Kava regulatory review: Changes in ANZ labelling ‘unreasonable and unnecessary’ – Fiji Kava

The Food Safety Australia New Zealand (FSANZ) last month commenced a public consultation on its proposed regulatory revisions for kava​.

Prior to this, Australia had lifted the ban on commercial importation of kava as food under a two-year trial programme in December last year.

Three months later in March this year, the FSANZ agreed to an urgent proposal to amend the kava standard. Since then, it has 12 months to assess the amendments to either re-affirm or prepare a new proposal.

To which, the FSANZ had called for public comment to either reaffirm the proposal, amend or repeal the proposal last month.

Some of the areas that the FSANZ is considering to either reaffirm or amend or repeal, are the labelling requirements for permitted kava foods. There are also requests from government agencies to consider mandating specific additional warning statements.

“They suggested additional warning statements, including some similar to those required on therapeutic goods containing kava. ​

“FSANZ will consider the need for additional warning statements as part of the assessment undertaken within 12 months of the approved draft variation. Other additional labelling matters will also be considered at this time,”​ the FSANZ said.

For instance, there are calls to add warning statements to kava beverages, just like how kava-containing therapeutic goods are regulated by the Therapeutic Goods Administration.

This is because there are concerns that the consumption of kava’s active components – kavalactones – could be higher by consuming kava beverages as compared to kava-containing therapeutic goods.

Responding to FSANZ’s call for public comment, one of the major kava firms, Fiji Kava, issued a statement stating its opinions, describing changes in labelling and other regulatory requirements at this point as placing “unreasonable and unnecessary burden”​ on companies.

It had called for appropriate post market surveillance instead to improve companies’ compliance.

“In particular, we believe that all Kava imports should be subject to random batch testing by a recognised facility such as the Analytical Research Laboratory at Southern Cross University in Lismore, NSW and regulated through Food Safety Australia New Zealand (FSANZ).​

“Further steps should be taken to ensure that all importers of drinking kava should be able to provide appropriate evidence to FSANZ of current compliance with HACCP accreditation requirements for facilities preparing and packaging kava imported into Australia, especially where those facilities are overseas.”​

At the same time, it reiterated that only Noble Kava varieties could be imported. Noble Kava has been historically used in ceremonies in regions such as Fiji. Other varieties, such as the Narafala Kava, on the other hand, are not suitable for human consumption.

“We believe that all the original reasons the Prime Minister and Department of Foreign Affairs and Trade identified for initiating trials of commercial importation of Kava have only become more pressing and that all relevant government departments and bodies should work constructively to ensure the success of the program and to maintain food safety,” ​the firm highlighted in its statement.

Allow limited claims ​

The ASX-listed company also called for the FSANZ to allow limited claims for kava food products, as there are already a body of clinical evidence supporting its benefits.

“For drinking kava, this may include ‘soothing the nerves’, ‘supporting relaxation’, ‘natural sleeping aid’, or ‘stress relief’,” ​the firm said in the statement.

It pointed out that kava has been used in the Western society for its effects on reducing anxiety and could serve as an alternative to antidepressants and benzodiazepines that were linked to side effects.

At the moment, nutrition content and health claims about kava are prohibited.

Impairment of driving and liver toxicity ​

Other points that the company addressed include reports associating kava consumption with impaired cognition and liver toxicity.

Citing existing findings, the firm said that studies on kava and its effects on cognitive impairment when driving have produced mixed results.

As such, it believes that it is best to exercise caution when driving or operating heavy machinery under the influence of high kava consumption. 

“While evidence for impairment of driving is mixed at best, Fiji Kava Limited has voluntarily added a warning related to driving and operating heavy machinery to all our drinking kava products which we consider to be best practice for companies selling drinking kava products.”​

With regard to reports on kava consumption leading to liver toxicity, the firm is of the view that liver toxicity concerns do not relate to drinking noble kava in aqueous solutions.

In 2002, kava was withdrawn by the EU due to reports associating kava with liver toxicity.

To which, the company pointed out that it was unclear if kava was responsible for the toxic effects on the liver in those reported cases.

This is especially when kava was consumed with other medications and/or alcohol that could potentially cause hepatotoxicity or when there was an overdose of kava.

At the moment, the World Health Organisation’s recommendation is that kava products from water-based suspensions should be studied and used preferentially over acetone and ethanol extracts.

In Australia only the use of water-soluble extracts is allowed at less than 250mg of kavalactones per day for medicinal use and are available over the counter.

“Fiji Kava Limited does not believe the current evidence for products allowed for sale in Australia warrants a liver toxicity warning, given no evidence for this risk being present for dried kava prepared in aqueous solutions and consumed in moderation (per current labelling requirements),” ​the firm said.