Seizure recommendations for non-complying products should be limited to substantial lots at the wholesale level.
Additionally, since the stated purpose of the FPLA is to facilitate value comparisons and to enable the consumer to obtain accurate information as to the quantity of contents, the initial seizure recommendations should be based upon non-complying quantity of contents declaration, and/or the size of individual servings *(21 CFR 101.9(b)(7)).* However, if other violations are encountered which are considered significant, they should be submitted.
REGULATORY ACTION GUIDANCE:
The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
Food products packaged for retail sale, that meet the definition of consumer commodity set forth in Sec. 10(a) of the Fair Packaging and Labeling Act (Public Law 89-755), may be recommended for legal action for any of the following reasons provided the commodity is not exempted under 21 CFR 1.24.
- Quantity of Contents Declaration, 21 CFR 101.105.
- The declaration does not appear on the principal display panel;
- The declaration is not separated from other printed label information as required by 21 CFR 101.105(f) to a degree that failure to be separated renders it inconspicuous;
- The declaration is qualified by terms such as "full quart," etc;
- The location of the entire declaration is in the top 50% of the principal display panel;
- The declaration fails to meet the minimum height requirements by l/32 inch or more;
- The declaration is not expressed in a dual fashion as required by 21 CFR 101.105(j);
- Number of Servings, *21 CFR 101.9(b)(7).*
The label bears a representation of the number of servings without declaring the net quantity of each serving.
*Material between asterisks is new or revised.*
Revised: 2/1/89, 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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