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cbd market

CBD Edible Market

CBD is not a Narcotic

#NOVELFOODS
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UK to take the lead and define the safety standards for the sustainable future of the CBD industry?

The European Commission (EC) has said on record that it is pausing all CBD novel foods applications as it reviews whether CBD should not be classified as a food at all, but instead a narcotic.

The reasoning behind this pause relates to a line on the United Nations Single Convention on Narcotic Drugs from 1961 which states that “extracts and tinctures” of the flowering tops of the hemp plant (cannabis sativa) should be classed as a narcotic. CBD companies have until September to put forward their case to the EC.

It is peculiar that the EC should be reassessing their forward-looking classification of CBD as a novel food based on a 60-year-old convention that resulted in the devastating war on drugs. A battle which has been, in the words of Barack Obama, “an utter failure”.

You would think they would have learnt the lesson on the damage caused through making popular substances illicit, based on non-scientific evidence.

The World Health Organization (WHO) produced a critical review of CBD in 2018, in which they concluded it “exhibits no effects indicative of any abuse or dependence potential” and “is generally well tolerated with a good safety profile”. They also say in the report that “there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.”

These WHO conclusions do not reflect the properties that you would associate with a “narcotic”. WHO have put forward a series of recommendations to the UN to amend the Single Convention on Narcotic Drugs from 1961, one of which is the removal of the phrase “tinctures and extracts”  from Schedule 1 of the 1961 treaty and another to make CBD exempt from international control. The UN will vote on these recommendations in December 2020.

You would think they would have learnt the lesson on the damage caused through making popular substances illicit, based on non-scientific evidence.

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The World Health Organization (WHO) produced a critical review of CBD in 2018, in which they concluded it “exhibits no effects indicative of any abuse or dependence potential” and “is generally well tolerated with a good safety profile”. They also say in the report that “there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.”

These WHO conclusions do not reflect the properties that you would associate with a “narcotic”. WHO have put forward a series of recommendations to the UN to amend the Single Convention on Narcotic Drugs from 1961, one of which is the removal of the phrase “tinctures and extracts”  from Schedule 1 of the 1961 treaty and another to make CBD exempt from international control. The UN will vote on these recommendations in December 2020.

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In the US, the FDA has approved Epidiolex, which contains CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older. This demonstrates that the FDA has concluded this particular drug product is safe and effective for its intended use.

The FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors they intend to take into account in prioritising enforcement decisions. They intend to balance the goals of protecting the public and providing more clarity to industry regarding their enforcement priorities as they move towards a clear regulatory pathway. This seems a well reasoned and realistic approach.

There exists a trend for consumers towards organic products and many foods are being consumed for their health benefits. The concept of food as a medicine is a powerful and healthy option, and CBD is a prime example of such a product with popularity on the rise, as reflected in sales.

Should the EC deem CBD to be a controlled narcotic it will have a devastating impact on the lives of millions of European CBD consumers who rely upon the therapeutic properties of CBD they consume. For these people, CBD has been a life-changer, if not a life-saver, and has enabled them to avoid or reduce more harmful prescription drugs, reduce smoking, decrease alcohol consumption and keep away from other dangerous drugs. You could argue that CBD would reduce demands on European health services and can make people’s lives healthier, thus making them a more productive workforce.

Beyond the impact on consumers, there will be the impact on the hundreds, if not thousands, of companies that have sprung up around the CBD economy. These companies employ hundreds of thousands of people and serve millions.

The European Commission cannot believe that consumers will simply stop buying CBD. The demand will continue to exist. This demand is increasing month on month as people spread their positive testimonies of the therapeutic benefits they experience from consuming CBD products.

The results of such a decision, should it come to fruition, would be CBD moving into the black market. There are already concerns over the safety and authenticity of CBD products on the market, and outlawing CBD will make the situation infinitely worse.

Despite the resistance from many in the CBD industry as to whether CBD should be a novel food in the first place, it does have great benefits. This is because it forces the industry to generate the data to verify the safety of CBD for humans. However, all that work will be in vain should the EC decide it is in fact a controlled narcotic.

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As for the UK CBD market, this decision would seem to have little impact, and could even be a golden opportunity for our domestic CBD industry, which is estimated to be worth £1 billion by 2025. The UK Foods Standards Agency (FSA) has on record said that they follow the lead of the Home Office who categorically say CBD is not a narcotic.

