November 1, 2017
Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Proposed Extension of Compliance Dates (FDA-2012-N-1210 and FDA-2004-N-0258)
Dear Dr. Gottlieb,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Food and Drug Administration (FDA) of the Department of Health and Human Services related to its October 2, 2017 docket item proposing to extend the compliance date for new food labeling regulations (FDA-2012-N-1210 and FDA-2004-N-0258) (the "proposed rule"). Representing more than 100,000 registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to supporting provision of essential food and nutrition services to the public in multiple settings, including nutrition education to the public using information on the Nutrition Facts Panel (NFP).
The Academy strongly supports the final revisions to NFP and would like to see them implemented without delay. Indeed, many products on the shelves are already labeled pursuant to the revised rules, and there is tremendous benefit to the public associated with the improvements to the NFP that would be denied to them for more than a year as a result of this proposed rule. Regrettably, however, the Academy recognizes that delays in finalizing directly relevant, critical FDA guidance related to fiber and added sugars and providing a short period of time for industry to obtain data from ingredient suppliers consistent with FDA guidance may necessitate delaying the compliance date. We strongly urge the FDA to finalize these guidance documents without delay to ensure that the FDA does not seek additional delays in implementing revisions to the NFP.
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."2 We remain concerned, however, with particular elements of the draft fiber 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."3 To eliminate consumer confusion and promote patient health, we encourage the FDA to act with alacrity and dispatch in reviewing and acting upon petitions filed to recognize additional substances as dietary fiber.
The Academy appreciates the opportunity to comment on the proposed rule extending the compliance date for revisions to food labeling rules. Please contact either Jeanne Blankenship at 312/899-1730 or by email at firstname.lastname@example.org or Pepin Tuma at 202/775-8277, ext. 6001 or by email at email@example.com 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 Academy of Nutrition and Dietetics Comments to FDA re Revision of Nutrition Facts Panel. Accessed February 2, 2017.
3 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.