Our contribution to the FDA to reassess cannabis at the World Health Organization
About a month ago, we submitted our comment to the US government, or, more specifically, the FDA, which was seeking comments from the public.
Because of cannabis’s international status, those countries that are signatories of drug control treaties should not be able to legalize it, although Canada and Uruguay already have — and Luxembourg, as the first country in Europe to do so, is soon to follow.
Unfortunately, WHO’s Expert Committee on Drug Dependence recently announced that it would not give recommendations or reschedule cannabis, explaining that it needs more time to carry out a detailed and critical review.
You can see my comments about that decision in Javier Hasse’s piece for Green Entrepreneur here.
Although this is already in the public realm, we thought with WHO’s decision, it is now more important than ever to be proactive and be the best possible advocate for a safe, fair, transparent and legal cannabis industry.
Here is our submission on behalf of all of JKB Research SA to the FDA, the original can also be found here.
October 2018
Re: Docket No. FDA–2018–N–3685
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB–FUBINACA; ADB–CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plant and Resin; and Eight Additional Substances; Request for Comments
We appreciate the opportunity to comment regarding the abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of cannabis and several other substances now under international review.
This comment focuses exclusively on cannabis and is submitted on behalf of JKB Research SA, the leading Swiss company for CBD cannabis products. JKB’s products under the brand CBD420 are available online and in over 700 retail points in Europe. Its founders have been medical patients treated with cannabis after unsuccessful traditional treatment attempts, and have studied the science and economics of cannabis for years. The comment has a strong focus on regulatory best practices, and synthesises the learnings from years of experience and contact with key stakeholders in the legal cannabis industries in North America, Europe and Uruguay. We explore not only the impact of medical use of cannabis, but also wider legalisation.
We argue that scheduling changes making cannabis more accessible to the public will have a significant impact for good in the health of a large number of patients with severe pathologies. With the right regulation, it would be easily controlled. Economically, this could bring millions of tax dollars while creating thousands of jobs almost instantly across the United States, as the cannabis industry is already significant. In doing so, informal employment and health hazards associated with the black market would be eliminated. Individual states in the US have already proven that it is possible, and their experiences should also be contemplated when thinking of reform at the federal level. Further, it will open the door for the scientific community to focus on cannabis to understand it, and its applications for enhancing health, better.
Minimizing abuse and maximizing medical usefulness will depend on the quality of the regulation
It is generally known that humans, as well as most mammals, count with an endocannabinoid system, which is designed to bind with substances that the body itself can produce, and which the cannabis plant contains, namely cannabinoids. Scientific literature points to the medical potential of understanding the cannabis plant, cannabinoids and the interaction between cannabinoids and our receptors better.
Although scientific research of cannabis has been limited due to its classification, numerous studies have already highlighted that cannabis not only has potential to treat a number of pathologies, but it is also generally less harmful than substances that are already legal, such as alcohol or tobacco.
With the right regulation covering product standards, distribution, controls and assuring the right prevention and education measures, it would be relatively easy to minimize any abuse of the substance and maximize medical usefulness.
We summarize how this regulation should be designed below.
Standards and labelling
Cannabis contains numerous compounds — phytocannabinoids, terpenes, flavonoids and amino acids. These have a huge impact on the effect of the cannabis on the user. The products, be it buds, edibles, topicals, or other, would have to be lab tested and provide certain key information:
i) Cannabinoids profile (CBD, CBDa, THC, THCa, CBN, CBG, etc.)
ii) Terpenes profile
iii) Assurance of non-appearance of heavy metals, mold or chemical products.
Cannabinoids should appear very clearly on every packaging. There should be a scale of potency and where that product sits within the scale to guide the user clearly and quickly. Likewise, the terpenes profile should appear in a way that is easy to read.
The packaging of cannabis products should include a QR code which, with the help of a smartphone application, points to a factsheet of the product, including the product profile and which reveals information about the actual plant and the growers. The QR code would also facilitate authorities to track or monitor products on market. The information triggered could also include information of use to authorities.
This will also create a competition and race to the top in terms of the quality of the plant that growers will attempt to achieve. Lower quality products will be less competitive. But most importantly, it will assure a level of quality and safety for users.
Distribution
The distribution of cannabis products, whether recreational or for health purposes, should be performed by individuals with adequate training. They need to be able to provide any information that clients or patients might need beyond that on the packaging.
Should specialised shops sell cannabis for wellness and recreational purposes, these should be separated, either in different shops or with an obvious room separation within the shop, even if the products are the same. The difference between should lie mainly in taxation. Products for medical use should be taxed at less than 5% and those for recreational purposes could be taxed between 5% and 15%.
