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US crackdown on CBD industry claims

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The US FDA and FTC have launched ‘Operation CBDeceit’

US watchdogs have launched a nationwide crackdown on CBD brands making ‘deceptive’ marketing claims about their products.

The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have announced the first law enforcement crackdown on ‘deceptive’ claims in the growing market for CBD products.

Known as ‘Operation CBDeceit’, it is part of the ongoing effort to protect consumers from false, deceptive, and misleading health claims made in advertisements on websites and through social media sites such as Twitter.

The FTC is taking action against six sellers of CBD products for allegedly making a wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.

The companies, and individuals behind them are required to stop making such unsupported health claims immediately, and several will pay monetary judgments to the agency.

The orders also bar the respondents from similar deceptive advertising in the future, and require that they have scientific evidence to support any health claims they make for CBD and other products.

Andrew Smith, Director of the FTC’s Bureau of Consumer Protection commented: “The six settlements announced today send a clear message to the burgeoning CBD industry: Don’t make spurious health claims that are unsupported by medical science. Otherwise, don’t be surprised if you hear from the FTC.”

The FDA has also issued warnings to several companies for selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions.

These include CBD products that are especially concerning due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the marketing of CBD products as dietary supplements.

Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.

“The FDA’s first priority is to protect the health and safety of Americans. Many questions remain regarding the science, safety, effectiveness and quality of products containing CBD,” said FDA principal deputy commissioner Amy Abernethy, M.D., Ph.D.

“We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritising those that pose the greatest risk of harm to the public.”

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.

Although consumers report using CBD to manage a wide range of health conditions, including stress, anxiety and pain, the FDA has not approved any CBD products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in human patients.

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What are the benefits of CBD?

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The benefits of CBD are wide-ranging, here’s a few of the most common ways people find it helpful – and the evidence to back it up.

Over recent years, as the use of CBD has rocketed in popularity, there seems to be no end of uses that people have discovered for it.

However, the ways in which it can be used are often broken down broadly into a few key categories. Cannabis Health takes a look at some of the most common complaints CBD can be used for.

Pain relief

While the conditions may vary, one thing is clear; CBD is a valuable weapon in the fight against chronic pain.

Anecdotally, it has provided much-needed relief to sufferers of endometriosis, fibromyalgia and arthritis, where previous, prescription-strength medications has failed.

As for the science, in December, a study of Canadian medical cannabis patients found that its use reduced the use of prescription painkillers. 

The research found that, at the start of the six-month study, 28 per cent of participants were using opiate-based painkillers, which dropped to 11 per cent at the end. 

Such findings are also good news for tackling the UK’s increasing addiction crisis; around 540,000 Britons are thought to be addicted to opioids.

It is understood that CBD’s pain-relieving properties stem largely from its anti-inflammatory effects – which is why it is also gaining popularity among athletes and sportspeople. 

Insomnia

Sleep – or the lack of it – is a huge issue, and for many it has only got worse over the past 12 months. Studies suggest than one in four people are struggling to get to or stay asleep, with mothers, key workers and people from minority ethnic backgrounds the worst affected.

While the effect of cannabis on sleeping patterns remains an underdeveloped area of research, it is gaining momentum – with some promising signs.

One study from 2019 showed that levels of cortisol, the stress hormone, reduced significantly in participants who took between 300 and 600mg of CBD oil before bed.

However, another study in the same year found that a more regular dose was needed to improve their ability to fall and stay asleep. After a month on a 25mg dosage of CBD oil, 66.7 percent of patients said their sleep had improved.

Stress and anxiety

We could all do with a stress-reliever from time to time, and too many people still use alcohol or cigarettes for this very purpose.

However, increasing research shows that CBD is a safer and healthier alternative to both of the above, accounting for its rise in popularity amongst the wellness sector.

A landmark study in the US – thought to be the first of its kind – was launched in October last year to investigate CBD’s use as a formal anxiety treatment.

The Cannabinoid Anxiety Relief Education Study is targeting millions of CBD and cannabis users across the US to assess the potential role of cannabinoids in reducing anxiety and other co-morbid conditions, such as insomnia and depression.

And while research still ongoing, preliminary studies also suggest that CBD has been shown to reduce stress in animals such as rats.

Study subjects were observed as having lower behavioural signs of anxiety, and the physiological symptoms of anxiety, such as increased heart rate, also improved.

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Medical cannabis to bring in £3 million annual boost for Isle of Man

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The Island's government recently gave the go-ahead to grow medical cannabis

The medical cannabis sector is expected to generate an additional £3 million a year for the Isle of Man economy after the go ahead was given for cultivation on the island. 

The Isle of Man Government voted to approve regulations to issue licenses for the production, distribution and export of cannabis products from the Island.

The Isle of Man is self-governing jurisdiction and following a series of consultations, its Parliament, Tynwald, approved changes to the Misuse of Drugs Regulations which will permit commercial operators to produce medical cannabis products.

The sector, which is estimated to generate around £3 million in annual benefit in the coming years and considerably more through the growth of associated infrastructure – including financial and operational – to support the sector. 

The Government also expects the medicinal cannabis sector to support and bring innovation to the Isle of Man’s Cleantech and construction sectors, as well as developing businesses from within and off the island. 

The growing global cannabis market provides significant opportunity for economic development in the Isle of Man, with the global market forecasted to account for USD 82.19 billion by 2027.

