UK regulators say they are making progress approving CBD products, and expect to cross an important milestone next year on the way to establishing the country’s estimated $850 million market.
The Food Standards Agency (FSA) plans to recommend a first set of three product applications to ministers in “Spring/Summer of 2025,” the agency said in a report last week. Consideration at the ministry level can take weeks to months, meaning the country’s first legal products could be on the market by the end of the year.
By now, stakeholders know better than to hope for too much too soon when it comes to the FSA’s CBD approval process – in which the agency is sorting through some 12,000 products under rules for new or “novel” foods. The process has been slow to unfold, and an eight-week public consultation planned for early next year could prove contentious over a couple of key issues.
Allowable THC
One is allowable THC levels in CBD products, with the FSA aligned with the Home Office’s strict interpretation that says any amount of THC in a product technically classifies it as a controlled substance under the Misuse of Drugs Act. However, products can qualify as exempt if the THC is present at extremely low levels, cannot be easily extracted in harmful amounts, and is not intended for delivering THC to humans or animals.
Exemptions are under “Exempt Product Criteria” (EPC), which have been central to recent legal disputes, including a case in which CBD company Jersey Hemp successfully challenged a Home Office decision to block imports of its products, highlighting that trace amounts of THC resulting from manufacturing do not necessarily disqualify a product under the EPC.
Legal experts have noted that CBD products can often satisfy the EPC, supporting their lawful trade under UK regulations.
Daily intake limits
The daily intake limit for CBD is also likely to be a lively topic during the public comment period. The FSA last year drastically reduced its recommendation for total daily intake of CBD, in light of guidance from key government committees – prompting some stakeholders to announce it a death knell for the sector.
The agency now recommends consumers take a maximum of 10mg or “about 4-5 drops of 5% CBD oil” per day, down from 70mg under guidance issued in 2020.
For comparison, the European Industrial Hemp Association has proposed a maximum daily intake level of 17.5mg per day of CBD to the European Food Safety Authority. FSA said it was concerned over evidence that showed taking more than 10mg daily over a period of time produced evidence of some adverse impacts on the liver and thyroid.
Slow to develop
CBD extracts were designated novel food in the UK in January 2019 and all CBD food products must be approved before they can be sold legally. FSA had said it expected the first CBD products to be fully authorized during the latter half of 2023, but the process has lagged well beyond that timeline, and has been controversial.
A wide range of CBD products have been on the UK gray market for several years, including drops, supplements and beverages. To remain on the market pending final approval, those products already in distribution had to have been on sale before Feb. 13, 2020, under FSA rules. Those introduced to the market after that date were not eligible for the agency’s consideration.
Of 12,000 products originally submitted to the FSA, roughly 8,000 are in the “validated” or first stage of the agency’s review while 6,000 have advanced to the second stage, in which they face risk management review. It is the three mentioned in the recent FSA report that have reached the final stage of the agency’s review and will be recommended to ministers next year.
Nearly 600 products have been eliminated from consideration and banned from the market.