I’m writing this submission as an individual who wants to buy over-the-counter Cannabidiol and also cultivate and produce therapeutic CBD products in NZ. I think I speak on behalf of many Kiwis who want the same opportunities and desire to make our own decisions about what we can and cannot put in our bodies. Cannabis and CBD-only products have helped me a lot and I know of many other people who also report that cannabis has changed their lives for the better.
Even if we are granted the right to buy CBD OTC, Medsafe has made it clear that it will be virtually impossible for most of us to enter the industry to be able to manufacture organic, full spectrum CBD-only rongoa. They state it will be even harder than following the current medicinal standards.
"It should be noted, however, that data required to support an approved medicine, even an over-the-counter product, remains far greater than that required to demonstrate a product meets the minimum quality standard under New Zealand’s Medicinal Cannabis Scheme. A large factor of cost for medicine applications is manufacturing to the standard required and running clinical trials."
It is unlikely that a small business would be able to fund and run clinical trials but even if they managed to, it would be unachievable to meet the requirement that ‘the products intended to be administered must be manufactured in a GMP facility that is licenced to manufacture medicines’.
I believe that the requirement from Medsafe to make the approval of low-dose CBD products dependent on presenting data from clinical trials is too extreme, yet it seems to favour those who are licenced to manufacture under Medicinal Regs as they will be able to do so under their GMP certification. The cost to achieve those standards is out for reach to most of us.
We have all travelled or seen online the plethora of hemp-derived CBD products that can be purchased in health food shops, supermarkets and gas stations globally. Since 2016 in the UK most CBD products are sold as food supplements and there are hundreds of brands to choose from.
Data shows that millions of people have been using them for many years without any issues, so I ask that we are not intentionally held back from experiencing the same opportunities due to potential risks that have not been proven to be associated with low-dose CBD. Read US statistics
My studies have noted the presence of a worldwide clinical acceptance that hemp-derived CBD is harmless, and, accordingly, should be regulated under the Dietary Supplements Act like all other herbal supplements with the addition of providing cannabinoid and terpene test results. It should be made readily available then studied using real-world data, surveys and reports from doctors if they see any changes in patients.
I ask you to be more realistic and progressive when considering changes to the regulations for the sale and production of CBD. Please reconsider the need for pharmaceutical restrictions over a safe therapeutic supplement that is proven to be of no harm to the great majority of people. The claim of a minimal risk of side effects in a very small group is with regards to consumption of high doses of CBD. These patients can be monitored by their GPs in the medical system and advised not to use cannabis products.
Medsafe refer to claims that CBD may result in increased serum levels and toxicity of mTOR and calcineurin inhibitors, of which fewer than 6000 people in NZ use. The studies that have been presented indicate that one very high CBD product administered to patients in the US at high doses may have caused an adverse reaction however it would be contrary to scientific methodology for that to be used to determine a decision on low-dose CBD.
I assert that there are plenty of herbal and pharmaceutical remedies that are readily available to everyone that contain herbs or chemicals that may interact with certain medications or conditions but it is up to the patient and their doctor to determine if there is a problem.
Having reviewed a paper submitted by Medsafe and sponsored by RuaBio, Helius, Cannasouth, and 7 pharmaceutical companies, I can see that much of that paper is inconclusive or not relevant and have provided examples below. Read the paper here
The first reference is to a study where the CBD dose was 750mg twice daily or 20mg/kg/day. This is much higher than a low-dose product. The comment from the NZ author explains that it is irrelevant:
“This article highlights that CBD may not have clinically significant DDIs with drugs that are commonly linked with pharmacokinetic DDIs. However, the relevance of these findings when CBD is co-administered with an mTOR or calcineurin inhibitor remains unknown.”
