Patience Wins The Race: TTS Pharma's CEO On Bringing The First Legal CBD Oil To The UK Market
Executive Summary
TTS Pharma wants to be the first to launch a legal CBD oil onto the UK wellness market. TTS CEO Mark Tucker explains how his firm's CBD is produced according to strict standards and can provide a model for future regulation.
“We don’t intend to sell CBD oil until such time as the UK Food Standards Agency gives us the consent to do so or we have a European Union novel food application that’s been approved,” declared TTS Pharma chief executive officer Mark Tucker at a meeting in London, UK, on 18 September.
In front of group of experts, pharmacists and journalists, Tucker confidently laid out TTS’s two-pronged regulation strategy aimed at putting the first legal CBD oil supplement on the UK market.
Alongside the UK-based firm’s novel food application currently being reviewed by the European Food Safety Authority (Also see "With CBD Poised To Become A Novel Food In Europe, Industry Must Think Ahead To Gain Advantage" - HBW Insight, 7 Feb, 2019.), TTS is working on perfecting its manufacturing processes to create the UK’s first tetrahydrocannabinol (THC) -free CBD oil.
Currently, CBD products with any level of THC are technically considered to be controlled substances under UK Home Office rules. (Also see "Slovakia Down-Schedules CBD As WHO Insists It Is Not A Narcotic " - HBW Insight, 3 Sep, 2019.)
Furthermore, as THC is produced as a by-product of the CBD oil manufacturing process, and therefore illegal for the production of consumer goods, hemp for CBD must be imported from outside the EU.
Therefore, much of the CBD oil on the market today comes from Russian or Chinese hemp, Tucker explained, which was invariably contaminated with a variety of harmful substances such as heavy metals due to their polluted manufacturing environments.
“If you’re a manufacturer you’ve got to get the provenance right, deal with all the relevant licensing issues,” Tucker insisted. “You’ve got to be able to show where that product comes from.”
“If you’re a manufacturer you’ve got to get the provenance right, deal with all the relevant licensing issues,” Tucker insisted. “You’ve got to be able to show where that product comes from.”
Even CBD oil sourced from the US was problematic under EU import rules, Tucker pointed out, as US hemp may be genetically modified.
“In terms of basic numbers, the consumer demand is greater than the current supply,” Tucker noted. “So where are we getting our CBD from? It must be coming from a different supply chain that is not being tracked and traced.”
This situation puts FSA in a quandary, Tucker pointed out, because it can either ban all CBD oils now being sold even in high street pharmacies and health food shops – slamming the breaks on what has become a lucrative wellness market in the UK – or continue to put consumers in danger from substandard products and unscrupulous retailers and manufacturers.
To help the UK move beyond this impasse, TTS wants to facilitate a “managed transition” for FSA by showing how “clean” CBD oils can be produced and by developing a supply chain and manufacturing model for other companies to follow.
TTS CHOs The Way Forward
To this end, TTS has established what it describes as a “fully traceable supply-chain system” – CHOtrak.
“CHOtrak is our ‘track and trace’ system,” TTS explains on its website. “Our in-line production controls establish provenance throughout our supply chain to ensure that our customers receive the highest quality product, meeting all regulatory standards, from ‘crop to shop’.”
While there isn’t much further detail available on CHOtrak, this system has enabled TTS to claim its CBD oil as the first UK product to be free from both THC and cannabinol (CBN) – a mildly psychoactive cannabinoid also present in small quantities in the cannabis plant – as well as harmful environmental contaminants.
TTS’ claim is based on an analysis by an independent laboratory, Fera Science Ltd – partly owned by UK Department for Environment, Food and Rural Affairs (DEFRA) – which undertook a series of in-depth tests to ensure that the product fully complies with all regulatory requirements.
“The analysis demonstrates that TTS Pharma’s CBD oil is completely free of THC and CBN within the limits of detection of less than 0.0001%,” the company maintained, “and confirms that the isolate is exempt from the UK Misuse of Drugs Regulations.”
Having presented this evidence to both the Home Office and FSA, TTS is now awaiting approval for its CBD oil to be able to put the first legal product on the market.
“My view is that we are playing the correct game,” Tucker commented. “I think countries like Canada have been rash and taken the decision [to allow CBD oils on to the market] too early.”
“Taking the cautious road has to be the right road,” he concluded.
Top-Three CBD Oils Not Only Illegal, But Dangerous
As well as proving the quality of its own not-yet-available CBD oil, TTS also commissioned Fera to analyse 31 CBD products currently available on the UK high street.
Echoing the Centre for Medicinal Cannabis analysis earlier this year (Also see "UK Body Calls For 'Clear Guidance' On THC Levels In CBD Oils" - HBW Insight, 12 Jul, 2019.), Fera found CBN and/or THC in almost half of the CBD oils sampled in levels mostly above the legal limit, according to TTS.
Furthermore, less than half were within 10% of the stated level of CBD, with four samples containing less than 50% of the level stated, the firm reported.
A further analysis of three of the UK’s top selling CBD products – the identity of which TTS wouldn’t share – showed a variety of toxic substances present, the company revealed, including terpenes, heavy metals, polycyclic aromatic hydrocarbons, polychlorinated biphenyls, polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans.
“These may have significant health implications including cancer, liver and kidney damage and neurological toxicity,” TTS warned.
“All three of our independent analyses demonstrate an urgent need for greater regulatory control of currently available CBD products to safeguard consumers from making product choices which ultimately may be risking their health,” Tucker argued.
“The implications of such a rapidly growing market being flooded with illegal products cannot be ignored,” he continued. “Without detailed analysis of CBD products by manufacturers and suppliers, consumers cannot be sure whether these products are safe to consume.”