June 14, 2018
The U.S. Food and Drug Administration today issued guidance and a supporting science review identifying eight additional non-digestible carbohydrates (NDCs) that the agency intends to propose to add to the list of non-digestible carbohydrates that meet the definition of "dietary fiber" that was established in the Nutrition Facts label final rule. The FDA also issued responses to citizen petitions requesting that additional NDCs be added to the definition of "dietary fiber." These actions provide industry with additional clarity to update their product labels and accurately declare dietary fiber content on the Nutrition Facts and Supplement Facts labels for consumers.
These actions are based on the FDA's careful review of the strength of scientific evidence from citizen petitions submitted to the agency by manufacturers, public comments and on the agency's independent evaluation of the available scientific literature based on guidance that we issued on the Review of the Scientific Evidence on the Physiological Effects of Certain Non-Digestible Carbohydrates. The eight additional dietary fibers include mixed plant cell wall fibers (a broad category that includes fibers like sugar cane fiber and apple fiber, among many others), arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch (resistant starch 2), galactooligosaccharide, polydextrose, and resistant maltodextrin/dextrin.
The new guidance issued today, "The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels," expresses the FDA's intent to exercise enforcement discretion if these eight NDCs are included in the declared amount of dietary fiber on food labels pending completion of the agency's rulemaking regarding adding additional fibers to the definition in FDA regulations.
Several petitions are still pending with FDA and reviewing this information is a very high priority for the Agency. Firms also can submit new citizen petitions, and we will review the petitions on a rolling basis. Firms whose non-digestible carbohydrates do not meet our regulatory definition of "dietary fiber" at this time can still use those non-digestible carbohydrates in foods and declare these as part of the amount of total carbohydrate on the food package.
The FDA is confident that after issuing this guidance and the science review, and responding to most of the citizen petitions we have received so far, many manufacturers can move forward to update their labels regarding dietary fiber and implement the new Nutrition Facts and Supplement Facts labels.
Today's actions also mark a step forward for public health. Fiber-containing fruits, vegetables and grain products, particularly soluble fiber, may reduce the risk of coronary heart disease and can help lower cholesterol levels. Certain dietary fibers can also increase calcium absorption in the intestinal tract, improve laxation, or reduce calorie intake. After manufacturers update their labels, consumers will be able to trust that if a food label states that a product contains dietary fiber, the source of that fiber is scientifically shown to have a beneficial health effect.
For Additional Information:
- Federal Register Notice – The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry
- Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels
- Review of the Scientific Evidence on the Physiological Effects of Certain Non-Digestible Carbohydrates
- Questions and Answers on Dietary Fiber