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Major breakthrough: UK approves five applications for a total of 850 CBD products, but will strictly limit daily intake to 10 milligrams

3-24

The lengthy and frustrating approval process for novel CBD food products in the UK has finally seen a significant breakthrough! Since early 2025, five new applications have successfully passed the safety assessment stage by the UK Food Standards Agency (FSA). However, these approvals have intensified the heated debate within the industry over the FSA’s strict 10 mg acceptable daily intake (ADI) limit—a substantial reduction from the previous 70 mg ADI announced in October 2023, which caught the industry off guard.

The five applications approved so far this year cover approximately 850 products, with over 830 of them stemming from a joint submission by TTS Pharma, Liverpool, and HERBL, California’s largest cannabis distributor.

Strict Limits on CBD Intake

Other applications moving forward include those from Brains Bioceutical, Mile High Labs, cbdMD, and Bridge Farm Group. All five newly approved applications comply with the 10 mg ADI limit, a threshold long criticized by industry stakeholders as overly restrictive. Observers suggest that by granting these approvals, the FSA is sending a strong signal to the industry that applications proposing higher ADIs are unlikely to pass safety reviews.

The Cannabis Trade Association, a UK industry group, has accused the FSA of misusing the ADI as a binding cap rather than advisory guidance, arguing that the limit fails to account for differences between CBD isolates, distillates, and full-spectrum extracts. Since the FSA lowered the ADI in October 2023, industry data has warned that such a low intake threshold could render CBD products ineffective, stifle market growth, and deter investment. In contrast, the European Industrial Hemp Association (EIHA) has proposed a more moderate ADI limit of 17.5 mg to European regulators, reflecting evolving scientific assessments.

Market Uncertainty

Despite widespread criticism of the ADI, the recent approvals indicate that the UK is moving toward comprehensive CBD market regulation—albeit at a slow pace. Since January 2019, when CBD extracts were classified as novel foods, the FSA has been grappling with the initial 12,000 product submissions. To date, around 5,000 products have entered the risk management review stage. Following positive outcomes, the FSA and Food Standards Scotland will recommend approval of these products to ministers across the UK.

These approvals follow three applications approved in 2024, including Chanelle McCoy’s Pureis and Cannaray products, as well as an application from a consortium led by the EIHA, which submitted over 2,700 products. According to the FSA’s latest report, the agency expects to recommend the first three product applications to UK ministers by mid-2025. Once approved, these products will become the first fully authorized CBD products legally available on the UK market.

In addition to the new approvals, the FSA recently removed 102 products from its public list of CBD product applications. These products must undergo full validation before they can continue to be sold. While some products were voluntarily withdrawn, others were removed without clear explanation. To date, nearly 600 products have been completely removed from the process.

It is reported that the EIHA consortium has another 2,201 products in a second application for CBD distillates, but this application remains in the first stage of FSA review—”awaiting evidence.”

An Uncertain Industry

The UK CBD market, valued at approximately $850 million, remains in a precarious state. Beyond the ADI debate, concerns over permitted THC levels have added further uncertainty. The FSA, aligning with the Home Office’s strict interpretation of the Misuse of Drugs Act, insists that any detectable THC could render a product illegal unless it meets stringent exempt product criteria (EPC). This interpretation has already sparked legal disputes, such as the Jersey Hemp case, where the company successfully challenged the Home Office’s decision to block its imports.

Industry stakeholders had anticipated that the FSA would launch an eight-week public consultation on CBD regulations in early 2025, expecting further clashes over THC thresholds and the strict enforcement of the 10 mg ADI. However, as of March 5, 2025, the FSA has yet to initiate the consultation, a critical step in the process of recommending the first batch of CBD product applications.

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Post time: Mar-24-2025