The FSA had also always been in agreement with the European Food Safety Authority (EFSA) that CBD is a novel food and products need to go through a safety and risk assessment before they can be legally sold as a food supplement. As the UK is about to go its separate way to the rest of the European Union, the FSA has put in place a plan to bring the equivalent of novel foods assessment in-house. This leaves the UK with an excellent opportunity to take the lead and define the safety standards for the sustainable future of the CBD industry.

what does novel food mean

Is the CBD bubble about to burst?

Business guidance on cannabidiol (CBD) as a novel food

#novelfoods #novelfood #cbddrinks

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Novel foods or novel food ingredients have no history of “significant” consumption in the European Union prior to 15 May 1997.

Any food or food ingredient that falls within this definition must be authorised according to the Novel Food legislation, Regulation (EC) No 258/97 of the European Parliament and of the Council.

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Novel foods

How to ensure the products you sell comply with the legislation for novel foods.

How to ensure the products you sell comply with the legislation for novel foods.

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  1. Novel food authorisation
  2. Union list and authorised novel foods
  3. Determining novel status
  4. Cannabidiol (CBD) products
  5. Consultation process (Article 4)
  6. Process for authorisation of a novel food
  7. Enforcement

Novel foods are foods which have not been widely consumed by people in the UK or EU before May 1997. This means that the foods don’t have a ‘history of consumption’. Examples of novel foods include:

  • new foods, for example, phytosterols and phytostanols used in cholesterol reducing spreads
  • traditional foods eaten elsewhere in the world, for example, chia seeds, baobab
  • foods produced from new processes, for example, bread treated with ultraviolet light to increase the level of vitamin D present

We are responsible for ensuring that novel foods coming on to the market are safe for consumers. 

Novel food authorisation

Before a novel food can be legally marketed in the UK, it is required to have a pre-market safety assessment and authorisation.

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This applies to any food and food ingredient that hadn’t been used in the UK or EU for human consumption to a significant degree before May 1997.
 
The food must also be either:

  • food ingredients with a new or intentionally modified primary molecular structure
  • micro-organisms, fungi, algae or cell culture
  • plants or animals
  • food produced by new production process that significantly changes the product nutritionally or in relation to the food safety risks
  • minerals or engineered nano-materials

Food additives, flavourings, and extraction solvents used in the production of food are excluded from the definition of novel foods, but also require pre-market safety assessment and authorisation. 

Union list and authorised novel foods

  • safe
  • not misleading for the consumer
  • not replace other foods in a way that would put consumers at a nutritional disadvantage

Unless the data protection measures are triggered, you can sell an authorised novel food in accordance with the conditions set out in the Union list. The Union list shows where data protection is in place.

You have to submit a novel food application if you want to sell a novel food in a way that is not included in the Union list. 

Where data protection is triggered, for a period of five years the authorisation can only be used by the applicant. This would not prevent other applicants seeking their own separate authorisation.

Determining novel status

It is your responsibility to know if the novel foods regulation applies to a product you want to sell. While there is no single list of novel foods, or a list of foods that are not novel, you can check the following resources:

Cannabidiol (CBD) products

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The novel food status of CBD extracts was confirmed in January 2019, and the Novel food catalogue has been updated to reflect this change. 

You can find more information on CBD products in our CBD guidance.

Consultation process

  • are unsure of the status of your product 
  • have evidence that it has a history of consumption in the UK or EU prior to May 1997 

Commission implementing regulation (EU) 2018/456 (Opens in a new window) details the information that is required by authorities to make a decision on whether the product is subject to the Novel Foods Regulation.

This consultation will need to be sent to an EU member state, and as the UK is no longer a member state we are not able to accept any requests at this time. The outcome of the process will be made publicly available on the Commission’s website.

If the consultation process decides your product is novel, then you will need to apply for authorisation to legally market the product in the EU. 

Process for authorisation of a novel food

If you intend to market a novel food which has not been authorised, you will need to apply for authorisation. There are two authorisation routes under the EU Novel Food Regulation no. 2015/2283  (Opens in a new window)and there is no fee payable.

In both cases you must provide a dossier of information and submit it to the European Commission through an electronic portal. (Opens in a new window)

There is further advice available on the procedure for submitting applications to the UK from 1 January 2021.

