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GUIDANCE DOCUMENT

Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels June 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-1323
Issued by:
Guidance Issuing Office
Human Foods Program

Contains Nonbinding Recommendations

June 2018

This guidance is intended to identify for manufacturers specific, additional isolated or synthetic non-digestible carbohydrates that we intend to propose adding to the list of those that meet our regulatory definition of "dietary fiber" (21 CFR 101.9(c)(6)(i)).

This guidance also is intended to advise manufacturers of our intent to exercise enforcement discretion relative to the declaration of these isolated or synthetic non-digestible carbohydrates as a dietary fiber on Nutrition Facts and Supplement Facts labels, and for the use of a caloric value for polydextrose of 1 kcal/g, pending completion of a rulemaking regarding revising our regulations. The following isolated or synthetic non-digestible carbohydrates are subject to our intent to exercise enforcement discretion: mixed plant cell wall fibers; arabinoxylan; alginate; inulin and inulin-type fructans; high amylose starch (resistant starch 2); galactooligosaccharide; polydextrose; and resistant maltodextrin/dextrin.

This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

Download the Guidance for Industry

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All written comments should be identified with this document's docket number: FDA-2018-D-1323.

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