CBD Regulatory Debacle | Project CBD

April Fools’ Day 2022 has a special meaning for the UK CBD industry. That’s the day that hundreds of companies, after over a year of anxious waiting, would find out if their CBD products could legally remain on the shelves.

The decision by the Foods Standards Agency (FSA) to classify CBD as a “novel food” had set off a whole chain of events, with the future of many companies hanging in the balance until the FSA released a definitive list of validated CBD products.

While most people in the UK CBD industry were in agreement that some form of regulation should be implemented, all but a few companies initially rejected the decision to regulate CBD products as novel foods.

Pre-Brexit CBD

In many countries, regulators have struggled to find an appropriate classification for CBD products. In the UK, CBD is considered a borderline product: it is both a medicine and a food. However, with most companies unable to afford the costly clinical trials to prove their efficacy as medicines, they have marketed their CBD products primarily as food supplements.

For a while this allowed a flourishing sector to take root – perhaps too flourishing some might argue with thousands of products clamouring for their share in an oversaturated market. Due to an anachronistic law preventing British farmers from selling the fruiting tops of the hemp plants they grow, most CBD products were white labelled or imported from European or North American suppliers. Despite these hurdles, the pre-Brexit CBD industry continued to grow exponentially and was valued at around £300 million in 2019.

The following year the European Food Safety Authority’s (EFSA) in Brussels added cannabinoids to their novel foods catalogue. This decision started a chain of events that some argue has had a catastrophic impact on the UK CBD industry.

What Is A Novel Food?

A food or ingredient is classed as novel if it wasn’t commonly consumed before 1997. In order to be sold to consumers, novel foods must be proven safe and applications for authorization should include information about the production process, compositional data, specifications, the history of use of the novel food and/or of its source, proposed uses and use levels and anticipated intake, absorption, distribution, metabolism and excretion, nutritional information and toxicological information and allergenicity.

The new rules have done nothing but stifle the UK’s fledgling CBD industry, hitting manufacturers and suppliers the hardest.

Despite an outcry from many in the industry who argued that hemp flowers had been safely used in food for hundreds of years, the UK’s FSA agreed that CBD extracts are indeed novel. However, unlike other novel foods that need authorization before entering the market, thousands of CBD products were already on sale to the public. So, the FSA retrofitted the existing novel food authorization procedure and announced that any CBD product sold prior to February 13, 2020, would need to have a novel food application submitted by March 31, 2021, in order to remain on sale.

After this arbitrary date, no CBD products would be allowed to enter the market until they have been fully authorized, a costly process that can take years. Nor could there be any ‘pre-13th February product’ formulation changes or rebranding to meet the new requirements.

The new rules have done nothing but stifle the UK’s fledgling industry, hitting manufacturers and suppliers the hardest, according to Clifton Flack, CEO of CiiTech, the Israeli/UK cannabis company behind one of the UK’s most long standing and successful CBD brands, Provacan. 

“If you can’t take on new white label clients, then you’ve got no business,” says Flack, who maintains that the novel food process has been a disaster from the start: “I think it’s been a debacle from day one. And whenever there’s been an update, a change or an advance, it’s become even more of a debacle. I think they just made the biggest pig’s ear.”

In other words, the regulators botched it bigtime.

The Industry Responds

For the first few months after the deadlines were announced, many companies, including Provacan, were in denial, hoping the whole thing would just go away.

Various CBD trade organisations pursued different approaches. The Association for the Cannabinoid Industry (ACI), whose membership includes some heavy North American hitters such as Aurora, Columbia Care, and GenCanna, as well as the biggest UK based manufacturer, British Cannabis, welcomed the development, deciding to work with the FSA rather than against them. They quickly realized that only expensive in vivo toxicology studies on mice or rats would provide sufficiently robust safety data for a successful application, so members pooled their resources to create a consortium application.

