U.K. CBD Shake-Up Gateway To Influx Of Global Consumer Brands

THE Food Standards Agency’s new Novel Food deadline looks set to open the door for the entry of the major global consumer brands into the U.K CBD market.

Concerns over the lack of a clear regulatory CBD framework from the FSA and other agencies has previously proved a deterrent to the Coca-Colas of this world.

Not anymore, a clear pathway to compliance will unleash the forces of  multi-national business and change the craft nature of the existing U.K. industry for good.

And, new health concerns over usage whilst taking other drugs, breast-feeding and during pregnancy will also require CBD sellers to double down on any advice they give consumers.

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What Has Happened? 

Following a year of procrastination the FSA has announced that all CBD products will have to be registered into the Novel Food process.

Novel Food authorisation is a costly and time consuming process –  priced at around £300,000, and taking around two years to complete.

All products on sale in the U.K will have to demonstrate they align with the requirements of this process by March 31, next year.

In theory, it should mean that all these products would then have to be removed from sale while the authorisation process, including various safety tests, take place.

But, the way things are shaping up, it is highly likely that there will be no enforcement action on applicants while this approval process is underway.

A Bit Of Background?

This FSA move follows the rapid growth of the of the U.K. CBD industry; it is said to be worth over £300 million and used by millions of people for its perceived health benefits.

However, as the industry has grown the regulator’s concerns over its nature have also increased.

Recent research showed that some products on sale in the U.K. had illegal levels of the psychoactive cannabis compound THC, while others actually continued no CBD, and there are further issues over potential contaminants.

In January, last year the European Union (E.U.) announced that all CBD products must conform to the Novel Food rules.

This has been fought tooth and nail by many in the industry, and with Brexit out of the way there was some hope that the Novel Food guidelines would be scrapped for a less onerous, U.K.-specific regime.

Why Has the FSA Moved Now? 

For the last year the industry has been on a warning that it is expected to conform to the Novel Food rule.

But, at the same time the FSA has also said it does not have ‘significant safety concerns over the CBD products for sale in the U.K market’ – hence no enforcement action. 

In July last year the FSA’s advisory body met to discuss CBD; known as the Committee on Toxicity (CoT) it said at the time it was unable to give any definitive guidance due to a lack of suitable evidence.

It met again in January this year after securing large quantities of research data from British firm GW Pharmaceuticals.

GW is the only company to have secured a licence from health regulators for a CBD drug; Epidiolex, which is available to patients in the U.K. and USA.

After analysing this data the CoT changed its health guidance on CBD, this, and the need to establish a clear regulatory framework prompted this move.

Industry Reaction?

Overall the industry has welcomed the FSA’s moves to establish a clear regulatory framework.

It’s fair to say that as the industry grew over the last few years a number of companies took advantage of the lax regulatory environment to prey on naive consumers.

Nevertheless, there is still some ground to cover before the FSA secures its full-backing.

The main sticking point for those such as the Cannabis Trades Association and the European Industrial Hemp Association, is their firm belief that CBD is just basically, not a Novel Food.

There is ample evidence to show it has been used for hundreds of years in food across Europe and there is a certain amount of disbelief in the industry that the FSA cannot recognise this.

What Happens Next?

The current market sees a dozen or so, mainly overseas, suppliers produce CBD for thousands of products and these will now have to secure Novel Food authorisation for their oils.

Whether they will all have deep enough pockets to all complete the £300,000 Novel Food process is an open question.

Industry bodies such as the European Industrial Help Association are galvanising smaller players into a consortium to take forward joint Novel Food applications and share the cost burdens.  

One thing looks certain, though –  smaller craft manufacturers – producing their own oils and products look like being squeezed out of the market.

One such business we spoke to, based in the North of England, said it was still assessing the situation and would be seeking further information from the various trade bodies before deciding how to proceed. 

However, there may be an alternative route for the smaller operators; one which is currently being explored by some industry figures.

