The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605).
The average of the subsamples (see note) examined deviates from the standards with respect to one or more of the individual factors listed below; and the number of subs out of compliance, for each such deviation, equals or exceeds the number required for action (Table 1 on page 2).
- The weight of any one nut ingredient is less than 2% of the total net weight found - 164.110(a).
- The weight of a nut ingredient is more than 80% of the total net weight found - 164.110(a).
- The weight of a nut ingredient exceeds 50% of the total net weight found and the label does not state this fact - 164.110(d).
- The percent weight of a nut ingredient (computed on the basis of the total net weight found) exceeds the labeled declaration (e.g. 60% peanuts) - 164.110(d).
- Fill of container is less than 85% of container volume - 164.120(c).
NOTE: A sample consists of 24 containers with a net weight declaration of 16 ounces or less; or at least 24 lbs. of mixed nuts consisting of containers bearing a net weight declaration of more than 16 ounces, where each container is considered a subsample.
|Container labeled declaration (pounds)||No. of Subsamples to be examined||No. of Subsamples required for legal action|
*Material between asterisks is new or revised*
Revised: 12/2/88, 3/95, 5/2005
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)
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