In a statement issued by the Food Standards Agency (FSA), the CBD industry has until 31 March 2021 to submit valid novel food authorisation applications.
After 31 March next year, only products, which have submitted a valid application will be allowed to remain on the market. The authorisation process ensures novel foods meet legal standards, including on safety and content.
“CBD products are widely available on the high street but are not properly authorised,” says Emily Miles, chief executive of the Food Standards Agency.
“The CBD industry must provide more information about the safety and contents of these products to the regulator before 31 March 2021, or the products will be taken off the shelves.”
Potential health effects
The FSA also issued precautionary advice recommending that CBD could be risky for vulnerable groups, and suggesting an upper limit of 70 milligrams (mg) a day for those taking the product.
Professor Alan Boobis, chair of the Committee on Toxicity, an independent scientific committee that provides advice to the FSA, says, “My committee has reviewed the evidence on CBD food products and found evidence there are potential adverse health effects from the consumption of these products.
“We are particularly concerned about pregnant or breast-feeding women and people on medication.
“We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead.”
Dr Parveen Bhatarah, regulatory lead at The Association for the Cannabinoid Industry (ACI) welcomed the FSA’s input, adding that the advice, “provided us with the regulatory clarity that the industry and consumers have been crying out for.
“It is critical that the industry now responds by undertaking all the investments required to ensure that we can deliver full regulatory compliance.”
CBD was confirmed as a novel food product back in January 2019 with today’s announcement concerning CBD extracts applying in England, Wales and Northern Ireland. Novel food regulations in Scotland are covered by Food Standards Scotland.
The FSA adds that the news will have no impact on those who take medically prescribed CBD or cannabis.
“Sativa Group wholeheartedly welcomes the FSA’s groundbreaking statement which outlines a clear path towards a safe and legal CBD industry in the UK,” says Dr Nick Horniman, director of regulatory affairs at the Sativa Group, a firm involved in the CBD Wellness and medicinal cannabis sectors in the UK.
“We believe this will position the UK as world leaders in this sector. Sativa is fully engaged with the process of novel food approval, with the support of ACI, to ensure legal compliance.”
Stephen Mueller, founder and CEO of Mile High Labs adds, “We applaud FSA for recognising the demand for CBD in the UK, and for taking the necessary steps to protect consumers.
“We are committed to filing our novel foods application and welcome the agency’s progressive focus on CBD compliance.”
Giving a pan-European view of today's developments, Luca Bucchini, managing director of Hylobates Consulting comments that the FSA's latest advice may be a glimpse of post-Brexit Britain, where illicit products are allowed on the market until evidence of risks comes up, or the authorities feel safety data gaps are too large, and consumption too prevalent, to ignore the issue through "enforcement discretion", which does not exist under EU law.
"It is what the US FDA does," he adds. "and some may see it as a positive. Of course the FSA is taking a tougher stance than the US FDA on CBD, but when application of a law is suspended for a year, who can be sure that no further postponement is on the cards?
"That said, yes, it is a pragmatic approach but contrasts sharply with Germany's and the EU's. Whether this is a sign of things to come or the FSA intends never to be in this position again, it is uncertain now - but CBD has been formally permitted for 13 months as of now, pending availability of evidence of its safety."
FoodNavigator is co-hosting a two-day CBD Global Summit in London, 16-17 March 2020.
The event wants to bring together the science, business and regulation governing CBD to look at how businesses can unlock this important market opportunity. For more details, check out our advanced programmed, and view confirmed speakers, visit the CBD Global Summit website.