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GUIDANCE DOCUMENT

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) February 2018

Final

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)

Docket Number:
FDA-2016-D-3401
Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

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 (hereinafter “added non-digestible carbohydrate”) 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 publicly available 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. This guidance includes revisions that we have made in response, in part, to comments that we received on the draft guidance.*

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

Related Resouces

* We intend to address in a subsequent guidance questions about “intrinsic and intact” fibers, the degree to which a non-digestible carbohydrate can be isolated or synthesized from its original plant source, but still be considered intrinsic and intact, and whether plant cell wall fibers containing a mix or combination of non-digestible carbohydrates would be an intrinsic and intact dietary fiber.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-3401.