The UK’s long and fraught CBD novel foods approval process is showing signs of progress, with five new applications passing the Food Standards Agency’s (FSA) safety assessment phase since the start of 2025.
However, the approvals have reinforced a contentious industry-wide debate over the FSA’s strict adherence to a 10mg acceptable daily intake (ADI) cap – a drastic reduction from the previous 70mg limit that blindsided the industry in October 2023.
The five applications approved so far this year advanced roughly 850 products, with more than 830 of those from a joint application submitted by TTS Pharma, Liverpool, and HERBL, California’s largest cannabis distributor.
Hard limit on CBD intake
Others applications advancing were those filed by Brains Bioceutical, Mile High Labs, cbdMD, and Bridge Farm Group. All five newly approved applications conform to the 10mg ADI, a threshold that industry stakeholders have long criticized as overly restrictive. Observers said the approvals send a strong signal from the FSA that applications proposing higher ADIs are unlikely to pass the safety review.
Industry group the Cannabis Trades Association has accused the FSA of misapplying the ADI as a binding cap rather than advisory guidance, arguing that the limit does not account for differences between CBD isolates, distillates, and full-spectrum extracts.
Since the ADI reduction in October 2023, industry figures have warned that such a low threshold could render CBD products ineffective, stifling market growth and discouraging investment. In contrast, the European Industrial Hemp Association (EIHA) has proposed a 17.5mg daily limit to European regulators, a more moderate threshold that reflects ongoing scientific evaluations.
Market uncertainty
Despite criticism over the ADI, the recent approvals suggest the UK is moving – albeit slowly – toward full CBD market regulation. Since CBD extracts were designated as novel foods in January 2019, the FSA has struggled to manage an approval pipeline that initially saw 12,000 product submissions. To date, approximately 5,000 products have advanced to the risk management review stage.
Pending positive outcomes, the FSA and Food Standards Scotland will then recommend those products to ministers across Great Britain.
The latest approvals follow three granted in 2024, including dossiers from Chanelle McCoy’s Pureis, Cannaray, and one from a consortium organized by the European Industrial Hemp Association that continues to carry more than 2,700 products.
According to the FSA’s most recent report, the agency expects to recommend a first set of three product applications to UK ministers by mid-2025. If approved, these would become the first fully authorized CBD products legally sold in the UK market.
Alongside the new approvals, the FSA recently removed 102 products from its public list of CBD products allowed to remain on the market pending full validation. While some products were voluntarily withdrawn, others were delisted with no clear explanation. Nearly 600 have been removed from the process entirely to date.
The EIHA consortium has another 2,201 products in a second application for CBD distillates which remains at the first stage of the FSA’s review, “awaiting evidence.”
An industry in limbo
The UK CBD market – valued at approximately $850 million – remains in a precarious position. Beyond the ADI debate, looming concerns over allowable THC levels add further uncertainty. The FSA, aligned with the Home Office’s strict interpretation of the Misuse of Drugs Act, maintains that any detectable THC could render a product illegal unless it meets stringent Exempt Product Criteria (EPC). This interpretation has already led to legal disputes, such as the case of Jersey Hemp, which successfully challenged a Home Office decision blocking its imports.
With an eight-week public consultation on CBD regulations expected in early 2025, stakeholders anticipate further clashes over both THC thresholds and the rigid enforcement of the 10mg ADI. As of March 5, 2025, the FSA has not yet initiated the consultation, a critical step in the FSA’s process to recommend the first set of CBD product applications.
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