The Therapeutic Goods Administration (TGA) announced its interim decision to down-schedule CBD to a schedule 3 substance on Sep 9.
This was after a-month-long public consultation held between April and May this year.
The decision effectively rejects calls from industry bodies such as the Complementary Medicines Australia in making CBD an AUST-listed, unscheduled substance, that could be used in OTC supplements, backed by information from efficacy monographs in other countries.
In its announcement, the TGA said CBD could be allowed as a schedule 3 substance in oral, oral mucosal, and sublingual formulations for therapeutic use upon pharmacist’s advice. No prescription from the doctor is needed.
The CBD content must comprise 98% or more of the total cannabinoid content of the preparation and any cannabinoids, other than CBD, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation.
If another active ingredient were included in a CBD preparation, this would be assessed by the TGA during the application for product registration process.
It also capped the maximum recommended daily dose at 60mg or less and that a CBD product could only be supplied to the market when they are already entered on the Australian Register of Therapeutic Goods (ARTG).
Australia Vs US and Europe
In contrast, the US and Europe have taken a more liberal route, CBD products without medicinal claims are available via the OTC route.
In Europe, there has been a quick rise in demand for CBD-based products for alleviating health problems, with the United Kingdom and Germany being the largest markets.
However, the European Commission (EC) recently paused over 50 novel food applications for non-synthetic CBD products as it decides whether to classify extracts from hemp flowers as narcotic or psychotropic. For the time being, it will be status quo while the authorities confirm the CBD regulations.
In Australia, drug-drug interaction is a key reason for why the TGA has decided to make CBD a pharmacist-only product.
“Due to uncertainty of adverse effects, the effects of longer-term use and the potential for drug interactions, I find that the risks cannot be managed with packaging and labelling in the absence of pharmacist advice,” the TGA said.
Another 5,409 public submissions were received by the TGA, about 46% agreed with the private applicant’s proposal to exempt CBD from scheduling while only about 2.5% supported the proposal put forth by TGA’s delegates.
The proposed implementation date for down-scheduling of CBD is on Jun 1 next year.
A giver and a taker?
The CMA believes that while TGA’s interim decision would seem like a piece of good news, it has in fact, set high barriers for a product to make the grade.
“CBD will need to be Australian Registered Therapeutic Goods-Registered (ARTG/AUST-R) and to do that, they require high levels of evidence,” CEO Carl Gibson said in response to queries from NutraIngredients-Asia.
“But there is no evidence I know that the 60mg/day dosage (the maximum daily dosage set by the TGA) has allowed…It is almost impossible to get those high-level evidence at 60mg/day,” he added.
“So, in effect, the TGA is giving with one hand – and taking away with the other,” he said.
The TGA’s interim decision is that CBD products can be supplied only when they are listed as ARTG-Registered (ARTG/AUST-R).
Aside from AUST-R, there are two more listing on the ARTG – the AUST-Listed (AUST-L) and the AUST-Assessed listed (AUST-L(A)).
According to the TGA, the AUST-R listing mostly cover prescription products, but also cover OTC products and a few complementary medicines.
“Complementary medicines containing a substance included in Schedule 3 to the Poisons Standard are regulated as registered medicines and as such, are pharmacist only medicines regardless of whether they are considered ‘complementary’,” a TGA spokeswoman said.
The spokeswoman told us that there is currently only one registered medicinal cannabis product on the ARTG. This is an oromucosal spray containing nabiximols (THC and CBD) – SATIVEX.
The product is included in Schedule 8 of the Poisons Standard and is available by prescription only.
At present, CBD products are only permitted in Australia when used in a clinical trial, via the TGA’s Authorised Prescriber Scheme or the Special Access Scheme.
Doors to new opportunities?
The move has been welcomed by manufacturer Bod Australia, which believes that the regulatory shift will “unlock large market opportunity” for the company.
It said that TGA’s interim decision will grow the consumer market for CBD and will allow the firm to bring new, lower dose products to the market.
It added that it was “progressing opportunities” to launch CBD-based products via both its medicinal cannabis and CBD and hemp consumer product divisions.
“Products launched through Bod’s CBD & hemp consumer products vertical would be undertaken in collaboration with exclusive global partner and Swisse Wellness parent company, Health and Happiness Group,” the firm said in a statement.
The company currently sells its higher dose medicinal CBD, MediCabilis, via the prescription route.
MGC Pharma, on the other hand, said it aimed to be one of the first companies to launch schedule 3 CBD products on pharmacy shelves once the proposed changes kick in next year. Its focus will be on medicinal cannabis.
There has been huge interest from brands in CBD products, according to product development and regulatory consultancy firm Take Friday Off.
The company also believes that TGA’s decision to make it a pharmacist-only medicine in view of the potential drug-drug interaction is a prudent move.
“We think overall, it is extremely positive, and a very measured response considered by the TGA.
“The level of interest we had from (dietary supplement) brands in the market in getting into CBD products as a consequence has been phenomenal,” founding partner Gabriel Perera said, adding that the brands would have already started working on pharmacist-ready products.
Founding partner Dane Renshaw said the AUST(R) route was more complex than what most of the brands were used to doing and there was a lot more requirements to be fulfilled.
“The advice that we will give to the brands is for them to spend time working on the exact requirements, so that they would not need to be backtracking and going round-and-round in circles,” he said.
They said that brands could perhaps work with European cannabis suppliers or producers who have done the research and have the evidence-based and quality manufacturing to support a AUST(R) application process.
The TGA is seeking additional advice on more details via a meeting in November. It will deliberate details on restrictions on dose, age, and advertising.