FDA to Propose Acacia (Gum Arabic) as a Dietary Fiber | Hogan Lovells

Via Peters

The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (gum arabic) as a dietary fiber.  As a result of the petition, FDA intends to propose to include acacia, or gum acacia, as part of the FDA definition of a dietary fiber.  FDA will exercise enforcement discretion and allow companies to treat acacia as a dietary fiber while the agency engages in rulemaking.  This memorandum summarizes the FDA announcement concerning the classification of gum acacia.

On December 17, 2021, the FDA announced that it intended to propose to include gum acacia in the FDA definition of dietary fiber for nutrition labeling purposes.  The 2016 final rule drew a distinction between intrinsic and intact fibers and isolated or synthetic fibers.  Isolated and synthetic fibers will not be treated as “dietary fibers” for  nutrition labeling purposes unless they have been determined by FDA to have “physiological effects that are beneficial to human health.”1 In order to make this determination, FDA will evaluate each potential fiber to see if it: (1) lowers blood glucose, (2) lowers cholesterol levels, (3) lowers blood pressure, (4) increases in frequency of bowel movements, (5) increases mineral absorption in the intestinal tract, or (6) reduces energy intake.2 FDA had rejected previous attempts to treat acacia as a dietary fiber.  Following the submission of a second citizen petition in December 2020, FDA determined the petitioner demonstrated sufficient scientific research to support the claim that gum acacia produces the necessary physiological effects based on various studies linking it to the reduction of blood glucose and insulin levels.3

FDA has now identified 18 categories of non-digestible carbohydrates that qualify for dietary fiber.  FDA identified seven (7) of these carbohydrates in the definition of “dietary fiber” in the final regulation and has since identified 11 additional non-digestible carbohydrates, including acacia, for which FDA intends to propose to add to the list of dietary fibers.4 FDA announced that it intends to extend enforcement discretion in regard to these eleven identified fibers5, which would allow manufactures to include these non-digestible carbohydrates in the dietary fiber declarations on Nutrition and Supplemental Facts labels.6

Next steps   

We will continue to monitor developments on nutrition labeling and will keep you notified of any changes.

References

1 21 CFR 101.9(6)(i), available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.9, see also, FDA Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber, https://www.fda.gov/food/cfsan-constituent-updates/fda-grants-citizen-petition-acacia-gum-arabic-dietary-fiber.

2 See, Questions and Answers on Dietary Fiber, https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-dietary-fiber.

3 See, FDA Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber, https://www.fda.gov/food/cfsan-constituent-updates/fda-grants-citizen-petition-acacia-gum-arabic-dietary-fiber.

4 See, Questions and Answers on Dietary Fiber, https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-dietary-fiber.

5 The eleven non-digestible carbohydrates that FDA intends to propose as dietary fibers are mixed plant cell wall fibers, Arabinoxylan, Alginate, Inulin and inulin-type fructans, High amylose starch (resistant starch 2), Galactooligosaccharide, Polydextrose, Resistant maltodextrin/dextrin, Cross linked phosphorylated RS4, Glucomannan, and Acacia (gum arabic). Questions and Answers on Dietary Fiber, https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-dietary-fiber.

6 See, FDA Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber, https://www.fda.gov/food/cfsan-constituent-updates/fda-grants-citizen-petition-acacia-gum-arabic-dietary-fiber.

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