REGULATORY ACTION GUIDANCE:
The following represents 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*:
The average Howard Mold Count for six or more subsamples exceeds 15% or if the Howard Mold Count for any one subsample exceeds 50%.
Article adulterated (when introduced and while in interstate commerce) (while held for sale after introduction into interstate commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it consists in part of a decomposed substance by reason of the presence therein of moldy, decomposed cranberries.
NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 11/1/81, 3/95
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.