FDA Issues 180-Day Interim Response to Citizen Petition

Nammex, the premier North American supplier of Certified Organic Functional Mushroom Extracts, has received an interim response from FDA to the Citizen Petition the company filed in June requesting 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.

“The FDA has 180 days to respond to this type of Citizen Petition and may approve, deny, or dismiss 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. “We are pleased that FDA staff within the Office of Dietary Supplement Programs are continuing to evaluate the petition.”

Nammex filed the Citizen Petition advocating for full transparency in product labeling and urging companies in the industry to identify ingredients from fungi according to the part of the fungal organism from which they are derived, consistent with FDA’s labeling requirement for botanicals. The issues Nammex raised in the Citizen Petition have been discussed in the trade press, at conferences and trades shows, and even covered by Rolling Stone magazine.

“We understand that the agency has its hand 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. “As a recent survey of 10,000 people on mushroom terminology we commissioned showed, the vast majority of consumers have a specific idea of what constitutes a mushroom, and it’s the cap (and stem), not myceliated grain.”

The petition asked 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. Nammex also requested that FDA issue industry guidance regarding the proper labeling of fungal ingredients, including a Glossary of Mycological terms. Further, Nammex requested that FDA increase regulatory enforcement to ensure foods and dietary supplements containing fungal ingredients are accurately labeled, and take appropriate action against products labeled as “mushroom” that actually contain other fungal parts, such as mycelium, and fail to identify the presence of grain in the product.