Document ID: FDA-2014-N-0964-0001
Agency: fda
Document Type: Notice
Title: Jun Yang: Debarment Order
Posted Date: 2015-04-01T04:00Z

[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17450-17452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07439]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0964]

Jun Yang: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 17451]]

SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) debarring Jun Yang for a period of 4 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. Yang was convicted, 
as defined in the FD&C Act, of one felony count under Federal law for 
conduct relating to the importation into the United States of an 
article of food. Mr. Yang was given notice of the proposed debarment 
and an opportunity to request a hearing within the timeframe prescribed 
by regulation. As of November 7, 2014 (30 days after receipt of the 
notice), Mr. Yang had not responded. Mr. Yang's failure to respond 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective April 1, 2015.

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, Division Of Enforcement, 
Office of Enforcement and Import Operations, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144), 
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 14, 2013, Mr. Yang was convicted, as defined in section 
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the 
Northern District of Illinois accepted his plea of guilty and entered 
judgment against him for the following offense: One count of smuggling 
goods into the United States, in violation of 18 U.S.C. 545.
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein. The factual basis for this conviction is 
as follows:
    On or about February 10, 2012, Mr. Yang facilitated the sale of 
imported honey with a declared value of $92,800, knowing that the honey 
was of Chinese origin and was imported and brought into the United 
States contrary to law. As part of his fraudulent practice, Mr. Yang 
brokered the sale of two container loads of purported ``100% pure 
Indian honey,'' knowing that the honey was falsely and fraudulently 
imported and brought into the United States as a product of India in 
avoidance of U.S.-imposed anti-dumping duties, thereby causing losses 
to the United States of approximately $97,625.
    Mr. Yang admitted that he operated and controlled National Honey, 
Inc., which did business as National Commodities Company, and served as 
the principal point of contact for brokering the sale of honey between 
overseas honey suppliers and U.S. customers. Mr. Yang further admits 
that between 2009 and 2012 he sold 778 container loads of honey valued 
at approximately $22,864,153 to Honey Holding and Honey Packer 1 (U.S. 
customers). This was part of a fraudulent practice to enter and 
introduce and cause others to enter and introduce transshipped Chinese-
origin honey into the commerce of the United States in avoidance of 
U.S. imposed anti-dumping duties. Mr. Yang continued this practice even 
though he knew that the honey was falsely and fraudulently imported, 
entered, marketed, and sold as purely non-Chinese honey, including as 
honey from Malaysia and India. This fraudulent practice caused losses 
to the United States of as much as $37,991,375.
    Mr. Yang also admitted that he ordered honey from Chinese honey 
suppliers, knowing that the Chinese honey suppliers would send the 
Chinese-origin honey to countries including Malaysia and India, where 
the honey was mislabeled as to the country of origin before it passed 
through a U.S. customhouse as non-Chinese origin honey. Mr. Yang and 
National Commodities caused the formation of at least three companies 
and used at least one other company to import and enter honey from a 
Chinese honey supplier knowing that some of the honey was Chinese in 
origin. Mr. Yang and National Commodities benefitted from the company's 
filing custom entry forms that falsely and fraudulently declared all 
the honey as originating from Malaysia and India. Mr. Yang and National 
Commodities purchased honey imported by the companies despite knowing 
that some or all of the honey was Chinese in origin, but declared at 
the time of importation and entry as entirely originating from Malaysia 
and India.
    Mr. Yang also admitted that he obtained and circulated and caused 
others to obtain and circulate false and fraudulent bills of lading, 
invoices, packing lists, country of origin certificates, and other 
papers, which he knew to be false and fraudulent. These records were 
used to declare Chinese-origin honey as having originated from Malaysia 
and India. Mr. Yang also instructed an undercover law enforcement agent 
to destroy unfavorable test results that showed purported Vietnamese 
honey that he sold tested positive for the presence of chloramphenicol, 
an antibiotic. Residues of chloramphenicol in honey cause the honey to 
be adulterated under the FD&C Act. In anticipation of an investigation 
by U.S. Customs and Border Protection and FDA, Mr. Yang knowingly 
concealed and covered up three laboratory reports showing the presence 
of chloramphenicol.
    As a result of his conviction, on October 1, 2014, FDA sent Mr. 
Yang a notice by certified mail proposing to debar him for a period of 
4 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. Yang's felony 
conviction for smuggling of goods into the United States in violation 
of 18 U.S.C. 545 constitutes conduct relating to the importation into 
the United States of an article of food because he committed an offense 
related to the importation of Chinese honey into the United States.
    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. 
Yang should be subject to a 4-year period of debarment. The proposal 
also offered Mr. Yang 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. Yang 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 Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 306(b)(1)(C) of 
the FD&C Act, under authority delegated to the Director (Staff Manual 
Guide 1410.35), finds that Jun Yang has been convicted

[[Page 17452]]

of one 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 4-year period of debarment.
    As a result of the foregoing finding, Jun Yang is debarred for a 
period of 4 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 Jun Yang is 
a prohibited act.
    Any application by Mr. Yang for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2014-N-0964 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: March 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07439 Filed 3-31-15; 8:45 am]
BILLING CODE 4164-01-P