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‘Like using a sledgehammer to crack a nut’ – experts respond to new CBD guidance

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The Food Standards Agency (FSA) has published new guidance for CBD novel food applications – including confirmation that these must include toxicology data.

In the latest guidance for CBD companies ahead of the March 2021 deadline, the FSA has confirmed that novel food applications will not be successful without the inclusion of toxicology safety data.

In February 2020, the UK Food Standards Agency set the deadline for the industry to apply for European Union safety evaluations for “novel food” status.

The new guidance, published on Thursday 24 September, highlights that applicants will need to include ‘details of the toxicological studies they have undertaken, or propose to undertake’ adding that without this it is ‘unlikely we will be able to validate an application’.

The FSA also states that applicants should consult the EFSA’s guidance on ‘the usual application process for all novel foods’, which includes the details of a 90 day rodent safety study.

Only products with this validation will be allowed on the market after 31 March 2021 – but the cost of generating this data is estimated to be between £300,000 and £1million.

The guidance has been welcomed by the Association for Cannabinoid Industry (ACI) which this week announced the launch of its ‘landmark’ safety study with a consortium of CBD companies.

In partnership with Advanced Development and Safety Laboratory (ADSL), the study will address the existing gaps in data identified by the Government Committee on Toxicity (COT)  – including whether CBD causes potential drowsiness, liver toxicity or has any interaction with other drug substances.

It will also provide the safety information mandated by the novel foods application process.

In a statement the ACI said it was ‘leading the way’ for the global CBD industry.

“The safety information generated in this study will respond to future demands of regulatory authorities in the US and EU,” it said, adding that the approach would also minimise animal testing by allowing all the members to use the data from one OECD 408 rodent study, instead of many companies conducting their own.

Steve Moore, strategic counsel for the ACI described it as a ‘transformational’ time for the industry, he commented: “We’re seeing evidence from studies that shows there is a wide variance at the moment in terms of product quality, so it’s very obvious to us that regulation will improve the industry.

He continued: “It is going to be a transformation time for the sector.

“It’s clear that not all the organisations currently operating in this marketplace are going to be able to meet all the regulatory requirements and the industry will be structured very differently this time next year.”

With the cost of generating the toxicology data in the hundreds of thousands of pounds, there is widespread concern that the FSA regulations will drive smaller, ethical CBD companies out of business.

Professor Mike Barnes, head of the Medical Cannabis Clinicians Society, believes we should be promoting a more diverse and ‘dynamic’ industry to boost the economy.

“The CBD industry is in need of regulation. However, the new novel food regulations are like taking the proverbial sledgehammer to crack a nut,” he said

“If implemented as stated it will drive most, if not all, of the small cbd suppliers and retailers out of business and plays into the hands of ‘Big Cannabis’ – those that can afford the huge fees of the ACI for example.”

He added: “In a post-Covid era we should be encouraging a new dynamic industry like the CBD sector, which creates jobs and tax income and provides the consumer with choice.

“The novel food regulations and those who support them are doing the industry no favours.”

Read the latest FSA guidance at www.food.gov.uk/business-guidance/cannabidiol-cbd

Lifestyle

NFL to explore effects of CBD in players with chronic pain

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The NFL-NFLPA Pain Management Committee wants to find alternative treatments to manage player's chronic pain

America’s National Football League (NFL) is looking into how cannabis and CBD can help in managing player’s chronic pain.

The league and player’s association (NFLPA) made a formal request for information to researchers on “pain management alternatives to opioids” earlier this month.

In an official statement, the NFL-NFLPA Pain Management Committee (PMC) said it is working to “improve player health through evidence-based treatment of acute and chronic pain” and to “facilitate research to better understand and improve potential alternative treatments.”

The NFL is seeking out qualified researchers who could lead studies into pain management and athletic performance in its players.

Areas of investigation include the potential therapeutic role of medications and “non-pharmacological interventions” that are considered to be alternatives to opioids in routine pain management of NFL players, including, but not limited to, cannabinoids such as CBD.

The committee also wants to explore the cannabis or cannabinoids on athletic performance in NFL players.

The PMC was formed in 2019 as part of the NFL-NFLPA Collective Bargaining Agreement with the goal of benefitting the health and safety of NFL players through education and research.

Last year it conducted two informational forums on CBD to learn about the current state of CBD science and manufacturing in the US, as part of its aim to find alternatives to opioids in the pain management of players.

Respondents to the request are expected to have experience conducting controlled, experimental studies in the relevant areas and should be affiliated with institutions or companies that meet state, federal, and IRB requirements.

However the NFL is not committing to funding any specific studies at this stage, and instead wants to seek out qualified scientists who can assist with future research projects.

CBD is not currently listed on the World Anti-Doping Agency’s Prohibited List and, as a result, is permitted for use in sport.

However, all other cannabinoids such as cannabis, marijuana and THC are prohibited in competition due to the receptors activated in the brain which cause a ‘high’.

A 2018 review assessed the impact CBD has on relieving chronic pain. The review examined a number of studies, concluding that CBD was effective in overall pain management and didn’t cause any other negative side effects.

In addition, it has been suggested that CBD can speed recovery and fight fatigue – welcome news for athletes suffering from long-term or recurring injuries.

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Health

How can CBD help arthritis?

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In a Canadian study, nine out of 10 patients said CBD was effective in managing their pain

In the UK, more than 10 million people have arthritis or other, similar conditions that affect the joints – and many are turning to CBD products to ease their pain and discomfort.

With an ever-expanding range of drinks, gummies and edibles on thee market CBD could be seen as something aimed at the younger generation.

