REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:
NOTE: Do not apply this guide when the deficiency in Brix density is due to overfilling with fruit.
The article is a canned fruit for which there is a standard of identity specifying Brix densities of the packing medium;
The average Brix measurement (at 15 or more days after canning) is more than below the minimum Brix density prescribed by the standard of identity for the packing medium declared on the label.
Seizures involving these products must be discussed with the U.S. Department of Agriculture. *E-mail* or FAX the following information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Amount of Lot
Date of Shipment
Improper Declaration of PACKING MEDIUM
Article misbranded when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 343(g)(2), in that it purports to be and is represented as canned peaches, a food for which a definition and standard of identity has been prescribed by regulation (21 CFR 145.170(a)) promulgated pursuant to 21 U.S.C. 341, and its label fails to bear, as section 145.170(a)(4)(ii) of such definition and standard requires, the name of the optional packing medium present in such food, since its label bears the statement "Packed in heavy syrup," whereas, the article is packed in a medium designated as "Light Syrup" in such definition and standard.
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 3/95, 5/2005
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.