Standard: HHS - 21 CFR PART 104


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General principles.

(a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional quality) appropriate for a given class of food.

(b) Labeling for a product which complies with all of the requirements of the nutritional quality guideline established for its class of food may state ‘‘This product provides nutrients in amounts appropriate for this class of food as determined by the U.S. Government,’’ except that the words ‘‘this product’’ are optional. This statement, if used, shall be printed on the principal display panel, and may also be printed on the information panel, in letters not larger than twice the size of the minimum type required for the declaration of net quantity of contents by § 101.7 of this chapter. Labeling of noncomplying products may not include any such statement or otherwise represent, suggest, or imply the product as being, in whole or in part, in compliance with a guideline.

(c) A product bearing the statement provided for in paragraph (b) of this section, in addition to meeting the requirements of the applicable nutritional quality guideline, shall comply with the following requirements:

(1) The label of the product shall bear the common or usual name of the food in accordance with the provisions of the guideline and §§ 101.3 and 102.5(a) of this chapter.

(2) The label of the product shall bear nutrition labeling in accordance with §§ 101.2 and 101.9 of this chapter and all other labeling required by applicable sections of part 101 of this chapter.

(d) No claim or statement may be made on the label or in labeling representing, suggesting, or implying any nutritional or other differences between a product to which nutrient addition has or has not been made in order to meet the guideline, except that a nutrient addition shall be declared in the ingredient statement.

(e) Compliance with a nutrient level specified in a nutritional quality guideline shall be determined by the procedures and requirements established in § 101.9(g) of this chapter.

(f) A product within a class of food for which a nutritional quality guideline has been established and to which has been added a discrete nutrient either for which no minimum nutrient level or nutrient range or other allowance has been established as appropriate in the nutritional quality guideline, or at a level that exceeds any maximum established as appropriate in the guideline, shall be ineligible to bear the guideline statement provided for in paragraph

(b) of this section, and such a product shall also be deemed to be misbranded under the act unless the label and all labeling bear the following prominent and conspicuous statement: ‘‘The addition of lll to (or ‘‘The addition of lll at the level contained in) this product has been determined by the U.S. Government to be unnecessary and inappropriate and does not increase the dietary value of the food,’’ the blank to be filled in with the common or usual name of the nutrient( s) involved.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 104
Publish Date: 2017-04-01
Page Count: 5
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 104 Change Type: COMPLETE REVISION Update Date: 2014-04-01 Status: ACTV
21 CFR PART 104 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV
21 CFR PART 104 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV

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