WASHINGTON – The American Bakers Association in a letter dated Feb. 13 requested that the Food and Drug Administration rescind its fiber definition.
“A.B.A. believes the current definition of dietary fiber is not practical or workable and requests that F.D.A. reconsider its definition,” the letter signed by Lee Sanders, the A.B.A.’s senior vice-president, government relations and public affairs, said. “A.B.A. has encountered numerous unintended consequences and unaccounted costs and burdens associated with the definition – likely a result of F.D.A.’s issuance of the definition prior to thoroughly understanding and addressing the impact of the decision.
“A.B.A., therefore, requests that F.D.A. rescind the definition of dietary fiber or at least stay the definition until it has adequately addressed the numerous concerns since it finalized the definition.”
The letter may be found here.
The F.D.A., as part of a Nutrition Facts Panel final rule issued in the May 27, 2016, issue of the Federal Register, said naturally occurring dietary fibers meet the definition as do added isolated or synthetic fibers that the F.D.A. has determined have a physiological effect beneficial to human health. The F.D.A. in the Nov. 23, 2016, issue of the Federal Register gave draft guidance on evaluating the scientific evidence of beneficial physiological effects and requested public comment.
The Washington-based A.B.A. gave its comments in the Feb. 13 letter. The A.B.A. said the F.D.A. did not provide ample time for industry input and for adequate research to understand the nature and benefits of ingredients currently declared in the definition of dietary fiber.
“It is clear that F.D.A. still does not sufficiently understand dietary fiber enough to define it or regulate a definition,” the letter said.
The F.D.A. identified seven non-digestible carbohydrates as meeting its dietary fiber definition: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose. The A.B.A. letter asked how the F.D.A. will treat an ingredient that has an identical chemical structure to one of the seven approved non-digestible carbohydrates. The F.D.A. lists cellulose as approved dietary fiber, for example, but other sources of cellulose, such as sugar cane fiber or sugar beet fiber, may have an identical chemical structure to the approved dietary fiber.
“A.B.A. believes that if an ingredient has the same chemical structure as an approved N.D.C. (non-digestible carbohydrate) and is in the same amount/proportion that demonstrated a beneficial physiological effect, then there is no reason to submit a citizen petition for that ingredient,” the letter said. “Instead, for such ingredients, F.D.A. should revise the draft guidance to include an alternative to the citizen petition process, such as recommending that manufacturers keep records of such determinations.”
The A.B.A. letter expressed concerns over isolated or synthetic non-digestible carbohydrates.
Beta-glucan soluble fiber and psyllium husk should be removed from the list of isolated or synthetic non-digestible carbohydrates, the A.B.A. letter said. Most beta-glucan soluble fibers clearly are intrinsic and intact, the letter said. They include oat bran, rolled oats, whole oat flour, oatrim, whole grain barley and dry milled barley.
“Identifying these fibers as ‘isolated or synthetic’ has already caused significant confusion on top of an already extremely confusing and unworkable definition of dietary fiber,” the letter said.Some ingredients may have the same name and yet have different traits, the letter said. Some corn hull fiber ingredients are highly processed and clearly “isolated and synthetic,” which means they need F.D.A. approval before being declared dietary fiber, but other corn hull fiber ingredients are mechanically processed only and arguably are “intrinsic and intact,” meaning they do not require F.D.A. approval.