Right now, users and suppliers of chicory root fiber, soluble corn fiber/resistant maltodextrin, acacia gum, and several other ingredients classified by FDA as ‘isolated or synthetic fibers’ are in a state of regulatory limbo as they wait for the agency to respond to a series of petitions arguing that they meet the criteria for dietary fiber classification.
While food manufacturers can continue to use fibers that are subject to industry petitions, they don’t know if they will be able to count them as grams of dietary fiber on the new-look Nutrition Facts label, which was slated to come into effect next July but may now be delayed until January 2020, giving stakeholders more time to find out how the FDA will classify fibers.
Asked about its timetable on dietary fibers, the FDA told FoodNavigator-USA that, “We can’t comment at this time,” and would not say whether it would respond to fiber petitioners all at once, or in a drip-drip fashion (which some stakeholders say could negatively impact those at the end of the queue).
ADM: 'The open-endedness of the citizen petition process... adds further confusion and anxiety'
ADM (which markets soluble corn fibers under the Fibersol brand in partnership with Matsutani) told the FDA: “The agency has not responded to the many citizen petitions on dietary fiber, nor issued their updated Scientific Review, nor issued their final guidance, leaving manufacturers in the dark on whether the non-digestible carbohydrates they have been using in their products might still be considered dietary fiber.
“The open-endedness of the citizen petition process, which leaves petitioners unaware of the Agency’s opinion for potentially unspecified amounts of time, adds further confusion and anxiety to manufacturers which has unfortunately been the case for many submitted dietary fiber petitions.”
The continued delay “limits dietary fiber choices or has resulted in the removal of dietary fiber in products for those companies choosing to proactively adopt the requirements of the Final Rule ahead of the compliance deadline,” said ADM.
The Corn Refiners Association (CRA) added: “If FDA ultimately does not designate additional non-digestible carbohydrates as dietary fibers, this could result in a major dietary fiber gap in products available on the market.”
ABA: 'Until the fiber guidance is finalized and published, bakers and other fiber users cannot move forward'
The American Bakers Association, which is equally frustrated, told FoodNavigator-USA that at a September 20 meeting, the FDA had indicated that it had “prioritized all of the guidances and would share [its conclusions] in prioritized order, not as a big package.”
So how big a deal is this for ABA members?
It’s a significant problem, SVP government relations and public affairs, Lee Sanders, told us: “Until the fiber guidance is finalized and published, bakers and other fiber users cannot move forward. Once the fiber guidance is final, then bakers may need to reformulate, and that takes time before they then can turn to label revisions.
“Additionally, the economic impact to both small and large fiber supplier companies is significant since many have petitions into FDA for approval and have been waiting for over a year; some are contemplating the need to close facilities. There are serious economic hardships related to the void of final guidance and a decision on the multiple fiber petitions.”
GMA: 'One in four products is affected by the new definition of dietary fiber'
Tate & Lyle, meanwhile, said it is still waiting for the FDA to decide whether allulose “should be excluded from the labeling of carbohydrate, sugars and/or added sugars.”
And all of this amounts to a significantly stumbling block for food companies, claimed the Grocery Manufacturers Association (GMA): “GMA estimates that one in four products is affected by the new definition of dietary fiber and eight out of ten products are affected by added sugar requirements.”
Manufacturers, argued the GMA, are “having difficulty determining the contribution of added sugars from certain ingredients, such as juice concentrates, concentrated fruit purees, and ingredients produced through hydrolysis.
“Without the critically needed final guidance on added sugars and dietary fiber, among other issues, the affected companies must make significant assumptions about nutrition information placed on a label which, if wrong, would require future re-work to correct.”
CSPI: 'Delay creates uncertainty, disruption, and competitive hurdles'
The Center for Science in the Public Interest (CSPI), however, said these issues did not warrant a delay “and requests that the FDA rescind the proposed 1½-year delay of the compliance dates [the FDA is now proposing to relay the compliance deadline for big companies from July 2018 to January 2020].
“This delay is not needed to assist the food industry—indeed, the delay creates uncertainty, disruption, and competitive hurdles for many companies.”
It also noted that “several large companies— including Mars, Inc., Panera Bread, Campbell’s, the Hershey Co., and KIND—have publicly committed to meeting the original compliance date of July 2018” and that “an estimated 8,000 updated labels [based on a Label Insight study from July 2017] are already on products in stores.”
As regards the dietary fiber confusion, said the CSPI, “The most appropriate course of action is for the agency to commit to a timely and expeditious completion of this guidance. To accommodate industry, the agency can elect to exercise enforcement discretion in those instances where awaiting the guidance prevents companies from a timely compliance with the original deadlines.”
American Diabetes Association: 'Strongly opposed' to a delay
The American Diabetes Association said it is also “strongly opposed to FDA’s proposal to delay implementation of the updated Nutrition Facts label,” while the Union of Concerned Scientists said that, “To delay compliance of this already long-awaited and scientifically supported rule would be an arbitrary step backward for public health.”
The American Heart Association meanwhile, said it would be “difficult for consumers to compare and evaluate products” if the old and new labels are allowed to co-exist in the market for a sustained time period.
“For example…. two yogurts may contain comparable levels of added sugars, but that may not be readily apparent to the consumer.”
Read all the comments HERE.
Under the FDA’s new definition, dietary fiber now means:
1 - Non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants [these don’t need FDA pre-approval and automatically meet the definition];
2 - 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 [the FDA has approved six: Beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose], but said all others must submit petitions.
Isolated and synthetic non-digestible carbohydrates FDA says need to be supported by petitions if they are to be classified as dietary fiber include:
Gum acacia, alginate, apple fiber, bamboo fiber, carboxymethylcellulose, corn hull fiber, cottonseed fiber, galactooligosaccharides, inulin/oligofructose/synthetic short chain fructooligosaccharides, karaya gum, oat hull fiber,* pea fiber,** polydextrose, potato fibers, pullulan, rice bran fiber, high Amylose cornstarch (Resistant Starch 2), retrograded cornstarch (Resistant Starch 3), resistant wheat and maize starch (Resistant Starch 4), soluble corn fiber, soy fiber, sugar beet fiber, sugar cane fiber, wheat fiber, xantham gum and xylooligosaccharides.
*OAT HULL FIBER: According to Mary O’Meara, director of quality and regulatory at Grain Millers, Inc: "Not all oat hull fiber is made the same way. The ones identified by FDA are made via a chemical process that results in an isolated nondigestible carbohydrate.
"By contrast, Grain Millers, Inc. oat hull fiber is made by grinding hulls such that nothing is added and nothing is lost, resulting in intrinsic and intact dietary fiber. Our customers identify it as 'dietary fiber' on their labels. For more information and the applicable science, please see the public comment we filed with FDA HERE."
**PEA FIBER: According to Margaret Hughes, VP Sales and Marketing at pulse ingredients supplier Best Cooking Pulses, Inc: "The Nutrition Facts overhaul has also created confusion around approvals (or not) for pea fiber as a fiber.
"Pea hull fiber, dry-milled from the outer [seed] coat or hull of peas, is considered by the FDA an 'intrinsic and intact' dietary fiber,"(see page 5 of the November 22 draft guidance) whereas inner pea fiber, a by-product of the wet milling process, is not approved as a fiber, and will require submission of a citizen’s petition in order to be approved as a synthetic or extracted fiber... We are able to label the ground pea hulls as pea hull fiber as the total dietary fiber level is 85% or greater.
"We been working hard to clarify for our current and potential customers that our BEST Pea Hull Fiber IS approved by the FDA as an 'intrinsic and intact' dietary fiber."