Do you need a prescription for cbd oil in canada

‘You must be very careful’: Common questions about CBD health claims for pain and other conditions answered

As consumer interest in CBD grows ahead of the Oct. 17 legalization of cannabis edibles, extracts and topicals, here’s a primer to answer common questions about its health claims for seizures, pain and other conditions.

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Doctors weigh the science behind cannabidiol claims

An oral administration syringe loaded with CBD hemp oil for treating a severely-ill child is shown at a home in Colorado Springs, Colo., in 2014. (Brennan Linsley/The Associated Press)

Cannabidiol, or CBD oil, is promoted for a wide range of medical conditions. Recently, a review for doctors weighed the science behind the claims.

The Clinicians’ Guide to Cannabidiol and Hemp Oils was published earlier this month in the journal Mayo Clinic Proceedings.

CBD is a compound found in the cannabis plant. It is not intoxicating, Health Canada said.

As of October 2018, the sale of dried cannabis, fresh cannabis, cannabis oil, cannabis plants and cannabis seeds are permitted under the the Cannabis Act.

As consumer interest in CBD grows ahead of the Oct. 17 legalization of cannabis edibles, extracts and topicals, here’s a primer to answer common questions about its health claims for seizures, pain and other conditions.

What is CBD approved to treat?

Epidiolex, a purified form of plant-based CBD, is the only CBD-related treatment approved by the U.S. Food and Drug Administration (FDA). It is used to treat severe forms of epilepsy. Epidiolex isn’t listed in Health Canada’s database of medications approved for use in this country.

Health Canada assigns a drug identification number (DIN) to all drug products evaluated and authorized for sale in this country. To qualify, a drug manufacturer needs to provide information including dosing, strength and how it’s taken.

“Currently, there are two cannabis-related drugs that have a DIN and are authorized for sale in Canada,” a spokesperson for Health Canada said in an email.

Nabilone, a synthetic tetrahydrocannabinol, or THC, product is approved to treat nausea. THC is the main psychoactive component in cannabis that gives users a high.

The other drug with a DIN is Sativex, which is manufactured from whole botanical extracts and contains THC and CBD, according to Health Canada. Sativex is added to treatments aimed at relieving spasticity in adults with multiple sclerosis. Spasticity is a muscle-control disorder.

No CBD-specific product has a DIN.

As well, no other “cannabis-related drug (including fresh or dried marijuana or cannabis oil) has been approved to be marketed as a drug for therapeutic use and sale in Canada,” Health Canada said.

What is CBD commonly used for?

There are anecdotal reports from users of CBD helping with certain types of pain, such as nerve-related back pain.

“Chronic pain management continues to challenge patients and physicians alike, and investigation into potential therapies such as CBD and hemp oils is a promising area for the future of clinical pain management for both pain relief as well as addiction management,” Dr. Karen Mauck, an internist at Mayo Clinic, and her co-authors wrote.

Dr. Hance Clarke, director of pain services at Toronto General Hospital who wasn’t involved in the U.S. paper, said he starts by asking patients what symptoms they want to use CBD to treat.

It’s one of the first times in Canadian history where a medication has made it to the population without the science actually leading us there. – Dr. Hance Clarke, director of pain services at Toronto General Hospital

“The evidence has not caught up to the story that’s in the public,” Clarke said. “It’s tricky. It’s one of the first times in Canadian history where a medication has made it to the population without the science actually leading us there.”

The world is looking to Canada for answers on CBD, said Dr. Hance Clarke. (University Health Network)

Physicians need to work with patients to figure out what people are using, the levels in their body and what’s actually helped and what hasn’t.

“The world is looking to Canada over the next five to 10 years,” Clarke said. An evidence-based perspective on cannabis is needed rather than solely industry’s, he said.

Canada’s Arthritis Society said there’s limited clinical evidence so far on the relative benefits and risks of medical cannabis to treat osteoarthritis and rheumatoid arthritis.

CBD now is widely used by people for all kinds of disease, in particular anxiety, panic attack, bipolar disorder, depression. But we don’t know if CBD is really good for these kind of diseases. – Dr. Gabriella Gobbi

In January, research into CBD’s effects on pain and anxiety in lab rats was published in the scientific journal Pain.

“CBD now is widely used by people for all kinds of disease, in particular anxiety, panic attack, bipolar disorder, depression,” said Dr. Gabriella Gobbi, the study’s author and a psychiatrist at McGill University’s faculty of medicine in Montreal. “But we don’t know if CBD is really good for these kinds of diseases.”

