Along with the Queensland Police Services and Australian Taxation Office, the TGA executed a search warrant at a business premises Queensland in May and seized 27 jars of bloodroot salve (commonly known as black salve), 84 bottles of Triple-Strength Bloodroot Capsules, and 30 bottles of Double-Strength Bloodroot Capsules.
This operation was part of a wider ongoing investigation into the alleged unauthorised import, marketing and distribution of unlicensed therapeutic health products, with several devices associated with the manufacture of such goods also confiscated.
According to current regulation, offenders can be imprisoned for a year and / or fined A$210,000, or be imprisoned for five years and / or fined A$840,000.
Can Cansema cure cancer?
Black salve — also known as red salve, bloodroot or Cansema — is typically sold in the form of a topical paste, and is classified as an 'escharotic', a substance that burns and destroys skin tissue, after which a thick, black scar called an eschar is formed.
It commonly contains zinc chloride, Larrea tridentata (also called chaparral, a medicinal herb) and bloodroot (Sanguinaria canadensis), which is often used in herbal medicine. Bloodroot extract is known as sanguinarine, a quaternary alkaloid that destroys living tissue and is also categorized as an escharotic.
Variations of this formulation include three ingredients — red clover, galangal, and sheep sorrel. These ingredients, along with the aforementioned ones, are usually crushed into a paste and applied to the affected skin area, which is then kept covered for two to three days.
One of its first recorded uses was as a treatment for skin lesions in the early 1900s, but has long since been replaced by safer, more effective methods.
However, it has recently experienced a revival among certain groups of consumers in Australia and the US, with online social media communities dedicated to discussions on the different applications of black salve. Its most common use is as an alternative cancer treatment.
Bloodroot capsules' ingredients are similar to that of black salve, making their ingestion even more harmful and dangerous than topical application.
In Australia, such products are sold to patients and general consumers as an 'alternative treatment' for cancer, particularly skin cancer.
According to the TGA, the use of products marketed as containing black salve has already led to serious skin damage in three Australian consumers, who used such products for various conditions, including skin cancer.
A TGA spokesperson told NutraIngredients-Asia: "We are aware of black salve products being supplied to consumers as an alternative treatment for cancer, particularly skin cancer.
"These products commonly contain dimethyl sulfoxide, a prescription-only medicine, and bloodroot, which contains the caustic ingredient sanguinarine.
"The TGA is not aware of any reliable scientific evidence that indicates that black salve products are effective in the treatment of cancer, and strongly advises consumers against purchasing or using black salve products.
"Therapeutic goods entered in the Australian Register of Therapeutic Goods (ARTG) can be lawfully supplied in Australia. However, there are no black salve products included in the ARTG, and the supply of them as a therapeutic product is prohibited."
The TGA has also advised consumers to avoid purchasing unproven products claiming to cure or treat cancer, urging them to consult with doctors or clinical specialists instead.
Furthermore, it has emphasised that therapeutic products carrying such claims must be included in the ARTG unless exempted, and warning that penalties of up to A$5.5m apply to the illegal import or supply of such goods.
Bloodroot's bloody effects
Prof Stephen Myers, an adjunct professor at Australia's Southern Cross University and a professionally trained medical doctor and naturopath, told NutraIngredients-Asia he had a "real concern about people who take black salve in capsule form".
"Black salve generally includes a significant amount of zinc chloride. It's a corrosive substance and it's indiscriminate in where or what it burns — it doesn't burn just a specific area, and can burn quite deeply or widely, depending on how it's applied.
"As a topical product, it already causes many problems. As an ingestible product, it's exceedingly dangerous. People who take it in capsule form are potentially burning their stomach walls and intestinal lining.
"There is no indication it has any health benefits. In fact, it could result in stomach lacerations that could then lead to gastric bleeding and other problems such as anaemia, blood loss, haemorrhage and eventually, death."
He added that black salve should not be used orally or topically (or in any other form or method) to treat cancer, saying surgery was a "much more precise option" that was significantly safer due to its clearly defined end results and highly controlled process.
"It targets the cancer and the surgeons know for sure if the tumour has been successfully removed or not. When you use black salve, you have none of those checks and balances.
“You have no idea if it's actually dealt with the cancer, and you just end up with a big hole in your body, be it internal or external. And then that would require a significant amount of surgery to fix."
Science and sensibility
In recent years, scientific research has reported more harmful effects of black salve than any potential health benefits.
A 2016 review published in the International Journal of Molecular Sciences stated: "Clinicians should engage with patients and discourage black salve use, especially for high-risk skin cancers."
A 2017 review in Evidence-based Complementary and Alternative Medicine found that contrary to popular belief, "black salve is not a natural therapy (and) contains significant concentrations of synthetic chemicals".
A 2018 review in the Journal of Applied Toxicology reported that the use of black salve products adulterated with argemone oil (seed oil derived from the Mexican prickly poppy) could lead to epidemic dropsy, a potentially life-threatening clinical condition characterised by bilateral pitting oedema of the extremities, headache, nausea, loose bowels, erythema, glaucoma and breathlessness.
The researchers also noted that sanguinarine was a major toxic alkaloid of argemone oil.
Despite all evidence to the contrary, however, a good number of consumers remain convinced of black salve's purported abilities to treat cancer.
Myers said, "Some people are very committed to the idea of 'natural medicine', and there is a naive belief that just because something is 'natural', it's safe.
"That's not necessarily the case with every natural ingredient. For instance, hemlock is natural, but it's a poison. Still, people use black salve because they want to feel they're engaged in some sort of self-help."
However, Myers is confident the TGA has the right approach to stemming the sale and use of products like black salve, and educating consumers on the dangers of such items, saying the regulator makes it a point to crack down swiftly on any unauthorised activity and to warn consumers of the harmful effects of such supplements.