The American Bakers Association (ABA) says that the current definition of dietary fiber is not practical or workable and requests that FDA reconsider its definition.
The association has encountered numerous unintended consequences and unaccounted costs and burdens associated with the definition and, therefore, requests that FDA rescind it. ABA also suggests FDA could address in the definition numerous concerns raised since it has been in use, including providing a comprehensive list of ingredients that can be declared as dietary fiber.
Alternatively, ABA requests the following:
• Consider a less burdensome definition of dietary fiber.
• Include additional examples of dietary fibers that meet FDA’s definition along with test methods that support
declaration of these fibers on the nutrition label.
• Include additional details on FDA’s scientific review process, including information on:
(1) the process by which manufacturers may show that an ingredient has an identical chemical structure to an approved National Drug Code (NDC); (2) FDA’s approach toward combination ingredients;
(3) additional examples of physiological endpoints and the agency’s suggested duration of studies for certain endpoints;
(4) what FDA considers to be appropriate statistical analysis of study results;
(5) the factors FDA will consider in evaluating scientific studies.
• Alternatives FDA will use in conjunction with the rule making requirements to publicly announce its approval that an ingredient meets its definition of dietary fiber so that a manufacturer can include that ingredient in its dietary fiber declarations in advance of and apart from the formal rulemaking process.
• Re-establish a compliance date based on a timeframe after FDA has worked out all the challenges associated with the new definition of dietary fiber, including approving pending citizen petitions. The current compliance date is less than 18 months away and FDA has indicated it will consider timing options to allow manufacturers to relabel or reformulate products once it has reviewed pending fiber petitions and comments submitted in response to the guidance and Science Review.
ABA will submit the comments it has received in response to FDA’s request for comments, to the Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non—digestible Carbohydrates Submitted as a Citizen Petition.
ABA says that bakers are significantly impacted by FDA’s changes to the nutrition label. Yeast-based bakery products are subject to fermentation and therefore face challenges with respect to the calculation of added sugars, even though added sugars from yeast—based products are not a high contributor to added sugars in the American diet. For products made from enriched flours, bakers must now, for the first time calculate and generate records reflecting the portion of folate that must be declared as folic acid, which has presented unforeseen challenges requiring consultation and clarification from the FDA.
In November 2016, the FDA published a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule.
Source: World Bakers