[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14304-14305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0777]


Adrian Vela: 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 (the FD&C Act) debarring 
Adrian Vela 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. Vela was convicted of three 
felony counts under Federal law for conduct relating to the importation 
into the United States of an article of food. Mr. Vela was given notice 
of the proposed debarment and an opportunity to request a hearing 
within the timeframe prescribed by regulation. As of November 3, 2012 
(30 days after receipt of the notice), Mr. Vela had not responded. Mr. 
Vela's failure to respond constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is effective March 5, 2013.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, 
MD 20857, 301-796-4640.

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 November 21, 2011, Mr. Vela was convicted, as defined in section 
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the 
Southern District of Florida accepted his plea of guilty and entered 
judgment against him for the following offenses: One count of 
conspiracy to falsely label and misbrand food, in violation of 18 
U.S.C. 371; one count of false labeling of seafood under the Lacey Act, 
in violation of 16 U.S.C. 3372(d)(2); and one count of misbranding food 
in violation of 21 U.S.C. 331(a).
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the importation 
into the United States of any food. The factual basis for these 
convictions is as follows: As alleged in the criminal information filed 
against Mr. Vela, he was the operating manager and sole shareholder of 
Sea Food Center, a seafood wholesaler engaged in various aspects of 
purchasing, importing, processing, packing, selling, and exporting 
seafood products.
    Beginning on or about June 30, 2008, and continuing through on or 
about June 29, 2009, he knowingly combined, conspired, confederated, 
and agreed with his co-conspirators to commit an offense against the 
laws of the United States related to the importation of food. The 
purpose of the conspiracy was for Mr. Vela and his co-conspirators to 
unlawfully enrich themselves by

[[Page 14305]]

introducing what the criminal information describes as a less 
marketable substituted seafood product into the U.S. seafood market. 
Those products--``Shrimp, Product of Thailand,'' ``Shrimp, Product of 
Malaysia,'' and ``Shrimp, Product of Indonesia''--were misbranded, 
marketed, and intended to be marketed as ``Shrimp, Product of Panama,'' 
a seafood product that the criminal information describes as more 
readily marketable. Mr. Vela instructed employees at Sea Food Center's 
Tampa facility to divide the shrimp received from Thailand, Malaysia, 
and Indonesia into smaller portions, and mark them as ``Shrimp, product 
of Panama,'' on the individual packages, and then place them in boxes, 
also marked as ``Shrimp, product of Panama.'' Employees under the 
direction of Mr. Vela's co-conspirator managed and directed the 
labeling operations at Sea Food Center by providing instructions and 
other directives to Mr. Vela. The relabeled shrimp were then sold to a 
food wholesaler based in Keene, NH, which in turn sold the shrimp to a 
supermarket chain headquartered in Landover, MD. This conduct was in 
violation of 18 U.S.C. 371.
    On or about July 8, 2008, Mr. Vela knowingly engaged in an offense 
that involved the sale and purchase of, the offer of sale and purchase 
of, and the intent to sell and purchase shrimp, with a market value 
greater than $350.00. He knowingly made and caused to be made 
individual labels, pre-printed bags, and other documents falsely 
identifying the shrimp as being ``Shrimp, Product of Panama,'' when in 
fact the shrimp were ``Shrimp, Product of Thailand,'' ``Shrimp, Product 
of Malaysia,'' and ``Shrimp, Product of Indonesia.'' This conduct was 
in violation of 16 U.S.C. 3372(d)(2).
    On or about July 8, 2008, Mr. Vela engaged in an offense that 
involved the introduction or delivery for introduction into interstate 
commerce of a food that was misbranded, with the intent to defraud or 
mislead, in that he created or caused to be created individual labels, 
pre-printed bags, and other documents falsely identifying the shrimp. 
This conduct was in violation of 21 U.S.C. 331(a).
    As a result of his conviction, on September 28, 2012, FDA sent Mr. 
Vela a notice by certified mail 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. Vela was convicted 
of three felony counts under Federal law for conduct relating to the 
importation into the United States of an article of food because he: 
Conspired to and committed offenses related to the importation of 
shrimp into the United States, falsely conveyed information about the 
shrimp's country of origin; introduced or delivered for introduction 
misbranded food into interstate commerce; and falsely labeled seafood 
under the Lacey Act. The proposal was also based on a determination, 
after consideration of the factors set forth in section 306(c)(3) of 
the FD&C Act, that Mr. Vela should be subject to a 5-year period of 
debarment. The proposal also offered Mr. Vela 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. Vela 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 Associate Commissioner for Regulatory Affairs, 
Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C 
Act, and under authority delegated to the Associate Commissioner (Staff 
Manual Guide 1410.21), finds that Mr. Adrian Vela has been convicted of 
three felony counts under Federal law for conduct relating to the 
importation of an article of food into the United States and that he is 
subject to a 5-year period of debarment.
    As a result of the foregoing finding, Mr. Vela 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). 
Under 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. Vela is 
a prohibited act.
    Any application by Mr. Vela for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2012-N-0777 and sent to the Division of Dockets Management (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(j).
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 8, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of 
Regulatory Affairs.
[FR Doc. 2013-05062 Filed 3-4-13; 8:45 am]
BILLING CODE 4160-01-P