11/3/17

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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5/31/17

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.

 

3/6/17

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:

  • Intrinsic and intact in plants
  • If determined by the FDA to not be intrinsic and intact, it is isolated and has beneficial physiological effects on human health

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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12/9/2016

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.

gum acacia status as fiber update

 

10/21/2016

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.

Next Steps

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