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Fiber suppliers at this year’s Institute of Food Technologists Annual Meeting & Food Expo told Nutritional Outlook that while they are confident FDA will eventually consider their ingredients to be dietary fibers, the path to FDA approval is unclear.
Fiber-ingredient suppliers have been on high alert for more than two years ever since FDA announced its intention to revamp U.S. Nutrition Facts labels. Along with those label changes, the agency finally created a definition for a dietary fiber-one that may leave many fibers out in the cold. The nutrition labeling rule goes into effect on July 26 of this year, and large companies have two years from then to comply with the new definition. Fiber suppliers at this year’s Institute of Food Technologists Annual Meeting & Food Expo told Nutritional Outlook that while they are confident FDA will eventually consider their ingredients to be dietary fibers, the path to FDA approval is unclear.
FDA’s new definition of a dietary fiber is a fiber that has a “physiological effect that is beneficial to human health.” The definition is limited to fibers that are 1) non-digestible carbohydrates (with 3 or more monomeric units) and lignins intrinsic and intact in plants, such as whole grains and natural fruit and vegetable fibers, or 2) added fibers, such as isolated or synthetic non-digestible carbohydrate fibers, including both insoluble and soluble prebiotic fibers, as long as FDA has pre-approved the fiber as a dietary fiber or as long as the ingredient is already the subject of an FDA-approved health claim. Alas, the list of approved fibers is short at the moment. For now, it includes only cellulose, guar gum, pectin, locust bean gum, and hydroxypropyl methylcellulose (HPMC), as well as beta-glucan and psyllium, which are the subject of health claims.
Even before FDA released its final nutrition facts panel rule, companies that supplied fiber began petitioning the agency to get their fiber ingredients added to the approved list by providing the agency with research data demonstrating that their particular fibers have shown physiological benefits in human studies. According to the publication Food Chemical News,Top Health Ingredients Inc., a Canadian fiber supplier, submitted a citizen’s petition as far back as April 9 for its AdvantaFiber isomalto-oligosaccharide fiber (IMO), stating that “IMO has long been considered by the scientific community to be a dietary fiber.”
During the IFT show, fiber suppliers Tate & Lyle (Decatur, IL) and Fibersol/ADM Natural Health and Nutrition (Decatur, IL) said they had either already submitted or would soon submit their own petitions to FDA. Most said they were confident that, given the breadth of scientific evidence supporting the health benefits of their fibers, their fibers would eventually gain FDA approval.
“We were anticipating these new FDA guidelines,” said Nancy Gaul, Tate & Lyle’s senior category manager for health, wellness, and dairy. Gaul said Tate & Lyle has submitted petitions for its Promitor soluble corn fiber and its Sta-Lite polydextrose fiber. The company did not have to submit a petition for its PromOat soluble oat beta-glucan fiber because it is already on FDA’s approved list. “We’re feeling positive that we will get the approval as a dietary fiber because we have a lot of science that we submitted with this petition that shows the health benefits of our fiber,” Gaul said.
Doris Dougherty, Fibersol technical service representative, said the company is likewise working to get Fibersol approved. On July 19 during IFT, she said, “We are in the process of submitting a citizen’s petition. We expect to have it by the end of the week.” She, also, seemed sure that FDA would approve the company’s fiber. “We are so confident. We have an enormous amount of data around Fibersol, so we’re very confident that once we file the petition and they have a chance to review all of our information, then they will accept it.”
Some companies are waiting to submit petitions until FDA provides more insight on the agency’s thinking, including what types of scientific evidence companies need in order to meet the new definition. FDA has said it would publish and make public, via the Federal Register, more details about the data the agency considered when devising the new fiber definition. The agency has not, however, made clear exactly when this information will be shared, and it was not yet released at the time this story was published.
Anke Sentko, vice president of regulatory affairs and nutrition communication for Beneo GmbH (Manheim, Germany), said her company is preparing a citizen’s petition for its Orafti chicory root inulin and oligofructose soluble fibers but is waiting for FDA to release more details. “Of course, we need first of all to develop intelligence on how FDA looked into the data and what kind of data they looked at, so everyone is waiting now for the notice to come out.” Sentko said she believes that when her company shares its ingredient research, “it will make a difference.”
