Oz Brands Uncle Frog’s Mushroom Gummies have been recalled and authorities are directing people to dispose of them following the hospitalisation of several people who had eaten them in New South Wales, Queensland, South Australia, and Victoria.
The two products – Uncle Frog’s Mushroom Gummies – Cordyceps and Uncle Frog’s Mushroom Gummies – Lion’s Mane – have been available for sale online nationally. Its website has shut down apart from listing an email address to be reimbursed.
Food Standards Australia New Zealand (FSANZ) said Cordyceps and Lion’s Mane are novel foods that have not been approved to be sold as food or ingredients.
The Cordyceps product claims to contain extracts of the fungus Cordyceps militaris. The Lion’s Mane product is based on the Hericium erinaceus species.
In his article on theconversation.com, Southern Cross University National Centre for Naturopathic Medicine foundation director and professor, Jon Wardle, said both fungi are available as therapeutic products in Australia via the Australian Register of Therapeutic Goods, which allows the sale of them as complementary medicines, or 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,” Wardle said.
The NSW chief health officer, Dr Kerry Chant, said that since April, at least five people had been treated after ingesting the gummies. Symptoms have included:
- nausea and/or persistent vomiting;
- seizure like activity and involuntary movement (such as arms/legs twitching, eye movement);
- anxiety;
- disturbing hallucinations;
- drowsiness or loss of consciousness;
- dizziness or light-headedness; and
- racing heart/pulse.
Chant said patients had experienced myriad symptoms and the investigation was complex.
“We don’t know the substances, but the hypothesis is that there is some sort of substance in the product that is leading to these signs of toxicity,” she said.
NSW Poisons Information Centre medical director, Dr Darren Roberts, urged consumers who had purchased the products not to eat them.
“Investigations are ongoing as to what these products contain. We are strongly recommending that people do not consume these products,” Roberts said.
On their packaging, both gummies said they were “infused with earth’s finest hemp”, cordyceps provided “natural energy and power”, and lion’s mane “supports memory and focus”.
Wardle, said foods that claim a therapeutic purpose are fast becoming the preferred way for people to get better health outcomes.
“This isn’t a problem in and of itself, but often the governance, regulations and quality controls aren’t keeping pace with that public demand.
“It is essential that companies work with regulators and get their products routinely verified and tested before going to market. There is a lot of growth in the functional food sector, and it is important we recognise that growth through appropriate support for regulations and quality controls,” Wardle said.
The sole director of Uncle Frog and Oz Brands, Rohan Bandil, told Guardian Australia, “We are really sorry that this happened to them, this was not the intention.
“We were just intending to bring the product and sell it in the Australian market as similar products have been extremely successful in the global market.”
In Australia, a product that requires TGA approval is also then subject to different marketing and advertising regulations than a ‘regular’ food or beverage.
“Therapeutic goods are not ordinary items of commerce. They are intended to have an effect on the body, and there may be risks involved with their use,” the TGA said in its advertising guide.
In its social media guide, the TGA outlines compliance requirements such as ads must include mandatory statements, including health warnings where applicable, which must be visible at all times.
To help manufacturers determine if their product should be defined as a food or therapeutic goods – and to then know which regulatory body it would fall under, the Therapeutic Goods Administration (TGA) developed the Food-Medicine Interface Guidance Tool.
“Australia is seen as a world leader in the regulation of natural medicines – including assessment of overseas manufacturing facilities 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 to narrow this gap, but more is probably needed,” Wardle said.
RMIT University Professor of Chemistry professor, Oliver Jones, put it succinctly, “It is worth remembering that just because something is ‘natural’ does not automatically mean it is good for you. Uranium is natural as are lead and mercury and bacteria and viruses. Many plants and fungi (including some types of mushrooms) also produce compounds that are potentially harmful to humans.
“I know what looks like a quick natural fix is tempting but, if you are feeling stressed or anxious, the best way to safe and effective treatment is probably to talk to your doctor or health provider.”
While Uncle Frog’s Gummies were recalled quickly, spare a thought for US consumers. Prophet Premium Blends, manufacturer of Diamond Shruumz microdosing confectionery (chocolates, gummies, candy cones), recalled all products on 27 June, despite the first complaints of illness being recorded on 27 May.
By the time of recall, 39 people had been affected, including 23 hospitalisations across 20 states. several patients required intubation, mechanical ventilation and admission to intensive care. The US Food and Drug Administration issued a warning about the chocolate bars on 7 June, at which time there were eight cases and six hospitalisations in four states.
Symptoms included central nervous system excitation (e.g., seizures, agitation, and involuntary muscle contractions), central nervous system depression (e.g., loss of consciousness, confusion, and sleepiness), gastrointestinal symptoms (e.g., nausea and vomiting), and cardiovascular involvement (e.g., abnormal heart rates and hyper/hypotension).
The US Centres for Disease Control and Prevention said, “Products containing psychoactive compounds such as cannabis or mushroom extracts are increasing in availability. These “edibles” are often sold as gummy candies, chocolate, or other snack foods. They might contain undisclosed ingredients, including illicit substances, other adulterants, or potentially harmful contaminants that are not approved for use in food.”
Announcing the recall on its website, Prophet Premium Blends said “some products” contained “higher levels of Muscimol than normal”.
Muscimol is found in some mushrooms and could be a potential cause of symptoms, the FDA said. In sample analysis on two bars, both contained 4-acetoxy-N,N-dimethyltryptamine (4-acetoxy-DMT, also known as O-acetylpsilocin or psilacetin) - a synthetic tryptamine used in psychedelics and similar to psilocybin, a mushroom-derived psychedelic, and LSD.
The company didn’t list ingredients on each of its products, instead saying they contained a “primo proprietary blend of nootropic and functional mushrooms”.
