Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)


How to Comment

The comment period opens November 23, 2016.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 13, 2017. 

Submit electronic comments on to docket number FDA-2016-D-3401.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2016-D-3401. 


For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1200.

Contains Nonbinding Recommendations
Draft - Not for Implementation

November 2016

This guidance is being distributed for comment purposes only. 

This guidance document explains FDA’s current thinking on information needed when submitting a citizen petition and the scientific review approach we plan to use for evaluating scientific evidence to determine whether an isolated or synthetic non-digestible carbohydrate that is added to food has a physiological effect that is beneficial to human health.

The purpose of this guidance is to provide information to those submitting evidence to us to determine if the added non-digestible carbohydrate meets the definition of dietary fiber in our regulations for nutrition labeling of food for declaring the amount of dietary fiber on the Nutrition and Supplement Facts labels.

This guidance document addresses our current thinking for:

  1. identifying published scientific articles that evaluate a physiological effect of an added non-digestible carbohydrate;
  2. evaluating those studies from which scientific conclusions can be drawn; and
  3. evaluating the strength of scientific evidence to determine whether there is a physiological effect that is beneficial to human health of an isolated or synthetic non-digestible carbohydrate that is added to foods.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in FDA guidances means that something is suggested or recommended, but not required. 

This draft guidance, when finalized, will represent 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 listed on the title page.

Download the
Draft Guidance for Industry
(PDF: 927B)

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