Traditional foods from countries outside the UK or EU

This is a simplified route to authorise products that have 25 years’ continuous use by a significant number of people in a country outside the UK or EU. 

This route has reduced data requirements reflecting their wide use in other parts of the world. The European Food Safety Authority (EFSA) has published guidance for traditional foods from third countries .

If no objections are received from member states or EFSA within a four-month period, the product is authorised and placed on the Union list.

If objections are raised, there is an additional opportunity to address the areas highlighted through a traditional food application.

Full applications

For all other novel foods, a full set of information is required to be submitted to the Commission which will ask the advice of EFSA where appropriate. EFSA has published guidance on the scientific requirements of an application.

It can take up to nine months for a risk assessment to be completed when further information is not required. If there is a positive EFSA opinion, the Commission has a further seven months to authorise the food and add it to the Union list of novel foods.

Enforcement

Local authorities, including Trading Standards and Environmental Health Officers, are responsible for the enforcement of novel foods legislation.

If you have a concern about products being marketed which may be illegal or dangerous to health contact the relevant local authority.

insights into the £billion pound cbd edibles industry

 CBD edible sales reached more than $1 billion during 2018 alone. This is expected to continue to grow exponentially to $4.1 billion by 2022.

If you’ve been anywhere near a health shop recently, you’ll have no doubt seen CBD – the non-psychoactive cannabis derivative turned lifestyle craze.

Some estimates say that 7 million people in Britain have already used CBD for its purported wellness benefits (which include relaxation and better sleep). Yet for all the hype, the truth is that the CBD industry is facing a bit of a roadblock. At least in the UK anyway.

CBD Infused Edible Industry-Market Size, Share, Demand, Trends, Statistics, Product Sales, Competitive Landscape and Industry Growth.

Though CBD seemingly arrived from nowhere, this wasn’t a case of it being ‘legalised’ by the government. It was actually never illegal: the oils contain such small traces of THC (the chemical that gets you high), they were never covered by our drugs legislation in the first place. But it wasn’t until cannabis went mainstream in America, that CBD got popular enough to be commercially-viable.

The UK CBD Edibles market is growing rapidly with new products becoming available all the time.

Then last year a bombshell report – the largest study of CBD products in Britain to date – revealed serious concerns about quality control. The report found that not only did most products in Britain suffer from inaccurate labelling, over half of those tested exceeded the permitted amount of THC. That made them illegal, and potentially dangerous too.

In response, the Food Standards Agency – the body that looks after food safety in Britain – has said that, as of March 2021, all CBD products sold here will have to be individually registered as a ‘novel food’. In order to get that status, they need to prove exactly what’s in them (and that they’re not dangerous to human health).

That won’t affect businesses making CBD products not intended to be consumed (like bath-bombs and body-oils) but it will throw a huge spanner in the works for anyone selling oils and vapes. Not least because the vast majority of those products are imported from Europe, often without a guarantee of exactly what’s in them.

Is this the end of CBD in Britain? Probably not. This week Crispin Blunt, the Tory MP and long-term drug reform campaigner, spoke at Europe’s biggest cannabis conference, where he called on Downing Street to take the opportunity to ‘onshore’ the industry – that is, to make it easier for British businesses to produce CBD here, rather than shipping oil from Poland, Czechia and Italy (three of the countries that dominate the CBD wholesale industry).

You can see how this might appeal to the government, but it would also require a major change to the licensing laws around growing cannabis.

After all, the UK has historically been one of the strictest countries in Europe even when it comes to industrial hemp – the low-strength ropey cannabis that is sometimes harvested into cheaper CBD products. Many of the oils you can buy perfectly legally in Britain – that is until next March anyway – would actually be illegal (or at least very difficult to make).

None of this has stopped the CBD fad taking off in Britain. Instead it’s led to a cottage industry of white-label CBD oils being shipped wholesale from Europe and then relabelled by UK companies. Many of these wholesalers exhibit at cannabis conferences in the UK, although the brands that re-sell their goods are less keen to shout about it.

Until now, there’s been no rule that CBD products have to show an independent lab report with an exact breakdown of their CBD and THC content (and that they don’t contain harmful toxins like DXM). While many oils do have test reports, they’re not always the ones that reach the high street. Last time I checked, most of the oils in Holland & Barrett didn’t.

