REGULATORY ACTION GUIDANCE:
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)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All comments should be identified with the title of the guidance.