As previously covered on the blog, FDA published a final rule on revisions to nutrition labeling requirements on May 27, 2016.  The final 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 – may be declared on the label under “Dietary Fiber.”  Prior to the issuance of this rule, fibers in foods could be labeled as dietary fiber without necessarily providing physiological effects that are beneficial to human health.  Naturally occurring fibers contained in foods have already been determined to have physiological benefits.  In addition to fiber that is naturally occurring in foods, the rule identified 7 fibers that, when added to foods, could be declared as “dietary fiber.”

Today, FDA issued 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 Nutrition Facts label final rule. The Agency has also issued draft guidance. This guidance document explains the Agency’s current thinking on information needed when submitting a citizen petition and the scientific review approach the Agency plans to use for evaluating scientific evidence to determine whether an isolated or synthetic non-digestible carbohydrate that is added to food has a physiological effect that is beneficial to human health.

FDA will formally publish and begin accepting comments on its request for scientific data, information and comments and the accompanying draft guidance tomorrow, November 23, 2016.  With respect to the draft guidance, the Agency notes that comments received within the first 60 days will be considered in the development of the final version of the guidance.  With respect to the Agency’s request for scientific data, information and comments, the Agency will be accepting comments within 45 days from its publication in the Federal Register.