REGULATORY ACTION GUIDANCE:
1. 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*:
Whole Cassia and Cinnamon Bark:
a. Insect Filth: The cassia or cinnamon bark averages 5% or more insect infested pieces by weight;
b. Mold: The cassia or cinnamon bark averages 5% or more moldy pieces by weight;
c. Mammalian Excreta: The cassia or cinnamon bark contains an average of 1 milligram or more of mammalian excreta per pound (mammalian excreta should be identified as to source when possible).
2. The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605): Ground Cinnamon: a. Insect Filth: The cinnamon powder contains an average of 400 or more insect fragments per 50 grams.
b. Rodent Filth: The cinnamon powder contains an average of 11 or more rodent hairs per 50 grams.
NOTE: Determination for all defects are made on a minimum of six (6) subsamples: 50-gram subsamples for the ground spice and 100-gram subsamples for the whole spice.
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 (whole cassia/whole cinnamon/ground cinnamon) 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 fragments), (insect damaged whole cassia/whole cinnamon/whole cinnamon/ground cinnamon), and (mammalian excreta), (rodent hairs); and that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed cassia/cinnamon).
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.*
Revised: 2/1/86, 3/95, 5/05
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.