FDA Responds to Three Dietary Fiber Citizen Petitions
On January 10, the FDA announced that it intends to propose that “glucomannan” be added to the definition of dietary fiber at 21 CFR 101.9(c)(6)(i). Based on available evidence, FDA determined that the scientific evidence suggests that glucomannan can help reduce blood cholesterol. Glucomannan is commonly found in the tuber or root of the elephant yam, also known as the konjac plant. The FDA’s action is in response to a Citizen Petition (CP) filed by The Food Lawyers on February 24, 2018.
FDA also denied two CPs on January 13 for isomaltooligosaccharide (IMO), which were submitted by Top Health Ingredients in April 2019, and BioNeutra North America in May 2019. In both denials, FDA stated that “the strength of the evidence does not show that the consumption of IMO has a physiological effect that is beneficial to human health.”
With the granting of the glucomannan CP, there are currently 17 categories of non-digestible carbohydrates (NDCs) (including a broad category of mixed plant cell wall fibers) that are either included in the definition of dietary fiber, or are non-digestible carbohydrates that FDA intends to propose to be added to the definition of dietary fiber. Those NDCs are as follows: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethylcellulose, mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch (resistant starch 2), galactooligosaccharide, polydextrose, resistant maltodextrin/dextrin, cross linked phosphorylated RS4, glucomannan.
There are currently 5 pending dietary fiber CPs that have been submitted for Agency review. Notably, some CPs have been under FDA review for upwards of 9 months or more. FDA states the CPs will be reviewed on a rolling basis, with the most recent CP submitted in December 2019 for alpha-cyclodextrin.