FDA declines to act on Nammex mushroom labeling petition

The U.S. Food and Drug Administration has deferred action on a citizen petition filed by mushroom supplier Nammex that sought changes to how fungi ingredients are labeled. 

In a letter addressed to Nammex founder Jeff Chilton that was dated Nov. 30, Cara Welch, Ph.D., director of FDA’s Office of Dietary Supplement Programs (ODSP), wrote that “we have not reached a decision on your petition within the first 180 days due to competing agency priorities. However, be advised that our staff is evaluating your petition.” 

Nammex (North American Reishi Ltd.) manufactures its fungal ingredients exclusively from fruiting bodies of fungi that are grown in facilities in China.  

In botanical ingredients, depending on the species, different parts of the plant may be used to manufacture the final product. Some plants might express their important bioactives only in their roots, or in their aerial parts, for example. 

Nammex: Labels should spell out fruiting body, mycelium, spores

In fungi, Nammex maintains, the bioactives are concentrated in the fruiting bodies, which is why the company maintains specific labeling is called for. (It’s worth noting that other fungal product suppliers don’t agree and argue no scientific consensus exists on the subject.) 

In the petition, which was filed on June 7, 2023, Nammex wrote that while an FDA regulation (21 C.F.R. § 101.4(h)) requires listing part of the plant from which a dietary ingredient originates, “the regulation is silent with respect to the requirement to list the ‘part’ e.g., ‘mushroom,’ ‘mycelium,’ [or] ‘spore’ from which a fungal ingredient is derived.”  

“Nammex believes this lack of clarity in the regulation has created confusion in the marketplace and opened the door for the deceptive marketing of dietary supplements containing ingredients from fungi,” the citizen petition added. “Thus, FDA should amend the cited dietary supplement labeling regulations to expressly mandate that the part of the fungus from which a fungal ingredient is derived must be listed on dietary supplement labels, along with the common or usual name of the fungus from which the fungal part is derived, as is expressly required for herbs and botanicals.” 

FDA's standard response: No action will be taken

Per its regulations, FDA must respond to citizen petitions within 180 days. However, the response that Nammex received seems to be the standard reply, namely, that the agency has other, more important work to do. 

In a Nov. 2, 2023 letter addressed to Steve Mister, president and CEO of the Council for Responsible Nutrition, Welch used the same boilerplate language to inform CRN that no decision had been reached immediately on its petition due to "competing agency priorities" and that FDA staff is "evaluating" the petition.

CRN has sought some changes to FDA's interpretation of the so-called drug exclusion clause and the “race to market” that it has created, which is a factor in determining if a new ingredient may be marketed as a supplement or must be sold exclusively as a pharmaceutical.