February 13, 2017
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2016-N-3389 for Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments;" Docket No. FDA-2016-D-3401 for "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)"
Dear Sir or Madam,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Food and Drug Administration (FDA) related to its open dockets regarding "Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments" (Docket No. FDA-2016-N-3389) and "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): Guidance for Industry" (Docket No. FDA-2016-D-3401) (the "Guidance"), both of which were published in the Federal Register on November 23, 2016. Representing over 100,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation's health through food and nutrition and to providing medical nutrition therapy (MNT) and other nutrition counseling services to meet the health needs of all citizens.
A. Academy's Labeling Principles
The Academy adopted in 2014 the following principles for labeling, which guide our comments. Those principles specifically relevant to the Academy's comments on the FDA's Guidance are bolded below.
- Label claims should be clear and understandable to consumers; consumers' nutrition literacy is key to promoting understanding.
- The label must be truthful and not misleading.
- Content on the label should help consumers make informed decisions to build a healthy diet.
- Labels should help to provide understanding about the nutrient density and overall healthfulness of overall food rather than a focus on particular nutrients.
- Label content should have consistent type and format so products can be read and consumers can make product comparisons.
- Labeling should enhance consistency among the various government nutrition recommendations.
- All claims should include labeling of accurate quantitative information about the dietary substance, including percent of Daily Value in a single serving of the products, when known, or the daily dietary intake necessary to achieve the claimed effect.
- Consumer research is imperative before making changes to the label.
- The label is only a source of information, and thus sustained support for educational programs and individual counseling by registered dietitian nutritionists is essential.
B. Defining Dietary Fiber
The Academy declared in 2015 that "[i]t is the position of the Academy of Nutrition and Dietetics that the public should consume adequate amounts of dietary fiber from a variety of plant foods." This position is in accord with the 2015 Dietary Guidelines for Americans ("2015 DGA") that "[i]f a healthy eating pattern... is consumed, amounts of... dietary fiber will meet recommendations."2
We should be clear that this understanding of dietary fiber relied upon an underlying definition of dietary fiber that is different from that recently adopted by the FDA, in that it accepted the Institute of Medicine's (IOM's) distinction between "dietary fiber" and "functional fiber," which when combined is "total fiber." It also differs from the most recent 2015 DGA, which differentiates between dietary fiber and functional fiber.3
Our formal comments to the FDA regarding revision of the Nutrition Facts Panel stated, "The Academy supports... FDA's proposed new definition of dietary fiber, which would allow declaration of only those forms of dietary fiber that the agency has determined to have a physiological effect that is beneficial to human health. This definition would exclude soluble and insoluble non-digestible carbohydrates that have not shown a demonstrated physiological benefit. We note the possibility that some manufacturers have fortified foods with processed fiber without physiological health benefits and thus could otherwise make less healthful foods appear to be a healthier choice. Given this, the FDA's proposed guidance test for added fiber that measures its physiological benefits represents a considerable advance."4 We remain concerned, however, with particular elements of the Guidance and recognize the conflation of the previous definition of "dietary fiber" with "functional fiber," which the Academy defined similarly to the Institute of Medicine as "isolated nondigestible carbohydrates that have beneficial physiological effects in humans."5
C. Concerns with Draft Guidance
We wrote to the FDA as it finalized revisions to the Nutrition Facts Panel and its proposed definition of dietary fiber that, "The Academy recommends that FDA further define 'physiological benefit' as science evolves, with consideration given to other authoritative regulatory bodies, such as Health Canada. Defining 'physiological benefit' provides clarity and helps support meaningful food product development and innovation, especially in specialized foods designed to meet medical needs as a part of medical nutrition therapy recommended by RDNs."6 We share the American Society of Nutrition's (ASN)concerns in its comments to the revision of the Nutrition Facts Panel "that the current proposed approach to approve dietary fiber using the citizen petition process is not appropriate given that this process has no timing constraint to ensure that FDA responds promptly."7 We also agree with the ASN encouraging the FDA to “consider preparation of a 'grandfather' list of dietary fiber sources for which there is existing substantial scientific agreement indicating their beneficial effects, similar to Health Canada's 2013 'List of Dietary Fibres Permitted for Use in Foods Available for Sale in Canada,' which will be updated regularly."8
The Nutrition Facts label successfully fulfills its statutory obligation to provide specific nutrition information about food products to consumers. Too often and for a variety of reasons, however, many consumers do not fully comprehend the information and are unable to effectively translate this information into healthy dietary practices.9 To that end, the Academy reiterates its concern with the FDA's purported requirement that the Nutrition Facts Panel includes only items, definitions, and values that are intended for the general healthy population. Because the DVs and its associated %DV figure are typically set at a level appropriate for the "general population," millions of Americans with various health conditions are obligated to rely upon the absolute amounts of nutrients, because the %DV may not be appropriate for their individual circumstances.
The Guidance here compounds this issue by questionably conflating the definition of "dietary fiber" with the extraordinarily rigorous requirements for making a specific health claim on the label. The Academy urges the FDA to show consistency in its process for defining items on the Nutrition Facts Panel, and we urge the FDA to detail not only exactly which — if any — definitions and values for other vitamins, minerals, or nutrients on the label are effectively required to meet the same high standards demanded for health claims that it is now requiring for "dietary fiber" but also for the FDA detail its rationale for the resulting lack of consistency.
In short, we share similar concerns of many others that the FDA's guidance would exclude significant evidence from its scientific evaluation of various fibers, because the studies included non-healthy populations. In addition to the above concerns with conflating the definition of dietary fiber with requirements for health claims, we share concerns with such a restrictive approach when nearly half of Americans are currently living with a preventable chronic disease. Whether the FDA does indeed prepare a grandfather list of fiber sources or it changes its Guidance so as not to unduly exclude studies conducted on non-healthy populations, it should recognize that the mechanism of action of fiber is fundamentally consistent across populations and thus can be extrapolated to a healthy population when studied in non-healthy populations. The Academy is concerned that changing both the definition of dietary fiber and the process by which studies are evaluated is problematic, given that the studies could not be retrospectively designed to accommodate such an extraordinary reinterpretation of the definition.
We also urge the FDA to consider and detail the impact of "delisting" substances presently understood by consumers, researchers, and manufacturers as dietary fibers. The Academy urges the FDA to conduct consumer research specifically related to the impact on consumers of delisting certain fibers on consumers' understanding and selection of the healthfulness of certain products (including therapeutic nutritional formulas) based upon the amount of “Total Carbohydrate” listed on the label.
The Academy appreciates the opportunity to comment on the Guidance related to the scientific evaluation of certain carbohydrates in order to be included within the new definition of dietary fiber. Please contact either Jeanne Blankenship at 312/899-1730 or by email at email@example.com or Pepin Tuma at 202/775-8277, ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation’s food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition; Ch. 2 at 60. December 2015.
3 Ibid at Introduction at 90.
4 Academy of Nutrition and Dietetics Comments to FDA re Revision of Nutrition Facts Panel. Accessed February 2, 2017.
5 Dahl WJ, Stewart ML. Position of the Academy of Nutrition and Dietetics: Health Implications of Dietary Fiber. J Acad Nutr Diet. 2015;115(11):1861-70.
6 Academy of Nutrition and Dietetics Comments to FDA re Revision of Nutrition Facts Panel. Accessed February 2, 2017.
7 American Society of Nutrition Comments to FDA re Revision of Nutrition Facts Panel. Accessed February 2, 2017.
9 National Kidney Foundation and American Dietetic Association. Usefulness of the nutrition label for persons with kidney disease. Submitted to Docket No. 2006N-0169, April 29, 2008.