The Food Standards Agency (FSA) has set the cannabidiol (CBD) industry a deadline of 31 March 2021 to submit novel food authorisation applications. After this point, all products which have not submitted a valid application will be removed from the market.
Local authorities have also been advised that businesses should be able to sell their existing CBD products during this time, provided they are not making unsolicited claims, are correctly labelled, safe to consume and do not contain substances that fall under medicinal products legislation.
The FSA has also provided their first-ever safety advice for consumers; healthy adults are recommended to take no more than 70 mg of CBD a day, whilst those who are pregnant, breastfeeding or taking any medication are not advised to consume CBD products.
A statement from the FSA regarding the enforcement of the novel food status for CBD had been expected, there have been estimates that the UK CBD market would be worth nearly £1 billion by 2025 and entrepreneurial companies have been quick to get a slice. Consumers have been turning to CBD because of its widely reported potential health benefits, but the lack of enforcement by the FSA or local authorities has meant that the safety and content of these CBD products is not guaranteed.
But the timing of the announcement is interesting, the FSA Chief Executive reported in the January 2020 FSA board meeting that “We have not been made aware of any safety incidents relating to CBD products on the market, so we are not planning to insist on the immediate removal of the products from shelves.” This change of position may be due to the recent media reports of liver toxicity following findings from the government’s Committee on Toxicity (COT) at the end of January.
The choice of an early 2021 deadline adds another layer of complexity. Given the relatively long assessment timeline for novel food applications (~ 9 months) and the fact that applications are assessed by the European Commission, unless companies act very quickly, the outcome of the assessment is likely to fall after the end of the transition period. It is possible that separate UK applications will be needed from the 1st January 2021, meaning any assessments will need to be fast-tracked to meet the March deadline.
JensonR+ will be continuing to monitor the situation in 2020 and beyond. To discuss the potential impact of this change to products, please contact [email protected].
This article was written by Ben Smith, Regulatory Officer at Medilink EM Patron Company JensonR+.