Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber: [1] non-digestible soluble and insoluble carbohydrates and lignin that are intrinsic and intact in plants; and [2] isolated or synthetic non-digestible carbohydrates determined by FDA to have acknowledged beneficial physiological effects. The FDA regulation listed 7 ingredients that had been found to have a beneficial physiological effect.
On June 14th, 2018, a little over 18 months before the compliance date for the new nutrition labeling, FDA issued two guidance documents regarding how isolated or synthetic non-digestible carbohydrates relate to the dietary fiber declaration. These guidance documents resolve nearly two years of uncertainty for at least 26 non-digestible carbohydrates under FDA review for their potential beneficial physiological effect.
FDA stated in one guidance document that the agency had found a beneficial physiological effect for 8 more ingredients and would use enforcement discretion to allow manufacturers to immediately reevaluate their fiber ingredients for inclusion in the dietary fiber declaration. The second document contained the scientific evaluation of data showing a beneficial physiological effect for those 8 ingredients.
The list of FDA-approved isolated or synthetic non-digestible carbohydrates with acknowledged beneficial physiological effects now include the following 15 substances:
- [beta]-glucan soluble fiber (as described in 101.81(c)(2)(ii)(A))
- psyllium husk (as described in 101.81(c)(2)(ii)(B))
- cellulose
- guar gum
- pectin
- locust bean gum
- hydroxypropyl-methylcellulose
- mixed plant cell wall fibers
- arabinoxylan
- alginate
- inulin and inulin-type fructans
- high amylose starch (resistant starch 2)
- galactooligosaccharide
- polydextrose
- resistant maltodextrin/dextrin.
The agency describes “Mixed plant cell wall fibers” as a large group of fibers that include cellulose, pectin, β-glucan, and/or arabinoxylan. FDA listed several examples of ingredients that include these fiber components, including apple fiber, citrus fiber, pea hull fiber and many others.
With the evaluation decisions in the new guidance, the list of 26 non-digestible carbohydrates under FDA evaluation as dietary fiber has now been shortened to 9. The ingredients where no determination has been reached include commonly used fibers such as gum acacia, carboxymethylcellulose, karaya gum, pullulan, xanthan gum and some other starches.
With the publication of these new documents, firms are encouraged to verify whether the updated guidance affects the dietary fiber declaration of their products. Nutrition information in recently created Nutrition Facts and Supplement Facts panels might need to be updated. EAS consultants are available to assist in evaluating ingredients in light of the new guidance and revising labels accordingly.
Posted in FDA and USDA Regulatory Update.