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*:

Whole Nutmeg

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):

Ground Nutmeg

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.

REMARKS:

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.

SPECIMEN CHARGE:

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.*

Issued: 10/1/80
Revised: 2/1/86, 3/95, 5/05
Updated: 11/29/05