Gum Acacia Status as Fiber
In its final guidance regarding the definition of dietary fiber in 2018, FDA determined that “isolated or synthetic non-digestible carbohydrates” must demonstrate “physiological effects that are beneficial to human health.”
In clinical studies, Acacia demonstrated the following physiological effects found to be beneficial to human health:
On 4/19/19, TIC Gums, along with others in the industry, submitted a citizen petition requesting FDA amend the definition of “dietary fiber” to add Acacia requesting FDA amend the definition of “dietary fiber” to add Acacia to the list of “isolated or synthetic nondigestible carbohydrates that have been determined by FDA to have physiological effects that are beneficial to human health and, therefore, shall be included in the calculation of the amount of dietary fiber.” (21 C.F.R. § 101.9(c)(6)(i)).
Submitted as supporting documents along with the petition were the findings from two new clinical studies:
Although TIC Gums is taking every step possible to provide this evidence, we cannot make assumptions on behalf of the FDA so we are unable to guarantee acacia will gain approval as a dietary fiber. While we cannot provide a timeline for a response from the FDA, we will provide further updates as they become available. Sign up for our special mailing list to receive the latest updates Click here to sign-up for the list
In our continuing effort to encourage the FDA to classify gum acacia as dietary fiber, TIC Gums, along with others in the acacia industry, commissioned two clinical studies designed to provide additional evidence of the physiological benefit of acacia as a dietary fiber.
Since then, TIC Gums, along with others in the acacia industry, has been directly involved in the development, execution, data analysis and scientific review of these two new clinical studies. That work is now complete.
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 are pleased to announce, based on the overall body of evidence, we are moving forward with the plan to submit a citizen’s petition for approval with the FDA this spring. TIC Gums will continue to be a part of the citizen’s petition process and any follow-ups.
Although TIC Gums is taking every step possible to provide this evidence, we cannot make assumptions on behalf of the FDA so we are unable to guarantee acacia will gain approval as a dietary fiber. While we can’t provide a timeline for a response from the FDA, we will provide further updates as they become available. Sign up for our special mailing list to receive the latest updates Click here to sign-up for the list
Since the FDA released guidance regarding the dietary fiber status of certain non-digestible carbohydrates, TIC Gums has met with the FDA and reviewed the overall body of evidence.
Although some studies previously submitted supported acacia as a dietary fiber it was deemed necessary to have more evidence to support FDA approval. TIC Gums is working jointly with others involved in the acacia industry to demonstrate a proven physiological benefit for acacia as a dietary fiber with clinical studies.
We anticipate completing the studies in early 2019 and will follow the study with a citizen’s petition for approval to the FDA. Although TIC Gums is taking every step possible to provide this evidence we cannot make assumptions on behalf of the FDA. Therefore, at this time, we cannot guarantee acacia will gain approval as a dietary fiber. We will provide further updates by July 2019 based on feedback from the FDA.
On June 14, 2018, the US Food and Drug Administration (FDA) released an updated guidance notifying the industry that Gum Acacia is not considered to be a dietary fiber under the new Nutrition Facts Rule. According to the FDA, due to the chemical structure and processing, Gum Acacia does not meet the definition of intrinsic and intact, and, therefore, cannot be approved as a dietary fiber.
While Gum Acacia was not approved as a dietary fiber, TIC Gums continues to work with our industry partners, General Counsel and the FDA to determine what additional information is needed to have Gum Acacia recognized as a dietary fiber. This has included literature reviews, scientific petitions and communication with the FDA. TIC Gums is now awaiting the explanation and scientific rationale for Gum Acacia not being approved.
Once data is available and reviewed, next steps and timelines will be developed and communicated.
How does this affect the Gum Acacia customer?
Any customers utilizing Gum Acacia that count the dietary fiber from Gum Acacia in the Dietary Fiber calculation on the Nutrition Facts label will need to review the nutritionals and labels.
When does this regulation go into effect?
January 1, 2020 for businesses with $10 million or more in annual food sales and January 1, 2021 for businesses with less than $10 million in annual food sales.
Update: Nutrition Facts Label Compliance Date Delay and Dietary Fiber
On October 2, 2017, the FDA announced in the Federal Register that it is proposing to delay the compliance date for the updated Nutrition Facts Labels. For companies with annual food sales in excess of $10 million, the newly proposed compliance date would change from July 26, 2018 to January 1, 2020. For companies with annual food sales of less than $10 million, the newly proposed compliance date would change from July 26, 2019 to January 1, 2021.
