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is cbd oil regulated

Cannabidiol (CBD)

There is increasing interest, both in Canada and worldwide, in CBD. CBD is a compound found in the cannabis plant. It is regulated in Canada under the Cannabis Act.

On this page

  • Where CBD comes from
  • How we regulate CBD in Canada
  • Growing cannabis plants containing CBD commercially
  • Producing and selling CBD
  • Importing and exporting CBD products
  • Industrial hemp
  • What industrial hemp licence holders may and may not do
  • Importing and exporting industrial hemp
  • The difference between cannabis oil and hemp-seed oil
  • CBD and prescription drugs
  • CBD in natural health products, veterinary health products and cosmetics
  • CBD in human food or pet food

Where CBD comes from

The cannabis plant contains hundreds of chemical substances. Over 100 of these are known as cannabinoids. Cannabinoids derived from cannabis plants are sometimes called phytocannabinoids.

Cannabidiol (CBD) is one of these cannabinoids. CBD is not intoxicating and may reduce some of the effects of tetrahydracannabinol (THC); however, it does have an effect on the brain.

CBD can be found in different varieties of the cannabis plant, including hemp.

All phytocannabinoids are regulated under the new Cannabis Act. The Act came into force on October 17, 2018.

How we regulate CBD in Canada

CBD is a controlled substance under United Nations drug control conventions. Consistent with the controlled status of CBD internationally, CBD is a controlled substance in Canada and other jurisdictions.

As a result, CBD and products containing CBD are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations. This includes CBD derived from industrial hemp plants, as well as CBD derived from other varieties of cannabis.

Under the Cannabis Act activities with phytocannabinoids (including CBD) remain illegal, unless authorized.

Before the Cannabis Act came into force, CBD was:

  • regulated under the Controlled Drugs and Substances Act
  • strictly controlled

It was not legal to produce, sell, import or export CBD unless authorized for medical or scientific purposes.

Under the Cannabis Act, CBD products remain strictly regulated and are only legal when sold in compliance with the Act and its regulations.

The Act and accompanying regulations place strict controls on cannabis:

  • possession
  • production
  • distribution
  • sale

Health Canada oversees the production of cannabis products. Health Canada is also responsible for overseeing the distribution and sale of:

  • cannabis, including any CBD-containing cannabis products for medical purposes

The provinces and territories are responsible for determining how cannabis is distributed and sold within their jurisdictions.

They set rules around:

  • how cannabis products can be sold
  • where stores may be located
  • how stores must be operated

Growing cannabis plants containing CBD for commercial sale

To cultivate any cannabis plants that you intend to sell, you must have a federal licence issued under the Cannabis Act.

This licence could be:

  • a cultivation licence under the Cannabis Regulations
    • authorizing growing of cannabis plants with varying amounts of THC and CBD
  • an industrial hemp licence under the Industrial Hemp Regulations
    • authorizing cultivation of specific varieties of cannabis plants with a THC content of no more than 0.3% in the flowering heads, branches and leaves.

Producing and selling CBD

CBD and products containing CBD are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations.

You must have a processing licence to manufacture products containing CBD for sale, no matter what the source of the CBD is.

CBD and products containing CBD, such as cannabis oil, may only be sold by a:

  • provincially or territorially-authorized cannabis retailer
  • federally-licensed seller of cannabis for medical purposes

Importing and exporting CBD products

Movement of cannabis and cannabis products between countries is covered by 3 United Nations drug conventions, including the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol.

CBD is currently a controlled substance under the Single Convention. CBD products may therefore only be imported or exported under very specific conditions. Any import or export must meet all of these criteria and may only be done:

  • by a holder of a licence issued under the Cannabis Regulations
  • under an import or export permit issued to the licence holder by Health Canada for that shipment
  • for a legitimate scientific or medical purpose, as per international agreements

Industrial hemp

Industrial hemp is cannabis that contains 0.3% THC or less in the flowering heads and leaves.

The Industrial Hemp Regulations under the Cannabis Act set out the requirements for cultivators of industrial hemp. As is currently the case, cultivators of industrial hemp must grow from the hemp varieties approved for commercial cultivation.

Although it may not have more than 0.3% THC, there is no limit to the amount of CBD that may be contained in industrial hemp plants.

The Cannabis Act and its regulations do not distinguish between CBD derived from industrial hemp and CBD derived from cannabis with greater than 0.3% THC.

