Changes in What Constitutes ‘Dietary Fiber’ for Nutrition Facts Labeling May be in the Works

One of the more controversial aspects of the FDA’s final rule on revising the Nutrition Facts Panel (NFP), 81 Fed. Reg. 33742(May 27, 2016), changes the definition of “Dietary Fiber” as it is disclosed on the NFP.

The new rule requires that only certain naturally occurring dietary fibers such as those found in fruits, vegetables and whole grains, and added isolated or synthetic fibers that FDA has determined have a physiological effect that is beneficial to human health, can be declared on the NFP under “Dietary Fiber.” Previously, fibers in foods could be labeled as dietary fiber without necessarily providing evidence of beneficial physiological effects.

Under the final NFP rule, a fiber ingredient that is “intrinsic and intact in plants” automatically meets FDA’s new dietary fiber definition. In addition to fiber that is naturally occurring in foods, the final regulation identifies seven isolated or synthetic non-digestible carbohydrates that, when added to foods, can be declared as “Dietary Fiber.” They are: [beta]-glucan soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)(A)), psyllium husk (as described in 21 CFR 101.81(c)(2)(ii)(A)(6)), cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose.

But other fibers that are “isolated” or “synthetic,” must gain FDA approval and show they have a beneficial physiological effect before they can be counted as “Dietary Fiber” on the NFP. Under the final rule, food manufacturers can submit petitions to FDA for approval of additional sources of “Dietary Fiber” with physiological benefits and many have done so already.

FDA reacted by publishing a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the NFP final rule.

The request for information, along with an accompanying draft guidance, is intended to help industry understand how FDA reviews the scientific evidence to determine whether other fibers beyond the seven identified in the final rule should be added to the regulations. It also provided an opportunity to add to or comment on FDA’s review of the science with respect to whether any of the 26 additional specific types of fiber provide a physiological effect that is beneficial to human health and thus should be included in the fiber definition. The comment period closed on February 13, 2017.

Some segments of the food industry remained unsatisfied. On April 7, 2017, the American Bakers Association (ABA) filed a petition urging the agency to revoke its new definition of “Dietary Fiber” for Nutrition Facts labeling purposes. Whether the ABA’s request will receive serious consideration remains to be seen.

On June 13, 2017, FDA’s Office of Nutrition and Food Labeling announced that it intends to extend the compliance date for the new Nutrition Facts rules. ABA praised the move. But how long the compliance date will be extended and whether FDA also will reconsider certain aspects of the regulation are unknown. FDA Commissioner Scott Gottlieb stated before a Senate Appropriations Sub-Committee hearing on June 20, 2017, “We are not reopening the regulation…We are just using this time to develop additional guidance documents.”

Whether industry dissatisfaction with FDA’s final regulation on the disclosure requirements for “Dietary Fiber” on the Nutrition Facts label will lead to a wholesale change in the agency’s approach, or merely the addition of a few more substances to its list qualifying as having beneficial physiological effects, remains to be seen. But some changes can be expected.

FDA Unveils Accredited Third-Party Certification Site

In one more step toward improved oversight of imported foods, FDA unveiled a new section of the FDA Industry Systems (FIS) websiteon June 21, 2017, to allow organizations – including foreign governments and agencies or private third-parties – to apply for recognition as third-party accreditation bodies under the FSMA voluntary Accredited Third-Party Certification program.

The accredited bodies will accredit third-party auditors, who can then conduct food safety audits of foreign food entities and issue certifications that qualify them for the Voluntary Qualified Importer Program (VQIP). Under VQIP, U.S. importers can use the certifications by foreign entities to secure expedited entry of food shipments.

The accreditation bodies will monitor the performance of the third-party auditors and submit reports to FDA. Third-party auditors accredited under the program must conduct unannounced facility audits, notify FDA of any serious public health risk, and must ensure that their agents are competent and objective.

The VQIP allows for two kinds of audits, regulatory and consultative, but only a regulatory audit can be used for certification. For regulatory audits, the auditor must submit an audit report to the FDA within 45 days of the audit.

Under fee-based VQIP, FDA may grant recognition to an accreditation body for up to five years.

Water Standards Delay

In another significant move last month, FDA announced that it plans to extend the compliance dates for agricultural water standards under the FSMA Produce Safety Rule, except in the case of sprouts. The agency is considering simplifying the standards, which have proved to be some of the most challenging to develop in the entire FSMA rulemaking process.

The agency said it remains committed to protecting public health while implementing rules that are “workable.” FDA said it will extend the compliance dates “using appropriate procedures at a later time.” It has not decided how long the extension will be. So, at least for now, that’s an indefinite delay.