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:
The cloves contain an average of 5% or more stems by weight.
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 adulterated while held for sale after shipment in interstate commerce, within meaning of 21 U.S.C. 342(b)(2), in that clove stems have been substituted wholly or in part for cloves.
*Material between asterisks is new or revised.*
Revised: 3/95, 5/05