Document ID: FDA-2020-N-0861-0002
Agency: fda
Document Type: Notice
Title: Phillip R. Carawan: Final Debarment Order
Posted Date: 2020-10-23T04:00Z

[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Notices]
[Pages 67553-67554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23501]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0861]

Phillip R. Carawan: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring 
Phillip R. Carawan 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. Carawan 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. Carawan was given notice of the proposed permanent 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. As of June 13, 2020 (30 days after receipt of 
the notice), Mr. Carawan has not responded. Mr. Carawan's failure to 
respond and request a hearing constitutes a waiver of Mr. Carawan's 
right to a hearing concerning this matter.

DATES: This order is applicable October 23, 2020.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029) Division of 
Enforcement, 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)(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.

[[Page 67554]]

    On January 9, 2020, Mr. Carawan was convicted as defined in section 
306(l)(1)(B) of the FD&C Act, in the U.S. District Court for the 
Eastern District of North Carolina, when the court accepted Mr. 
Carawan's plea of guilty and entered judgment against him for the 
offense of violating the Lacey Act and Aiding and Abetting. This 
offense was in violation of 16 U.S.C. 3372(d)(1) and 3373(d)(3)(A)(j) 
and 18 U.S.C. 2.
    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 Indictment, filed on June 
26, 2019, Mr. Carawan served as the owner and operator, and acted as 
the President and Chief Executive Officer, of Capt. Neill's Seafood, 
Inc. (Capt. Neill's). Capt. Neill's is a North Carolina corporation in 
the business of purchasing, processing, packaging, transporting, and 
selling seafood and seafood products, including crab meat from 
domestically harvested Atlantic blue crab, and products made from 
Atlantic blue crab. From as early as January 1, 2012 and continuing 
through December 31, 2015, Mr. Carawan caused Capt. Neill's to purchase 
foreign crab meat from South American and Asia. Mr. Carawan directed 
Capt. Neill's employees to repackage the foreign crab meat into 
containers labeled ``Product of USA.'' Mr. Carawan then knowingly 
caused those containers of foreign crab meat to be sold as jumbo 
domestically harvested blue crab to customers. During the relevant time 
frame, Mr. Carawan caused the sale of approximately 200,536 pounds of 
crab meat falsely labeled ``Product of USA'' with a total retail market 
value of $4,082,841.
    As a result of this conviction FDA sent Mr. Carawan, by certified 
mail on May 6, 2020, 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. Carawan's felony 
conviction of violating the Lacey Act and Aiding and Abetting in 
violation of 16 U.S.C. 3372(d)(1) and 3373(d)(3)(A)(j) and 18 U.S.C 2, 
constitutes conduct relating to the importation into the United States 
of an article of food because the offense involved Mr. Carawan aiding 
and abetting the importation of foreign crab meat to be falsely labeled 
as ``Product of USA.''
    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. Carawan should be subject to a 5-year period of debarment. The 
proposal also offered Mr. Carawan an opportunity to request a hearing, 
providing Mr. Carawan 30 days from the date of receipt of the letter in 
which to file the request, and advised Mr. Carawan that failure to 
request a hearing constituted a waiver of the opportunity for a hearing 
and of any contentions concerning this action. Mr. Carawan 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. 
Carawan 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. Carawan 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 Phillip R. 
Carawan is a prohibited act.
    Any application by Mr. Carawan for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2020-N-0861 and sent to the Dockets Management Staff (see 
ADDRESSSES). 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 https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m. Eastern 
time, Monday through Friday.

    Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23501 Filed 10-22-20; 8:45 am]
BILLING CODE 4164-01-P