FDA Guidance Proposes Including Additional Ingredients to “Dietary Fiber” Definition

05/07/18

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08h00 - 16h30

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In June, the U.S. Food and Drug Administration (FDA) published the Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels. The FDA identifies several ingredients that they propose to add to the definition of “dietary fiber” as found in 21 CFR 101.9(c)(6)(i). Until these specified non-digestible carbohydrates are formally added to the CFR, the FDA intends to exercise enforcement discretion when the following ingredients are included in the declared dietary fiber content on Nutrition Facts and Supplement Facts labels:

• Mixed plant cell wall fibers (e.g. sugar cane fiber and oat hull fiber)
• Arabinoxylan
• Alginate
• Inulin and inulin-type fructans
• High amylose starch (resistant starch 2)
• Galactooligosaccharide
• Polydextrose (caloric value of 1 kcal/g, pending completion of rulemaking and regulatory revision)
• Resistant maltodextrin/dextrin

It should be noted that the guidance is effective immediately and the FDA is still reviewing citizen petitions requesting the addition of more ingredients to the definition of “dietary fiber” for the purposes of food and dietary supplement labeling.

Click to view the Guidance Document:

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