sildenafil Oral Jelly and was a 
misbranded drug because the product was a prescription drug product 
that failed to contain the ``Rx-only'' symbol on its label. The product 
was refused entry on May 17, 2019. The product contained in the third 
parcel was 245 packets (pieces) of Kamagra Sildenafil Oral Jelly and 
was a misbranded drug because the product was a prescription drug 
product that failed to contain the ``Rx-only'' symbol on its label. The 
product was refused entry on May 17, 2019.
    On or about September 13, 2019, Mr. Tran offered for import four 
parcels. The product contained in the first parcel was 312 Kamagra 
Sildenafil Citrate Chewable Tablets and was a misbranded drug because 
it was a prescription drug product that failed to contain the ``Rx-
only'' symbol on its label. The product was refused entry on October 
22, 2019. The product contained in the second parcel was 312 Kamagra 
Sildenafil Citrate Chewable Tablets and was a misbranded drug because 
it was a prescription drug product that failed to contain the ``Rx-
only'' symbol on its label. The product was refused entry on October 
22, 2019. The product contained in the third parcel was 196 packets 
(pieces) of Kamagra Sildenafil Citrate Jelly and was a misbranded drug 
because it was a prescription drug product that failed to contain the 
``Rx-only'' symbol on its label. The product was refused entry on 
October 22, 2019. The product contained in the fourth parcel was 231 
packets (pieces) of Kamagra Sildenafil Citrate Jelly and was a 
misbranded drug because it was a prescription drug product that failed 
to contain the ``Rx-only'' symbol on its label. The product was refused 
entry on October 22, 2019.
    On or about September 26, 2019, Mr. Tran offered for import a 
parcel that was intercepted and processed by FDA. The product contained 
in the parcel was 196 packets (pieces) of Kamagra Sildenafil Oral Jelly 
and was a misbranded drug because it was a prescription drug product 
that failed to contain the ``Rx-only'' symbol on its label. The product 
was refused entry on October 29, 2019.
    Because of this pattern of importing or offering for import 
misbranded drugs (i.e., in an amount, frequency, or dosage that is 
inconsistent with his personal or household use) that are not 
designated in an authorized electronic data interchange system as 
products regulated by FDA, in accordance with section 306(b)(3)(D) of 
the FD&C Act, FDA sent Mr. Tran, by certified mail on August 7, 2020, a 
notice proposing to debar him for 5 years from importing or offering 
for import any drug into the United States.
    In proposing a debarment period, FDA weighed the considerations set 
forth in section 306(c)(3) of the FD&C Act that it considered 
applicable to Mr. Tran's pattern of conduct and concluded that his 
conduct warranted the imposition of a 5-year period of debarment.
    The proposal informed Mr. Tran of the proposed debarment and 
offered him 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. Tran received the proposal and notice of opportunity for a 
hearing on August 15, 2020. Mr. Tran failed to request a hearing within 
the timeframe prescribed by regulation and, therefore, has 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)(3)(D) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. Tuan 
Anh Tran has engaged in a pattern of importing or offering for import 
misbranded drugs (i.e., in an amount, frequency, or dosage that is 
inconsistent with his personal or household use) that are not 
designated in an authorized electronic data interchange system as 
products regulated by FDA. FDA finds that this pattern of conduct 
should be accorded a debarment of 5 years as provided by section 
306(c)(2)(A)(iii) of the FD&C Act.
    As a result of the foregoing finding, Mr. Tran is debarred for 5 
years from importing or offering for import any drug 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 any drug or controlled substance by, with the 
assistance of, or at the direction of Mr. Tran is a prohibited act.
    Any application by Mr. Tran for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2020-N-1255 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

[[Page 76585]]

ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500.

    Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26250 Filed 11-27-20; 8:45 am]
BILLING CODE 4164-01-P


