(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
NOTE: The revision of this Import Alert dated 10/17/2017 removes the non-FDA laboratory and surveillance information and updates the "Guidance" section by providing additional information.
Previous revisions of this Import Alert dated 7/8/2013 added sampling and laboratory information for non-FDA laboratory testing and dated 8/28/2012 updated the "Guidance" section by providing additional information.
*** Honey is a commodity that is known to potentially be subject to economic adulteration through addition of cane or corn sweeteners.
Note: ORS contact information updated on 08/16/2019
Recommendations for addition to Detention Without Physical Examination:
Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Food Safety and Applied Nutrition (CFSAN), when necessary, will evaluate regulatory packages on a case-by-case basis.
Release of Articles Subject to Detention Without Physical Examination under This Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or other responsible party to the shipment should provide results of a third-party laboratory analysis, which verifies the product does not contain added cane or corn sugar according to AOAC Official Method 991.41.
All analytical packages will be reviewed by CFSAN, Dietary Supplement and Labeling Assessment Branch.
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof wishes to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov.
Questions or issues involving import operations should be addressed to ORA/DIO/Import Operations and Maintenance Branch at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSCS/Import Compliance Systems Branch at firstname.lastname@example.org.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at email@example.com .
Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement at CFSANEnforcement@fda.hhs.gov. ***
Note: ORS contact information updated on 12/09/2020
PRODUCT CODE: 36C
OASIS charge code - SUBSTITUTE
"The article is subject to refusal under 801(a)(3) in that it appears to be food which has damage or inferiority concealed in any manner." [Adulteration, Section 402(b)(3)]
OASIS charge code - CONCEALED
"The article is subject to refusal under 801(a)(3) in that the food appears to have a substance added to, mixed or packed with it so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is." [Adulteration, Section 402(b)(4)]
OASIS charge code - ADDED BULK
MULTIPLE COUNTRIES (PODS ONLY)
(36 C - - --) HoneyDesc: HoneyNotes: economic deception
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)