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AACCI Comments on USFDA's Proposed Changes to Dietary Fiber Labeling

January 6, 2017

Paula R. Trumbo, PhD
Office of Nutrition, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
5001 Campus Drive, HFS-009
College Park, MD 20740-3835

Docket ID: FDA-2016-N-3389-0001

Dear Dr. Trumbo:
AACC International (AACCI) is a nonprofit organization dedicated to advancing the knowledge and understanding of cereal grain science through research leadership, education, superior technical service, and advocacy. AACCI commends the USFDA’s efforts to improve consumer health through more informative food labels. The AACCI Dietary Fiber and Other Carbohydrates Technical Committee has been a leader in providing education and information to AACCI members on dietary fiber and in validating analytical methods for dietary fiber (DF) quantification. Numerous of the AACCI DF methods have been validated in collaboration with the FDA and with AOAC International and are methods of choice for food labeling worldwide. This committee developed a science-based DF definition1 in 2000 following discussions with FDA staff at the AACCI 1998 annual meeting, a definition which was later adapted for the 2011 Codex Alimentarius DF definition. We would like to comment on FDA’s DF definition in 21 C.F.R. § 101.9(c)(6)(i)2 and related guidance documents issued on November 23, 2016 3,4:

  1. The compliance timeline provided by the FDA, i.e. July 26, 2018 (a mere two years and two months) for most manufacturers2 was inadequate in as much as FDA has yet to issue final labeling guidelines, which become de facto rules for the food industry, nor has the final review and acceptance of many fibers as dietary fibers been completed. Using the recent General Mills Citizens Petition5 as a basis, this means that the labels for foods having a one-year shelf-life need to be compliant by July 26, 2017. Considering the January 9, 2017 deadline for comments, food companies will have less than 7 months to collaborate, align with, and audit their current ingredient supplier(s), or, if necessary to establish new consumer acceptable formulas, arrange for supply chain and quality assurance, update package label information, print new packaging, and bring the updated packaging into production to avoid shipping misbranded foods. This situation may well counteract the desired outcome of increased DF consumption by Americans, since companies will likely need to remove DF, under-report DF, or stop selling fiber-rich foods if they cannot meet this short implementation deadline. A more reasonable and relevant deadline is three years after final issuance of guidance and determination of dietary fiber(s) status.

  2. In some instances, the information provided to industry is incomplete. In the FDA’s response to comment 76 in the Federal Register Notice for the final rule2, the following statement was made “If a substance is a fiber, but not a ‘‘dietary fiber’’, that has a physiological effect beneficial to human health (such that the fiber is not eligible to be, and not listed as, a ‘‘dietary fiber’’ in the codified definition of ‘‘dietary fiber’’), a manufacturer may still declare the substance as part of total carbohydrate. Furthermore, a manufacturer may make a statement about the amount of these other fiber substances in the food, provided the statement is truthful and not misleading.” Additional guidance on acceptable statements is required. without clarification on how manufacturers can communicate the presence of these fibers to the consumer, the fibers will likely be removed from food products, thus reducing the consumption of dietary fiber, contrary to stated goals of increasing dietary fiber intake.

  3. The guidance3 published in November lacks clarity, is arbitrary and has increased confusion. The specific guidance of “Non-digestible carbohydrates that are obtained from non-food sources, such as stems, branches, and trunks of trees, inedible hulls and husks, seaweed, and fungus, also are not considered to be intact and intrinsic” is causing confusion. Seaweed is consumed intact as salads, in soups, and as sushi; mushrooms are fungi that are consumed intact in many dishes. Cinnamon, or cassia is obtained from the bark of trees and provides several grams of DF per tablespoon serving. Hulls of some pulses and grains, besides peas, are foods that meet the intrinsic and intact definition. One approach that would eliminate uncertainty is to remove products which FDA agrees are currently food items (fungus, seaweed) from the list, and replace the term “non-food sources” with requiring “GRAS status”. Other products would have to meet the IOM standards of “intrinsic and intact.” Inadequate guidance in this regard may well result in a particular ingredient having multiple standards applied with regard to its status as dietary fiber.

  4. Additional guidance is needed regarding which approved dietary fiber analytical methods are considered equivalent to the Codex Alimentarius recognized AACC Intl 32-45.01(AOAC 2009.01) and AACC Intl 32-50.01 (AOAC 2011.25). Further, as the science of dietary fiber progresses and new sources are studied, guidance is needed on whether new methods approved by AACCI and/or adopted by AOAC International will automatically be accepted for labeling purposes in the future based on the scientific and laboratory collaboration that leads up to approval and adoption. The AACC International Dietary Fiber and Other Carbohydrates Technical Committee is open, willing, and eager to collaborate with FDA and offer its support as new refinements in analytical methods develop.

  5. Further consideration must be given by FDA to harmonizing with other regulatory jurisdictions on accepted dietary fiber physiological benefits to health beyond the five listed. This harmonization should be coupled with guidance on conducting acceptable physiological efficacy tests necessary to establish the stated physiological benefits for a particular dietary fiber.

In summary, the food industry needs 3 years after clear guidance is available to determine an ingredient’s status regarding dietary fiber, to complete testing to meet the physiological benefits to health criteria for a particular DF ingredient if necessary, or to implement new formulations, arrange for supply chain and quality assurance, update package label information, print new packaging, and bring the updated packaging into production. Thus we request that FDA extend the timeline for compliance with the DF labeling regulations to 3 years after the Agency provides final guidance to include (1)listing approved isolated and synthetic DF from the list published4, (2) guidance of proper labeling of food fibers that have not been approved as dietary fibers by FDA, (3) replacing the arbitrary “non-food” standard with “GRAS status” and the requirement to meet intrinsic and intact fibers standards, and (4) listing all acceptable analytical tests and to ensure compliance by requesting industry keep records of test results.

If the above proposals are accepted, we are confident that FDA’s commendable vision in issuing this regulation will be met. An orderly and accurate compliance protocol will ensure that this labeling regulation will have a positive effect on human health by increasing physiologically relevant fiber consumption. If you have any additional questions please contact AACCI’s Executive Vice President Amy Hope here or 651.994.3827 for further assistance. Thank you.

Sincerely,

Robert L. Cracknell
AACCI President

1 Anonymous 2000, AACC Board Holds Midyear Meeting, Cereal Foods World, 45(6):237 (AACCI Definition of Dietary Fiber was Adopted); The Definition of Dietary Fiber (2001) Report of the Dietary Fiber Definition Committee to the Board of Directors of the American Association of Cereal Chemists. Author/Editor-Jonathan W. DeVries. Cereal Foods World 46(3): 112-124.

2 FDA May 2016. Changes to the Nutrition Facts Label http://www.fda.gov/Food/GuidanceRegulation/
GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm (accessed December 28, 2016).

3 FDA November 2016. Guidance for Citizen Petition process for fibers. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm528532.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery (accessed December 28, 2016).

4 FDA November 2016. Science review of isolated and synthetic fibers. http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm525656.htm  (accessed December 28, 2016).

5 General Mills. Oct 4, 2016. Citizens Petition. A Citizen Petition regarding the timeline for compliance with the revised dietary fiber definition in 21 C.F.R. § 101.9(c){6){i). https://www.regulations.gov/document?D=FDA-2016-P-2860-0001 (accessed December 27).

AACC International is a global, nonprofit association of more than 2,000 scientists and food industry professionals working to advance the understanding and knowledge of cereal grain science and its product development applications through research, leadership, education, superior technical service, and advocacy.