(P10-025-20) FDA Approval of Added Fiber as Dietary Fiber
Objectives: The FDA after approximately 25-plus years of deliberations approved the definitions of dietary fiber (DF). Concurrently with these definitions, the FDA has approved 16 sources of Added Fiber (AF) to DF status, thus allowing their inclusion as DF in foods and on the Food Label. While the Institute of Medicine defined DF as the nondigestible carbohydrates (NDC) mainly in plant foods, they also used the term Added Fiber (AF) for any NDC extracted from a food or synthesized. The 16 sources of AF were approved for their clinical ability to demonstrate a “beneficial physiological effect for human health” (BPEFHH). The objective of this report is to give the range and mean value in grams, reported respectively, after each named AF to achieve a BPEFHH.
Methods: The method used to obtain this information was to review the major references used by the FDA is making their decisions.
Results: The results of the FDA approvals are: -glucan (3 g/day) and psyllium husk (7 g/day} were reaffirmed as DF having previously been granted health claims to lower cholesterol. Other sources of AF approved to attenuate blood cholesterol levels were guar gum (15-30; 20), pectin (9-36; 17), locus bean gum (8-24; 17) and hydroxypropylmethylcellulose (5-15;9). The FDA approved, “mixed plant cell wall fibers” (intrinsic and intact)” as an encompassing term incorporating many of the AF individually approved. Arabinoxyln (2.6-15; 8), alginate (1.5-15; 9), and the resistant starches, RS-2 (25-40; 32) and RS-4 (17;17-one study) were approved for their ability to attenuate blood glucose and or insulin levels. Inulin and inulin-type fructans (3-44; 8), galactooligosaccharide (5-20; 11), and resistant maltodextrin were approved having demonstrated enhanced calcium absorption and or bone calcium retention. Polydextrose ((6.25; 13) was approved for its ability to reduce food (calorie) intakes thus helping to reduce body weight, promote satiety while only providing one (1) kcal/g.
Conclusions: In the FDA approval declarations, they commented they will “consider enforcement discretion for declaring the amount of [AF]” as DF to demonstrate BPEFHH. But for the time being, these FDA approvals explain the BPEFHH of AF and help justify the need for more DF in the diet.
Funding Sources: None
Professor Emeritus North Dakota State University Chicago, Illinois