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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 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 two rare, severe forms of epilepsy.
  • 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 two rare, severe forms of epilepsy, 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.

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.

What is CBD oil and is it legal in the UK?

Cannabidiol has entered the mainstream, but effects are unclear

CBD oil can be used in various forms

CBD oil has entered the mainstream in recent years, bringing with it zealous advocates and dismissive sceptics.

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Also known as Cannabidiol, CBD is found in the cannabis plant. But unlike THC – the ingredient that makes cannabis users high – CBD has no psychoactive effect.

Instead, it is used by people who want to manage conditions like chronic pain, PTSD and epilepsy. The substance is also being trialled to see if it can help with anxiety and arthritis.

CBD can now be found in a range of products in high street stores, from vape liquid to “sweets, creams and even sexual lubricants”, says ITV News.

The number of people using CBD oil, also known as cannabidiol, in the UK alone is estimated to stand at around 1.3m. As GQ magazine says, “thanks to a brand reimagining and increased medical research”, the naturally occurring compound has “gone from dangerous to desirable”.

Advocates of CBD oil say it can relieve chronic pain and inflammation, depression and insomnia, among other conditions. But others say its benefits are oversold and unproven, while many others are confused over its legal status.

Here’s what you need to know:

What is CBD oil?

Cannabis plants are made up of more than 100 different cannabinoids, chemical compounds that act on cannabinoid receptors in cells that alter neurotransmitter release in the human brain. These have different impacts on the body and are concentrated to different extents in certain parts of the plant, the BBC reports.

The most well known of the compounds are tetrahydrocannabinol (THC) and cannabidiol (CBD).

In the UK, it is possible to get a prescription for oil made from CBD because it won’t get users “high”. By contrast, THC is a psychoactive chemical and is a controlled substance under the Misuse of Drugs Act 1971.

Why and how is it used?

A 2017 report by the World Health Organisation (WHO) found that CBD could provide relief for a variety of debilitating conditions including Alzheimer’s disease, Parkinson’s, multiple sclerosis, cancer and diabetic complications, as well as general pain, anxiety and depression.

“There isn’t enough evidence to say that the oil definitely does help with these things, nor that simply cramming some in a milkshake will do the slightest bit of good, just that doctors are optimistic about their research,” says lifestyle magazine The Street.

One recent study has also now linked CBD oil to healthy weight loss. The research, published in the journal Molecular and Cellular Biochemistry, linked the drug to three causes of “fat browning”, which turns the dangerous white fat associated with obesity and diabetes into hard-working brown fat cells. These actively aid weight loss by burning extra calories through thermogenesis, your body’s heat-production process.

What’s more, CBD “reduces the expression of proteins involved in creating new fat cells, and it boosts the number of mitochondria in your brown fat cells”, says Men’s Health. This could further increase their fat-stripping power, the scientists suggest.

However, it is important to note that licences for CBD oil as a medicine have not been granted yet, and manufacturers cannot make claims about their alleged medical benefits.

CBD oil can be used in a number of different ways, says health information site Verywell. “You can smoke it (typically in vape pens), take it in capsule form, use it sublingually (under the tongue), use oral sprays or drops, or apply it topically to your skin,” the site explains.

Gels and rubs aimed at athletes are available in shops, while pensioners are using the products in the hope of alleviating arthritis.

“A crystalline form of pure CBD is also available, and it’s generally taken sublingually.”

CBD is available in a range of products sold on the high street and online, including creams, oils, tinctures and edible treats such as gummy sweets. There are even CBD-infused pillowcases and yoga classes offering CBD-assisted guided meditation.

The medical effects of CBD aside, “in many cases, the industry is taking consumers for a ride”, says Mike Power in The Guardian. He cites lab tests commissioned by the think tank Centre for Medicinal Cannabis (CMC) which analysed high-street offerings and found that more than half of the most popular CBD oils sold do not contain the level of CBD promised on the label.

Yet market research by the CMC estimates that the CBD market in the UK could be worth almost £1bn a year by 2025, “equivalent in size to the current entire UK herbal supplement market”, writes Power.

Ultimately, says ITV News, there’s a big difference between CBD you are given by a healthcare professional, and the less regulated CBD oil you can get on the high street.

CBD available in shops is often of lower quality and far lower strength than the oil used in clinical trials.

According to the British Medical Journal (BMJ), high street products contain roughly 25mg CBD, compared to the 150-1,500mg/day that users are given in clinical trials, says ITV.

But is it legal?

As Business Matters notes, there is currently “a great deal of confusion around CBD oil UK law”, with the vast majority of cannabinoids listed as controlled substances under the Misuse of Drugs Act.

However, CBD is an exception and is completely legal in the UK, “provided it has been derived from an industrial hemp strain that is EU-approved”, or comes from outside the EU.

For CBD oil to be legal in the UK, it must contain no THC. Cannabis oil, which has THC content, is not usually allowed in the UK.

There is an exemption to this rule, the BBC reports. Sativex, a 50-50 mix of THC and CBD produced in a lab, has been approved for use in the UK as a treatment for multiple sclerosis.

And specialist clinicians are allowed to prescribe other cannabis-derived medicinal products under changes to the law that came into force in November.

However, medicinal cannabis is currently unlicensed – so it can only be prescribed if a patient has a need that cannot be met by licensed medicines.

One of the arguments against the use of the medication “is that there have not been satisfactory drug trials to prove its safety and effectiveness”, reports the BBC’s Debbie Jackson.

In The Guardian, Mike Power writes: “There is now no denying the medicinal value of CBD and THC – not even by the British government, which for years maintained that lie even as it rubber-stamped the cultivation and export of the world’s largest medicinal cannabis crop. But the landmark decision in November 2018 to allow UK doctors to prescribe cannabis under extremely limited circumstances, inspired by the cases of Billy Caldwell and Alfie Dingley, whose epilepsy is improved immeasurably by medicinal cannabis products containing both THC and CBD, has left many in a limbo: knowing or believing that cannabis offers a cure, yet remaining unable to access it.”

This has resulted in a number of high-profile cases of parents taking their children out of the UK in order to access treatment.

One such parent is Julie Galloway, who left Scotland with her severely ill daughter Alexa, seven, almost 12 months ago to live in the Netherlands.

“I feel like a refugee forced to live abroad to save my child,” Galloway told the BBC. “I want to come home but I am terrified the medication will be confiscated. I am struggling to pay for it and I know this can’t go on forever.”

Cannabidiol has entered the mainstream, but effects are unclear