Novel foods delays and rising costs a 'perfect storm' for struggling CBD brands

Steve Moore, the founder of the Association for the Cannaboid Industry (ACI), says the industry is struggling to survive, with many brands closing shop, as the Food Standards Agency (FSA) reaches the risk assessment stage of the slow-moving novel foods process.

The FSA claims that we can expect to see product authorisations occur at the end of this year or the beginning of next. 

But Moore questions this, as he points out there is no official legal acceptable limit for THC in CBD products, or even an officially agreed testing methodology. 

He explains the Advisory Council on the Misuse of Drugs’ (ACMD) provided a report on consumer CBD​ products back in 2021 advising the government on a legal framework for consumer CBD products. The report advised a limit of a total dose of each controlled phytocannabinoid of 50 micrograms (µg) per unit of consumption. But the Home Office is yet to formally respond.

Moore says any product authorisations remain subject to the introduction of a defined permitted level. This process has left the industry mired in uncertainty, reducing investor confidence and limiting innovation, with many companies already having to fold during this lengthy and costly process.

“CBD companies are struggling to survive. Many of these companies were not large operations to start and have had to expend large amounts of investment simply to get through the process. Combined with a cost of living crisis, this has been a perfect storm for the CBD industry. Now investors are losing confidence in the regulator’s approach and the market in general. 

“The bureaucracy of British institutions has potentially blocked one of Brexit Britain’s only obvious chances at exploiting an emerging market.

“We can still be confident that when all is said and done the UK will have a first-mover advantage and with some sensible investment could become a global hub for consumer cannabinoid research and development. But will there be any British CBD brands left?”

Responding to these concerns, a spokesperson for the Home Office tells NutraIngredients: "The application process continues with the potential for authorisation recommendations in 2024 but for most applications we recognise that this remains subject to the introduction of a defined permitted level."

The spokesperson adds: “We want to provide greater clarity for responsible suppliers by introducing defined permitted limits on the controlled cannabinoid content of consumer CBD products. This will enable responsible suppliers to produce and supply CBD consumer products more easily.

“This is a complex area of policy and we are giving close consideration to the recommendations in the ACMD’s report."

Also responding to these concerns, an FSA spokesperson tells NutraIngredients it has adopted a threshold of >1mg of THC/container as the benchmark for whether a food product could be regarded as a controlled drug, while it awaits a legal framework for consumer CBD products: “As with all novel foods, we are carrying out a rigorous and thorough assessment of CBD products which have been submitted for authorisation, and this naturally takes some time to complete.

“The Home Office has stated its intention to establish a legal framework for consumer CBD products and is considering the advice of the Advisory Council on the Misuse of Drugs on THC and other currently illicit substances in food. The FSA is working closely with the Home Office to ensure a coordinated approach to CBD.

“In the meantime, the FSA has recognised that many CBD and hemp products contain trace amounts of THC and, on a pragmatic and proportionate basis, has adopted a threshold of >1mg of THC/container as the benchmark for whether a food product could be regarded as a controlled drug and therefore referral to the police.”

The spokesperson adds that validated tests are available for testing for different cannabinoids within CBD products and there are UK accredited laboratories that can perform this testing.

How did we get here?​

Four years ago, in January 2019, the FSA announced that it was going to follow the European Food Safety Authority (EFSA) and regulate cannabidiol (CBD) as a novel food product.

The decision was taken to follow the retained EU law but enact it retrospectively - use a pre-marketing authorisation tool for all those products currently on the market and assess any new entrants as per usual once those applications had all been dealt with. 

The announcement was greeted with enthusiasm with brands thinking the UK was to become the first jurisdiction globally to officially regulate CBD as a food product.

However, three years down the line and the industry is at a standstill.

Moore explains: “Many were unprepared for the costly and time-consuming nature of the regulatory process designed first and foremost to protect consumers. 

“The FSA demanded toxicology data to prove that CBD was safe for ingestion at the rates that consumers would typically take these products. This would be expensive to produce, but the industry reacted in innovative fashion: consortiums were formed by groups of companies to spread the cost of this data.” 

Finally the studies were complete and the safety data was submitted to the FSA alongside product applications.

“This occurred close to nine months ago and we are yet to see any CBD products be authorised for sale”  

What are the complications?​

Discussing the reasons for the slow process, Moore says: “Firstly, it is clear that the FSA has a major resource issue. The FSA has had to deal with an overwhelming number of applications from CBD companies, but is also constantly responding to other novel food applications such as chia seeds, insects and UV-treated mushrooms.” 

There is also the concern about the potential for CBD products to contain controlled psychotropic substances. This means that a variety of government agencies need to be involved, including the FSA, Trading Standards, Home Office, Border Force, and to some extent the MHRA. 

“This has all been accentuated by the attempt to use a pre-marketing authorisation tool retrospectively,” Moore adds, “the FSA deserves great credit for its boldness and accommodation. Rather than following the letter of the law, which would have required that all CBD products be removed from sale before approval, the regulator allowed products to remain on shelves in order to prevent all of these companies going bust. But this has perhaps led to a slow rather than swift death.”