NPA files citizen petition requesting action on the labeling of dietary supplements containing mushroom ingredients

Shiitake mushrooms. Photo © AdobeStock.com/NORI26

The Natural Products Association (NPA; Washington, D.C.) has submitted a citizen petition to the U.S. Food and Drug Administration (FDA), requesting the agency to “amend 21 C.F.R. § 101 to incorporate the following labeling aspects, primarily based on the American Herbal Products Association (AHPA) labeling guidelines/guidance, for mushrooms and/or (2) commit to exercise enforcement discretion until the Agency provides guidance or publishes a regulation concerning a standard of identity for ingredients and supplements derived from any multicellular fungal species, along with the terms ‘mushroom,’ ‘mycelia,’ and ‘fruiting bodies,’ and their combinations and associated constituents.”

NPA explains in its petition that clarity is needed regarding the nomenclature and declaratory guidelines of dietary supplements derived from multicellular fungal species given the increasing public interest in mushroom products and ingredients. “Mushroom dietary supplements are extremely innovative and as the business grows, require a standard nomenclature,” said Daniel Fabricant, Ph., president and CEO of NPA, in a press release. “By requesting that the FDA incorporate AHPA’s labeling guidelines or exercise enforcement discretion until the Agency publishes its own standard of identity regulation, we aim to protect domestic farmers who continue to be economically harmed by foreign entities damaging the credibility of this evolving market.”

In June, North American Reishi Ltd. (Nammex; Gibsons, BC, Canada) submitted a citizen petition of its own, requesting the agency to amend labeling requirements to reduce the ambiguity and mislabeling the company says is present in the marketplace. There does, however, appear to be some disagreement about how mushroom ingredients should be labeled. Following the citizen petition from Nammex, other stakeholders in the mushroom industry signed an open letter critical of suggestions Nammex makes for how these products should be labeled. For example, Nammex argues in its petition that products made from mushroom mycelium should not be labeled as “mushroom” and that the term “mushroom mycelium” is not an accurate description of fungal ingredients as they are two separate parts of the fungi. The open letter disputes this and states that the company’s position, “obfuscates the use well-established mycological definitions.”

The stakeholders did however agree with Nammex that product labels should disclose the fungal part/growth stage of the mushroom ingredient. This is in line with AHPA’s guidance and what NPA is advocating for in its citizen petition.