Under rules issued in summer 2016, the FDA explained that isolated or synthetic non-digestible carbohydrates must be determined to have physiological effects beneficial to human health before they can be counted as dietary fiber for nutrition labeling purposes on the new-look Nutrition Facts labels.
Should suppliers convince the FDA that gum acacia (also known as gum Arabic) delivers beneficial physiological effects, manufacturers will be able to count it as dietary fiber on the new Nutrition Facts labels, which come into effect in January 2020 for firms generating more than $10m in food sales, and January 2021 for smaller firms.
In February 2017, gum acacia manufacturers including Nexira, Ingredion (TIC Gums), Importers Service Corporation (ISC), Alland & Robert, and Kerry submitted comments to FDA outlining the beneficial physiological effects of gum acacia on energy intake, blood glucose levels, and bowel function/laxation.
In an email to FoodNavigator-USA last summer, however, an FDA spokeswoman said that gum acacia "didn’t meet the definition based on the evidence reviewed."
In an August 8, 2018 meeting, the manufacturers above sought feedback from the FDA about what evidence it was looking for, according to Nexira, which said Keller and Heckman LLP is now preparing a Citizen Petition to be submitted to the agency later this month, requesting that gum acacia be recognized as a dietary fiber.
“Based on the discussion we had with the FDA… Nexira, along with representatives of the gum acacia industry, decided to conduct additional studies to strengthen the body of evidence supporting the beneficial physiological effects of gum acacia on blood glucose attenuation and energy intake."
TIC Gums added: "In a continuing effort to encourage the FDA to classify gum acacia as dietary fiber, TIC Gums and others in the acacia industry commissioned two clinical studies designed to provide additional evidence of the physiological benefit of acacia as a dietary fiber. In addition to supportive studies previously submitted in comments to the FDA, these two new studies demonstrate physiological benefits to support including gum acacia as a dietary fiber under the updates to the Nutrition and Labeling Education Act.
"We have put forth a strong argument that acacia meets the definition of [an] intact and intrinsic [fiber]."
Alland & Robert R&D director Isabelle Jaouen said: "The citizen petition is currently being drafted. A work group, composed of Alland & Robert, ISC, Tic Gums and Nexira, is working on it. Only when the four companies agree, the petition will be submitted to the FDA."
Asked for more detail on the studies, she added: "Two laboratories that specialize in clinical nutrition, including one university, have been mandated by the workgroup for the clinical trial design and the realization of clinical tests. The results of these studies will be published [in a ] timely [fashion], by the research teams who completed the studies."
TIC Gums regulatory affairs manager Lorien Reynolds added: "The industry group has worked together to review and approve both studies, including the study initiated by Nexira. In addition, the Ingredion group of companies has led the effort for the second clinical study and the results of that study are complete and will be made publicly available soon."
What happens next?
While the firms cannot predict how or when the FDA might respond, said Nexira, “We’re hopeful to receive a positive response to our Citizen Petition in Summer 2019.”
Should the FDA reject the findings of the petition, or fail to respond before January 2020, gum acacia may continue to be used as an approved food additive after the compliance date and would be included in the declaration for total carbohydrate with a caloric value of 2 kcal/gram. However, it could not count towards grams of dietary fiber on the label.
- Read more HERE about the FDA’s long-awaited guidance spelling out which isolated or synthetic non-digestible carbohydrates it believes should be classified as ‘dietary fiber.