How a product like mushroom jelly can fall through the cracks of regulation

Several people across the country were recently hospitalized after consuming mushroom gummies distributed by Australian brand Uncle Frog and manufactured in the United States. Their reported symptoms included rapid heart rate, nausea, anxiety and hallucinations.

This resulted in the product being withdrawn from sale and local health authorities issuing warnings not to consume the gummies.

This applies to two varieties: Cordyceps and Lion’s Mane. The Cordyceps product claims to offer “natural energy and power,” while the Lion’s Mane variety “supports memory and concentration.” Both varieties of mushrooms are infused with cannabis.

So what in these products could be making people sick? And how are they regulated in Australia?

Cordyceps and lion’s mane

The Cordyceps product claims to contain extracts from the Cordyceps militaris mushroom. The Lion’s Mane product is based on the species Hericium erinaceus.

Both Cordyceps and Lion’s Mane have a long history of use in traditional medicine to improve mental function – particularly in traditional Chinese medicine.

Increasing research interest and very early but emerging evidence suggests that these mushrooms may have some positive effects on mood and cognition. My team at Southern Cross University is also investigating the therapeutic potential of these ingredients, although our work has not yet been published.

Both mushrooms are available as medicinal products in Australia either through the Australian Therapeutic Goods Register, which allows various Cordyceps and Lion’s Mane products to be sold as complementary medicines, or in dried form for medical practitioners only.

None of these mushrooms appear to be associated with the side effects reported in people who have taken Uncle Frog mushroom gummies.

So why did people get sick?

The product also claimed to be infused with “the best hemp on Earth.” Hemp is a term often used to refer to a cannabis plant that contains less THC (the main psychoactive ingredient in cannabis) than recreational or medicinal marijuana.

Although the distributor stated the product had been tested to confirm the absence of active THC, many affected individuals described symptoms consistent with excessive cannabis use.

One user even claimed that after taking this product, a THC test showed its presence.

This suggests to me that the adverse reactions may have been due to the cannabis ingredient, rather than the mushroom ingredient in the gummies – and that the cannabis ingredient was more potent than the use of the term “cannabis” suggests.

However, the investigation is ongoing and it is likely that more information will become available in due course.

What is functional food?

Cordyceps and Lion’s Mane are so-called “functional foods”. These are essentially foodstuffs that are claimed to contain specific ingredients that may provide specific health benefits or prevent disease.

This can apply to both unprocessed foods (such as purple sweet potatoes, which have recently been in the spotlight for their antioxidant potential) and processed foods and beverages (such as kombucha drinks).

An example of a highly processed functional food would be mushroom jellies.

Functional food is becoming more and more popular

As the lines between medicines and food become increasingly blurred and consumers often prefer products that were once available in tablets now in edible forms such as gummies and powders, the regulatory situation becomes complex.

The Therapeutic Goods Administration (TGA) regulates medicinal products – including natural products such as herbal medicines and dietary supplements – for safety and quality. This means you can be sure that what is written on the bottle is what is in the bottle and is safe to consume. For most complementary medicines, the TGA does not assess effectiveness.

Meanwhile, Food Standards Australia and New Zealand (FSANZ) regulates food. The development of functional foods has brought many interesting new ingredients to Australia, often in new forms. To ensure that such products are suitable for sale as food, FSANZ must approve these new ingredients.

FSANZ has officially withdrawn the gummies from legal sale because Cordyceps and Lion’s Mane are unapproved novel foods.

Food or medicine?

All of this sheds light on the issue of quality control of products intended for sale in Australia, particularly imported products.

To help manufacturers (and the public) determine whether products should be placed on the market as food or medicinal products, and therefore to which regulatory body they should be subject, the Australian Government has developed the Food-Drug Interface Determination Tool.

However, public health experts have previously noted that the tool can be confusing, especially for products such as gummies, and can lead to confusion between regulators and public health experts.

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

But perhaps it’s time to narrow the gap between food — at least those that make or imply broad therapeutic claims — and drugs. FSANZ is doing a lot of work to reduce this gap, but more is likely needed.

One element of this may be strengthening regulations for functional foods as a separate category. Japan was the first country to use the term functional food, and its Ministry of Health provides a regulatory path for this difficult middle ground between food and medicine.

What should you do?

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

When it comes to functional foods more broadly, I would refer to the following advice from Michael Pollan, an American author who has written extensively on the subject: don’t eat anything that your great-grandmother wouldn’t recognize as food.

If you want to explore the potential of mushrooms or plants as natural medicines, look for products regulated by the TGA (look for products with a number starting on the packaging with AUST L, AUST L(A) or AUST R) or speak to a qualified healthcare practitioner.

This article is republished from The Conversation under a Creative Commons license. Read the original article.