The handover of regulatory powers to the EU risks thousands of CBD products going from on shelf to over the counter only, the UK’s health watchdog has been warned.
In a letter to the Food Standards Agency this week, the Cannabis Trades Association said there was “increasing concern” that the SPS dynamic alignment would drive CBD away from its status as a regulated consumer food product to become “quasi-medicinal, pharmacy-only” products.
The trade body represents hundreds of cannabis-based business, many of which have submitted some of the 12,000-plus applications pending with the FSA for approval under its novel foods regulations. It this week bombarded the FSA with nearly 60 questions over the impact of the proposals, warning of the unintended consequences of the regulatory reset.
Marika Graham-Woods, CEO & chairman of the the trade body, told the FSA: “The issue is whether CBD, a low-risk hemp-derived consumer product when produced to appropriate standards and sold without medicinal claims, is now at risk of being regulated out of ordinary consumer access entirely.“
Last week The Grocer revealed thousands of applications for CBD food and drink products were in “limbo” amid uncertainty over the outcome of the government’s discussions, with a summit between the UK and Europe set for next month.
Legal experts said it was looking “increasingly likely” that CBD companies may have to launch fresh applications into Europe, with the FSA set to hand over responsibility for so-called novel food authorisations.
Fears among CBD companies have been heightened amid moves within the EU to tighten restrictions on the sale of CBD products.
“If future SPS alignment results in the UK adopting a more restrictive EU position, or if CBD is pushed towards an OTC medicine or pharmacy-only model, the consequences for consumers, SMEs and the wider hemp sector would be severe,” added Graham-Woods.
The FSA has operated a “grace period” for CBD products since 2020, allowing manufacturers with novel food applications pending to sell their products. However, the trade body said with the future of the sector now under threat it was time for the health watchdog to either publish any evidence of harm or confirm that the products were safe.
“The FSA has now operated a novel foods process for CBD for approximately six years,” she said.
“During that time, the process has not yet delivered a fully functioning authorised CBD market for consumers or businesses. To our knowledge, the FSA board has stated that there is no evidence of a pattern of food safety incidents arising from compliant CBD food products during that period.
“If such evidence exists, it should be published and scrutinised. If it does not, the board must ask whether further restriction is justified by real-world harm or by hypothetical regulatory caution.”
Among the questions to the board, the trade body asks if the FSA will confirm whether CBD products sold without medicinal claims should continue to be capable of regulation as foods or food supplements, rather than medicines. It also asked what evidence the FSA holds of food safety incidents arising from compliant CBD food products.
The letter adds: “The current novel foods system has already placed significant pressure on compliant UK businesses. The burden has fallen most heavily on SMEs.
“It would be deeply unfair to move the goalposts again after years of industry investment in the novel foods process.”
FSA CEO Katie Pettifer told today’s meeting the extent of concern expressed by the trade body was “a reminder of how significant this process may be for our authorisation applications. ”
She said the FSA had written to all companies with an application for a CBD product to set out what the dynamic alignment with the EU could mean.
Earlier this week, The Grocer revealed there were fears the more than £320m invested to give the UK leadership in novel foods was being jeopardised by negotiations for dynamic alignment with the EU, as fears grow investors are starting to withdraw from the sector.
In April, The Grocer revealed that plans for the UK to become a centre for lab-grown meat and other new novel foods faced being dashed by the move to realign the UK with EU single market rules.
New evidence submitted to the House of Commons Business & Trade Committee by the Alternative Proteins Association warns that the UK is risking its “progressive” policies on developing Lab-grown meat being taken over by an EU framework that is “slower, more politically contested, and increasingly hostile to the technologies”.
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