The U.S. Food and Drug Administration (FDA) yesterday issued guidance and a science review that named eight additional non-digestible carbohydrates (NDCs) that meet the new definition of "dietary fiber" established in the Nutrition Facts label final rule. While the rulemaking regarding additional fibers is pending, FDA will exercise enforcement discretion for food manufacturers that opt to count these ingredients when calculating the total amount of fiber per serving to declare on the Nutrition Facts and Supplement Facts labels. 

The updated Nutrition Facts label uses a definition for dietary fiber that requires NDCs to be naturally occurring in plant-based food or to provide a health benefit if added. The original regulations regarding dietary fiber labeling identified seven ingredients that, when added to foods, would meet this requirement. They are beta-glucan soluble fiber; psyllium husk; cellulose; guar gum; pectin; locust bean gum; and hydroxypropylmethylcellulose.

The eight new fibers are: mixed plant cell wall fibers, a broad category that includes 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. 

According to FDA, the expanded the list is based on the agency’s review of scientific evidence included in petitions submitted by manufacturers, public comments and the agency's independent evaluation of the available scientific literature. 

Guidance Clarifies Calorie Calculation Value for Polydextrose

In addition to the allowance for more substances to qualify as dietary fiber, FDA also changed values that could affect the calorie declaration. While most carbohydrates, such as lactose or sugar, contain 4 calories per gram for the purposes of calculating calorie values, NDCs like those included in the definition of dietary fiber contain 2 calories per gram. In the guidance, FDA clarified that polydextrose, now considered a dietary fiber, would contain 1 calorie per gram of polydextrose. 

FDA Welcomes More Petitions

In a statement posted yesterday, FDA commissioner Scott Gottlieb, M.D. Gottlieb said the agency was taking a flexible approach to dietary fiber, adding that even more fibers could be added to FDA’s list if the scientific evidence shows they are beneficial to health. 

“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,” Gottlieb said. “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.”

He added, “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.”

“We’re glad that FDA has included more ingredients in the definition of dietary fiber, including some fibers such as inulin that are used as prebiotics in dairy products,” said Cary Frye, IDFA senior vice president of regulatory affairs. “We look forward to additional information on other substances.”

Background

When the final rule was released in May 2016, FDA declined to make a determination about NDCs beyond the original seven. Instead, the agency asked for comments on the available science regarding the physiological effects of additional ingredients. IDFA and 11 other food industry associations sent a letter in Sept. 2016 to FDA officials requesting clarification and asking for enforcement discretion to allow companies time to find viable solutions that meet the new definition.

For more information:

Members with questions may contact Cary Frye, IDFA senior vice president of regulatory affairs, at cfrey@idfa.org or Michelle Matto, IDFA’s consultant on nutrition and labeling, at amfoodnutrition@gmail.com.