REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:
- Insect Filth and Mold:
The mace contains an average of 3% or more insects infested and/or moldy pieces by weight;
- Mammalian Excreta:
The mace contains an average of 3 or more milligrams of excreta per pound;
- Foreign Matter:
The mace contains an average of 1.5% or more foreign matter through a 20-mesh sieve.
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 (mace) 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 mace), and (mammalian excreta); and that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed mace); and is unfit for food by reason of presence therein of (stones), (clay), and (sand); or 342(b)(2) in that (stones), (clay), and (sand) have been substituted wholly or in part for mace.
*Material between asterisks is new or revised.*
Revised: 3/95, 5/05