After initially opposing the novel foods classification, the European Industrial Hemp Association also took the consortium approach, raising the equivalent of $4.5 million from 170 partners to conduct toxicology studies for full spectrum and CBD isolate, as well as for a THC study on 400 human subjects with the hope of proving that higher THC levels than currently allowed are safe to consume in food.

THC – The Elephant in The Room

With all the focus on CBD, it’s easy to forget that until now roughly a third of CBD products sold in the UK also contained trace amounts of THC (less than 0.2%), as well as other minor cannabinoids.

Wittingly or unwittingly, many of these full spectrum products on sale contained more than the 1mg of THC per container legally permitted by the Home Office.

This could mark the end of full spectrum CBD products, further entrenching the current trend towards isolate, distillate, and synthetic CBD.

Before the novel foods decree, this didn’t seem to matter. However, in order to gain novel foods authorization, a product cannot contain illegal levels of controlled substances. For many in the industry, this clearly signified the writing on the wall for full spectrum CBD options. 

The Advisory Council on the Misuse of Drugs, meanwhile, recently weighed in with their own recommendations to the UK government that no more than 50 micrograms of THC should be present in a single CBD serving. But the Advisory Council’s approach is wholly unworkable. For starters, no one can say for sure how much an individual CBD serving actually is. If this recommendation is adopted it would likely mark the end of full spectrum CBD products, further entrenching the current trend towards isolate, distillate, and synthetic CBD.

The Chaos Continues

Back to April Fools’ Day – With bated breath and no guarantees of success, all eyes were on the publication of the FSA list of CBD products that had successfully made it to validation and could therefore continue to be legally sold to consumers.

In the preceding months, over 900 applications had been whittled down to 182 and on the morning of the First of April, 3,536 products from 70 applications were formally approved. (Rather surprisingly, the list contained a small number of full spectrum consumables.) But there’s a caveat: most of these products were awarded pre-validated status, pending further evidence including relevant data from the promised toxicology studies.

The FSA was quick to emphasize that any products not on the list and still on sale should be removed from shelves and online sales discontinued. The CBD trade consortium ACI went so far as to launch their own website encouraging consumers to report noncompliant CBD products, and a number of companies were even named and shamed due to their omission from the FSA list.

One such company, CBDfx, discovered their absence from the list was due to an FSA clerical error. This was also the case for 700 other CBD products. On LinkedIn CBDfx Managing Director Carlo Buckley revealed how it took the FSA 17 days from when the error was detected to the day CBDfx was finally added to the FSA public list. The delay cost the company tens of thousands of pounds after one of their retailers followed FSA advice and temporarily withdrew their products.

Winners & Losers

As of the 27th of April, the previously definitive list had swelled to almost 6000 products. A final update is due on June 30th.

Despite the host of ebullient press releases from CBD brands announcing their inclusion, for many the list is little more than a stay of execution, as validation is no guarantee of final authorization. And it won’t be until well into 2023 that the matter will be settled.

For the moment, Provacan has secured its spot, although rather pragmatically Flack expects his full spectrum CBD range to be removed from the list at some point. In order to mitigate the risks, Provacan, like many other brands, launched a ‘novel foods-proof’ CBD isolate range just in time to beat the February 13th cut-off date.

One has to ask, who will ultimately benefit most from this whole process? Will it be the members of the Association for the Cannabinoid Industry whose applications reportedly comprise 69% of the FSA’s public list? Or the companies with “aggressive expansion plans” that could afford to spend £1.5 million on toxicology studies for their synthetic CBD product lines?

And who will be the big losers? The consumers without legal access to the full spectrum CBD products they’ve come to rely upon. Many will turn instead to the illicit market, an unintended but likely outcome of trying to shoehorn a natural plant extract into a framework designed for synthetic food ingredients.

Mary Biles, a UK-based journalist, educator, and Project CBD contributing writer, is the author of The CBD Book (Harper Collins, UK).

Copyright, Project CBD. May not be reprinted without permission.