Right now, suppliers and users of inulin and oligofructose – and 25 other ingredients classified by FDA as ‘isolated or synthetic fibers’ including alginate, pea fiber,* sugar beet fiber, soluble corn fiber and various resistant starches – are in a state of regulatory limbo as they wait for the FDA to respond to a series of petitions arguing that they meet the criteria for dietary fiber classification (demonstrate “a beneficial physiological effect in humans.”).
While formulators can continue to use inulin and other fibers 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, the July 2018 deadline for which is rapidly approaching.
‘The timeline is getting tighter and tighter’
Not surprisingly, this is pretty frustrating, admits Cargill (which is the exclusive distributor of Oliggo-Fiber chicory root fiber products from Belgian firm Cosucra in North America); there’s a lot of science behind chicory root fiber’s digestive health benefits, but suppliers can’t guarantee to their customers that petitions will be viewed favorably, and the pressure to get nutrition labeling ducks in a row before next summer is increasing.
“Inulin is one of the most well-researched fibers out there so we’re pretty confident the petition [filed by chicory root experts Cosucra, Beneo and Sensus] will be successful,” Cargill product line manager Taylor Halstead told FoodNavigator-USA.
“However, the timeline is getting tighter and tighter [so far the FDA has not responded to any of the petitions beyond acknowledging receipt]. We’re in a tough spot but other fibers are in the same position.”
His comments echo frustration voiced in a petition filed by the American Bakers Association calling on the FDA to revert to the chemical definition of dietary fiber, adopt a friendlier definition of dietary fiber such as that employed by Health Canada, or simply stay this part of the new nutrition labeling regulations until the fiber issue is sorted out.
“Companies explained to FDA that to revise a food label under the new requirements by July 26, 2018, they would need to have their new Nutrition Facts label data calculated and entered into their databases months in advance to get their labels and packaging revisions in queue with the printing companies.”
“The American Bakers Association is aware that at least one of its members that is a fiber manufacturer with a fiber petition currently under review with FDA has already lost - and may imminently lose - future contracts due to the uncertainty created by FDA’s dietary fiber definition.”
Petition, filed by Covington & Burling LLP on behalf of the American Bakers Association, April 7, 2017
‘Chicory root fiber is a clean label sugar reduction tool’
Regulatory woes aside, chicory root fiber remains an attractive ingredient from a technical, nutritional and consumer perspective, said Halstead, who was speaking to FoodNavigator-USA as part of our digestive health special edition. It can replace full-calorie carbs and sugars, add bulk, and improve the flavor and texture of low fat and sugar formulations, while it has obvious clean label credentials.
“Our research also shows that 'chicory root fiber' ranks much higher than 'inulin' with consumers, so we take that to heart in our marketing,” said Halstead. “It’s a clean label sugar reduction tool, but people also like the story – they like the fact that it comes from the chicory root and that it’s also non-GMO.”
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.
Feeding your gut
And while its prebiotic effects (chicory root fiber has been shown to stimulate the growth of good bacteria in the gut) are not necessarily the primary purchase driver for customers right now, all ingredients with proven digestive health benefits will gain traction in the years ahead as consumers understand the importance of feeding your gut bacteria, predicted Halstead.
As for fiber in general, we all know Americans are short of it, although from a marketing perspective, protein (which most Americans are not short of) might appear hotter right now, he added.
“Consumer understanding of pre- and probiotics is evolving and chicory root fiber even at low doses can be an effective prebiotic. We’re also seeing customers pair it with probiotics.”
Read more about the FDA’s process for classifying dietary fibers HERE.
What is chicory root fiber?
Inulin-type-fructans (non-digestible carbohydrates including inulin, long-chain inulin, oligofructose, and various combinations of these) are extracted from chicory root by hot water.
The chain length influences their technical functions in foods, but "they all have the same physiological health benefits which are associated with the f3 (2-1) binding of the fructans chains," claim Cosucra, Beneo and Sensus in a Sept 2016 petition to the FDA.
Beneficial effects of the fructans, which "reach the large intestine essentially complete," are claimed to include: Improved bowel function, increased calcium absorption, reduced blood cholesterol in hypercholesteremic individuals and attenuated postprandial glycemic response.
In a petition filed in April 2017 by law firm Covington & Burling LLP, the American Bakers Association claims that food manufacturers “are in a holding pattern waiting for FDA to issue a final definition of dietary fiber before they print the new labels…
“Companies explained to FDA that to revise a food label under the new requirements by July 26, 2018, they would need to have their new Nutrition Facts label data calculated and entered into their databases months in advance to get their labels and packaging revisions in queue with the printing companies.
“FDA finalized its definition of “dietary fiber” well before it resolved a number of issues that are critical to compliance, and though the compliance date is rapidly approaching, FDA has still not resolved these issues. These issues cause the definition to be unworkable.”
The ABA has called for the FDA to revoke its new definition of dietary fiber and revert to a chemical definition. Failing that, the agency should “adopt a less burdensome definition of dietary fiber, such as the definition adopted by Health Canada,” it said, or put the definition on ice until issues are resolved.
If inulin suppliers are frustrated by the FDA process, meanwhile, so are those of pea fibers, Margaret Hughes, VP Sales and Marketing at pulse ingredients supplier Best Cooking Pulses, Inc, told FoodNavigator-USA.
"The Nutrition Facts overhaul has also created confusion around approvals (or not) for pea fiber as a fiber."
She added: "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."