But there’s one other factor that might save the CBD industry. So far the big cannabis firms from North America – the ones with the means and expertise to meet FSA standards – have held back on exporting CBD products to Britain. But that probably had something to do with the fact that the legal status of CBD was slightly ambiguous in the UK.

If nothing else, the FSA ruling shows that the authorities aren’t necessarily worried about CBD per se; just the potential for unsafe products to sneak on to the market. Of course, the government might still decide to ban it, but I’d suspect not. And that just might give the big American firms the confidence to export here.

Does this mean that CBD fans should stock up on their favourite product before March? That might be a little overcautious. You’d hope, after all, that the brands who wax lyrical about the brilliance of the stuff might be willing to ensure their CBD is sourced from quality suppliers. But it does raise a shadow of uncertainty over the industry: and one that’s worth keeping an eye on.

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cbd market

CBD Food Products UK

UK CBD MARKET FACING SHAKE UP

#novelfood #novelfoods

CBD food uk

food.gov.uk/business-guidance/cannabidiol-cbd

Over the last two years, the UK CBD market has enjoyed low barriers to entry, a lack of regulatory standards and extremely high premiums for inconsistent high street products.

However, consumers are advancing their knowledge of CBD and expecting a higher-grade product in return for their investment. With the introduction of real consumer brands on one side and budget brands on the other, along with the inevitable shift away from oils and higher standards across the board, is the age of high margins and poor quality products finally behind us?

A combination of consumer interest, changing legislation and the growing base of knowledge around CBD has led to a rapid increase in CBD sales over the last three years, with poor quality products retailing for a premium. However, the fall of raw material prices, as a result of the immense development of global hemp cultivation, is driving the commoditization of CBD, eroding producers margins and encouraging the emergence of new brand-led value propositions and value added products like CBD-infused food, drinks and cosmetics.

UK market beginning to diverge

Despite the UK being the largest CBD consumer market in Europe, the cultivation of hemp for both CBD and industrial use is comparatively small, estimated at under 1,000 hectares, compared to 50,000 hectares in the US or 18,000 hectares in France. While CBD in the UK is imported owing to restrictions on extraction, analysis from our proprietary price database shows that the evolution of retail prices in the country is more nuanced than what international wholesale prices may suggest.

High-demand categories, like oils and tinctures, have experienced a fall in price per item over the last 12 months. This reflects the strategy of a growing number of producers to cut their prices in order to compete and stand out in this increasingly crowded marketplace. At the same time, we’re observing an increase in the average price of value-added infused products, like edibles and topicals. This would appear to mark a fork in the road of the CBD market as producers are choosing between a pathway of price undercutting and commoditisation or taking steps toward the added value of brand development.

cannabidiol cbd food safety

Cannabidiol

fsa-.gov-Cannabidiol-CBD-guidance-@cbdcakes-DOWNLOAD

Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of 113 identified cannabinoids in cannabis plants and accounts for up to 40% of the plant’s extract. As of 2019, clinical research on cannabidiol included studies of anxiety, cognition, movement disorders, and pain, but there is insufficient high-quality evidence that it is effective for these conditions.

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Cannabidiol can be taken into the body in multiple ways, including by inhalation of cannabis smoke or vapor, as an aerosol spray into the cheek, and by mouth. It may be supplied as CBD oil containing only CBD as the active ingredient (no included tetrahydrocannabinol (THC) or terpenes), a full-plant CBD-dominant hemp extract oil, capsules, dried cannabis, or as a prescription liquid solution. CBD does not have the same psychoactivity as THC,and may change the effects of THC on the body if both are present.As of 2018, the mechanism of action for its putative biological effects has not been determined.

Not to be confused with Cannabinol or Cannabinodiol.

In the United States, the cannabidiol drug Epidiolex was approved by the Food and Drug Administration in 2018 for the treatment of two epilepsy disorders. Since cannabis is a Schedule I controlled substance in the United States, other CBD formulations remain illegal to prescribe for medical use or to use as an ingredient in foods or dietary supplements.

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Medical uses

Epilepsy

In 2018, CBD was FDA-approved (trade name Epidiolex) for the treatment of two forms of treatment-resistant epilepsy: Dravet syndrome and Lennox-Gastaut syndrome in children with refractory epilepsy. The recommended daily dose of Epidiolex is 10 mg per kg body weight per day in epileptic children 2–5 years old. While Epidiolex treatment is generally well tolerated, it is associated with minor adverse effects, such as gastrointestinal upset, decreased appetite, sleepiness and lethargy, and poor sleep quality.