This could involve renaming CBD products as ‘hemp extracts containing CBD’, and in doing so circumvent the Novel Food process.

This is based on the premises that extracts squeezed from the hemp plant are not novel – for a full explanation see the comments in this article from leading cannabis lawyer Robert Jappie.

What Is The FSA Saying On CBD & Health?

The FSA still has no concerns over the general safety of CBD products but has now flagged up some real ares of concern in relation to health.

Its press release says: “The FSA is today advising those who are pregnant, breastfeeding or taking any medication not to consume CBD products. 

“Healthy adults are also advised to think carefully before taking CBD, and the FSA recommends no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction. This new precautionary advice is based on recent findings by the government’s Committee on Toxicity (COT).

Its press release referenced Professor Alan Boobis, Chair of the Committee on Toxicity: “My committee has reviewed the evidence on CBD food products and found evidence there are potential adverse health effects from the consumption of these products. We are particularly concerned about pregnant or breast-feeding women and people on medication.

“We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead.”

Final Thought 

In a presentation at last year’s CBD and Hemp & CBD Expo in Birmingham, cannabis executive Garrett Bain elaborated on the industry’s future.

“The pathway for the CBD industry into the big box retail outlets, in the U.K. with the likes of Tesco and Boots, in the U.S. with Walmart and the others, will be regulation.

“At the moment we are a boutique, and online retail industry, coming from a place of little regulation, but as we grow we will start to see a change taking place. 

“It will start with start with compliance, the delivery of consistent product and establishing a chain of custody – whereby regulators can easily identify where a product has come come from. Any lack of trust across the value chain, will trouble the consumer and trouble the regulators.”

This FSA move is seeing the CBD industry evolve from its pupae phase, but in which direction it develops and spreads its wings remains to be seen.

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‘Incredible Launch Year’ For FDA-Approved CBD Medication

The numbers are in and the first FDA-backed medication using
cannabidiol has surpassed even the most optimistic expectations, says GW
Pharmaceuticals CEO Justin Gover.

The British-based pharmaceutical company just announced their fourth quarter and total year earnings for 2019, which were $104 million and $296 million, respectively. “It’s an incredible launch year for any medication [that] I think proves that this kind of medicine is really making a difference to patients,” Gover told CNBC’s Jim Cramer in a “Mad Money” interview about Epidiolex. “It shows real value to the health-care system, and it sets us up, I think, in a very nice way for what should be another great year for us in 2020.”

Epidiolex – whose main active ingredient is cannabidiol – is used to treat severe and rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. In 2018 the U.S. Food and Drug Administration approved Epidiolex and it has since been approved for clinical trials in 28 European countries as well as Japan.

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We can expect to see the first European prescriptions to roll out in France, Germany, and the U.K., followed by Spain and Italy, then the remaining 23 countries.

“It’s a new mechanism to treat epilepsy. We’re obviously treating
very high-need patients, often children. They’re having many seizures a day,”
Gover said. “So the ability to provide a real advance in this therapeutic area,
together with the fact that this is the first ever cannabis product approved by
the FDA, has together created I think an exceptional environment for us to
commercialize this product.”

Following this announcement, shares of GW pharma rose almost 2%.
This brings the total cost per share to just under $120.

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U.K. U-Turn Means 10,000 Patients May Get Cannabis Medicine

Global cannabis powerhouse GW Pharmaceuticals has been successful in its talks with the U.K. health authorities and NHS patients can now access its drugs for two types of epilepsy and spasticity.

This should allow over 10,000 patients easier access to GW’s Sativex and Epidyolex cannabis medicines through the country’s National Health Service (NHS). The decision has been welcomed by U.K. firm GW, charities and campaigners whilst others say its a missed opportunity as the new recommendations ‘have not gone far enough’.

In August, the U.K.’s National Institute for Health and Care Excellence (NICE) interim report into the cost-effectiveness of Cannabis Based Medicinal Products (CBMPs)  was unveiled. 

Epidyolex Over-Priced?

