Industry experts have raised questions about the credibility of the FSA Novel Food list after a number of featured CBD products appear to have levels of THC above recommended limits.
The new Food Standards Agency (FSA) list features CBD products linked to what it describes as “credible” applications. These products may remain on sale in the UK as they pass through the next phase of the process, whilst those not on the list must be removed from shelves.
Featuring more than 3,500 ingestible CBD products, the list applications will now move into the risk assessment stage before final authorisation as a safe product for human consumption.
In December 2021, a report from the Advisory Council on the Misuse of Drugs (ACMD) outlined its recommendations to the UK Government on establishing guidelines for the CBD industry. The report suggested that the dose of each controlled phytocannabinoid ‘should not exceed 50 micrograms per unit of consumption’.
Previously, the limit was set at 0.2 or 0.3 per cent of THC per serving of CBD. The FSA has recommended consumers have a maximum daily limit 70mg per day of CBD.
Read more: ACMD releases new advice on THC levels in consumer CBD products
Kyle Esplin of the Scottish Hemp Association and member of the Cannabis Industry Council has pointed out that the Novel Foods authorisation process was triggered by reports of CBD products containing four times the recommended amount of THC. Esplin states that the FSA has not followed its own criteria after CBD food products have appeared the list with well above the FSA’s criteria and the ACMD’s recommendations.
In a comment to Cannabis Wealth, Esplin commented: “The novel foods update highlights that in addition to being a massive waste of time and money, the process now lacks any credibility.
“The FSA have not even followed their own criteria for submissions, and while many products on the list may be removed before the end of the process, we aim to overturn the entire novel foods requirement for hemp based products before it comes to that.
“Here in Scotland, the FSA list does not apply anyway and will not be referenced. We are continuing our negotiations with Food Standards Scotland to facilitate the growth of a domestic industry, one where whole plant hemp extracts are treated like any other Hemp food supplement.
“The FSA has also been slack on labelling specifics, for example if a product is made from two isolates with added terpenes it should not be called ‘full spectrum’. In Scotland we want a more comprehensive labelling requirement so that consumers can make an informed choice. If a product contains synthetically produced CBD, then the consumer should be informed of this.
“The FSA has accepted products onto the list that contain more than 200mg THC per container. Considering the negative headlines that the industry received about the average 4mg THC per product found in the Centre for Medicinal Cannabis’s (CMC) blind trials leading to calls for tighter regulation, either the 1mg THC limit no longer applies, or the FSA is not fit to conduct its own process.
“While I expected the Novel Foods process to be a disaster for the hemp industry, I didn’t expect it to be so erratic and listing products with an even higher THC content than has been reported prior.”
In a personal blog, he stated: “…you can imagine my surprise to scan through the updated Novel Foods list (which is only valid for England and Wales) and find there are products listed with over 200mg THC in a single consumer product…
“So, 50x more THC than the newspapers headlines which led to the CBD industry getting a negative reputation about THC content and the need for stricter regulation…”
Responding to Cannabis Wealth, the FSA stated: “The ACMD recommendations are proposals and do not have a legal basis. We are monitoring developments on this.
“Unless and until any legislation on exemption levels is in place we will continue to act by removing products from the list if the Police take action against them on the basis of them being a narcotic and therefore not a food. Concerns whether a CBD product is a narcotic should be raised with the relevant Police force.”
Read more: Mixed response from CBD industry to publication of FSA product list
Dr Parveen Bhatarah, director of regulatory and compliance unit at the Association for the Cannabinoid Industry Association of the Cannabinoid Industry (ACI), who has worked closely with the ACMD on its THC recommendations, told Cannabis Wealth: “The application/products appeared on FSA’s published list have not been through the Risk Assessment stage of the novel food application process yet. Therefore, the impact of the ACMD’s recommendations is not relevant here. In addtion, ACMD’s recommendations are just guidance at present.
“All the Novel Food applications submitted to the FSA should contain the sufficient data to prove that their products meet the UK’s current regulatory limits for the psychoactive phytocannabinoids, along with the validated methodology to support the results as per their CoA (certificate of analysis).
“Therefore, risk of exceeding the ACMD’s recommendations are very low. However, this can only be evaluated once applications have been through the Risk Assessment process.”
The process has already been described as a “monumental waste of time and money” given the World Health Organization (WHO) has already decided that CBD is safe. However, others believe the moment is a milestone for the industry that will now have the certainty it needs for innovation and investment.
Professor Mike Barnes, founder of the Cannabis Industry Council, commented: “This whole thing is a mess as the Novel Foods process does not impact on the legality of the products which are still subject to the 1mg per container rule. This whole thing is a total incomprehensible mess.”
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