FDA Petitions Target Labeling Misrepresentation in the Mushroom Supplement Industry

Not all mushroom products are created equally, and many are beginning to take notice. The boom of the medicinal mushroom industry has led to conflicting views about what is actually considered a “mushroom product.” The U.S. Food and Drug Administration (FDA) has recently received two separate citizen petitions to clarify the information on the labels of functional mushroom products and supplements. The petitions recognize that many supplements claiming to contain mushrooms may not accurately represent the actual composition of the products, which could potentially mislead consumers. 

Urging the FDA to amend supplement labeling regulations

On June 7th, Nammex, a supplier of functional mushrooms, submitted a citizen petition to the FDA. In their petition, they requested the administration to ensure that supplements or food products containing fungal ingredients are appropriately labeled. Specifically, they want the labels to indicate whether the product contains the actual fruiting body of the fungus or just the mycelium stage.

Additionally, Nammex has requested that these products “disclose the presence of any substrate on which the fungal ingredient is grown, to prevent deception and fraud in the marketplace, protect consumers from economic and other potential harm, and restore a level playing field for businesses operating in this sector.”

Nammex argues that this mislabeling problem is widespread in the supplement and functional food industries, as many companies inaccurately label their products as if they contain mushrooms when, in reality, they only include mycelium along with the filler grain substrate that the mycelium grows upon.

Similarly, the Natural Products Association (NPA) has followed suit, filing a closely related citizen petition on August 8th. In their petition, the NPA urges the FDA to update the labeling regulations and incorporate aspects based on the American Herbal Products Association (AHPA).

According to the AHPA’s guidelines, supplements containing fungi dietary ingredients should include all of “the stage(s) of the fungi present or, in the case of an extract, the stage(s) of the fungi from which the extract was manufactured. Parts may include, for example, fruitbody; mycelium; sclerotium; spores; etc.” Additionally, other ingredients, such as the fungal substrate, must be labeled, and the product should only use the term “mushroom” if it contains the actual fruiting body of the fungus.

Difference between fruiting body and mycelium products

Many functional mushroom supplements resort to deceptive marketing tactics, suggesting that they contain the genuine fruiting bodies of functional fungi. In reality, fungi undergo various growth stages, and any of these stages can be utilized in supplements and labeled as the functional mushroom they originate from, despite not containing any real mushrooms to begin with.

Mycelium is a root-like, threaded structure of a fungus that grows in a substrate, while mushrooms are the more recognizable external fruiting body of a fungal organism. Since mycelium grows easier and faster than fruiting bodies, it’s commonly used in many functional mushroom supplements. And although both fungal growth stages contain beneficial compounds, many functional mushrooms have significantly higher amounts of these compounds compared to their mycelium.

One of the most noteworthy compounds found in medicinal mushrooms is beta-glucans which have various health benefits such as antioxidants, cholesterol management, and immune-boosting properties. Several studies have found that the fruiting bodies contain significantly higher amounts of these compounds than the mycelium. According to Jeff Chilton, founder of Nammex, mushrooms have around 30-40% of beta-glucans on average. In comparison, grain-grown mycelium usually has about 5-7%.

Still, mycelium from some medicinal mushrooms has compounds not found in the fruiting body. Consider the case of lion’s mane, a popular mushroom known for its neuroprotective properties. The medicinal mushroom contains two primary compounds, hericenones and erinacines. Both compounds work together to support the growth of neutrons in the brain. Hericenones can be found in the fruiting body of lion’s mane, while erinacines are located in the mycelium. In cases like this, the addition of mycelium is necessary for a full-spectrum mushroom extract. 

Unfortunately, many supplements that use mycelium in their products do not use pure mycelium. Since mycelium grows within a substrate like rice or other grains, it is typically processed alongside this substrate, resulting in a supplement laden with starch and diminished nutritional value.

Ensuring labeling transparency in mushroom products

The FDA plays a significant role in ensuring the safety and quality of consumable products, such as supplements. The issue of mislabeling within the functional mushroom industry has prompted calls for regulatory intervention.

The separate parts of a mushroom’s growth stage can have differing health benefits, but it is necessary for mushroom brands to properly label their products so that consumers are aware of what’s truly in them. Furthermore, as the citizen petitions argue, the substrate fillers should be clearly marked in the ingredients for full transparency and to alert consumers of any potential allergens that may be in their products. 

In 1976, the FDA created a policy to clearly label and identify the difference between mushrooms and mycelium in food products. The regulation has been amended twice since. However, the regulation does not identify all parts of the fungus, nor does it apply to dietary supplements.

Chilton is adamant that “When consumers buy a product labeled as ‘mushroom,’ they should feel confident that they are getting a genuine mushroom product.” However, industry attorney Marc Ullman is unsure whether the FDA will approve these kinds of petitions. “Unfortunately, it seems FDA views [citizen] petitions as an annoyance rather than something that deserves serious attention, regardless of the subject,” Ullman admits in an interview. “I would expect this to be no different.”

President and CEO of the NPA, Daniel Fabricant, Ph.D., has also admitted doubt that the FDA will go through with approving these requests since the FDA is prioritizing the reorganization of the dietary supplements program.

Nonetheless, Nammex and the NPA hope that the petitions will at least spread awareness towards the subject and eventually lead to change within the mushroom supplement industry. The FDA has 180 days to respond to the petitions.