It ruled GW’s Epidyolex and Sativex too expensive, but following months of talks GW Pharmaceuticals has learnt both drugs have now been approved for use by the NHS in England. Experts estimate the cost of Epidyolex at around £20,000 to £30,000 a year and GW’s chief operating officer Chris Tovey said, at the time, it was in discussions with NICE over pricing.

Responding to the latest news in a company press release, he said: “This is a momentous occasion for UK patients and families..(and)… proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous NICE evaluation process to reach patients.”

Doctors will now be able to prescribe Epidyolex, for children with two types of severe epilepsy – Lennox Gastaut syndrome and Dravet syndrome. An estimated 3,000 people with Dravet and 5,000 with Lennox Gastaut syndrome in England will benefit.

Sativex, a mouth spray that contains a mix of THC and CBD, has been approved for treating muscle stiffness and spasms, known as spasticity, in multiple sclerosis. However doctors will not be allowed to prescribe it to treat pain.

‘Great News’

Prof Helen Cross, a consultant in pediatric neurology at Great Ormond Street Hospital, who led UK trials of Epidyolex, said it was ‘great news’. However the campaign group, End Our Pain, said the new guidelines are a massive missed opportunity.

The BBC report spokeswoman Millie Hinton saying: “This restrictive guidance is condemning many patients to having to pay for life-transforming medicine privately, to go without or to consider accessing illegal and unregulated sources.”

Genevieve Edwards, from the MS Society, said they had been campaigning for access to Sativex for years and ‘it was brilliant NICE has finally listened’. But, she hit out at the lack of recommendations on pain saying it is a common symptom of MS.

The NICE guide guidelines found a lack of evidence regarding the use of cannabis drugs in the management of chronic pain.

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French Medical Cannabis Trial Would Initially Support 3,000 Patients

France is moving closer to the launch of a medical cannabis trial which could benefit 3,000 patients.

The French National Assembly is expected to give approval to the two-year trial which is being backed by president Macron’s La République En Marche majority party, reports Marijuana Business Daily.

The trial was recommended by a special committee of the French Agency for the Safety of Medicines and Health Products (ANSM) last summer. If approved the trial is set to get underway later this year and the ANSM has suggests that only ‘pharmaceutical standard’ products for ‘certain medical conditions’, will be included.

Up To One Million Patients

If this recommendation remains unchanged then this initially will be of major benefit to GW Pharmaceuticals as its two drugs, Sativex and Epidyolex for treating multiple sclerosis and epilepsy, respectively, are the only two French approved cannabis drugs.

The France24 website reports that between 300,000 and one million patients could eventually benefit from its adoption.

Professor Nicolas Authier, the head of pharmacology at Clermont-Ferrand University Hospital Centre’s pain clinic, told France 24 that, as there is no medical cannabis grown in France, medicine would have to imported until a domestic cultivation program is established.

Despite there being no French medical cannabis program and recreational cannabis being illegal, it has for some time between the largest hemp producer in Europe.

France Grows 40% Of Europe’s Hemp

A report by New Frontier Data says France accounts for 40% of the European cultivation. In the mid-1800’s France had more than 100,000 hectares of hemp under cultivation which was used for the production of linen, fabric, twine, rope, cordage, and seed oil. 

But this declined to 700 hectares by 1960s as the era of sail boats ended and other natural and synthetic fibres became available.

The Sustainable Farming website reports that there are currently around 6,000 hectares under cultivation in the west/central region of France with the crop being used in the production of high-quality paper for currency and cigarettes.

Meanwhile, CBD retailers in France are still encountering problems with the authorities who say their products should contain absolutely no THC. This has seen many shops raided and some closed down, although many continue to trade unhindered and the CBD industry continues to attract investment from overseas.

In September this year Canadian cannabis accessory company Greenlane Holdings, announced plans to partner high-end Paris retailer NOUS, which has agreed to stack its premium smoking accessories.

