Dietary fiber is a macronutrient that permissibly may be declared in the Nutrition Facts on a conventional food’s label, and in the Supplement Facts on a dietary supplement’s label. 21 C.F.R. §§ 101.9(c)(6)(i), 101.36(b)(2)(i).
To clarify what may be included in nutrition labeling declaration of Dietary Fiber content, § 101.9(c)(6)(i) provides:
Dietary fiber is defined as non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.
Further clarification now has been provided in recently released guidance documents:
This Q&A-style guidance confirms that naturally occurring fiber (often referred to as “intrinsic”) occurs in foods such as vegetables, whole grains, fruits, cereal bran, flaked cereal, and flours. The fibers also are considered to be “intact” because they have not been removed from the food.
The guidance lists the physiological effects that, if demonstrated in humans, presently would make the subject carbohydrate eligible for listing as a “dietary fiber”:
Other physiological effects, of course, could be added to the list if scientific evidence exists to support their inclusion prospectively.
To date, FDA has identified the following non-digestible carbohydrates as meeting the “dietary fiber” definition:
To add to this present list, a manufacturer prospectively may submit a Citizen Petition for FDA’s consideration that provides scientific evidence of a beneficial physiological effect to human health associated with the purported dietary fiber.
Inasmuch as analytical methods cannot distinguish between non-digestible carbohydrates that do and do not meet the “dietary fiber” definition, labeling firms must maintain records that support dietary fiber declarations.
This guidance explains FDA’s current thinking on information needed when submitting a Citizen Petition, and the scientific review approach FDA plans to use for evaluating submitted 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 guidance provides information for those intending to submit evidence to FDA to determine whether the added non-digestible carbohydrate meets the definition of “dietary fiber” in its regulations.
The guidance finalizes a draft guidance published by FDA on November 23, 2016. It includes some revisions, based on submitted comments. Changes to the guidance include: (1) the inclusion of studies on diseased populations under certain circumstances as part of FDA’s evaluation of the totality of the scientific evidence; (2) additional detail and clarity on the physiological endpoints that FDA considers when reviewing the scientific evidence; and (3) additional detail regarding factors FDA consider when evaluating the strength of the scientific evidence.
Comments may be submitted to FDA on these guidance documents at any time.