The Natural Products Association is seeking greater clarity on the labeling of fungal dietary supplements.

Hank Schultz, Senior Editor

August 17, 2023

3 Min Read
Reishi mushrooms

The Natural Products Association (NPA) has joined the chorus of voices asking for mushroom labeling to be clarified to distinguish products made only from the fruiting bodies from those that include the mycelium.

NPA filed a citizen petition last week with the Food and Drug Administration. It asks that FDA amend the Federal Food, Drug and Cosmetic Act to incorporate mushroom products identity principles laid out in a guidance put out by the American Herbal Products Association (AHPA). Alternatively, NPA requests FDA issue a labeling guidance of its own, and exercise enforcement discretion in the meantime.

When is a mushroom a mushroom?

The issue revolves around the definition of what can be called a “mushroom.” Fungi typically have a threadlike portion of the organism called the mycelium that digests organic material, whether it be wood, humus on the forest floor or in the soil. In commercial operations, this is usually wood pulp or grain or a mixture of the two, while other products are grown in liquid media.

The other portion of the organism is the fruiting body, which is what many consumers might understand when using the term “mushroom.”

Proponents of the fruiting-body-plus-mycelium approach claim that labeling these products with the species name of the fungi in question along with the word “mushrooms” adequately describes what consumers are purchasing.

Related:Mushroom primer part II: Nammex on FDA petition, full spectrum products

Companies that use only the fruiting bodies themselves­­—whether grinding these whole for powders or using them as the basis for extracts—counter that the concentration of bioactive material is far higher in their products. 

They maintain products that include mycelium are less potent and should not be compared with their products. However, they contend labeling practices in the market make it difficult for consumers to make that distinction.

The AHPA guidance recommends that when the word “mushroom” is used alone in an ingredient panel, that should mean the fruiting bodies only.  Products that contain more of the organism should spell that out. The guidance uses this example: “reishi mushroom composite (mycelium, fruitbody, spores).”

“Mushroom dietary supplements are extremely innovative and as the business grows, require a standard nomenclature,” said Daniel Fabricant, Ph.D., president and CEO of NPA in a statement accompanying the filing of the citizen petition.

“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,” he added.

In an interview with Natural Products Insider, Fabricant said evolving market conditions make the time right to address mushroom labeling questions.

“If you look across the landscape, you see how much more important fungal components are becoming,” he said. “And there has also been the counterfeiting problem on Amazon.”

Mushroom primer

One company that has advocated for this labeling approach for years is Nammex, which pioneered the production of organic mushrooms in China. Nammex founder Jeff Chilton said he believed that was the way to get high-quality, fruiting-body-only products into the hands of American consumers at a reasonable price.

Bill Chioffi, Nammex’s chief strategy and innovation officer, recently wrote a two-part article for Natural Products Insider that laid out the major issues surrounding mushroom product labeling.  (Those articles can be accessed here and here).

Mycelium question already appears in regs

FDA has already weighed in on the mycelium question, via a regulation issued first in 1976 and amended twice since then. The regulation states: “[M]ushroom mycelium has an identity different from mushrooms, and food products in which it is used should be labeled to clearly indicate that they contain mushroom mycelium.”

But Fabricant said supplement labeling questions differ in some respects from straight food products, which the above regulation was originally written to address.

“We want to make sure all the parts of the fungus are defined and represented in the regulation,” he said.

Fabricant admitted that a citizen petition is unlikely to get FDA to move on the issue, especially considering the agency’s impending reorganization of its food programs.

“But with the growth of the category, we need to get the question out there,” he explained. “It helps raise awareness.”

About the Author(s)

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the senior editor of Natural Products Insider since early 2023. He can be reached at [email protected]

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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