Other uses

Research on other uses for CBD includes several neurological disorders, but the findings have not been confirmed to establish such uses in clinical practice. In October 2019, the FDA issued an advisory warning that the effects of CBD during pregnancy or breastfeeding are unknown, indicating that the safety, doses, interactions with other drugs or foods, and side effects of CBD are not clinically defined, and may pose a risk to the mother and infant.

Side effects

Research indicates that cannabidiol may reduce adverse effects of THC, particularly those causing intoxication and sedation, but only at high doses. Safety studies of cannabidiol showed it is well tolerated, but may cause tiredness, diarrhea, or changes in appetite as common adverse effects. Epidiolex documentation lists sleepiness, insomnia and poor quality sleep, decreased appetite, diarrhea, and fatigue.

Potential interactions

Laboratory evidence indicated that cannabidiol may reduce THC clearance, increasing plasma concentrations which may raise THC availability to receptors and enhance its effect in a dose-dependent manner. In vitro, cannabidiol inhibited receptors affecting the activity of voltage-dependent sodium and potassium channels, which may affect neural activity. A small clinical trial reported that CBD partially inhibited the CYP2C-catalyzed hydroxylation of THC to 11-OH-THC. Little is known about potential drug interactions, but CBD mediates a decrease in clobazam metabolism.

Pharmacology

Pharmacodynamics

Cannabidiol has low affinity for the cannabinoid CB1 and CB2 receptors,although it can act as an antagonist of CB1/CB2 agonists despite this low affinity. Cannabidiol may be an antagonist of GPR55, a G protein-coupled receptor and putative cannabinoid receptor that is expressed in the caudate nucleus and putamen in the brain. It also may act as an inverse agonist of GPR3, GPR6, and GPR12.CBD has been shown to act as a serotonin 5-HT1A receptor partial agonist. It is an allosteric modulator of the μ- and δ-opioid receptors as well. The pharmacological effects of CBD may involve PPARγ agonism and intracellular calcium release.

Pharmacokinetics

The oral bioavailability of CBD is approximately 6% in humans, while its bioavailability via inhalation is 11 to 45% (mean 31%). The elimination half-life of CBD is 18–32 hours. Cannabidiol is metabolized in the liver as well as in the intestines by the cytochrome P450 enzymes CYP2B6, CYP2C19, CYP2D6, CYP2J2, and CYP3A4, and by the isoenzymes UGT1A7, UGT1A9, and UGT2B7. CBD may have a wide margin in dosing.

Pharmaceutical preparations

Nabiximols (brand name Sativex), a patented medicine containing CBD and THC in equal proportions, was approved by Health Canada in 2005 to treat central neuropathic pain in multiple sclerosis, and in 2007 for cancer-related pain. In New Zealand, Sativex is “approved for use as an add-on treatment for symptom improvement in people with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication.”

Epidiolex is an orally administered cannabidiol solution. It was approved in 2018 by the US Food and Drug Administration (FDA) for treatment of two rare forms of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Chemistry

At room temperature, it is a colorless crystalline solid. In strongly basic media and the presence of air, it is oxidized to a quinone. Under acidic conditions it cyclizes to THC, which also occurs during pyrolysis (smoking). The synthesis of cannabidiol has been accomplished by several research groups.

Biosynthesis

Cannabidiol and THC biosynthesis

Cannabis produces CBD-carboxylic acid through the same metabolic pathway as THC, until the next to last step, where CBDA synthase performs catalysis instead of THCA synthase.

Isomerism

History

Efforts to isolate the active ingredients in cannabis were made in the 19th century. CBD was studied in 1940 from Minnesota wild hemp and Egyptian Cannabis indica resin. The chemical formula of CBD was proposed from a method for isolating it from wild hemp. Its structure and stereochemistry were determined in 1963.

Society and culture

Cannabidiol is the generic name of the drug and its INN.

Food and beverage

An example of beverages claiming to contain CBD in a Los Angeles grocery.

Food and beverage products containing CBD were introduced in the United States in 2017. Hemp seed ingredients which do not naturally contain THC or CBD (but which may be contaminated with trace amounts on the outside during harvesting) were declared by the US Food and Drug Administration (FDA) as Generally recognized as safe (GRAS) in December 2018. CBD itself has not been declared GRAS, and under U.S. federal law is illegal to sell as a food, dietary supplement, or animal feed. State laws vary considerably as non-medical cannabis and derived products have been legalized in some jurisdictions in the 2010s.

