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The proposed allowance applies to pullulan's use in tablets and capsules of dietary supplements.
August 12, 2020
By: Mike Montemarano
The American Herbal Products Association recently supported a proposal being made by the U.S. Department of Agriculture (USDA) which would allow manufacturers to use pullulan, a widely-used food additive, in tablets and capsules of dietary supplements labeled organic. Pullulan was declared to be a safe ingredient by the FDA in 2002. In a letter to the USDA’s Agricultural Marketing Service (AMS) AHPA supported the rule—proposed on June 8, 2020—which would amend the national list of allowed and prohibited substances within USDA’s organic regulations. The substances which are pending approval for use in organic supplements were originally submitted to the Secretary of Agriculture by the National Organic Standards Board. AHPA’s membership includes numerous companies which offer herbal products certified under the USDA’s National Organic Program, including products that contain pullulan. While pullulan is a non-organic ingredient, it is widely used in the handling of active, organic ingredients in dietary supplements. “Pullulan has long been included as an ingredient in encapsulated dietary supplement products certified as organic in compliance with the NOP, on the basis of accredited certifying agent’s previous identification of pullulan as agricultural,” Michael McGuffin, AHPA president, wrote. “Interpretations of NOP’s Guidance on Classification of Materials as issued in December 2016, however, suggested pullulan instead be classified as a nonagricultural substance, necessitating its addition to the National List at 7 CFR § 206.605. The addition of pullulan to the National List will therefore maintain the status quo and allow dietary supplement products in tablet and encapsulated forms that include pullulan to continue to be labeled, “Made with organic (specified ingredients or food group(s)).” Pullulan appears in dietary supplements with organic botanical ingredients including liquids, such as tinctures and extracts, as well as solid forms, such as teas, tablets, and capsules. Pullulan also offers an alternative to animal-sourced gelatin in capsules, making it a viable vegetarian option.
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