The new regulatory framework responds to industry and consumer demand for stringent and flexible licensing of a broad range of cannabis products, ranging from outdoor grown industrial hemp to indoor grown medicinal products. 

The framework only relates to an export industry and there are no changes to domestic legality of prescription medicinal cannabis or the legality of non-medical adult use of cannabis in the Isle of Man.

The Gambling Supervision Commission (GSC) will serve as the launch regulator for the sector and will be issuing guidance for hemp applications from Isle of Man growers soon.

For high-THC operators, the GSC is finalising its approach to its regulation and is consulting with relevant commercial and government stakeholders, and anticipates issuing guidance and accepting license applications in the first quarter of 2021.

Lawrie Hooper MHK, political member with responsibility for Business Isle of Man, said: “We are delighted to launch this exciting new sector in the Isle of Man and to take advantage of the expertise in regulating new, complex industries while providing stringent consumer safety. We’re confident that GSC’s regulation will once again attract quality businesses to the Island transforming the cannabis export sector into a key contributor to the Isle of Man’s post-COVID economic recovery.’

Mark Rutherford, responsible for preparing the new regulatory framework at the GSC, commented: “The Island has a track record as an early adopter of new sectors. Over the course of the past 20 years acting as the regulator for the Island’s eGaming sector, the GSC has developed expertise in keeping the industry crime free, protecting consumers and providing transparency, and this experience is complementary to the skills that will be required for this new and emerging sector.

“This is an exciting opportunity and we have a sophisticated framework for supervising gambling which can be easily adapted to regulate the cultivation and processing of cannabis. We recognise there is huge potential for this new sector to create real positive economic benefit so we need to ensure we treat the new cannabis sector like we have treated the gambling sector: that license stakeholders that are competent, credible and crime free from the outset.”

 

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CBD in Northern Ireland – what you need to know about EFSA novel food applications

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UK FSA novel food regulations no longer apply to Northern Ireland

Northern Irish CBD companies have just ‘days’ to get European novel food applications under way if they have not already. 

Hemp Federation Ireland has urged CBD companies in Northern Ireland to submit their European Food Standards Agency (EFSA) novel food applications imminently, in order to meet the spring deadline. 

While the rest of the UK will fall under Food Standards Authority (FSA) regulations, Northern Ireland must continue to follow EU law after the end of the Brexit transition period. 

As set out in the ‘Northern Ireland Protocol’, any companies seeking authorisation for a CBD product to be placed on the market will have to follow EU and EFSA rules

This is to allow trade to continue uninterrupted between Northern and Southern Ireland.

However, the news has placed CBD companies in Northern Ireland, and those who wish to trade there, in a ‘difficult position’ with just weeks left before the deadline for novel food applications on 31 March.

Hemp Federation Ireland has been advising Northern Irish companies to proceed with the dual application process, allowing them to gain novel food status in both the UK and the EU. 

But those who were not aware of this, or have not already begun the dual application process have now been left at a ‘considerable disadvantage’, Chris Allen, of Hemp Federation Ireland, told Cannabis Health. 

While Northern Ireland is still within UK customs territory it is still subject to the provisions of EU law, including food law.

“This does put companies in a difficult position because the time frame is so tight for applications to EFSA, which I believe will close in mid-February. They really want to have those applications well underway within the next couple of days if they want to be covered by EFSA regulations.

“In reality, there is about a 10 day window for them to get the house in order and when you consider the cost of the novel food application, I can only imagine that there are a lot of companies in the UK scratching their heads now.”

All applications must include 90-day toxicity data, with the cost of this estimated to be between £300,000 and £1million.

Stephen Oliver, of London-based cannabis consultancy firm, The Canna Consultants said it is likely that many companies in Northern Ireland will have already invested in the application process, believing they could remain on the market after this date.

“There is bound to be teething problems arising as a result of Brexit, but this does seem a little bit unfair to companies who didn’t know about it,” continued Allen.

“It does seem that UK and Northern Ireland stakeholders in the industry have been placed at a considerable disadvantage.”

As things stand, CBD brands elsewhere in the UK, will no longer be able to sell their validated products in Northern Ireland after March 2021.

England-based CBD firm Honest Hemp, which sells products in Northern Ireland, said the company was hoping to find a solution. 

“It’s very sad to hear that the CBD companies based in Northern Ireland will now have their products deemed ‘unlawful’, despite going through the same extensive processes as the rest of us in the UK. So, we do feel very lucky to be able to continue operating as an England-based company, said marketing manager, Georgious Mesimeris. 

“Here at Honest Hemp, we are working hard to find a solution that will allow us to continue selling to our customer base in Northern Ireland and ensure their needs are covered. Of course, it’s hard to predict the future in a time like this, but we can keep hoping that things work out for the best eventually.”

Hemp Federation Ireland is working with Irish companies on navigating the post-brexit regulations and is happy to advise on the EFSA application process. 

“The whole industry has been constantly shifting in regulations over the past few years and it’s really not the fault of the companies themselves that they find themselves in this position now,” Allen added.

“There is poor understanding of the regulations in Ireland and that is not something that can continue long term, it will have to be resolved. The really important thing now is for people to know what their options are going forward and to understand how Brexit works from this side of the Irish Sea.”

Allen can be contacted by email on: chris@hempfederationireland.org 

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