However, there is a growing body of research that suggests CBD can also be of great use for the older members of the population – and one condition in particular.

Arthritis is a common condition that causes pain and inflammation in a joint, and while it can affect people of all ages, it is more likely to begin when people are in their 40s and 50s, worsening with age.

A Canadian study from 2020 found that up to one in five patients who consulted an orthopedic surgeon for chronic musculoskeletal pain were using a cannabis product to treat them, with the express aim of reducing pain.

The researchers also found that interest in the compound was high, with two thirds of non-users curious to try a cannabis product to treat their muscle and joint pain.

Furthermore, those patients already using CBD had generally positive experiences using the products. Nine out of 10 said it was effective in managing their pain, and four in 10 said it decreased their reliance on other pain medications. Nearly 6 in 10 said cannabis products were more effective than other drugs.

Such findings corroborate what we already know about CBD; thanks to its anti-inflammatory and analgesic properties, early research into its use as a treatment for acute and chronic pain is promising.

A 2016 study found that transdermal cannabidiol has potential for reducing pain and inflammation associated with arthritis without any noticeable side effects.

Cannabis-based medicines can help manage the pain of arthritis by rebalancing the body’s natural endocannabinoid pain-processing system and soothing inflamed body tissues.

There are two primary ways of taking a CBD supplement; topically or orally.

In the case of arthritis, a cream or ointment containing CBD would be rubbed into the affected area. Topical products may also include common over-the-counter ingredients such as menthol, capsaicin or camphor, which could make it difficult to determine if any positive effect is due to the CBD or another ingredient.

There are a number of ways to take CBD orally, from gummies, snacks and drinks to tinctures and capsules – although gummies are discouraged in households with children, due to their similarity with sweets.

However, all work in largely the same way, being absorbed through the digestive tract. However, it is worth noting that absorption can be slow and dosing is tricky due to the delayed onset of effect (one to two hours), unknown effects of stomach acids, recent meals and other factors.

Whichever method you choose, it is always a good idea to check with your medical practitioner first, as CBD, although it is natural, may interact with other treatments, such as prescription medications.

However, for those looking for an alternative to prescribed drugs, with fewer side effects, CBD could well prove to be the answer.

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9 out of 10 readers have self-medicated with cannabis

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Nine out of 10 Cannabis Health readers have consumed cannabis for medical purposes without a prescription – and almost all said they found it to be more effective than conventional medicines.

 

Over the last few weeks, we’ve been asking for your views on social media to delve deeper into how people are consuming cannabis.

As expected, the proportion of our readers who self-medicate with cannabis was high, but the results also demonstrate the perceived effectiveness of cannabis in comparison with traditional medication, highlighting a need for wider access to safe cannabis based medicines.

Self-medicating

Despite the law around medical cannabis changing over two years ago, gaining a prescription can still be challenging, particularly on the NHS.

This has forced a lot of patients to take matters into their own hands.

According to research, as many as 1.4 million Brits are self-medicating with cannabis, equivalent to just over two percent of the country’s population.

Studies from the US have backed this up, with one suggesting that as many as a third of teenagers with a chronic health condition have taken it upon themselves to manage their symptoms with cannabis.

We asked our readers if they were self-medicating to treat a health condition, with the results confirming that almost 94 percent of people said they were.

On top of this, a further five percent said they were not currently, but were open to the idea.

Just over one percent said they weren’t self-medicating due to the stigma attached, however no one responded that the law was a factor in this. 

Effectiveness of self-medicating 

 

Anecdotal evidence and some early studies suggest that cannabis can ease symptoms of some chronic pain conditions, such as fibromyalgia, where other, more conventional medicines have failed.

There is also promise in the potential of cannabis to relieve some mental health conditions, with some saying it has provided huge relief for disorders such as PTSD.

Ninety five percent of Cannabis Health readers polled said they found cannabis extremely effective at relieving symptoms. 

In addition no one said they had found it ineffective when it comes to treating their condition.

The remaining five percent said they found it to have a similar effect as their conventional treatments. 

Route to administration 

How patients consume cannabis can have an impact on its effectiveness, as well as how quickly it kicks in.

With such high numbers both self-medicating and reporting positive effects, we wanted to discover the common consumption methods.

Smoking the flower is the traditional method of consuming cannabis and often viewed as the one which can provide the most relief.

However, even though it has been seen to be less harmful than tobacco, smoking can still lead to a number of other health issues and is note recommended by health professionals.

Despite this, it remained the most popular choice among Cannabis Health readers, with just over a third saying this is how they consume cannabis.

The modern alternative to this is vaping, which was the second most common route to administration among Cannabis Health readers.

Around a third of readers said this was their preferred consumption method.

Some professionals argue this is the healthiest way for consumption, with clinics recommending vaping cannabis flower, but more research is needed in this area.

One method which has few negative effects is the use of oils or tinctures.

This is typically how CBD is consumed, with 21 percent of readers saying this was their preferred method.

Self-medicating alongside conventional medicines

The NHS says it is unlikely that many people in the UK will be able to gain access to a medical cannabis prescription.

Despite this, many patients have chosen to self-medicate with cannabis either alongside or often in the place of conventional therapies. 

The majority of readers agreed with this, with 55 percent saying they no longer use conventional medicines in favour of cannabis.

A further 22 percent said they would only use their conventional medicines if they did not have access to cannabis and the remainder said that they still consume cannabis alongside conventional medication.

Want to get involved? Cannabis Health will be running a number of polls over on our social media pages, to find out more about your views on CBD and cannabis for medical and wellbeing purposes.

Follow @CannabisHnews on Twitter and @Cannabishealthmag on Instagram and keep an eye out.

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