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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 505.100 Bakery Products, Candy - "Catch-All" or "Shotgun" Ingredients Declaration November 2005

Final
Issued by:
Guidance Issuing Office
Human Foods Program
Office of Inspections and Investigations

BACKGROUND:

The Food and Drug Administration has consistently objected to "catch-all" or "shotgun" ingredient statements in labeling. At the same time it has recognized that there may be instances where this may be a practical technique for labeling assortments or multiple items containing nonuniform ingredients. Therefore, the Food and Drug Administration has not ruled out entirely the possibility of designing labels that are suitable for more than one similar product or for use on packages of assortments. However, it has maintained that any such labeling should not deny the consumer information to which he is entitled, nor should such labeling be misleading.

POLICY:

*21 CFR 101.4(a)(1) states that ingredients shall be listed by common or usual name in descending order of predominance by weight.* The declaration shall be presented on any appropriate information panel in adequate type size, without obscuring design, vignettes, or crowding. The entire ingredient statement shall appear on a single panel of the label.

Optional ingredients used in standardized food shall also be listed by common name, usually the name by which the ingredient is specified in the standard of identity, in order of decreasing predominance on a single panel of the label except that the standard may require certain words or statements to appear immediately preceding or following the name of the food.

The Food and Drug Administration will not object to "shotgun" ingredients labeling -- labels that are designed for more than one product -- provided other requirements of the Act and regulations are met and such labeling is not false or misleading. It is possible to devise this kind of ingredient labeling for bakery products and candy where:

  1. One wrapper is to be used for two or more closely related items in which one or more ingredients are not included in all such items.
  2. Assortments in one package and all ingredients are not common to items in the assortments. 21 CFR *101.100(a)(1)* permits such labeling when "in terms which are as informative as practical and which are not misleading." In cases where such labeling is necessary, those ingredients common to all items should be listed first in the ingredient declaration followed by a listing of ingredients not common to all, including specific indications of which ingredients are actually present in designated articles. Few instances will defy such organization and with the possible exception of candy assortments the statement of identity in conjunction with the ingredient declaration must enable the consumer to tell exactly what is in each article of food.

It is not possible to devise shotgun labeling in instances where a manufacturer wishes to be able to use one or more ingredients interchangeably although it may be possible to devise adequate labeling if the several ingredients are ones that can be designated by a general common or usual name such as leavening or baking powder or in cases where the ingredient is a standardized article. Names that are not accepted common or usual names such as fruit purees, fruits, edible oils, gums, emulsifiers, nut meats, etc., should not be used. Such ingredients should be listed each by specific common or usual names.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 8/96, 5/05
Updated: 11/29/05

Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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