One study is using a drug Epidiolex which is 100% CBD, again very different to a low-dose CBD product.This study seems irrelevant with regards to proving there is a risk as the final comment states:
“There were no significant changes in drug levels with CBD dose titration in the other AEDs analysed (valproate, levetiracetam, phenobarbital, clonazepam, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, ethosuximide, vigabatrin, ezogabine, pregabalin, perampanel, and lacosamide).”
The reference to Stockley’s Drug Interaction Checker states:
“There were no interactions listed for CBD and systemic mTOR/calcineurin inhibitors. Generally, listed interactions were mild to moderate in severity and are based on theoretical evidence. Only interactions with Rimimazolam, Valproate, Difelikefalin, and Ganaxolone are considered severe.”
Are the interactions with these 4 drugs sufficiently significant to warrant being described as contraindications? The Stockley’s website does not show the details and state they ‘are based on theoretical’ evidence anyway so cannot be used as valid data. See report for May 10, 2022
Two more studies do not say what CBD product was being administered, but as it was for epilepsy can we assume it may have been Epidiolex? Without having that information the studies should not be used in any decision-making. The dosages were also very high, ranging from 5-20mg per kg.
“Although this study has a small participant group, the findings do show a clinically significant increase in mTOR inhibitor levels associated with CBD use. Additional large prospective studies of CBD and mTOR inhibitors that assess the optimal dose reduction (of either medicine) to reduce the risk of toxicity would be helpful.”
Three case study reports concluded the following so should therefore also be disregarded:
“The authors were unable to obtain the patients CBD levels during the study period and therefore could not assess the degree of CBD exposure that resulted in the change in tacrolimus level. Additional long-term follow up information was not available.”
“As only the abstract is available, the information provided in the article is limited. Potential confounders were not discussed.”
“Without THC and CBD levels being recorded the quality and dose administered in this patient is unable to be assessed.”
Medsafe claimed that CBD-only 'did not have an established long-term safety profile' so can they explain how, after many years of use across the US, UK and EU, there have been no major warnings on it’s safety? It would be very apparent by now if CBD products were causing any questionable health issues in the general public. Recently a novel mRNA vaccine was approved and, although there was no long-term data and a list of potential side effects, it was declared safe and effective.
In comparison, I think Medsafe and the MoH should be able to establish that, based on the wide and longstanding consumption of CBD-only products abroad, there is a clear indication that there are no serious concerns in relation to its use. This should provide more than enough evidence for them to be comfortable with allowing therapeutic products to market without having to provide clinical trial data or pass GMP pharmaceutical testing standards.
Our endocannabinoid systems (ECS) are all different and are often unbalanced or depleted, the cannabinoids in cannabis are designed to enhance and support homeostasis as they connect with our ECS like a lock and key. Many find CBD and other cannabis treatments helpful in managing a variety of conditions and they find a dose that suits them, they know what their body needs.
The efficacy or benefits provided by consuming low-dose CBD are sometimes considered negligible and I would suggest that if the dosage is so low that it is not having any effect then it is comparable to taking a hemp supplement. Therapeutic hemp oils may even contain other, lesser-known, cannabinoids that are considered to be safe and remain unregulated. This standard should apply to CBD which is also a very safe and well-tolerated cannabinoid.
This Australian cannabis research agency supports the belief that CBD at such low doses is ineffective so this begs the question of how it could possibly be risky when it is potentially having no effect whatsoever. Visit the ACR page
“The few existing placebo-controlled studies using doses ≤150mg of CBD alone have not shown any significant effect over placebo in a range of indications including insomnia, anxiety and inflammatory bowel disease (IBD).”
“The safety profile of CBD has been explored explicitly in a number of Phase I clinical trials, as well as being a primary outcome of a number of pilot randomised controlled trials (RCTs) and observational open-label studies. Existing evidence has shown that doses of up to 6000mg of CBD taken orally are safe and generally well tolerated in adult subjects”.