Similar to energy drinks and protein bars which may contain vitamin or herbal additives, food and beverage items can be infused with CBD as an alternative means of ingesting the substance. In the United States, numerous products are marketed as containing CBD, but in reality contain little or none. Some companies marketing CBD-infused food products with claims that are similar to the effects of prescription drugs have received warning letters from the Food and Drug Administration for making unsubstantiated health claims. In February 2019, the New York City Department of Health announced plans to fine restaurants that sell food or drinks containing CBD, beginning in October 2019.

Plant sources

Selective breeding of cannabis plants has expanded and diversified as commercial and therapeutic markets develop. Some growers in the US succeeded in lowering the proportion of CBD-to-THC to accommodate customers who preferred varietals that were more mind-altering due to the higher THC and lower CBD content. In the US, hemp is classified by the federal government as cannabis containing no more than 0.3% THC by dry weight. This classification was established in the 2018 Farm Bill and was refined to include hemp-sourced extracts, cannabinoids, and derivatives in the definition of hemp.

Non-psychoactivity

CBD does not appear to have any psychotropic (“high”) effects such as those caused by ∆9-THC in marijuana, but is under preliminary research for its possible anti-anxiety and anti-psychotic effects. As the legal landscape and understanding about the differences in medical cannabinoids unfolds, experts are working to distinguish “medical marijuana” (with varying degrees of psychotropic effects and deficits in executive function) from “medical CBD therapies”, which would commonly present as having a reduced or non-psychoactive side-effect profile.

Various strains of “medical marijuana” are found to have a significant variation in the ratios of CBD-to-THC and are known to contain other non-psychotropic cannabinoids. Any psychoactive marijuana, regardless of its CBD content, is derived from the flower (or bud) of the genus Cannabis. As defined by US federal law, non-psychoactive hemp (also commonly termed “industrial hemp”), regardless of its CBD content, is any part of the cannabis plant, whether growing or not, containing a ∆9-tetrahydrocannabinol concentration of no more than 0.3% on a dry-weight basis. Certain standards are required for legal growing, cultivating, and producing the hemp plant. The Colorado Industrial Hemp Program registers growers of industrial hemp and samples crops to verify that the dry-weight THC concentration does not exceed 0.3%.

CBD and sport

CBD has been used by professional and amateur athletes across disciplines and countries, with the World Anti-Doping Agency removing CBD from its banned substances list. The United States Anti-Doping Agency and United Kingdom-Anti-Doping Agency do not have anti-CBD policies, with the latter stating that, “CBD is not currently listed on the World Anti-Doping Agency Prohibited List. As a result, it is permitted to use in sport. All other cannabinoids (including but not limited to cannabis, hashish, marijuana, and THC) are prohibited in-competition. The intention of the regulations is to prohibit cannabinoids that activate the same receptors in the brain as activated by THC.” In 2019, the leading cannabis products manufacturer, Canopy Growth, acquired majority ownership of BioSteel Sports Nutrition, which is developing CBD products under endorsement by numerous professional athletes. The National Hockey League Alumni Association began a project with Canopy Growth to determine if CBD or other cannabis products might improve neurological symptoms and quality of life in head-injured players. Numerous professional athletes use CBD, primarily for treating pain.

Legal status

United Nations

Cannabidiol is not scheduled under the Convention on Psychotropic Substances or any other UN drug treaties. In 2018, the World Health Organization recommended that CBD remain unscheduled.

Australia

Prescription medicine (Schedule 4) for therapeutic use containing 2 percent (2.0%) or less of other cannabinoids commonly found in cannabis (such as ∆9-THC). A schedule 4 drug under the SUSMP is a Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.

Following a change in legislation in 2017, CBD was changed from a schedule 9 drug to a schedule 4 drug, meaning that it is legally available in Australia.

Bulgaria

In 2020, Bulgaria became the first EU country to allow retail sales of food products and supplements containing CBD, despite the ongoing discussion within the EU about the classification of CBD as a Novel food.

