美国FDA 指导原则 CPG SEC525.500种叶香料，月桂叶除外 英文原版.pdfVIP

CPG Sec. 525.500 Leafy Spices, Other than Bay Leaves - Whole Oregano Leaves, Whole Marjoram, Whole Sage Leaves and Whole Thyme Leaves - Adulteration with Insect Filth; Mold; Mammalian Excreta REGULATORY ACTION GUIDANCE: The following represents criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*: 1. Insect Filth and Mold: The spice contains an average of 5% or more insect infested and/or moldy pieces by weight. or 2. 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). 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 (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 reg