REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:
- Insect Filth and Mold:
The spice contains an average of 5% or more insect infested and/or moldy pieces by weight.
- Mammalian Excreta:
The spice contains an average of 1 milligram or more of mammalian excreta per pound, after processing (mammalian excreta should be identified as to source when possible).
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 (Leafy Spices (name specific spice)) 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 damaged spice), and (mammalian excreta) and in that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed spice).
NOTE: Only use direct 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 in new or revised.*
Revised: 2/1/86, 3/95, 5/05