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Epidyolex Approved For Use In Over 30 European Countries

Patients in over 30 European countries could soon be able to get access to GW Pharmaceuticals Epidyolex cannabis medicine after it was approved by the European Commission.

Since its launch in the U.S last year GW’s sales have rocketed with Epidiolex (as it is known in America) boosting its revenues by over $30m in its first quarter, with more than 7,600 patients accessing the drug.

Now the European Medicines Agency has approved marketing authorisation in the 28 member states of the European Union, for its use for two conditions associated with childhood epilepsy; Lennox‑Gastaut syndrome and Dravet syndrome.

The medicine – a strawberry-flavoured oral CBD with the anti-seizure drug clobazam – can now be launched across Europe. Up to 50,000 children and young adults in Europe have one of the two syndromes, reports The Guardian newspaper.

GW was formed in the 1990s and and created one of the first medical cannabis medicines with Sativex – a one to one combination of CBD and THC – used to treat muscle spasms caused by MS and other conditions. In its market statement on the EC approval GW said it had stemmed from the results of four randomised, controlled Phase 3 trials, incorporating data from more than 714 patients.

In GW’s press release Isabella Brambilla, Chairman, Dravet Syndrome European Federation said: “The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex and life-long forms of epilepsy.”

In an earlier market statement GW said it was looking at five European markets to initially launch Epidyolex: France, Germany and the U.K. with the other two unnamed countries to follow. Justin Gover, GW’s Chief Executive Officer said the approval is the realisation of ‘many years of dedication and collaboration between GW, physicians and the epilepsy community’. 

He added: “We are delighted to be the first to offer this solution to the epilepsy community.”

The E.C. decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein. However, despite this good news GW has still to convince the U.K. medical authorities to approve both Epidyolex and Sativex.

In the last few weeks, the U.K. deemed both to be too costly at around £30,000 a year. GW’s chief operating officer, Chris Tovey, said the company was in discussions with the UK’s National Institute for Health and Care Excellence (NICE) about making the drug available on the NHS. 

He said: “The feedback [in the US] has been incredibly positive.” He said it is ‘very optimistic’ that NICE would agree to fund Epidiolex. We are hoping for a relatively rapid decision from NICE and we are hoping to make it available for U.K. patients in the next couple of months,” he said in a press release.

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The Medical Cannabis Weekly Review: CBD Absorption, Terpenes Benefits, U.K. Health System Flaws, and more

If you’ve ever made edibles, you know that the cannabis or extract you use needs to be mixed with some type of fatty-base like butter.

As it turns out, that doesn’t only apply to the cooking process, but fat is a major part the CBD absorption equation as well. Also, we’re taking a look at some of the benefits of plant terpenes and how they interact with the endocrine system. And learn what to look out for when buying vape pods, so you can avoid a hospital visit. All that and more in this week’s Medical Cannabis Weekly Review and Newsletter.


FEATURED STORY: New Research Suggests CBD Absorption Is Increased With Fatty Foods

cbd fat

According to an interesting new study, when CBD is taken along with fatty foods, absorption rates are increased up to 14 times. The study, published in June in the Epilepsia Journal, was entitled “Food effect on pharmacokinetics of cannabidiol oral capsules in adult patients with refractory epilepsy.”

The study looked at the difference between taking CBD in oral form with a high-fat meal as compared with fasting. While some research has been carried out on the relationship between CBD and various conditions, only a small amount of research is available when it comes to CBD absorption.

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Must Read Articles:

The Importance of Plant Terpenes in Human Health

terpenes homeostasis

While the human body is permanently trying to bring itself to a state of equilibrium – known as homeostasis – there are numerous external factors to consider. Compounds known as Terpenes – found in cannabis and various other plants – are on that list.

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How To Ensure The Vape Pods You Buy Are Safe

vape pods

Recent headlines in the media over the safety of vaping have some people understandably concerned. With a spate of emergency room admissions in various states, it turns out tainted vape pods caused the issues. So how can you make sure the products you’re buying are actually safe?

