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FDA Announces Citizen Petition to Grant Fiber Status to IMO

  • As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulation. The final rules regarding nutrition labeling established a definition for the term “dietary fiber.” In March 2018, FDA published final guidance on dietary fiber that communicated the Agency’s revised standard of review of the scientific evidence that shows non-digestible carbohydrates (NDCs) have a beneficial physiological effect on human health. Then, as previously reported on this blog, FDA announced on June 15, 2018, that it had responded to five citizen petitions requesting that additional NDCs be added to the definition of “dietary fiber,” including one for isomaltooligosaccharides (IMOs), which the Agency denied. (FDA did grant fiber status to three of the substances that were the subject of those Citizen Petitions.)

  • FDA received a Citizen Petition on March 4, 2019, from Top Health Ingredients, Inc., requesting that IMO be included within the list of dietary fibers identified in 21 C.F.R. §101.9(c)(6)(i). The petition identifies IMOs as glucose oligomers that contain D-(1,6)-linkages and cites two requirements for including IMO within the list of  “dietary fibers.

    • The food substance must be composed of isolated or synthetic non-digestible carbohydrates with 3 or more monomeric units and

    • The food substance must be the subject of a petition submitted to FDA under 21 C.F.R. §10.30 demonstrating that such carbohydrates have a physiological effect that is beneficial to human health.

  • The petition continues to explain how IMO satisfies both of those requirements. The beneficial physiological effects cited are reductions in blood cholesterol concentrations and improved laxation. More information on the petition, including how to comment, can be found here.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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