FDA’s Proposal on Nutrition Labeling and Fiber

May 20, 2014

By Riëtte van Laack

FDA’s proposed rule regarding nutrition labeling (see our previous post here) will have far-reaching consequences that may not be obvious.  For example, FDA intends to make major changes in its approach to defining and measuring dietary fiber – changes that could have a significant impact on those who have a stake in the manufacture or use of fiber ingredients.  Those changes include:

  • FDA proposes to establish a definition for dietary fiber that is the same as the Institute of Medicine’s (IOM’s) definition of total fiber and would include:

1. soluble and insoluble non-digestible carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants, and

2. certain isolated and synthetic non-digestible carbohydrates (with 3 or more monomeric units).  However, these isolated and synthetic carbohydrates would qualify as dietary fiber only pursuant to FDA’s approval of a citizen petition or a health claim petition.  FDA proposes that the citizen petition must provide evidence of a physiological effect beneficial to human health. According to FDA, there are currently only two isolated non-digestible carbohydrates, ß-glucan and barley ß-fiber, that would meet the proposed definition of dietary fiber.  The vast range of other non-digestible carbohydrates currently marketed would not qualify as dietary fiber until FDA approves a citizen petition providing the “evidence of a physiological effect beneficial to human health” for that carbohydrate.  FDA does not provide further information as to the type of evidence required.  Although FDA states that it intends to publish a guidance addressing the type of evidence that will be required, the Agency does not indicate when it would publish this guidance.  Moreover, the Agency does not give any indication about the timing of the review of these citizen petitions.  Thus, FDA’s proposal potentially will call into question (at least temporarily) the status of various ingredients marketed as fiber. 

  • FDA also proposes to change the method of verification of dietary fiber content.  Because of limitations of analytical methods, for products that contain a mixture of non-digestible carbohydrates that meet the proposed dietary fiber definition and those that do not, FDA proposes to require manufacturers to make and keep written records to verify the amount of added non-digestible carbohydrates that do not meet the proposed definition of dietary fiber.  The amount of non-digestible carbohydrate measured analytically (by established AOAC methods) minus the amount of added non-digestible carbohydrate that has not been determined by FDA to have a physiological effect that is beneficial to human health would reflect the amount of dietary fiber lawfully declared on the label. 
  • FDA also proposes to increase the daily reference value for dietary fiber from 25g to 28g.  Consequently, products may need to contain more dietary fiber to be eligible for a nutrient content claim for dietary fiber.   Since the proposed dietary fiber definition excludes (at least until FDA’s approval of a citizen petition) certain non-digestible carbohydrates that currently are included in the calculation, a significant number of products may no longer be eligible for nutrient content claims for dietary fiber.

The proposed changes concerning dietary fiber are likely to have a profound effect on the marketing of certain foods and many dietary supplements that frequently are formulated with “isolated and synthetic non-digestible carbohydrates” rather than “non-digestible carbohydrates that are intrinsic and intact in plants.”   Companies manufacturing and marketing these types of products would be well-advised to review FDA’s proposal and consider the potential ramifications.

Unless FDA grants an extension, the comment period closes on June 2, 2014.