Regulator to recommend market authorisation for CBD products in England and Wales

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MARKET authorisation for cannabidiol (CBD) products in England and Wales moved a step closer last week after the Food Standards Agency (FSA) confirmed it would recommend the government approves its plans to regulate the cannabis-derived food supplements. 

CBD is a cannabinoid that can be produced synthetically or extracted from hemp plants and is an essential component of medicinal cannabis. Widely marketed as a consumer product, food supplements containing high-purity CBD with only trace amounts of tetrahydrocannabinol (THC), the psychoactive substance in recreational marijuana, have grown in popularity over the past decade owing to their perceived wellbeing benefits, evidence of which remains scarce. 

CBD gels, oils, sweets and drinks are widely available in shops and cafes, but a 2019 EU ruling classifying CBD as a “novel food” meant they required market authorisation to remain on sale. The FSA allowed products to remain on the market as long as they submitted applications for authorisation, and has been developing a regulatory process since 2021.

The FSA drew up plans last year to recommend authorisation for three forms of CBD covering roughly 3,000 individual products. The agency will now recommend authorisation to ministers in England and Wales, despite mixed responses to its public consultation on a number of technical issues.

Safety concerns around CBD remain contended. The World Health Organization’s Expert Committee on Drug Dependence said there does not appear to carry risk of harm or abuse. By contrast, the European Chemicals Agency’s Risk Assessment Committee has recommended it be classed as a reproductive and lactation toxicant. Impacts to young, pregnant or breastfeeding people are relatively unknown.

During the FSA’s consultation, the recommended acceptable daily intake (ADI) “generated some of the strongest and most detailed feedback across the consultation”, the agency said. One consultation respondent described the existing ADI of 10 mg/day as “absurdly low”, while industry respondents suggested a bodyweight-based threshold would be more suitable. 

However, the FSA rejected industry calls to change the ADI, describing its existing limit as “an integral part” of its consumer guidance. The agency added: “It is expected that a healthy consumer will not come to harm with this level of intake of pure form CBD.”

The upper limit on trace THC, however, will increase 1,000-fold to 0.01% following an industry response to the consultation. The FSA said the change is intended to make manufacturing within the limit more achievable, and that the threshold is still 70 times lower than the safe upper limit for THC consumption. 

The decision was criticised by the Cannabis Trades Association in a blog post last week, arguing that “regulatory specifications should be determined principally by safety and legal compliance, not simply by what manufacturers can more easily achieve”.