Nammex files Citizen Petition requesting FDA to revise labeling regulations for mushroom products to increase transparency

Shiitake mushrooms. Photo © AdobeStock.com/NORI26

North American Reishi Ltd. (Nammex; Gibsons, BC, Canada) has announced filing a Citizen Petition with the U.S. Food and Drug Administration (FDA). According to a press release from the company, the petition asks the Agency “to address the mislabeling of dietary supplements and functional foods as ‘mushroom’ or containing ‘mushrooms’ when they contain other fungal parts, and do not contain ‘mushrooms’ as claimed, or fail to disclose added grain ingredients.”

“Given the explosive growth the mushroom category is undergoing and entry of new companies marketing products with fungal ingredients that may not be aware of the regulatory requirements, it made sense to undertake this action now. We hope to raise awareness of the mislabeling problem that exists today in the U.S., and obtain FDA regulatory guidance on the labeling of mushrooms and other fungal ingredients to ensure truth-in-labeling,” said Jeff Chilton, founder of Nammex, in a press release.“When consumers buy a product labeled as ‘mushroom,’ they should feel confident that they are getting a genuine mushroom product.”

“Citizen Petitions provide a public forum through which interested parties can request FDA to issue or amend a regulation or take other administrative action,” explained Nammex’s regulatory counsel, Holly Bayne of the Law Office of Bayne & Associates, in a press release. “As the petition has made clear, remedial action from FDA is warranted, including revisions to the Agency’s compliance policies to ensure foods and dietary supplements containing fungal ingredients are accurately labeled and not misbranded.We look forward to engaging with FDA on this important issue.”

In Nammex’s view, this is about label transparency. Part of problem, says the company, are the limitations of FDA’s current labeling regulations and compliance policy. For example, the Citizen Petition explains that FDA’s dietary supplement labeling regulations do not require dietary ingredients derived from fungi to be identified by their fungal parts. Therefore, the company requests that FDA revise 21 C.F.R. § 101.4 (h) of the Food, Drug, and Cosmetics Act to revise this ambiguity.

In the petition, Nammex is also critical of a compliance policy guide published by FDA in 1988 that allows manufacturers to use the term “mushroom mycelium.” While the guide acknowledged at the time that mycelium is distinct from mushrooms, Nammex argues that the distinction is not sufficiently clear when using this language, nor does it offer much transparency to the consumer. As such, Nammex suggests that the guidance be revised and reissued to clarify the distinction, and change the policy to require manufacturers to identify the specific fungi the mycelium is from, ie. “shitake mycelium” or “reishi mycelium.”