There was a comment period for the proposed compliance date extension that was open until November 1, 2017.
TIC Gums is continuing to monitor the situation as it relates to acacia as a dietary fiber. We remain in contact with the FDA, which has confirmed that they will reply to each citizen petition received in relation to the dietary fiber rules.
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Update: Decision is in final review
We have been in communication with the FDA and the decision regarding the dietary fiber status of gum acacia is in final review.
FDA has not provided a timeline for any announcements, however, we will remain in contact with the appropriate parties until such time as a decision is announced.
Update: Public Comment Period has Closed
The FDA published its Science Review of Isolated and Synthetic Non-Digestible Carbohydrates and opened a period for public comment on November 23, 2016. At that time, the comment period was originally scheduled to close on January 9, 2017; that deadline was later extended to February 13, 2017.
On February 13, 2017, Keller and Heckman LLP, working on behalf of TIC Gums and other companies in the industry, submitted a comment in the form of a 31-page document. The response included references supporting our position that gum acacia should be added to the list of approved dietary fibers because it meets both criteria outlined in the FDA’s new definition:
Read the full comment
Additionally, our public comment received support from the International Food Additives Council in its public comment posted on February 13, 2017:
“IFAC supports the evidence presented in these petitions and encourages the Agency to closely consider this information in their evaluation of potential dietary fibers. IFAC also supports the February 9 comments submitted by Keller & Heckman to the Agency with relation to gum acacia.”
The period for public comment has closed and the FDA has not given a timeline for response or approval. We will remain in communication with the appropriate parties until the dietary status of gum acacia is decided.
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Update: Status of Gum Acacia as an Approved Dietary Fiber and Request for Public Comment
On November 23rd, 2016, the Food and Drug Administration (“FDA”) released its Science Review of Isolated and Synthetic Non-Digestible Carbohydrates. This review document includes the scientific data the FDA examined in making its initial determination as to Gum Acacia’s status as a dietary fiber, and how each piece of data was seen in regards to specific physiological effects.
TIC Gums, working with other companies and trade groups in industry, are reviewing this document and the scientific data used in order to strengthen our position that Gum Acacia meets the definition of dietary fiber with beneficial physiological effects on human health.
In addition to releasing the Science Review, the FDA has requested scientific data, information, and comments from the public. If you have compelling scientific data, comments, or information on a business or economic impact related to the status of Gum Acacia as a dietary fiber, please consider submitting a public comment. The Federal Register has Tips for Submitting an Effective Comment available, which are useful in crafting a compelling public comment. The comment period is open until 11:59 p.m. (Eastern) on January 9, 2017.
Because this topic is of such interest, we’ve created a special mailing list to share updated information. You can sign up for that list at www.ticgums.com/acacia-list.
In May 2016, the FDA published new regulations for the Nutrition Fact Labels, representing the first major update to the nutritional panel since its introduction over 20 years ago.
FDA Changes Definition of Dietary Fiber
While there are many changes, the one that most affects our customers is a change in regards to the dietary fiber definition. Under the new rule, in order to qualify towards the total dietary fiber calculation the source of the fiber must meet FDA’s new definition.
“non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; 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.”
Fibers currently on FDA’s list that meet this definition:
[beta]-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose.
FDA has indicated that this list is not exhaustive and that it may change as they review additional scientific evidence.
The Status of Gum Acacia as Fiber
Notably absent from the list of approved fiber sources is gum acacia, an ingredient that was previously approved as a fiber source.
TIC Gums, working with other companies in industry, has taken the lead in petitioning the FDA to add acacia to the list of approved fibers. We have put forth a strong argument that acacia meets the definition of intact and intrinsic and will be providing FDA with data to support the beneficial physiological effect of acacia on human health.
We are confident that the arguments we’ve made will result in gum acacia’s ultimate approval as a fiber under the new rules as we firmly believe, it is both intrinsic and intact and has physiological benefits.
At this time, the FDA has not provided a timeline for public comment or approval, however, rest assured that we will remain in communication with the appropriate parties until the dietary fiber status of gum acacia is decided.
Because this topic is of such interest, we’ve created a special mailing list to share updated information. Click here to sign-up for the list