FDA Dietary Fiber Guidance and Its Impact on the Food Industry

The latest developments on dietary fiber may have a major impact on many companies currently making "dietary fiber" declarations in the U.S.

02 December 2016

The U.S. FDA released a definition for "dietary fiber", which communicates to the food industry the types of dietary fiber that can contribute to the "dietary fiber" declaration in Nutrition and Supplement Facts labels. In a 2-part definition stated in 21 CFR §101.9(c)(6)(i), the FDA defines dietary fiber as:

  1. Non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants [e.g., fiber consumed from fruits, vegetables, whole grains, or derived from them, such as flours, vegetable purees, cereal bran];
    or
  2. 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 [e.g., (beta)-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethylcellulose].

Currently, the FDA considers only 7 "isolated or synthetic non-digestible carbohydrates" to have demonstrated beneficial effects in humans (see part 2 of the definition above); these fibers are now listed in the regulatory definition of dietary fiber appearing in 21 CFR §101.9(c)(6)(i). For the regulatory definition of a dietary fiber to be amended so that it includes an additional "isolated or synthetic non-digestible carbohydrate", a company can either submit a citizen petition (21 CFR §10.30) or a health claim petition (21 CFR §101.70).

On November 22nd, the FDA published a "draft guidance" document to help industry understand FDA's evaluation process of citizen petitions submitted on isolated or synthetic non-digestible carbohydrates (Part 2 of the definition above). In evaluating whether beneficial physiological effects of an isolated or synthetic non-digestible carbohydrate exist, the FDA will:

  • Review all publicly available evidence (i.e., favourable and unfavourable studies);
  • Base their evaluation on human intervention studies, particularly controlled studies;
  • Base their evaluation on studies conducted in "healthy" populations;
  • Determine whether the effects of a dietary fiber can be considered "beneficial physiological effects".

As per FDA's draft guidance document and a "Questions & Answers" document, "beneficial physiological effects" include:

  1. Lowering of blood glucose: i.e., fasting or post-prandial
  2. Lowering of blood cholesterol
  3. Lowering of blood pressure
  4. Increased mineral absorption
  5. Improved laxation: e.g., reduced transit time, increased rates of defecation/stool frequency (an increase in stool weight is not a beneficial physiological effect per se; it needs to be associated with a change in defecation frequency)
  6. Reduced energy intake (increased satiety is not a beneficial physiological effect per se; it can be used to explain mechanism of reduced energy intake)

Effects on glycaemic index, fermentation, and changes in the microbiota are not considered to be beneficial physiological effects by the FDA.

FDA's "draft guidance" is open for comment. The deadline for comments is January 23, 2017.

Additionally, the FDA has published a "scientific review" of the evidence on the potential beneficial physiological effects of 26 other isolated or synthetic non-digestible carbohydrates. FDA is inviting interested parties to comment on the "physiological endpoints" addressed in this review and other potentially relevant physiological endpoints. Comments are due by January 9th, 2017.

We encourage stakeholders to capitalize on these comment periods since FDA's guidance on dietary fibers will ultimately dictate which ingredients can be included in the declaration of dietary fiber in the Nutrition and Supplement Facts tables.

If you are impacted by the FDA definition of dietary fiber, have questions regarding the process for getting a fiber included in FDA's regulatory definition of dietary fiber, or need support in making stakeholder comments to the FDA, please contact our team of experts! Intertek has extensive experience in the areas of health claims, novel fiber petitions, human clinical trials, and regulatory strategy. Intertek will delve into the details of this topic with a webinar hosted in January (2017) so stay tuned for details!

Today's expert blogger is Dr. Kathy Musa-Veloso, Director of Health Claims and Clinical Trials within Intertek's Food & Nutrition Group. Dr. Musa-Veloso leads a team of scientific and regulatory consultants in the preparation and stewardship of health claim applications in key markets globally, including Canada, the United States, and the European Union. Dr. Musa-Veloso is a recognized expert on global scientific and regulatory requirements for health claim substantiation and has been invited as a guest speaker at numerous conferences and symposia, both domestically and internationally.