As previously reported here, in May 2016, the Food and Drug Administration (FDA or agency) published new final regulations on Nutrition and Supplement Facts labeling. As part of the final rules, FDA defined “dietary fiber,” in relevant part, 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.”[i] The final rule identified only 7 isolated or synthetic fibers that met this definition.[ii] Under the prior method of identifying “dietary fibers” for labeling (which involved analytical methods for measuring levels of fiber present), there were many other types of isolated or synthetic non-digestible carbohydrates that manufacturers routinely declared as dietary fiber on Nutrition Facts labels. In drafting the final regulations, FDA indicated that there was insufficient evidence of a beneficial physiologic effect for other previously considered dietary fibers to be included in the definition, but indicated that anyone could provide evidence to support the addition of other dietary fibers through the Citizen Petition process. This immediately led to questions about what data had been reviewed and the standard the agency would apply to determine beneficial physiological effects. The new report and draft guidance issued on November 22, summarized the results of the agency’s scientific review of 26 routinely identified, non-digestible carbohydrates by providing brief summaries of each study reviewed with an identification of whether each study met or failed FDA’s criteria for inclusion. The 26 non-digestible carbohydrates included in the report are:
|Gum Acacia||Alginate||Apple Fiber|
|Corn Hull Fiber||Cottonseed Fiber||Galactooligosaccharides|
|Oat Hull Fiber||Pea Fiber||Polydextrose|
|Rice Bran Fiber||High Amylose Corn/Maize Starch (Resistant Starch 2)||Retrograded Corn Starch (Resistant Starch 3)|
|Soy Fiber||Sugar Beet Fiber||Sugar Cane Fiber|
|Xanthan Gum||Bamboo Fiber||Inulin/Oligofructose/Synthetic Short Chain Fructooligosaccharides|
|Potato Fibers||Resistant Wheat and Maize Starch (Resistant Starch 4)||Wheat Fiber|
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