Gibsons, BC, Canada–North American Reishi Ltd (Nammex) has filed a Citizen Petition with the Food and Drug Administration (FDA). At issue, according to a press release: Nammex is requesting that the agency "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."   

Outlining its reasoning, Nammex said it has been advocating for full transparency in product labeling and urging companies to identify ingredients from fungi according to the part of the fungal organism from which they are derived. This, Nammex said, is consistent with FDA’s labeling requirement for botanicals, yet the company added that there is ambiguity in FDA’s labeling regulations and compliance policies. Looking to address this, Nammex Founder Jeff Chilton opted to file the petition in an effort to raise public awareness, request guidance, and secure increased attention from FDA to ensure industry compliance.

“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," Chilton said. "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. When consumers buy a product labeled as 'mushroom,' they should feel confident that they are getting a genuine mushroom product.” 

Nammex's Citizen Petition asks FDA to:

  • Correct ambiguity in the dietary supplement labeling regulations to clarify that proper listing of ingredients from fungi on product labels includes identification of the part of the fungal organism from which the ingredient is derived.  
  • Issue industry guidance regarding the proper labeling of fungal ingredients, including a Glossary of Mycological terms.  
  • Increase regulatory enforcement to ensure foods and dietary supplements containing fungal ingredients are accurately labeled.
  • Take appropriate action against products labeled as “mushroom” when they do not contain mushrooms as claimed, but contain other fungal parts, such as mycelium, and fail to identify the presence of grain in the product.  

Competitors Respond to Nammex Citizen Petition

The makers of Host Defense Mushrooms, Fungi Perfecti, LLC, along with M2 Ingredients Inc., Gourmet Mushrooms, Inc., and Monterey Mushrooms Inc., jointly issued an open letter response to the petition. Their goal: To express a show of unity to "emphasize the importance of conveying scientifically accurate information to the public, to FDA, and to other thought leaders in the field."

Calling the stance put forth in the Citizen's Petition a "puzzling opinion," these companies maintained that Nammex petition "obfuscates and misrepresents the use of well-established mycological definitions that impact responsible consumer messaging about mushroom products."

The letter, signed by Paul Stamets, Member & Founder, Fungi Perfecti, LLC, David Law, CEO, Gourmet Mushrooms, Inc., and Steve Farrar, President, M2 Ingredients, Inc., takes specific issue with the idea of eliminating use of the word "mushroom" for products using mushroom mycelium. According to a press release from Fungi Perfecti: "This is both confusing and concerning as the collective industry use of 'mushroom mycelium' is scientifically accurate, just as the use of 'mushroom spores,' 'mushroom fruit bodies' are descriptively accurate. The word 'mushroom' describes the organism as a whole, whereas terms like 'mycelium' and 'fruit body' refer to distinct parts of the mushroom organism. This is perfectly parallel to saying 'plant roots,' 'plant seeds/spores,' and 'plant flowers.' Both sets of terminologies describe the parts of the organism. To propose the elimination of the word 'mushroom' results in confusion and misdirection."

In his response to the Citizen Petition, Stamets said, "As mycologists, scientists, and industry experts, we are concerned by the public confusion being created and spread by this Citizen Petition about widely accepted and settled terminology, and are moved to collectively write this open letter in response so that industry policies will be grounded in scientific accuracy. This is critical for clear and sound regulations. We advocate for truth and scientific accuracy in labeling. In our opinion, the proposals being advocated by Nammex in their Citizen Petition do neither."

What's next?

Holly Bayne, Nammex's regulatory counsel, of the Law Office of Bayne & Associates, said, “Citizen Petitions provide a public forum through which interested parties can request FDA to issue or amend a regulation or take other administrative action. 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.”  
The FDA has 180 days to respond to the Nammex Citizen Petition. Nammex said it intends to keep the industry informed throughout the process.

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