In a Citizen Petition submitted to the U.S. Food and Drug Administration (FDA) on August 9, the Natural Products Association (NPA) requested that FDA:

• Amend 21 C.F.R. § 101 to incorporate labeling aspects based on the American Herbal Products Association’s (AHPA) labeling guidance for mushrooms; and/or
• Commit to exercising enforcement discretion until the Agency provides guidance or publishes a regulation concerning a standard of identity for dietary supplements or ingredients from fungal ingredients, including mushrooms, mycelia and fruiting bodies.

“Mushroom dietary supplements are extremely innovative and as the business grows, require a standard nomenclature,” said Daniel Fabricant, PhD, president and CEO of NPA. “By requesting that the FDA incorporate AHPA’s labeling guidelines or exercise enforcement discretion until the Agency publishes its own standard of identity regulation, we aim to protect domestic farmers who continue to be economically harmed by foreign entities damaging the credibility of this evolving market.”

NPA has also filed citizen petitions to the FDA on NAC and NMN.

For more information, visit www.npanational.org.