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On December 17, 2021, The U.S. Food and Drug Administration (FDA) recently granted a citizen petition Nexira, Alland & Robert and Importers Service Corporation 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 Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber

  • The FDA will allow Companies to treat acacia as a dietary fiber for nutrition labeling purposes.
  • FDA wants Acacia added to the list of dietary fibers that would allow manufacturers to include these non-digestible Carbohydrates in the dietary fiber statements on Nutrition and Supplement Facts labels.

Rulemaking Timelines of Additional Fibers

Until the FDA completes rulemaking to add additional fibers to the regulatory definition of dietary fiber, the agency intends to exercise enforcement discretion for manufacturers to include the amount of these additional fibers in the dietary fiber declaration on the Nutrition and Supplement Facts labels.

Physiological Effects : Acacia (Gum Arabic) as a dietary fiber for nutrition

  • Lowering blood glucose
  • Lowering cholesterol levels
  • Lowering blood pressure
  • Increase in frequency of bowel movements (improved laxation)
  • Increased mineral absorption in the intestinal tract
  • Reduced energy intake (for example, due to the fiber promoting a feeling of fullness).

What isolated or synthetic fibers has FDA included in its dietary fiber definition?

Addition to intact and intrinsic fibers, FDA has identified the following isolated or synthetic non-digestible carbohydrates as meeting the dietary fiber definition:

  • Beta-glucan soluble fiber
  • Psyllium husk
  • Cellulose
  • Guar gum
  • Locust bean gum
  • Hydroxypropylmethylcellulose

How Can Companies Request the Inclusion of Fiber?

Firms can submit citizen petitions at any time requesting that additional fibers be added to the definition of dietary fiber. Those petitions will be reviewed on a rolling basis. 

Learn CFR – Code of Federal Regulations chic here.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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