Only clinical trials in humans can show if CBD is really effective for an illness, Gobbi said.

In Canada, pharmaceutical companies are sponsoring clinical trials to test CBD products in people.

How do you know what’s in the product?

Depending on what part of the plant is extracted, different components will be present in the oil, the Mayo Clinic authors said. Their list of what clinicians should look for includes:

  • Manufacturing standards certification, such as pesticide or herbicide testing.
  • European Union or Australian organic certification.
  • Lab testing to confirm cannabinoid levels and the absence of heavy metals.

“We see variations from batch to batch where patients are doing well on something, and potentially the next time they seek that same product, potentially they’re not seeing the same effects,” Clarke said.

A research letter published in 2017 in JAMA found nearly 70 per cent of CBD extracts sold online were mislabelled.

“A lot of CBD oil can have very little or contain lots of THC, so you must be very careful,” Gobbi said. “We need more quality control.”

What side-effects have been reported?

In larger studies on CBD treatment for epileptic patients, it was associated with drowsiness, decreased appetite and diarrhea in up to 36 per cent of people, the Mayo Clinic authors said, adding the side-effects were less severe and frequent compared with a conventional anticonvulsant medication.

CBD oil products can have very little of the active ingredient or contain a lot of THC, the main psychoactive component in cannabis that gives users a high. (Tijana Martin/The Canadian Press)

The FDA said its review of a marketing application for Epidiolex suggested potential for liver injury associated with CBD.

“You can’t just self-treat,” Gobbi said.

What about drug interactions?

The main drug interactions doctors and pharmacists look for are drugs, such as morphine, oxycodone, sleeping pills, antidepressants or antipsychotics, that already make you sleepy, confused or impair co-ordination.

“If you’re taking those medications to begin with and you use cannabis, we’d expect that those side effects would get worse,” said Kelly Grindrod of the University of Waterloo’s School of Pharmacy.

Doctors should look for lab testing to confirm cannabinoid levels when looking for products for patients, researchers say. (Guillaume Payen/SOPA Images/LightRocket/Getty)

People should talk to their physician, nurse or pharmacist to discuss potential drug interactions when determining whether to try CBD.

Maddie Brown, a registered practical nurse and cannabis consultant based in Ottawa, helps patients with medical cannabis prescriptions understand how CBD works and obtain it.

“I’m definitely most concerned about blood thinners,” Brown told CBC Radio’s White Coat, Black Art. “CBD can make Coumadin [a blood thinning medication] more potent.”

The general advice is to start low and go slow, especially if taking medications that are known to interact, Grindrod said.

Do You Need a Prescription for CBD Oil in Canada?

As of October 2019, CBD (cannabidiol) oil with a THC level > 3% continues to require a prescription, however laws are subject to change and alternatives continue to be available (details below).

The regulation of cannabis and all its derivatives in Canada continues to be governed by the Cannabis Act which set forth regulations for the production, sale and distribution of cannabis since 2018.

Of particular concern is the legality of CBD oil. Known to be helpful for a variety of ailments, its popularity has increased substantially around the world due to its therapeutic use in a variety of conditions. Some of the well-known positive effects relate to its relaxing effect on the brain which in turn affects the nervous system and eases pain, anxiety and promotes healthy sleep.

Since CBD is one of the chemical substances in the highly regulated/prohibited cannabis plant, there has been a great deal of confusion regarding the legalities and possible prescription requirements for the purchase of CBD oil in Canada.

Under the Cannabis Act, strict regulations on products containing CBD (including CBD oil) continue to be enforced. Sale of these products is legal when they are sold under compliance with the regulations governing possession, production, distribution & sale through licensed producers and distributors.

Each province has its own age limits and licensing agency. The regulatory body in Ontario, for example, is the Alcohol and Gaming Commission of Ontario which has been given the right to regulate the sale of marijuana in private stores in this province.

Prior to all this, the Access to Cannabis for Medical Purposes Regulations (ACMPR) came into effect in 2016 recognizing the rights of individuals to produce medical cannabis products including oils, tinctures, edibles and plant flowers with a valid authorization (prescription) from their healthcare practitioner.

Cannabis Act Amendment (2019)

The Cannabis Act was recently amended on October 17, 2019, to allow growth in the market that was hindered as a result of heavy legal barriers and government restrictions.

The main changes involve regulatory laws regarding provincial approval of operating licenses for sale of edible and topical products containing cannabis.

The amendment now allows licensed producers to submit edible and topical products to Health Canada which are then subject to a 60-to-90-day approval and procurement process.

