FDA yet to come to decision on Nammex citizen petition

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The U.S. Food and Drug Administration (FDA) has issued a response to a citizen petition filed by Nammex (Gibsons, BC, Canada) asking the agency to correct what the company calls ambiguity in dietary supplement labeling regulations by having companies list ingredients from fungi by fungal part and the specific fungi it was derived from. FDA’s response does not address the company’s concerns. Rather, the response advised Nammex that FDA has not come to a decision in the required 180 days “due to competing agency priorities,” but that the staff is evaluating the petition.

“The FDA has 180 days to respond to this type of Citizen Petition and may approve, deny, ordismiss the petition, or provide an interim response indicating why the agency has not reached a decision, which is often due to competing agency priorities,” said Holly Bayne of the Law Office of Bayne & Associates, Nammex’s regulatory counsel, in a press release. “We are pleased that FDA staff within the Office of Dietary Supplement Programs are continuing to evaluate the petition.”

“We understand that the agency has its hands full with the reorganization of the Human Foods Program and look forward to further engagement with FDA and a positive decision in 2024, especially given the rapid growth of the mushroom product category,” said Skye Chilton, CEO of Nammex, in a press release.“As a recent survey of 10,000 people on mushroom terminology we commissioned showed, the vast majority of consumers have a very clear understanding of what constitutes a mushroom, and it’s the cap (and stem), not myceliated grain.”

To learn more about the debate around how mushrooms should be labeled, click here