UK CBD Regulation Reaches Critical Point with New Guidance

UK CBD Regulation Reaches Critical Point with New Guidance

The Cannabis Trades Association (CTA), a prominent UK trade organization, announced that the regulatory framework governing CBD products in the UK is at a critical juncture following recent updates from health and safety officials. The Food Standards Agency (FSA) has closed the application window for new CBD products, tightening the approval process under the category of ‘novel’ foods.

In its statement, the CTA highlighted that the updated regulations are clearer and more stringent, aligning closely with scientific evidence and public safety standards.

The FSA and the Medicines and Healthcare products Regulatory Agency (MHRA) have both released new guidelines aimed at clarifying regulations within the CBD sector. The MHRA reiterated that any CBD product claiming medicinal properties must be classified and treated as a medicine, requiring formal marketing authorization for legal sale. The agency emphasized that products marketed with medicinal claims fall under the definition of medical products.

Concurrently, the FSA stressed that all ingestible non-medical CBD products classified as novel foods must obtain authorization before they can be sold. Only those meeting specific safety, labeling, and usage criteria will be permitted on the market.

Previously, products with ongoing or validated novel food applications were allowed to remain available through a CBD Public List. However, with the list now closed, any product not linked to an ongoing application is deemed non-compliant. Additionally, the FSA has prohibited a common compliance method known as ‘white labeling,’ where businesses could rebrand a single approved formulation under multiple product names. Each product must now have its own validated application.

In a recent communication with the CTA, Rebecca Sudworth, FSA Director of Policy, reaffirmed the agency’s focus on processing CBD applications based on quality and order of submission. Since the beginning of 2025, five applications have progressed through the FSA’s risk management phase. Since CBD extracts were categorized as novel foods in January 2019, the FSA has faced challenges managing an initially overwhelming 12,000 product submissions, with around 5,000 products now in the risk management review stage.

The FSA also plans to establish safe upper limits for THC levels in CBD products, guided by recommendations from its scientific advisory committees. The CTA has criticized the FSA for treating a 10 mg acceptable daily intake (ADI) as a binding limit, arguing that this threshold does not consider the differences between various CBD formulations, such as isolates, distillates, and full-spectrum extracts. Following an unexpected reduction in the ADI in October 2023, industry representatives have warned that such a low limit could hinder market growth and deter investment. In contrast, the European Industrial Hemp Association (EIHA) has suggested a more moderate 17.5 mg daily limit for European regulators, which is more reflective of ongoing scientific evaluations.

A public consultation regarding the first round of CBD authorizations is anticipated to commence in May. These initial approvals will serve as a template for future applications, establishing key criteria such as maximum allowable THC levels, labeling requirements, and the specific formulations under which products may be legally sold.

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