The FDA’s plan to seek “real-world data” on CBD has been criticised by some, but UK regulators could learn something from across the pond, according to one industry expert.
This month, FDA officials provided an update on cannabidiol and unveiled plans to “fill in the current gaps” in its understanding of CBD products.
The report has received criticism from the US CBD sector; however, a British CBD advocate says the UK’s Food Standards Agency (FSA) has something to learn from the FDA’s approach to regulation.
Penned by the Commissioner of Food and Drugs, Stephen Hahn, and Principal Deputy Commissioner, Amy Abernethy, the announcement stated that the FDA needs “better” data to grow its limited understanding of the safety profile of CBD and other cannabis-derived compounds.
The authors wrote: “We still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use of CBD products.
“Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health.”
Hahn emphasised that filling in the knowledge gaps will not be a “trivial exercise” and will require “high-quality data analysed using robust methods”.
Setting out a framework which aims to utilise real-world data to answer outstanding questions, Hahn announced a number of guiding principles relating to future research projects and data collection which the FDA will follow moving forward.
Following the removal of “hemp” from the definition of “marijuana” under the Controlled Substance Act in 2018, the US CBD industry has skyrocketed, however, as the sector expands, regulations have lagged behind.
The Council for Responsible Nutrition (CRN), a trade association for the dietary supplement and functional food industry, criticised the report saying it “misses the point entirely”.
“[The] notice is nothing more than an end-of-Administration desk-clearing exercise from an FDA that has failed to lead in this crucial policy area,” president and CEO of CRN, Steve Mister, said in a statement.
“Because of the FDA’s failure to act, the public continues to be exposed to possible harms by a wild-west market that continues to expand without meaningful regulatory bounds.
“Responsible manufacturers of dietary supplements containing CBD – who are dutifully abiding by those regulations and incurring the costs of doing so – suffer as their products are sold alongside products that may or may not contain CBD, may contain THC, make illegal disease claims, or contain unsafe adulterants.”
Speaking to Cannabis Health, president of CLEAR Cannabis Law Reform, Peter Reynolds described the FDA statement as “massive overkill”.
“It is exactly the same as the FSA and the EU in that, as far as I know, there is no evidence at all anywhere in the world of anyone ever coming into any significant harm from taking CBD as a food supplement,” Reynolds said.
But despite these criticisms, he believes the FSA in the UK has something to learn from the FDA in its treatment and regulation of cannabis-based products.
He continued: “When they indicated that they were looking at regulation, the FDA immediately went out to a public consultation, where they asked people what their views were. And not just people in the industry, but consumers as well.”
Last year, the FSA revealed that companies producing CBD products would be required to apply for novel food status by the 31 March 2021 in order to continue selling its products.
The decision was faced with backlash from industry advocates, including Reynolds, who believes the “pointless” regulations will put many small companies out of business.
“You have to ask why on earth people being made to invest a quarter of a million pounds in these utterly pointless novel food applications when there’s no evidence of there being any danger from CBD.
“There’s a lot wrong with American democracy, clearly. But on the other hand, it does seem to be working out right in the end.”
Provacan brings high-strength, 72% CBD to UK
The science-led brand is bringing the latest cannabis technology to the UK with two high potency CBD formulas.
Provacan, the CBD brand from cannabis research company CiiTECH, has introduced the two 72 percent products as part of its popular VapePod range developed in partnership with Kanabo.
The Provacan range of VapePod compatible pre-filled pods have grown to become one of the company’s most popular vape products.
The VapePod device was developed by Israel-based Kanabo Group and provides users with a certified, safe and effective vaporisation system with innovative metered dosing with high bioavailability.
Vaporisation of CBD improves the rate of absorption when compared to other means such as ingestion.
The device optimises efficiency while delivering CBD formulas more safely and simply. It can only be used with compatible pre-filled cartridges, such as Provacan’s Day and Night pre-filled pods.
Kanabo recently became the second cannabis company to list on the London stock exchange.
This is a revolutionary step for the VapePod entering the medical cannabis scene in the UK and is vital for patients for whom this delivery method will replace the smoking of cannabis flowers.
Avihu Tamir, CEO at Kanabo, said: “We are pleased to have CiiTECH as a partner in the UK for developing pure innovative hemp formulas. The unique formulas are coupled with the VapePod platform which give consumers great satisfaction in knowing that they’re getting the most out of their CBD.”
Building on the popularity of the 55 percent CBD VapePod range, Provacan has worked with Kanabo Research to launch two new higher strength vape formulas for its customers.
The all-new Night Terpene and Day Terpene CBD VapePod formulations contain 72 percent CBD together with other minor cannabinoids and a potent mix of terpenes.
Terpenes are widely used and can be found in essential oils and aromatherapy.
Additionally, the all natural pods are free from traces of pesticides, heavy metals and solvents and don’t containing PG, VC, MCT, nicotine or vitamin E.
Provacan is part of the growing portfolio of brands by leading British cannabis company CiiTECH Ltd, with R&D management based in Israel.
Founded by Clifton Flack in 2017, Provacan is the flagship brand within the portfolio and focuses on bringing the latest cannabis technology to its loyal consumers in the UK and across the world.
Partnerships with international medical cannabis research companies fuel CiiTECH’s product development and provide brands like Provacan with forward thinking industry knowledge and the ability to create highly respected science-backed CBD products for sale in the UK today.
Eli Whiteman, CiiTECH’s VP business development, said: “Our partnership with Kanabo goes back a long way and beyond technological innovation. Our main priority is to strive to ensure our customers have access to a superior combination of bioavailability, unique delivery systems and consistent CBD products that they can rely on.
