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FDA declines to act on Nammex mushroom labeling petition

A citizen petition from mushroom ingredient supplier Nammex that sought clarifications on fungi product labeling has received the standard non-response from the Food and Drug Administration.

Hank Schultz

December 8, 2023

3 Min Read

At a Glance

  • Mushroom supplier Nammex had petitioned FDA for clarifications on rules regarding fungi product labeling.
  • The company says mushroom product labels should list the parts – fruiting body, mycelium, or spore – that are in the bottles.
  • FDA has declined to act on the petition, saying it has other priorities.

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. 

 

 

About the Author(s)

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the Senior Editor of Natural Products Insider since early 2023. 

Prior to joining the Informa team he was an editor at NutraIngredients-USA, a William Reed Business Media publication.

His approach to industry journalism was formed via a long career in the daily newspaper field.  After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors.  The newspaper won two Pulitzer Prizes during his time there.

The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.

Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.

In 2015, Hank was recognized by the American Herbal Products Association with a Special Award for Journalistic Excellence.

When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking, and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.

Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.

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