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*:
1. Mold: The strawberries have an average mold count of 45% or more and the mold count of at least one-half of the subsamples is 55% or more.
2. Sand: The berries taste gritty.
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
1. Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a decomposed substance by reason of presence therein of decomposed strawberries.
2. Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(3), in that it is unfit for food by reason of being gritty to the taste.
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 3/95, 5/2005 Updated: 11/29/05
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.