CBD is being used in trials to show how high dosages can be useful in the treatment of meth addiction. With that being such a big problem in NZ, it should be a priority to produce it on a large scale rather than making it extremely difficult to even get a low-dose product to market. Read the study here
I would advocate for the public to have access to stronger CBD products but we have to start somewhere. A demand for higher dosages will occur over time and hopefully, by that stage, all CBD decisions will be managed within the natural health products domain, as was always intended.
In this 2018 Bill CBD-only was removed from the Misuse of Drugs Act and was not to be considered a controlled drug. It was agreed to be descheduled and also refers to removing the need for a prescription. See the 2018 Amendment Bill
“Regulations were amended last year to remove a number of controlled drug restrictions for the import and prescribing of CBD products, but it was not possible to remove all controlled drug restrictions for CBD by regulations. This bill will declassify CBD and CBD products with less than 2 percent of other cannabinoids.”
You may recently have read and heard many of the submissions from New Zealanders on their objections to rongoa and Natural Health Products being included in the Therapeutics Bill. They are the voices of many who want to have the freedom to treat themselves with plant medicines rather than pharmaceutical drugs and many see cannabis as an herbal remedy.
The NZ Drug Foundation statistics reveal that 94% of medicinal cannabis users are accessing their products through ‘green fairies’. The public are speaking through their actions and they will continue to do so until the regulations and product approval processes allow a fair and equitable market for production and access for all Kiwis to use locally grown and affordable cannabis products. The 2018 Bill specifies the policy intent must be an “approach based on the principles of fairness, quality and safety, and compassion.” Perhaps they were referring to fairness in the marketplace too.
I would like to see the Ministry of Health and Medsafe listen to us and act in our best interests by revising the current regulations over this safe and wholesome natural health product so that they achieve more balanced and equanimous rules of engagement that will in turn give the public easier access to a more affordable (and potentially more effective) range of products.
Low-dose hemp-derived CBD should be cultivated under a Hemp Licence with extraction and production regulated under the Dietary Supplements Regulations 1985, which fall under the Food Act 2014. Considering it’s availability and use globally, many of us believe that listing low-dose CBD as a pharmacist-only medicine (that requires a datasheet) is unwarranted and we would like to see that decision revised.
This statement from Medsafe illustrates how a low-dose CBD-only product would require ministerial consent to be approved for pharmacy shelves; however, if the same product is manufactured via the Medicinal Cannabis Regulations it is allowed to be sold, with a prescription, as an unapproved medicine. It seems like an obstacle and deterrent to the production of any CBD products outside of the current medicinal scheme.
“If CBD were to be down-scheduled, and therefore available as pharmacist only in New Zealand, this would only impact products that have ministerial consent. It would not impact products that have been verified through the medicinal cannabis agency. These would remain unapproved medicines for the purposes of the Medicines Act 1981 and would remain prescription medicines that may be supplied in accordance with section 25 and 29 of the Act.”
Recently the change of structure for Industrial Hemp Licences to be administered by the Regulatory Practice and Analysis (RPA) branch of Medsafe, which also administers the Medicinal Cannabis Scheme, indicates that there is a shift and consolidation occurring. This suggests that now would be a good time to make positive changes for more inclusive regulations.
I would like to see all cannabis cultivation and production have less regulatory controls as the people of NZ and it’s economy will prosper from Kiwis producing outstanding brands, just as they do in our food and wine industries. I hope we will get there eventually and your decision can help us by initially opening up the CBD-only market and allowing us all to benefit from a plant that so many of us love and appreciate. I am guessing you also want what’s best for our communities and GDP and can understand that CBD does not need to be controlled like a pharmaceutical drug. Infact in the 2018 Amendment Bill, it was stated:
“The overall standard for medicinal cannabis products is not expected to match that of pharmaceutical grade products, e.g. manufacturers will not be required to provide clinical trial data. Standards will however cover the manufacturing process and end product quality, and will apply to all products manufactured domestically and imported.”
This recommendation was disregarded by the MoH and Medsafe at the time but perhaps it can now be honoured with regards to CBD-only.
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