Canada

In October 2018, cannabidiol became legal for recreational and medical use by the federal Cannabis Act. As of August 2019, CBD products in Canada could only be sold by authorized retailers or federally licensed medical companies, limiting their access to the general public The Canadian government states that CBD products “are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations.” It requires “a processing licence to manufacture products containing CBD for sale, no matter what the source of the CBD is, and that CBD and products containing CBD, such as cannabis oil, may only be sold” by an authorized retailer or licensed seller of medical CBD. Edible CBD products were scheduled to be permitted for sale in Canada on October 17, 2019, and are to be used only for human consumption.

European Union

In 2019, the European Commission announced that CBD and other cannabinoids would be classified as “novel foods”, meaning that CBD products would require authorization under the EU Novel Food Regulation stating that because “this product was not used as a food or food ingredient before May 15, 1997, before it may be placed on the market in the EU as a food or food ingredient, a safety assessment under the Novel Food Regulation is required.” The recommendation – applying to CBD extracts, synthesized CBD, and all CBD products, including CBD oil – was scheduled for a final ruling by the European Commission in March 2019. If approved, manufacturers of CBD products would be required to conduct safety tests and prove safe consumption, indicating that CBD products would not be eligible for legal commerce until at least 2021

Cannabidiol is listed in the EU Cosmetics Ingredient Database (CosIng). However, the listing of an ingredient, assigned with an INCI name, in CosIng does not mean it is to be used in cosmetic products or is approved for such use.

Several industrial hemp varieties can be legally cultivated in Western Europe. A variety such as “Fedora 17” has a cannabinoid profile consistently around 1%, with THC less than 0.3%.

Sweden

CBD is classified as a medical product in Sweden.

New Zealand

In 2017 the government made changes to the regulations so that restrictions would be removed, which meant a doctor was able to prescribe cannabidiol to patients.

The passing of the Misuse of Drugs (Medicinal Cannabis) Amendment Act in December 2018 means cannabidiol is no longer a controlled drug in New Zealand, but is a prescription medicine under the Medicines Act, with the restriction that “the amount of tetrahydrocannabinols and psychoactive related substances must not exceed 2 percent of the total CBD tetrahydrocannabinol and psychoactive related substances content”.

United Kingdom

Cannabidiol, in an oral-mucosal spray formulation combined with delta-9-tetrahydrocannabinol, is a product available (by prescription only until 2017) for the relief of severe spasticity due to multiple sclerosis (where other anti-spasmodics have not been effective).

Until 2017, products containing cannabidiol marketed for medical purposes were classed as medicines by the UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA) and could not be marketed without regulatory approval for the medical claims. As of 2018, cannabis oil is legal to possess, buy, and sell in the UK, providing the product does not contain more than 0.3% THC and is not advertised as providing a medicinal benefit.

In January 2019, the UK Food Standards Agency indicated it would regard CBD products, including CBD oil, as a novel food having no history of use before May 1997, and stated that such products must have authorisation and proven safety before being marketed. The deadline for companies to register a CBD product as an authorised novel food with the FSA is 31 March 2021; failure to register will exclude companies from selling CBD.

United States

As of March 2020, CBD extracted from marijuana remains a Schedule I Controlled Substance, and is not approved as a prescription drug or dietary supplement or allowed for interstate commerce in the United States. CBD derived from hemp (with 0.3% THC or lower) is legal to sell as a cosmetics ingredient, but cannot be sold under federal law as an ingredient in food, dietary supplement, or animal food. It is a common misconception that the legal ability to sell hemp (which may contain CBD) makes CBD legal.

In September 2018, following its approval by the FDA for rare types of childhood epilepsy, Epidiolex was rescheduled (by the Drug Enforcement Administration) as a Schedule V drug to allow for its prescription use. This allows GW Pharmaceuticals to sell Epidiolex, but it does not apply broadly and all other CBD-containing products remain Schedule I drugs. Epidiolex still requires rescheduling in some states before it can be prescribed in those states.

In 2013, a CNN program that featured Charlotte’s Web cannabis brought increased attention to the use of CBD in the treatment of seizure disorders. Since then, 16 states have passed laws to allow the use of CBD products with a physician’s recommendation (instead of a prescription) for treatment of certain medical conditions. This is in addition to the 30 states that have passed comprehensive medical cannabis laws, which allow for the use of cannabis products with no restrictions on THC content. Of these 30 states, eight have legalized the use and sale of cannabis products without requirement for a physician’s recommendation. As of March 2020, CBD was not an FDA-approved drug eligible for interstate commerce, and the FDA encouraged manufacturers to follow procedures for drug approval.