“We achieve this by channelling consumer demands into product development and by partnering with like minded medical cannabis companies that do the same.”
The new Night Terpene CBD and Day Terpene CBD VapePods are available from Provacan now, retailing at £49.99 each. To find out more information about the products, visit https://provacan.co.uk/vapes/.
Dragonfly expansion to deliver over 1,000kg of CBD per month
Dragonfly Biosciences is expanding its CBD extraction capability, to enable the large scale delivery of over 1,000kg of CBD per month.
The manufacturers of Dragonfly CBD oil has acquired full ownership of Premium Extraction Services Limited – a large scale state of the art ethanol extraction facility.
As a result Dragonfly Biosciences will be able to offer the large-scale delivery of over 1000kg of CBD per month, in comparison to other extraction facilities which can deliver on average around 50kg per month.
Dragonfly CBD can currently be found at a variety of stockists on the UK high street including Boots, Tesco, Sainsbury’s, as well as in pharmacies.
The expansion will enable the firm to deliver bespoke CBD distillate and CBD isolate in significant quantities, adding to its expanding portfolio.
Chief executive, Regan Saveall, described the move as a “significant step forward” for the company in delivering “first-class” CBD.
“The acquisition of the Premium Extraction Services Company is a significant step forward for Dragonfly Biosciences and importantly our range of CBD products,” he commented.
“We are committed to innovation and investment, and already have our own vertical integrated supply chain, which allows us to provide high-quality CBD products, all of which are compliant with all regulatory status.
“The extraction facility will enable us to control and produce even more first-class CBD on a much larger scale. This will support the demand for our current products and allow us to explore different types of CBD offerings. There are only a handful of large-scale fully permitted facilities in the EU, so this is really exciting for us.
“By investing as a company, we can ensure our CBD brand is as always safe, legal and best in class when it comes to quality and consumer transparency. “
The Dragonfly Bioscience extraction plant is based in Romania close to the Bulgarian border and fields where Dragonfly Bioscience has 650 hectares of organically certified land.
The extraction facility is built to EU-GMP standard with full accreditation status in progress.
Cannabliss to open brick and mortar dispensary
UK-based medical cannabis group, Cannabliss aims to help patients transition from the illicit market into the legal cannabis space.
Following a long, “drawn-out” application process, Cannabliss has secured a pharmacy licence for dispensing medical cannabis through its online platform.
Now, after handing out its first private prescription this month, the company has announced it will be opening a brick and mortar site in Preston in April 2021.
Set to open on 12 April, the store will sell legal, over-the-counter cannabis-based products and also offer advice and guidance to people who are seeking to secure a medical cannabis prescription.
Cannabliss was founded by Michael Dobson, who was involved in a legal battle for several years over the legality of cultivating cannabis plants. In a saga that climaxed with him taking the then Home Secretary, Amber Rudd to court, he fought for a judicial review of cannabis legislation.
Having spent many years involved with the illicit cannabis market, including a period behind bars for growing several of his own plants, Dobson is now on a mission to widen access to legal medical cannabis.
“The vast majority of people have very little understanding of the legal cannabis market,” he tells Cannabis Health.
“What we’re doing is effectively creating a concierge service in which we help guide [people] through the process of becoming a legalised cannabis patient.”
Cannabliss says it aims to build trust with its customers and establish itself as a “go-to” place for trusted information about the medical cannabis landscape.
Dobson explains: “Customers have the opportunity to have a face-to-face conversation with somebody who specialises in this particular area, rather than it just being a vape shop or health food store that has added cannabis products to its already existing range.
“If we do have somebody coming in and asking about the process of getting access to medical cannabis, we can explain that to them.”
Currently, in the UK, there are qualifying conditions that must be met before being considered for cannabis-based treatment.
Although an estimated 1.4 million people consume cannabis for medicinal purposes, very few can access it via a prescription.
Dobson believes that there is a “great deal” of people that could meet the criteria for a medical cannabis prescription but have never considered it due to the cost and exclusivity of private healthcare.
He says Cannabliss will provide support to its customers if they choose to go through the official process.
“Even though the prices have dropped significantly over the past few years, we still think there’s going to be a hurdle to overcome in terms of breaking down that barrier; that stigma that is there for a lot of people,” he says.
The company is already putting plans in motion to expand into a franchise with two provisional stores set to open this summer in Leicester and Essex.
As part of this franchising effort, Cannabliss aims to provide opportunities for people who may have previously been involved with the illicit cannabis market.
Dobson believes that it is “morally right” to give people the chance to enter the burgeoning legal market.
“I always wanted to include as many people as possible within what we’re doing, and support people that have been in a similar position to myself,” Dobson adds.
“We will not discriminate on somebody because they maybe have a criminal history like myself.
“In actual fact, these people are actually the best people to have running our franchises because they’re so knowledgeable.”
Dobson also believes that this approach could help reduce the influence and scale of the illegal market.
“By removing people from the illegal market and bringing them into the legal market, you’re getting rid of the black market rather than putting something in place that’s in competition with it,” he says.
Looking ahead, Dobson says the company is feeling “very positive”. It has formed partnerships with suppliers in the UK and Europe, including a distribution agreement with Canopy Growth Corporation subsidiary, Storz and Bickel, for its range of medical-grade vaporisers.
“It’s going very well and we’re anticipating a lot of interest,” Dobson adds.
“Feedback that I’m getting from different people [in the sector] is that a lot of people are interested in what we’re doing, how we’ve got to where we’ve got to and, in particular, my backstory and how that fed into the whole ethos of what we’re trying to do.
“I feel very strongly that the UK is going to become a world leader in the legalised cannabis space over the next few years and I’m looking forward to playing my own small part in that.”
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