What industrial hemp licence holders may and may not do

An industrial hemp licence holder may cultivate hemp to produce a number of different products. They may:

  • sell viable seeds
  • sell grain (i.e. non-viable seeds) or hemp seed derivatives for use in:
    • food
    • cosmetics
    • other products
  • cultivate hemp for the flowering heads, branches and leaves, which may contain CBD
  • sell those flowering heads, branches and leaves to a licence holder under the Cannabis Regulations, who may then extract the CBD

Hemp producers may not extract the CBD themselves, unless they also have a cannabis processing or research licence.

Importing and exporting industrial hemp

The Industrial Hemp Regulations authorize importing and exporting industrial hemp seed or grain, but not the flowering heads, branches or leaves.

The flowering heads, branches and leaves may only be imported or exported by a licence holder under the Cannabis Regulations:

  • with a permit issued under those regulations
  • for legitimate medical and scientific purposes

To import or export the industrial hemp seeds or grain, you must:

  • hold a licence from Health Canada
  • have an import or export permit issued by Health Canada

When importing or exporting industrial hemp seeds or grain, you may also need to obtain an import or export permit from the other country, depending on their rules.

The difference between cannabis oil and hemp-seed oil

Cannabis oil is 1 of the 5 classes of cannabis that may currently be legally sold in Canada by provincially and territorially-authorized retailers:

  • cannabis oil
  • fresh cannabis
  • dried cannabis
  • cannabis seeds
  • cannabis plants

Cannabis oil is a combination of:

  • cannabis:
    • usually in the form of a THC and/or CBD-rich extract from the leaves and flowering heads of the cannabis plant, which may include plants classified as industrial hemp
  • a vegetable-based or plant-based oil such as:
    • olive
    • canola
    • grape seed
    • hemp-seed oil

Hemp-seed oil is oil made from pressing the grain of hemp plants. It is processed like other oil seeds, such as canola. In order for hemp-seed oil to be exempt from the Cannabis Act, it can’t contain more than 10 parts per million of THC.

For hemp-seed oil to be exempted from the Cannabis Act, no phytocannabinoid including THC and CBD may be added or concentrated by processing.

Hemp-seed oil is marketed in Canada in:

  • food
  • cosmetics
  • natural health products
  • veterinary health products

CBD and prescription drugs

All phytocannabinoids, with several exceptions, are listed on the Prescription Drug List. If you wish to manufacture and sell a health product containing CBD that makes a health claim, you require approval for the product as a prescription drug under the Food and Drug Regulations.

CBD in natural health products, veterinary health products and cosmetics

Only limited parts of cannabis or hemp plants may be used in a:

  • natural health product (NHPs)
    • under the Natural Health Product Regulations
  • veterinary health product (VHPs)
    • under the Food and Drug Regulations

NHPs and VHPs may only contain parts of the cannabis and hemp plants that are not considered cannabis under the Cannabis Act or that are excluded from the application of the Act. This includes things such as:

  • non-viable seeds
  • hemp-seed derivatives that are compliant with the Industrial Hemp Regulations
  • mature stalks that do not include any leaves, flowers, seeds or branches and fibre from such stalks are also excluded from the Cannabis Act, but they may not be used in veterinary health products.

Deliberately adding phytocannabinoids to such products is not permitted.

These same restrictions also apply to cosmetics, which may only contain hemp derivatives.

CBD in human food or pet food

Edible cannabis will not be permitted for sale until the Regulations Amending the Cannabis Regulations (New Classes of Cannabis) come into force on October 17, 2019.
These regulations set out strict controls to reduce the:

  • appeal of such products to youth;
  • risk of accidental consumption, especially of edible cannabis, including by youth;
  • risk of overconsumption associated with edible cannabis because of the delay in experiencing the effects of cannabis when it is ingested rather than inhaled; and
  • risk of foodborne illness associated with the production and consumption of edible cannabis.

Edible cannabis will only be available for human consumption.

Cannabidiol (CBD) is found in cannabis plants. About its regulation, growing, selling, importing, exporting, about industrial hemp and CBD in drugs, food and other products.

U.S. Food and Drug Administration

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

Cannabis leaves and Cannabidiol (CBD) chemical structure montage

  • Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the component that produces the “high” associated with marijuana use. Much interest has been seen around CBD and its potential related to health benefits.
  • Marijuana is different from CBD. CBD is a single compound in the cannabis plant, and marijuana is a type of cannabis plant or plant material that contains many naturally occurring compounds, including CBD and THC.
  • The FDA has approved only one CBD product, a prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older.
  • It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
  • The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.
  • Some CBD products are being marketed with unproven medical claims and are of unknown quality.
  • The FDA will continue to update the public as it learns more about CBD.

