In FDA regulations, Laws and regulations
fda dietary fiber

The new, stricter definition of dietary fiber will almost assuredly result in some products being taken off the shelves or having to be reformulated to ensure the correct amount of fiber is being listed on the nutrition label. Image by Steve Buissinne from Pixabay

Background Regarding the FDA and Dietary Fiber

Prior to May of 2016, there was no regulatory definition for dietary fiber provided by the U.S. Food and Drug Administration (FDA). As many in the industry are aware, many changes were brought on with the FDA’s release of the final rule: Food Labeling: Revision of the Nutrition and Supplement Facts Labels. Along with the many sweeping changes brought on by the final rule, a definition for dietary fiber was included. Dietary fiber was defined as: “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.” This definition included seven non-digestible carbohydrates identified as the following:

  • beta-glucan soluble fiber
  • psyllium husk
  • cellulose;
  • guar gum;
  • pectin;
  • locust bean gum;
  • hydroxypropylmethylcellulose

In June 2018, after the review of the scientific evidence and citizen petitions, the FDA made the decision to also include the following eight carbohydrates to the definition of dietary fiber, in addition to the seven previously listed non-digestible carbohydrates:

  • 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
  • Resistant maltodextrin

As of June 2018, the FDA was still receiving additional petitions and looking into additional fibers that could be recognized as dietary fibers. A press release from FDA Commissioner Scott Gottlieb, M.D., included the following: “Our work is not done. We have received additional petitions asking for additional fibers to be recognized in a similar fashion to the eight dietary fibers we are identifying today. We are actively evaluating these additional requests, working through the petitions and, in some cases, supplementary information provided by the petitioners, in an efficient manner. We recognize the importance of providing timely responses so that food makers have certainty around their manufacturing decisions. We also welcome the submission of additional petitions in the future as science emerges and as new ingredients are identified. Our expectation is that we will continue to evaluate additional dietary fibers on a rolling basis, and we expect that additional fibers may be recognized in the future.”

How to Comply with the New Dietary Fiber Definition

The compliance date to meet the final rule provided by the FDA for food manufacturers with over $10 million in annual sales is January 1, 2020. Food manufacturers with under $10 million in annual food sales are given until January 1, 2020.

The new, stricter definition of dietary fiber will almost assuredly result in some products being taken off the shelves or having to be reformulated to ensure the correct amount of fiber is being listed on the nutrition label.

The new definition provided by the FDA confirms that the dietary fiber provides at least one of the following health benefits:

  • Lowering blood glucose and 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).

The FDA-compliant nutrition facts label provided by LabelCalc will provide food manufacturers with the listed correct amount of dietary fiber. Nutrient Comparison in LabelCalc is easy to utilize and will show how different ingredients contribute to the varying amounts of dietary fiber. Having dietary fiber in your food product is now guaranteed to provide a health benefit which can be utilized in advertising claims.

LabelCalc is an industry-leading recipe analysis tool used by food manufactures, global retail stores and food entrepreneurs. To get started, see our pricing today.

References:

https://www.fda.gov/food/labelingnutrition/ucm528582.htm

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm610641.htm

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