Functional mushroom ingredient provider Nammex has caused a commotion in the nutraceutical industry.
In the citizen petition to the FDA, Canada-based North American Reishi operating under the name Nammex, requested the agency take action to "ensure dietary supplements and other food products containing ingredients from fungi are properly labelled to identify the fungal part/growth stage of the ingredient, and disclose the presence of any substrate on which the fungal ingredient is grown".
The petition, sent by Nammex owner Jeff Chilton, says that he is taking this action 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.
Mushroom vs mycelium
The issue really comes down to the matter of nomenclature.
Currently, the FDA's compliance policy guide (CPG) uses the term "mushroom mycelium" to describe any fungi product submitted to it. Whereas Nammex argues these are in fact two different parts of the fungi and should be differentiated.
Mushroom – The term “mushroom” describes the above-ground, fleshy fruiting body of a fungus. Mushrooms are produced from mature mycelium when environmental conditions are suitable. Mushroom is the fungal part or stage that produces spores and is commonly eaten as nutritious food
The mycelium, as a whole, is the non-reproductive, vegetative part of the mushroom found in soil or other organic matter, that precedes the "fruiting body" which is the mushroom.
In simple terms, Mycelium is a growth stage of the fungi that comes before the mushroom. The makeup of which differs.
The Canadian company argues that this creates ambiguity in the regulations and can cause issue for the consumer. The example given is that you wouldn't call a soup made with mycelium "mushroom soup".
Mycelium – “Mycelium” is a network of hyphae, the fine thread-like filaments that grow within and around their food source, e.g., woody debris, soils, grasses, other organic matter. Mycelium is considered the vegetative body of the fungus and has a different identity and chemical profile than “mushroom”
As a way of addressing this, Nammex suggests that the FDA provide a glossary of terms relevant to fungal ingredients. The suggested glossary would include Spores, Hypha, Mycelium, Primordia, Mushroom, Spawn, Grain spawn, and Myceliated grain.
Adulteration
The other angle to the petition, is the clarification on growth substrate of the fungi.
Nammex argues that the specific grain should be disclosed on supplement labelling as it is often mixed into the final product.
Without this disclosure, Nammex believes products would be deemed misbranded and adulterated, as they fail to disclose a "valuable constituent".
Many new companies are looking to quickly and economically scale up the production of these ingredients
Nammex has announced that through third-party analytical labs, it has discovered the extent of this misrepresentation in the exploding functional mushroom market.
"Sample testing of dietary supplements purchased from the US market demonstrates significant differences in chemical composition among products all claiming to contain “mushrooms”," the company explains.
It reveals that many products labelled as “mushrooms” are: (i) deficient in β-(1-3)(1-6)-glucans (“beta-glucans”), the bioactive and predominant of the polysaccharides in fungi, and (ii) high in starch – a component that is not found in mushrooms, but is found in grain substrates.
Nammex has been working with analytical labs for decades as part of its internal quality system. In a LinkedIn post, it explains that it is continuing to develop advanced analytical techniques such as Nuclear Magnetic Resonance (NMR) to understand these materials through metabolomics, non-targeted analysis, and complete chemical profiling. "We're proud to partner with Purity-IQ using their NMR technology and look forward to more work in the future," the post added.
Now we wait...
The submission of this document has set the clock running, and the FDA has now got 180 days to respond to the petition.
A decision may take even longer, however, as the FDA can respond with further information requests.
With the pandemic catalysing an explosion in the functional mushroom industry, many new companies are looking to quickly and economically scale up the production of these ingredients.
Nammex says these companies are not fully informed on the legal labelling requirements and this is causing "unfair competition" and "other harms insofar as consumers may not be getting genuine mushroom products".