The FDA to offer acacia (gum arabic) as a dietary fiber | Hogan Lovells

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The United States Food and Drug Administration (FDA) recently granted a citizen petition regarding the classification of acacia (gum arabic) as a dietary fiber. As a result of the petition, the FDA intends to propose including acacia, or acacia gum, as part of the FDA’s definition of a dietary fiber. The FDA will exercise its enforcement discretion and allow companies to treat acacia as a dietary fiber while the agency engages in rule making. This memorandum summarizes the FDA’s announcement regarding the classification of acacia gum.

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

The FDA has now identified 18 categories of indigestible carbohydrates that qualify for dietary fiber. The FDA identified seven (7) of these carbohydrates in the definition of “dietary fiber” in the final rule and has since identified 11 additional indigestible carbohydrates, including acacia, which the FDA intends to propose to add. to the list of dietary fibers.4 The FDA has announced plans to expand enforcement discretion with respect to these eleven identified fibers5, which would allow manufacturers to include these indigestible carbohydrates in dietary fiber claims on nutrition and supplemental labels.6

Next steps

We will continue to monitor the evolution of nutrition labeling and keep you informed of any changes.

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

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

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

5 The eleven non-digestible carbohydrates that the FDA intends to offer as dietary fiber are mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-like fructans, high starch. Amylose content (resistant starch 2), galactooligosaccharide, polydextrose, resistant maltodextrin / dextrin, phosphorylated RS4 crosslinked, glucomannan and acacia (arabic gum). Dietary Fiber Questions and Answers, https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-dietary-fiber.

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

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