“What FDA surely did not have is our confidential and unpublished data” when they made their decisions, Sentko added. The data “was enough for EFSA to agree on a claim [in the EU], so we hope that this will change the picture.”
All suppliers said they hope FDA will disclose information and respond to petitions in a timely manner because large companies have only two years-until July 26, 2018-to comply with the new nutrition labeling requirements, including for fiber. (The compliance dates differ depending on a company’s size. Companies with sales above $10 million must comply with the rule by July 26, 2018, while those with sales under $10 million have an additional year to do so, until July 26, 2019.)
“We hope that FDA will respond quickly because clearly it impacts the industry,” said Tate & Lyle’s Gaul.
“Everybody’s hopeful it will be the next couple of months,” said Rajen Mehta, PhD, senior director, specialty ingredients, for Grain Millers (Eden Prairie, MN). “It could be anywhere from a few weeks to several months.”
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Even companies that are relatively sure their ingredients already fall under FDA’s new fiber definition said they are treading cautiously and not making assumptions. Grain Millers, for instance, supplies whole-grain ingredients like oats, wheat, barley, and rye. These ingredients are cooked and ground-milling processes the firm believes FDA does permit for intrinsic and intact fibers. However, Mehta said, FDA has not clarified which processes it allows under the definition. For this reason, his company is still consulting legal advisors to ensure its ingredients meet regulations.
“We are confident that our oat fibers meet FDA’s new guidelines as ‘intrinsic and intact’ and thus meet the definition of dietary fiber for FDA’s revised nutritional facts label, but we are still going through the due-diligence process and being careful,” Mehta said. “Everybody’s a little confused about the FDA’s current thinking on the process for establishing this status.”
“I have a feeling FDA has some questions, too, as to where they want to go,” he added. “So we’re just going to get all our data together” in the meantime, he said.
In terms of whether companies need to start reformulating their products now, Tate and Lyle’s Gaul said, “I don’t think there are reformulation concerns yet.” If FDA sanctions a company’s fiber before the compliance deadline, the company’s clients should not need to change their product recipes to exclude the fiber.
Still, there is one situation in which companies might need to reformulate anyway. FDA is also planning to raise the daily value for dietary fiber from 25 g to 28 g for a 2,000-calorie diet-a level in line with current Institute of Medicine recommendations. If companies want to continue making “good source of” or “excellent source of” fiber claims, they might need to reformulate if their fiber content is no longer high enough to meet the level needed to make claims.
Gaul noted that food products will need to contain 5.6 g of fiber per serving in order to make an “excellent source of" claim, versus the 5 g originally required. “Those customers and manufacturers that do want to continue making an 'excellent source' claim will need to reformulate to add more fiber,” she said.
The companies interviewed pointed out that FDA’s fiber definition is now one of the strictest in the world. “In terms of the definition of dietary fiber, up until now the United States was probably one of the least stringent in terms of dietary fiber. Now, all of a sudden, we’ve gone to the top of the list,” Mehta says.
These recent regulatory challenges have not stopped fiber companies from innovating. At the IFT trade show, fiber suppliers showcased sophisticated food and beverage prototypes with high fiber content. Tate & Lyle sampled a savory summer mango gazpacho with 9 g of fiber, an excellent source thanks to the combination of Promitor soluble corn fiber as well as PromOat beta-glucan. Fibersol showcased its new Fibersol-2L ingredient, a liquid version of the company’s original Fibersol-2 soluble fiber powder that Dougherty said enables easier bulk handling and is easier to incorporate in certain types of products. The company sampled Fibersol-2L in prototypes previously not achievable with Fibersol-2, including gummies with 54% fiber content and a chewy honey peanut butter nougat bar. The bar combines Fibersol-2, which provides firmness, and Fibersol-2L, which lends plasticity. These soluble fibers are also being used to replace added sweeteners, to reduce calories, and to boost satiety.
All suppliers said they hope FDA provides more clarity “as soon as possible, I hope,” said Beneo’s Sentko, “because this is very irritating for the whole industry.”
“Everyone is nervous,” she continued, “and at the end of the day, it’s the consumer who is suffering because the consumer will get less fiber. That is the consequence of all that, because if you cannot claim it as a fiber, the fiber gap will be bigger.”
Nutritional Outlook magazine