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 whole allspice contains an average of 5% or more moldy berries by weight.
- The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
The ground allspice contains an average of 30 or more insect fragments per 10 grams, or the average of rodent hairs is 1 or more per 10 grams.
NOTE: Determinations for all defects are made on a minimum of six (6) ten (10) gram subsamples of ground allspice. See Microanalytical Procedures Manual for weight and subsamples used in analyses of whole spices.
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/ground allspice) adulterated (when introduced into and while in interstate commerce)(while held for sale after shipment in interstate commerce), within the 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/ground allspice), and (rodent hairs); and that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed allspice).
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
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