Some manufacturers ship CBD products nationally, an illegal action which the FDA did not enforce in 2018, with CBD remaining the subject of an FDA investigational new drug evaluation, and is not considered legal as a dietary supplement or food ingredient, as of March 2020. Federal illegality has made it difficult historically to conduct research on CBD. CBD is openly sold in head shops and health food stores in some states where such sales have not been explicitly legalized.

State and local governments may also regulate CBD. For example, the Massachusetts Department of Agricultural Resources issued a rule in June 2019 aligning state CBD regulations with FDA regulations. This means that although recreational marijuana is legal in the state, CBD cannot legally be sold in food or as a dietary supplement under state law.

Health concerns

In November 2019, the FDA issued concerns about the safety of CBD, stating that CBD use has potential to cause liver injury, interfere with the mechanisms of prescription drugs, produce gastrointestinal disorders, or affect alertness and mood. In March 2020, the FDA updated its safety concerns about CBD, acknowledging the unknown effects of protracted use, how it affects the developing brain, fetus or infants during breastfeeding, whether it interacts with dietary supplements or prescription drugs, whether male fertility is affected, and its possible side effects, such as drowsiness.

In February 2020, the UK FSA advised vulnerable people, such as pregnant women, breastfeeding mothers, and those already taking medication for other medical concerns not to take CBD. The FSA further recommended that healthy adults should not consume more than 70 mg CBD per day.

2018 Farm Bill and hemp

The 2014 Farm Bill legalized the sale of “non-viable hemp material” grown within states participating in the Hemp Pilot Program which defined hemp as cannabis containing less than 0.3% of THC. Although the 2018 United States Farm Bill led some states to interpret the bill as enabling private farmers to grow hemp for extraction and retail of CBD, federal agencies – including the FDA and DEA– retained regulatory authority over hemp-derived CBD as a Schedule I substance. By federal law, private enterprises developing hemp-derived CBD are obligated to cultivate hemp exclusively for industrial purposes, which involve the fiber and seed, but not the flowering tops which contain THC and CBD. Hemp CBD products may not be sold into general commerce, but rather are allowed only for research. The 2018 Farm Bill requires that research and development of CBD for a therapeutic purpose would have to be conducted under notification and reporting to the FDA.

FDA warning letters

From 2015 to November 2019, the FDA issued dozens of warning letters to American manufacturers of CBD products for false advertising and illegal interstate marketing of CBD as an unapproved drug to treat diseases, such as cancer, osteoarthritis, symptoms of opioid withdrawal, Alzheimer’s disease, and pet disorders. The FDA said that the letters were issued to enforce action against companies that were deceiving consumers by marketing illegal products for which there was insufficient evidence of safety and efficacy to treat diseases. In July 2019, the FDA stated: “Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD.”

In October 2019, the FDA and the Federal Trade Commission (FTC) announced a joint warning to a Florida supplements company marketing CBD products as unapproved drugs to treat childhood autism, attention-deficit hyperactivity disorder, Parkinson’s disease, Alzheimer’s disease, acne, and infant teething and ear aches. The warning also applied to hemp CBD capsules and oil that were being marketed illegally while not adhering to the federal definition of a dietary supplement. Additionally, Idaho, Nebraska, and South Dakota are the only three states as of January 7, 2020 to ban the use of CBD in any form or capacity.

Mislabeling and poisoning

A 2017 analysis of CBD content in oil, tincture or liquid vape products purchased online in the United States showed that 69% were mislabeled, with 43% having higher and 26% having lower content than stated on product labels.

As of September 2019, 1,085 people contacted US poison control centers about CBD-induced illnesses, doubling the number of cases over the 2018 rate and increasing by 9 times the case numbers of 2017. Of cases reported in 2019, more than 33% received medical attention and 46 people were admitted to a hospital intensive care unit.

Switzerland

While THC remains illegal, CBD is not subject to the Swiss Narcotic Acts because this substance does not produce a comparable psychoactive effect. Cannabis products containing less than 1% THC can be sold and purchased legally.

Research

As of 2019, there was only limited high-quality evidence for cannabidiol having a neurological effect in people, mainly due to the weak design and small number of subjects in randomized controlled trials.