[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Notices]
[Pages 42787-42788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0589]


Anneri Izurieta; Conviction Reversal; Final Order Withdrawing 
Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an 
order, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 
withdrawing its January 13, 2012, order debarring Anneri Izurieta from 
importing food or offering food for importation into the United States. 
FDA is issuing this order because the U.S. Court of Appeals for the 
Eleventh Circuit issued an order vacating the conviction and sentence 
of Anneri Izurieta.

DATES: Effective Date: July 17, 2013.

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: In a notice published in the Federal 
Register on January 13, 2012 (77 FR 2070), FDA debarred Anneri Izurieta 
for a period of 30 years from importing articles of food or offering 
such articles for importation into the United States. FDA issued the 
debarment order under section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 
335a(b)(1)(C)), which permits FDA to debar an individual from importing 
an article of food or offering such an article for importation into the 
United States if FDA finds, as required by section 306(b)(3)(A) of the 
FD&C Act (21 U.S.C. 335a(b)(3)(A)), that the individual has been 
convicted of a felony for conduct relating to the importation into the 
United States of any food. The debarment was based on FDA's finding 
that Ms. Izurieta was convicted of six felony counts under Federal law 
for conduct relating to the importation into the United States of an 
article of food. Ms. Izurieta, the president and director of Naver 
Trading, was convicted on May 11, 2011, and sentenced on July 29, 2011, 
for conspiracy to smuggle goods into the United States and smuggling 
goods into the United States. The basis for Ms. Izurieta's conviction 
was her alleged role in distributing shipments of dairy products that 
were adulterated and not authorized for entry into the United States. 
On August 3, 2011, Ms. Izurieta appealed her conviction and sentence.
    On February 22, 2013, the U.S. Court of Appeals for the Eleventh 
Circuit issued an order vacating the conviction and sentence of Ms. 
Izurieta. A copy of the court's order is available in Docket No. FDA-
2011-N-0589. By this order, the court vacated Ms. Izurieta's 
conviction. The order was issued as a mandate on April 23, 2013. 
Section 306(d)(3)(B)(i) of the FD&C Act (U.S.C. 335a(d)(3)(B)(i) states 
that ``If the conviction which served as the basis for the debarment of 
an individual under subsection . . . (b)(3) is reversed, the Secretary 
shall withdraw the order of debarment.''
    Accordingly, the Acting Associate Commissioner for Regulatory 
Affairs, Office of Regulatory Affairs, under section 306(d)(3)(B)(i) of 
the FD&C Act and under authority delegated to the

[[Page 42788]]

Associate Commissioner (Staff Manual Guide 1410.21), issues this order 
withdrawing the order of debarment of Anneri Izurieta, thereby allowing 
her to import food or offer such articles for importation into the 
United States. This order is effective July 17, 2013.

    Dated: July 12, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of 
Regulatory Affairs.
[FR Doc. 2013-17123 Filed 7-16-13; 8:45 am]
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