Updated: 2005-11-29
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:
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 (sesame seeds) 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 sesame seeds), and (mammalian excreta); and that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed sesame seeds); 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 sesame seeds.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95, 5/2005