FDA Approval Explained by Nexira Regulatory Affairs Manager
Thanks to Nexira Proprietary Study, Acacia is Now Officially Confirmed as a Dietary Fiber by the FDA!
Nexira’s discussions with the FDA were at the forefront of the process, helping bring together other manufacturers to provide evidence for the beneficial effects of the fibre.
Read all the story details through the interview of Olivier Bove, Nexira Regulatory Affairs Manager.
What was the starting point?
On May 2016, FDA published final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations (including “dietary fiber” new definition). These new rules were impacting and questioning the dietary fiber status of acacia.
When and how Nexira was involved in the dossier?
Actually, Nexira was involved very early for the dietary fiber status of acacia. In 2011, Nexira submitted a food additive petition which succeed in 2013: Acacia gum was then recognized as a dietary fiber by FDA.
Since May 2016 and the new labeling rules, Nexira was at the forefront of the discussions with FDA, successively inviting other manufacturers around the table. We were a real catalyst in this action! Inviting TIC Gums on October 2016, Kerry and ISC were added early 2017 and Alland & Robert was the last one to be incorporated in the group on 2018.
What is the FDA process?
To convince FDA, we had to prove that Acacia meets the US definition of dietary fiber through the submission of a Citizen Petition.
What was the FDA request?
Based on the discussion with FDA, the objective was to strengthen the body of evidence supporting the beneficial physiological effects of acacia gum on blood insulin and glucose attenuation.
How many studies were conducted?
At the end of 2018, 2 clinical studies were launched, financially supported by the Acacia Gum Group: one coordinated by Nexira at the University of Minnesota, under the supervision of Pr Joanne Slavin and another one at GI Labs, coordinated by Ingredion/TIC Gums. A Citizen Petition was submitted based on these new clinical evidences.
As we wanted to anticipate and to have a strong dossier, Nexira decided to conduct an additional new clinical study with Analyze & Realize under the supervision of Pr Uebelhack: “effect of gum acacia on post prandial glucose and insulin levels in healthy subjects”. 1
1 Uebelhack, 2020, Study report on the effect of gum acacia on post-prandial glucose and insulin levels in healthy subjects (publication in progress, available on the FDA website: https://www.regulations.gov/document/FDA-2020-P-2357-0003)
What was the FDA feedback?
On January 2020, FDA denied the Citizen Petition including the 2 first studies, considering that the strength of the evidence was insufficient to demonstrate that the consumption of acacia gum has a physiological effect that is beneficial to human health.
On July 2020, Nexira shared the excellent results of its own proprietary study with the Acacia Gum Group and a new Citizen Petition was submitted on December 2020. On December 2021, FDA granted the Citizen Petition with Nexira’s study and concluded that the strength of the evidence supports the beneficial physiological effect that acacia has on postprandial blood glucose and insulin. Acacia gum meets the definition of dietary fiber.
What are your thoughts at the end?
Considering the strong scientific evidence on acacia fiber we were confident, but we are satisfied with the FDA decision to add acacia fiber to the approved list of dietary fibers. Nexira is extremely proud to have led this important campaign and immensely pleased with the results.
What is the impact for your customers?
In terms of labeling and formulation, this outcome is excellent news for Nexira’s US customers who use its brand inavea™ for fiber enrichment to actively position their products as a source of dietary fiber.
Watch the full interview ⤵️
Nexira proprietary study, the game changer in FDA approval, is now published
Results from our new clinical study conducted with Analyze and Realize under the supervision of Pr Uebelhack: “The effect of gum acacia on post-prandial glucose and insulin levels in healthy subjects” are now published.