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Second GW Pharmaceutical Setback Exposes U.K. Health System Flaws

u.k. health

The U.K. medical body charged with determining which treatments can be accessed through the National Health Service (NHS) has dealt a second blow to GW Pharmaceuticals in a matter of days. Last week, findings on the potential for U.K. medical cannabis ruled GW’s drug for MS, Sativexm as not cost effective.

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Other Trending News:

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Second GW Pharmaceutical Setback Exposes U.K. Health System Flaws

The U.K. medical body charged with determining which treatments can be accessed through the National Health Service (NHS) has dealt a second blow to GW Pharmaceuticals in a matter of days.

Last week, in its findings on the potential for U.K. medical cannabis, NICE  (The National Institute for Health and Care Excellence) ruled GW’s Multiple Sclerosis drug Sativex as not cost effective.

And it has now delivered the same verdict on its epilepsy drug Epidiolex – for the time being, at least.

Another U.K. Anti-Medical Cannabis Ruling

In its announcement NICE went to say that it would continue to work with GW on a number of issues. Epidiolex – comprising of CBD and the anti-seizure drug clobazam – was approved by the FDA last year and has prompted a major sales boost for GW in the U.S.

In the U.S it costs over $30,000 a year for, often young patients, suffering from Dravet and Lennox-Gastaut epilepsy – and it is this cost which is causing problems for the NHS. Needless to say NICE has come under fire for this latest anti-medical cannabis ruling.

Securing NHS Cannabis ‘Seems A Lost Cause’

Former U.K. Drugs Czar Prof David Nutt, now Head of the Centre for Neuropsychopharmacology, said that this decision, and last week’s ruling, mean ‘getting pure extracts of plant cannabis products into the NHS now seems a lost cause’.

In a press release NICE said it would work with GW on the issues it has raised. It said the duration of the clinical trials, at only only 14 weeks, meant the ‘longer-term effectiveness of cannabidiol with clobazam is uncertain’.

It also had concerns about the ‘economic models’ provided by GW saying it excluded some key cost impacts. Its ruling is open to consultation with a final decision due next month. In England, some 600 people with Dravet syndrome and around 4,000 people with Lennox-Gastaut syndrome could benefit.

Ruling Exposes Flaw in U.K Health System

While some see the two decisions as further evidence of U.K. clinical bias against cannabis drugs, it all exposes one of the key flaws of the country’s socialised health care model. NICE generally funds treatments that cost less than £20,000 a year, but baulks at those costing over £30,000.

As well as taking into account the cost of the drug, its deliberations include equipment and time spent administering and managing the treatment. It  aims ‘to make decisions that will improve the health of the whole population’. In the U.S. over 90% of health insurance providers have agreed to list Epidiolex, and as such the U.K. system now seems to undermine the NHS’s founding principle of ‘providing universal care, according to need’.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, accepted the evidence on Epidiolex but went on to say  ‘the committee was not convinced about the way the company had modelled the effect on people living longer or having a better quality of life’.

A spokesman for GW, a U.K. company listed on the NASDAQ, told the Telegraph: “We are working with NICE to address the questions raised in this draft guidance, with the aim of ensuring patients can access the medicine on the NHS once approved. We remain hopeful that NICE will recommend cannabidiol oral solution at the end of its appraisal process.”

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The CBD Business Weekly Review: Vaping-Related Hospitalizations, Cannabis Situation in Mexico, Arizona Recreational Bill, and more

Welcome to this week’s edition of the CBD Business Weekly Review and Newsletter.

This week we’re starting with some important developments in the U.S. where vaping-related injuries have left dozen hospitalized. Also, Mexico is expected to soon iron out the details of the medical and recreational programs. And Arizona is looking in the direction of legalization. Read on for more exciting news!

FEATURED STORY: Midwest Doctors Puzzled Over 22 Vaping-Related Hospital Admissions

vaping hospital

Nearly two dozen patients are in the hospital in three Midwestern state, suffering from severe breathing issues. Their condition is believed to be connected to vaping E-cigarettes. For now, it’s unclear which devices the patients used and the E-liquid they vaped. 

