REGULATORY ACTION GUIDANCE:
1. 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*:
The whole nutmeg contains an average of 10% or more insect infested and/or moldy pieces by count.
2. The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
The nutmeg powder contains an average of 100 or more insect fragments, or the average of rodent hairs is 1 or more per 10 gram sample.
NOTE: Determination for all defects are made on a minimum of six (6) subsamples; 10 gram subsamples for ground nutmeg and 100 nuts by count subsamples for whole nutmeg.
Since the majority of spices are imported, determine that the lot in question has not been previously examined and released by FDA as an import. If the lot has been examined and released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for seizure consideration in the usual manner.
Article (whole/ground nutmeg) adulterated (when introduced into and while in interstate commerce)(while held for sale after shipment in interstate commerce), within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by reason of presence therein of (insects), (insect webbing), (insect excreta), (insect fragments), (insect damaged nutmeg), and (rodent hairs); and that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed nutmeg).
*Material between asterisks is new or revised.*
Revised: 2/1/86, 3/95, 5/05
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.