Rules Governing CBD Oil & Prescriptions

The current rules governing the requirement of a prescription for CBD oil are as follows:

  • CBD oil with a THC level > 3% is legal with a prescription from a licensed supplier or dispensary
  • CBD oil with a THC level < 0.3% is legal in Canada without a prescription, for personal use only

CBD oil is available for sale in Canada with or without a prescription from either provincially or territorially-authorized cannabis retailers or federally-licensed seller of cannabis for medical purposes.

The Popularity of CBD Oil Continues to Rise

CBD is an extract from the cannabis plant that has been used to support health by supplementing the human endocannabinoid system.

The system contains receptors that produce an effect on the brain when supplemented with CBD compounds, producing a positive effect on the nervous system and overall feeling of wellbeing.

CBD does not produce THC (tetrahyrocannabinol), the primary psychoactive component of cannabis that creates an intoxicated or “high” feeling.

Cannabinoids such as CBD direct certain receptors in the brain to use cannabinoids naturally produced in the body. The net effect of this action is the therapeutic effect commonly associated with the use of CBD oil.

The Benefits of High-Quality CBD Oil

CBD Oil is being used for a variety of health conditions, including:

  • Depression
  • Epilepsy
  • Pain relief
  • Reducing inflammation
  • Anxiety
  • PTSD
  • Multiple sclerosis
  • Acne & other skin conditions

How Do You Take CBD Oil?

CBD Oil can be taken through ingestion of edible food products such as baked goods, candies or infused into butter or other oils. Other popular ways include capsules, pills or inhalation through the use of vaporization devices.

A very effective way to take CBD oil is via a tincture commonly administered under the tongue which has been shown to be best for absorption.

CBD Oil & Canadian Law

Despite its many benefits, CBD oil in Canada continues to be a highly-regulated product requiring a prescription when THC levels exceed 3%.

CBD oil legally available with a prescription in Canada is only available through producers licensed by the government under the Cannabis Act.

Issues with CBD Oil Quality in Canada

The quality of CBD oil available by government-licensed producers has come into question with consumer complaints being made about the minimal availability and quality of the product.

The most common issue about the oils produced by licensed distributors concerns the “carrier” oil, which has been suspected to be of low quality and contain significant amounts of pesticides and herbicides.

Consumer reviews about the quality of CBD oil have determined that the best quality CBD oil was available from “grey market” retailers that were operating in the dispensary market prior to the Cannabis Act of 2018.

Availability of High-Quality CBD Oil

The current law states that only federally-approved companies may sell CBD oil in Canada which has been found to be of lower quality.

Companies with the capacity to produce high-quality CBD oil and sell through dispensaries are not legally allowed to sell their products in Canada due to restrictions in the current licensing framework.

Plans to include dispensary operations in the current framework are currently underway for inclusion in the regulatory framework. Until that time most Canadians currently opt to purchase high-quality CBD oil with THC from online sources.

Why Can’t I Easily Get Legal CBD Oil In Canada?

In October of 2018, Canada joined a very niche club, becoming only the second country in the world (after Uruguay) to legalize recreational cannabis. However, if you thought that meant the streets would be paved in green leaves up north, you would be wrong.

Canada is divided into provinces that, like the states in the U.S., have their own laws and regulations separate from federal rulings. That means that although the Cannabis Act applies to all of Canada, depending on where you live your ability to purchase cannabis may differ. As the law rolled out some infrastructure problems made the transition a little bumpy, with supply chain issues and confusing regulations. When it came to accessing CBD products, in particular, consumers were really confused.

In October 2018, Canada became the second country in the world to legalize psychoactive cannabis (“marijuana”).

Is CBD Oil Legal in Canada?

This is where things get tricky. CBD has had a complicated journey towards legislation in the U.S. with different states determining it to be either legal or illegal, with the final say often coming down to how it was produced. CBD derived from hemp has generally been considered permissible while CBD from marijuana has not.

With the passing of the Farm Bill, it was thought that all hemp-derived CBD would be totally legal but a press release from the FDA threw more confusion into the mix with a warning that CBD cannot be added to foods, that health claims would be rigorously tested, and a suggestion that in the future they would “consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement.”

One of the sticking points seems to be that although there are studies showing CBD can alleviate feelings of social anxiety and that it reduces inflammation and works as a pain reliever, medical claims made by CBD producers and manufacturers are untested and not regulated federally.

As reported by Ministry of Hemp, in some states CBD products are sold out in the open in major grocery chains and yet in other states, people are still being arrested for selling CBD products.

