How a product like mushroom gummies can fall through the regulatory cracks

Several people across the country have recently been hospitalised^[1] after consuming mushroom gummies distributed by Australian brand Uncle Frog and made in the United States. Their reported symptoms included^[2] elevated heart rate, nausea, anxiety and hallucinations.

This has prompted a product recall and warnings from local health authorities^[3] not to consume the gummies.

Two varieties are affected: Cordyceps and Lion’s Mane. The Cordyceps product purports to offer “natural energy and power”, while the Lion’s Mane variety “supports memory and focus”. Both fungal varieties are infused with hemp.

So what in these products could have made people sick? And how are they regulated in Australia?

Cordyceps and Lion’s Mane

The Cordyceps product claims to contain extracts of the fungus Cordyceps militaris^[4]. The Lion’s Mane product is based on the Hericium erinaceus^[5] species.

Both Cordyceps and Lion’s Mane have a long history of use in traditional medicine for improving mental function – in particular traditional Chinese medicine.

There’s increasing research interest and a very early but emerging body of evidence^[6] suggesting these mushrooms may have some positive effects on mood and cognition^[7]. My team at Southern Cross University are also researching the therapeutic potential of these ingredients, though our work is not published yet.

Both fungi are available as therapeutic products in Australia, either via the Australian Register of Therapeutic Goods^[8], which allows the sale of a variety of Cordyceps and Lion’s Mane products as complementary medicines, or via practitioner-only dispensing of dried products.

Neither of these fungi appear to be associated with the side effects reported among people who took the Uncle Frog’s mushroom gummies.

So why did people get sick?

The product also claimed to be infused with “Earth’s finest hemp”. Hemp is the term often used for a cannabis plant^[9] that contains a smaller amount of THC (the principal psychoactive component in cannabis) than recreational or medicinal marijuana.

While the distributor said the product had been tested^[10] to confirm there was no active THC present, many of those affected described symptoms consistent^[11] with excessive cannabis use.

One user even claimed THC had shown up on a drug test^[12] after they used the product.

This suggests to me the adverse reactions may have been due to the cannabis component, rather than the fungus component of the gummies – and that the cannabis component was stronger than use of the term “hemp” suggests.

But investigations are ongoing and more information will likely come to light in due course.

What are functional foods?

Cordyceps and Lion’s Mane are what we’ve come to call “functional foods^[14]”. These are essentially foods that are claimed to contain specific ingredients that may have certain health or disease prevention benefits.

This can be both in the form of unprocessed foods (for example, purple sweet potatoes^[15] have recently been in the spotlight for their antioxidant potential) or processed foods and beverages^[16] (for example, kombucha drinks).

The mushroom gummies would be an example of a highly processed functional food.

Functional foods are growing in popularity

As lines between medicines and foods increasingly blur, and consumers often prefer products that once came in tablets to come in edible forms such as gummies and powders, the regulatory situation becomes complicated.

The Therapeutic Goods Administration^[17] (TGA) regulates therapeutic goods – including natural products such as herbal medicines and nutritional supplements – for safety and quality. This means you can be confident what it says on the bottle is in the bottle, and it’s safe to consume. For most complementary medicines, the TGA doesn’t assess efficacy.

Meanwhile, Food Standards Australia and New Zealand^[18] (FSANZ) regulates foods. The rise of functional foods has brought a number of interesting new ingredients, often in new forms, to Australia. To ensure such products are appropriate to be sold as foods, FSANZ must approve these novel ingredients^[19].

FSANZ officially removed^[20] the gummies from legal sale because Cordyceps and Lion’s Mane are unapproved novel foods.

Food or medicine?

All this highlights the issue of quality control of products for sale in Australia, particularly imported products.

To help manufacturers (and the public) determine whether products should be marketed as foods or therapeutic goods, and therefore which regulatory body they should fall under, the Australian government has developed a Food-Medicine Interface Guidance Tool^[21].

However, public health experts have previously noted this tool can be confusing^[22] – particularly for products such as gummies – and can result in disagreement between regulators and public health experts.

Australia is seen as a world leader in the regulation of natural medicines – including assessment of overseas manufacturing facilities^[24] producing goods for the Australian market.

But perhaps it’s time to narrow the gap between foods – at least those making or implying broad therapeutic claims – and medicines. FSANZ is doing a lot of work^[25] to narrow this gap, but more is probably needed.

One part of this may be beefing up the regulation of functional foods as a category in its own right. Japan was the first country to use the term functional foods, and its Ministry of Health provides a regulatory pathway^[26] for that tricky middle ground between food and medicine.

What should you do?

If you happen to have any of the gummies in question, throw them away.

In terms of functional foods more broadly, I would refer to the following advice from Michael Pollan^[27], an American author who has written extensively on the topic: don’t eat anything your great grandmother wouldn’t recognise as food.

If you want to explore the potential power of fungi or plants in the form of natural medicines, seek out products regulated by the TGA^[28] (look for a number beginning with AUST L, AUST L(A) or AUST R on the package^[29]) or speak to a qualified health practitioner.

References

1. ^{^} recently been hospitalised (www.theguardian.com)
2. ^{^} symptoms included (www.health.nsw.gov.au)
3. ^{^} local health authorities (www.health.nsw.gov.au)
4. ^{^} Cordyceps militaris (www.ncbi.nlm.nih.gov)
5. ^{^} Hericium erinaceus (www.healthline.com)
6. ^{^} emerging body of evidence (www.sciencedirect.com)
7. ^{^} cognition (www.sciencedirect.com)
8. ^{^} Australian Register of Therapeutic Goods (www.tga.gov.au)
9. ^{^} cannabis plant (www.healthline.com)
10. ^{^} had been tested (www.abc.net.au)
11. ^{^} symptoms consistent (www.healthdirect.gov.au)
12. ^{^} shown up on a drug test (www.abc.net.au)
13. ^{^} IgorCheri/Shutterstock (www.shutterstock.com)
14. ^{^} functional foods (www.healthline.com)
15. ^{^} purple sweet potatoes (www.abc.net.au)
16. ^{^} beverages (www.news-medical.net)
17. ^{^} Therapeutic Goods Administration (www.tga.gov.au)
18. ^{^} Food Standards Australia and New Zealand (www.foodstandards.gov.au)
19. ^{^} novel ingredients (www.foodstandards.gov.au)
20. ^{^} officially removed (www.foodstandards.gov.au)
21. ^{^} Food-Medicine Interface Guidance Tool (www.tga.gov.au)
22. ^{^} can be confusing (theconversation.com)
23. ^{^} simona pilolla 2/Shutterstock (www.shutterstock.com)
24. ^{^} assessment of overseas manufacturing facilities (www.tga.gov.au)
25. ^{^} doing a lot of work (www.foodstandards.gov.au)
26. ^{^} provides a regulatory pathway (www.mhlw.go.jp)
27. ^{^} Michael Pollan (michaelpollan.com)
28. ^{^} regulated by the TGA (www.tga.gov.au)
29. ^{^} on the package (www.tga.gov.au)