As well as buds, edibles, topicals, concentrates and other types of cannabis products should be legal to sell. All products should be tested in the same way to guarantee the safety of users.
Access to the wellness products should be reserved to people with a doctor’s prescription. Doctors themselves should receive specific training when it comes to prescribing cannabis, in order to make sure they are able to effectively explain effects of cannabis. They should also receive a list of pathologies cannabis can help treat. This list, meant to be flexible over time, should be confirmed by the relevant authority.
Dr Jokūbas Žiburkus Ph.D., Associate Professor at the University of Houston, has performed laboratory research to understand neuronal interactions in health and disease with the objective of finding therapeutic treatments for neurological disorders for years. In his scientific work he has recognised several pathologies where cannabis is a relevant treatment option:
Epylepsia
Cancer
Fibromyaligia
Multiple sclerosis
Crohn decease
Arthritis
Muscle pain
Insomnia
ADHD
Parkinson’s
Autism
Tourette syndrome
Spasm
PTSD
Anxiety
Stress
Controls
The product profile and QR code mentioned earlier would facilitate tracking products’ lab analyses and companies involved for the authorities.
Licensed growers, manufacturers and shops will make it easy to track the actors involved in the industry. To obtain a license, shop owners, staff, growers and manufacturers would need to undergo training, and be tested to be allowed to work with cannabis products. The training should be tailored to the role performed, and should include knowledge on products, cannabis plants, pathologies, effects and ethics.
Education and Prevention
Equally important to having good regulation and enforcing it will be to educate the public and prevent them from breaking the law or getting harmed by cannabis. Should the legal landscape change, consumers need to be aware of what they can and can’t do from a legal point of view, and despite its health advantages, it should be used responsibly.
To give an example, edibles with THC can take up to 4 hours to give a high. Inexperienced users lacking this knowledge could overconsume if this fact is not clearly mentioned. Cannabis is not meant for everyone, and when it comes to THC it can get dangerous for children or pets. Users should be told to store cannabis safely. Mixing cannabis and alcohol should also be prevented. It is very difficult to overdose from cannabis. The government and companies selling products should educate the public on possible effects of excessive consumption: severe nausea, vomiting, anxiety, paranoia, extreme confusion, panic, fast heart rate, delusions, hallucinations, increased blood pressure.
Ideally, a standardised measurement system should be created that helps consumers understand what to expect from each individual product. This already exists for alcohol and allows consumers to compare across products. Consumers should be able to understand exactly what cannabis product they are consuming and what their effects are. Driving can be dangerous under the influence of any drug, and should also be discouraged.
Reclassifying cannabis could help eliminate black markets, create jobs and raise tax money
The black market poses a threat to people’s health. Products are not quality tested, and could be cut down or contain ratios of THC to CBD that increase the chances of harmful effects. Worse, they could contain harmful substances that seriously compromise the user’s health. If cannabis was sold legally and with the proper regulation, this threat could be eliminated. Dealers selling cannabis illegally are not equipped to properly advise buyers and are usually financially motivated to sell more, and potentially more harmful, drugs.
The fact that cannabis is illegal has also contributed to it changing genetically, having been engineered over time to contain higher levels of THC in detriment of CBD. This ‘stronger’ cannabis represents the highest risks of suffering psychotic symptoms. But worse than strong cannabis is the threat of synthetic cannabinoids, which have achieved high penetration in developed economies, especially among the homeless and those that are most uneducated and vulnerable.
Just like any other commercialized product, should cannabis be legalized, it should be taxed. Cannabis is already a notably large industry moving large amounts of money and employing a large number of individuals. Legalising cannabis would mean the collection of millions of tax dollars and the creation of thousands of real jobs almost instantly.
However, excessive taxation could prevent the more important objective of reducing the black market and improving the safety of cannabis users. When it comes to recreational use, the tax level could match that of tobacco and alcohol. However, it has been observed that high tax may lead to prolonging black markets. Tax levels between 5% and 15% could both secure high revenues for the government and help users shift from an underground industry to one that is well regulated. Products for wellness purposes should be taxed at 5% or less.
Conclusion
We recommend descheduling. Cannabis is a natural plant scientifically demonstrated to have the potential to treat a number of pathologies that afflict humans, while being relatively safe and controllable. Minimizing abuse and maximization of medical usefulness will depend on the effectiveness of the regulation. An effective regulation could also create thousands of legal jobs and millions of tax dollars, while removing the black market together with its lack of standards, and health hazards. We argue cannabis access and taxation should be controlled but in a fair manner, as a regime that is excessively restrictive will not have an impact on the black market.