As Dr. Emily Chapman, chief medical officer for Children’s Minnesota, explained to reporters, “We know there are certain characteristics in common with these cases, but we have not been able to get to the bottom of exactly what aspect of the vaping habit or product or solvent or oil is causing the injury.”

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Mexico’s Health Ministry Ordered To Clarify Medical And Recreational Cannabis Status

mexico cannabis

The issue of legalizing cannabis in Mexico has been a hot topic, debated for years. Having endured numerous iterations, the country seems a finally little closer to making medical cannabis available for patients who want it. 

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Visit Tel Aviv for the CannX Conference Next Month


The 4th international CannX conference – which aims to bring people in the industry together to learn and gain a deeper understanding of all the complex caveats surrounding the cannabis industry – will be taking place in Israel from September 9th to 10th at the Tel Aviv Convention Center. 

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Recreational Cannabis Bill Could Hit Arizona Polls In 2020

arizona cannabis

Back in 2016, Arizona tried to legalize recreational cannabis. That effort failed but only by a small margin. A new campaign to legalize cannabis has its sights firmly set on 2020, but how will citizens in the Grand Canyon State vote?

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Other Trending News


We hope you enjoyed this week’s review. Don’t forget to send your friends to subscribe to our CBD Business Weekly Newsletter for more articles like these!

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Epidiolex Launch in U.S. Prompts GW Pharmaceuticals Sales Surge

BRITISH cannabis firm GW Pharmaceuticals is close to securing European approval for its Epidiolex drug after seeing its success in the U.S. lead to record sales.

NASDAQ-listed GW Pharmaceuticals announced its second quarter results with revenue topping $72 million, far above the $3.3 million in the same period, last year – and surpassing analysts’ expectations of around $50 million. Its Epidiolex drug, which received FDA approval in late 2018, was the key driver of this stellar performance accounting for more than $68 million of sales.

12,000 U.S. Patients To Date

Epidiolex, which treats certain forms of epilepsy, has been prescribed by more than, 2,500 doctors and more than 12,000 patients have received it since its U.S. launch, says the company in a market release.

GW Pharmaceuticals said it achieved a profit of almost $80 million for the quarter ending June 30 – compared to a loss of  $84 million in the same period last year.  This was mainly the result of a one-off of gain of $104 million on the sale of an FDA-approved drug review voucher, it said.

Widespread Insurance Coverage

The market announcement highlighted how the cost of the drug, at around $30,000 a year, is not deterring insurance firms with over 90% of plans including it. GW Pharmaceuticals also announced that Epidiolex has become the first cannabis drug to win European medical approval.

The European Medicines Agency has recommended that Epidiolex be approved, and the European Commission will make its final decision in two months, with this being seen as a rubber-stamping exercise, reports The Daily Telegraph.

Epilepsy Treatment

Epidiolex is mainly used to treat children who suffer from two severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome, and it is thought around 40,000 European patients could benefit.

GW says Epidiolex will be launched in France and Germany first, followed closely by the U.K., where GW has been in price negotiations with The National Institute for Health and Care Excellence (NICE), the body that decides which drugs the NHS will pay for.

Chris Tovey, chief operating officer at GW, said in a market conference call that some 800 European patients had already benefited from an early access program for Dravet syndrome and Lennox-Gastaut syndrome.

“As a result, we’re launching into an environment where a large number of clinicians have already developed important clinical management experience with Epidiolex,” he said.

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Synthetic CBD and Solvents in Epidiolex?

GW Pharmaceuticals has been creating unusual blends of clinical cannabis for over two decades. Epidiolex is an abnormal, proprietary cannabidiol tincture that was developed for epilepsy. This clinical concoction has been under some well-deserved criticism for several reasons, such as a liver damage warning. Can solvents or Synthetic CBD in Epidiolex be the culprit? Other […]

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