Updated: 2005-11-29
REGULATORY ACTION GUIDANCE:
NOTE: Determinations for all defects are made on a minimum of six (6) ten-gram subsamples for ground and six (6) twenty-five-gram subsamples for unground thyme.
See Macroanalytical Procedures Manual for number of grams of subsamples used in analyses of whole spices.
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 CHARGES (for all including leafy spices):
Article (whole plant unprocessed/unground processed/ground thyme) 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 fragments), (insect webbing), (insect excreta), (insect damaged thyme), (mammalian excreta), and (rodent hairs); and that it consists in part of a decomposed substance by reason of the presence therein of (moldy, decomposed thyme) (mold).
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 regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 2/1/86
Revised: 6/1/86, 3/95, 5/2005