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:
The Bay Leaves contain an average of 5% or more insect infested pieces by weight;
The Bay Leaves contain an average of 5% or more moldy pieces by weight;
The Bay Leaves contain an average of 1 milligram or more mammalian excreta per pound, after processing.
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 (bay (laurel) leaves) 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 bay (laurel) leaves), and mammalian excreta); and that it consists in part of a decomposed substance by reason of the presence therein of (moldy, decomposed bay (laurel) leaves).
*Material between asterisks is new or revised.*
Revised: 3/95, 5/05