Pullulan can be used in “made with organic” tablets and capsules, USDA final rule states

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Pullulan, a natural polysaccharide used to make vegan and vegetarian dietary supplement capsules, has officially been added to USDA’s list of ingredients that can be included in organic products in the U.S. Products containing pullulan can be labeled as “made with organic [specified ingredients or food groups].”

The news was reported by the American Herbal Products Association (AHPA; Silver Spring, MD), which has actively submitted past comments to USDA urging the addition of pullulan to National List of Allowed and Prohibited Substances section (“National List”) of USDA’s organic regulations.

Pullulan was not, however, listed as an agricultural substance. Other nonagricultural ingredients on the National List include citric acid, xanthan gum, and gellan gum. Specifically, pullulan is included on the list of nonagricultural, nonsynthetic substances. As such, a product containing pullulan can only be listed as being “made with” organic ingredients, but the product cannot state that it is “organic” or “100% organic.”

“Products labeled ‘organic’ or ‘100% organic’ cannot contain nonorganic pullulan as an ingredient under this final rule,” the Federal Register states.

This regulatory development is important, as AHPA’s press release notes that pullulan, which is excreted by the yeast-like fungus Aureobasidium pullulans, is commonly used today to manufacture dietary supplement tablets and capsules; moreover, it is the only nonsynthetic substance available for creating vegetarian dietary supplement capsules certified under USDA’s National Organic Program. As the Federal Register amendment states, “Nonorganic forms of pullulan are necessary because organic forms of pullulan are not readily available.”

The text further states that “the substance is not harmful to human health or the environment; is necessary to production because of the unavailability of wholly natural substitute products; and is consistent with organic farming and handling.”

A petition to add pullulan to the National List was first filed in January 2018, with the National Organic Standards Board recommending its addition in April 2019. “In its recommendation, NOSB noted that there are few, if any, other encapsulation options available compliant with organic composition requirements…for consumers seeking a suitable alternative to gelatin for religious and dietary requirements (e.g., vegan, halal, kosher.)”