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The Natural Products Association (NPA) has submitted a citizen petition to the U.S. Food and Drug Administration (FDA) regarding dietary supplement labeling of fungal ingredients. The petition seeks amendments to federal labeling regulations that would largely integrate the contents of the American Herbal Products Association (AHPA) 2017 guidance policy on the labeling of dietary supplements containing fungi dietary ingredients.
All regulatory revisions proposed in the NPA citizen petition are identical to the recommended labeling practices described in the AHPA guidance policy, with the addition of a statement that the definition of “mycelium biomass” should be permitted to reflect the “combination of the mycelium grown on a solid substrate and any remnant of the myceliated substrate still present,” and to say that spores naturally present in a fruitbody do not need to be identified as a separate part unless added as a stand-alone ingredient. The NPA citizen petition also seeks an FDA policy of enforcement discretion on fungal dietary ingredient labeling until the relevant regulations can be modified.
“AHPA is pleased to be acknowledged in this citizen petition for the good work we completed in 2017, with broad industry input, to provide a self-regulatory framework for accurate labeling of dietary supplements containing fungi dietary ingredients,” said AHPA President Michael McGuffin. “As this important segment of the marketplace continues to grow, we encourage wide adoption of this AHPA guidance policy to establish consistent product labeling that clearly informs consumers.”
FDA has 180 days to respond to the NPA petition. AHPA has previously reported on a citizen petition submitted by Nammex requesting FDA actions on labeling of foods and dietary supplements containing fungal ingredients, and on an open letter published in response to that petition by Fungi Perfecti, along with M2 Ingredients Inc., Gourmet Mushrooms, Inc., and Monterey Mushrooms Inc.
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