Potential harm, side effects and unknowns

  1. CBD has the potential to harm you, and harm can happen even before you become aware of it.
    • CBD can cause liver injury.
    • CBD can affect how other drugs you are taking work, potentially causing serious side effects.
    • Use of CBD with alcohol or other drugs that slow brain activity, such as those used to treat anxiety, panic, stress, or sleep disorders, increases the risk of sedation and drowsiness, which can lead to injuries.
    • Male reproductive toxicity, or damage to fertility in males or male offspring of women who have been exposed, has been reported in studies of animals exposed to CBD.
  2. CBD can cause side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced.
    • Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness).
    • Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite.
    • Changes in mood, most commonly experienced as irritability and agitation.
  3. There are many important aspects about CBD that we just don’t know, such as:
    • What happens if you take CBD daily for sustained periods of time?
    • What level of intake triggers the known risks associated with CBD?
    • How do different methods of consumption affect intake (e.g., oral consumption, topical , smoking or vaping)?
    • What is the effect of CBD on the developing brain (such as on children who take CBD)?
    • What are the effects of CBD on the developing fetus or breastfed newborn?
    • How does CBD interact with herbs and other plant materials?
    • Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

Unanswered questions about the science, safety, and quality

You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products. Other than one prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.

Cannabidiol (CBD) chemical structure image graphic superimposed over photo of marijuana leaves

The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.

Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.

The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:

  • Liver Injury: During its review of the marketing application for Epidiolex — a purified form of CBD that the FDA approved in 2018 for use in the treatment of two rare and severe seizure disorders — the FDA identified certain safety risks, including the potential for liver injury. This serious risk can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how it might be managed when CBD is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling. Although this risk was increased when taken with other drugs that impact the liver, signs of liver injury were seen also in patients not on those drugs. The occurrence of this liver injury was identified through blood tests, as is often the case with early problems with the liver. Liver injury was also seen in other studies of CBD in published literature. We are concerned about potential liver injury associated with CBD use that could go undetected if not monitored by a healthcare provider.
  • Drug Interactions: Information from studies of the FDA-approved CBD drug Epidiolex show that there is a risk of CBD impacting other medicines you take – or that other medicines you take could impact the dose of CBD that can safely be used. Taking CBD with other medications may increase or decrease the effects of the other medications. This may lead to an increased chance of adverse effects from, or decreased effectiveness of, the other medications. Drug interactions were also seen in other studies of CBD in published literature. We are concerned about the potential safety of taking other medicines with CBD when not being monitored by a healthcare provider. In addition, there is limited research on the interactions between CBD products and herbs or other plant-based products in dietary supplements. Consumers should use caution when combining CBD products with herbs or dietary supplements.
  • Male Reproductive Toxicity: Studies in laboratory animals showed male reproductive toxicity, including in the male offspring of CBD-treated pregnant females. The changes seen include decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone, among others. Because these findings were only seen in animals, it is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD. For instance, these findings raise the concern that CBD could negatively affect a man’s fertility. Further testing and evaluation are needed to better understand this potential risk.

In addition, CBD can be the cause of side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced. This could include changes in alertness, most commonly experienced as somnolence (sleepiness), but this could also include insomnia; gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite but could also include abdominal pain or upset stomach; and changes in mood, most commonly experienced as irritability and agitation.

The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:

  • Cumulative Exposure: The cumulative exposure to CBD if people access it across a broad range of consumer products. For example, what happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day? How much CBD is absorbed from your skin cream? What if you use these products daily for a week or a month?
  • Special Populations: The effects of CBD on other special populations (e.g., the elderly, children, adolescents, pregnant and lactating women).
  • CBD and Animals: The safety of CBD use in pets and other animals, including considerations of species, breed, or class and the safety of the resulting human food products (e.g., meat milk, or eggs) from food-producing species.

Unproven medical claims, unsafe manufacturing practices

Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices

Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.

Misleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care. For that reason, it’s important to talk to your doctor about the best way to treat diseases or conditions with available FDA-approved treatment options.

In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).

CBD products are also being marketed for pets and other animals. The FDA has not approved CBD for any use in animals and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals. The FDA recommends pet owners talk with their veterinarians about appropriate treatment options for their pets.

The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.

Evaluation of the regulatory frameworks

The FDA is Continuing to Evaluate the Regulatory Frameworks for Products Containing Cannabis and Cannabis-Derived Compounds

The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.

We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is illegal to market CBD this way.

The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.

The FDA is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know. We encourage consumers to think carefully before exposing themselves, their family, or their pets, to any product, especially products like CBD, which may have potential risks, be of unknown quality, and have unproven benefits.

Our Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make informed choices about CBD products. Also, as the regulatory pathways are clarified we will take care to inform all stakeholders as quickly as possible.

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.