An Overview Of Legal Cannabis in Canada

The new official rules in Canada allow members of the public to possess and share up to 30 grams of legally acquired cannabis and grow up to 4 plants per residence for personal use. That provision that the cannabis must be “legally acquired” states that it must come from an approved provincial or territorial retailer. It’s also of note that in the official announcement mentions of CBD products specifically are missing.

The Cannabis Act states that “Other products, such as edible products and concentrates, will be legal for sale approximately one year after the Cannabis Act has come into force and federal regulations for their production have been developed and brought into force.”

It seems that the Canadian government is going with a soft launch focusing on psychoactive cannabis containing THC with plans to address CBD and other cannabis products at a later date.

After Uruguay, Canada is the second country in the world to legalize the recreational use of cannabis. However, legal CBD oil in Canada remains difficult to come by.

Coupled with this slow rollout is the fact that government officials and lawmakers have not made a distinction between products containing THC and CBD, as Trina Fraser, partner at Brazeau Seller Law, in Ottawa, Ontario explained:

“CBD, in and of itself, falls within the definition of “cannabis” in the federal Cannabis Act. As such, it is regulated just like all other cannabis products containing THC. Hemp farmers can grow hemp for the purpose of CBD extraction, but the plant must be sold to a federally licensed processor to conduct the CBD extraction, and then the CBD is subject to the same rules as all cannabis extracts.”

Canadian Cannabis Law Causes Confusion Over CBD Products

Fraser explained that there was a proposal to permit natural health products containing CBD, but it seems the process was stalled and never completed.

As CBD oil products do not have the same effect as THC consumers believe falsely that they are always legal. “There seems to be a pervasive misunderstanding as to the legal status of CBD,” said Fraser.

“Mary” from Ottawa [name changed to protect from possible prosecution] is one such confused consumer. She uses CBD to control her anxiety and told us that life without it is immeasurably worse. “I really need my CBD products, they help to keep me relaxed and to deal with symptoms of PTSD, but I really don’t understand whether or not I am allowed to legally purchase them. I order offline from a US company and they mail it to me. I have always received it with no problem, but I find I am anxious until I get my package,” she said.

What Are Licenced Producers?

Steven Looi, Director of Origination at White Sheep Corp and an industry expert from Toronto said that “CBD is treated the exact same way that THC is treated, in fact, all cannabinoids receive the same treatment in Canada. CBD is illegal unless it comes from a licensed producer.”

Health Canada claims that to become a licensed producer in Canada applicants must go through a screening process that is the toughest in the world for cannabis producers.

Consumers cannot legally purchase cannabis from any other producer.

“I really need my CBD products, they help to keep me relaxed and to deal with symptoms of PTSD, but I really don’t understand whether or not I am allowed to legally purchase them.” — “Mary,” a Canadian CBD consumer

According to Statistics Canada, there are over 100 licensed producers registered in Canada, although there may not be that number currently producing and selling their products.

Only those people with a prescription for medical marijuana can purchase CBD and only through companies authorized by the MMPR — the Marijuana for Medical Purposes Regulations. Of those 100 licensed Canadian producers, only 23 have been registered under the MMPR and are able to sell directly to the public. Therefore legally purchasing CBD in Canada, even if you have a prescription, can be very difficult.

Change is Coming For Canadian CBD Consumers

Changes are coming soon though in conjunction with ongoing public consultation, slated to be completed by the end of 2022. “All sorts of new product types will enter the legal marketplace and permit the legal sale of many products that are currently only available illegally,” said Fraser.

Experts expect access to legal CBD in Canada will improve in the coming year.

However, although it may seem that all of this uncertainty will be ironed out by years end, purchasing CBD in Canada will still require effort, despite the new laws. Legal CBD products will continue to only be available through authorized retailers and products will carry security features on the packaging like cigarettes and alcohol. There will also be strict limitations in place in terms of the health claims producers can make. Health Canada follows the legislative leaders and also makes no distinction between CBD from hemp or marijuana.

Looi pointed out that “For folks going the legal route for a CBD, legalization will give them greater access, and more products. For folks that always sourced their meds in the black market, not a whole lot has changed.”

Once edibles and other cannabis products are legalized Looi said Canadians will have access to some of the same types of products that are currently flooding the American market.

“Canadians will have better access to a proliferation of CBD products. Marketing, storytelling, and promotion will encourage many new consumers to purchase products featuring CBD,” he said.

As with any emerging industry, there are certain to be teething problems both in Canada and the United States. Unfortunately for CBD users in Canada, the much longed-for legalization has not automatically made CBD accessible for all.