A leading UK trade association said the country’s regulatory framework for CBD products has reached a “significant inflection point” after health and safety officials recently issued updated guidance.
The guidance comes as the Food Standards Agency (FSA) has closed the window for new candidate products and further tightened the CBD approval process under rules for new or “novel” foods.
In a statement, the Cannabis Trades Association (CTA) said, “The regulatory expectations are now clearer, stricter, and more aligned with scientific evidence and public safety.”
Updated guidance
The FSA and the Medicines and Healthcare products Regulatory Agency (MHRA) both issued statements recently they said are intended to bring more clarity to the sector.
The MHRA reaffirmed that any CBD product making medicinal claims must be classified and regulated as a medicine.
“Products containing cannabidiol (CBD) used for medical purposes are medicines,” the agency said. “If a company markets a CBD-containing product that makes a medicinal claim, it will be considered to fall within the definition of a medical product.” To be legally marketed, such products require a formal marketing authorization, the MHRA said.
Simultaneously, the FSA reasserted that all ingestible non-medical CBD products considered novel foods must be authorized to be sold. The agency said only those products that meet detailed safety, labeling, and usage specifications will be permitted.
Tightened rules
Through a CBD Public List, the FSA had allowed products with ongoing or validated novel food applications to remain on the market in the absence of regulations. With the closure of the Public List, products not already linked to progressing or validated applications are now considered non-compliant.
At the same time, the FSA banned a once-common compliance shortcut through which businesses could rebrand an approved formulation under multiple product names as long as it was tied to a single application. The practice, “white labeling,” is no longer allowed.
The FSA has made it clear that compliance will now be evaluated not only by formulation but also by branding, labeling, and traceability. Each distinct product name must be directly associated with its own validated application.
FSA commitment
Meanwhile, in a recent letter to the CTA, Rebecca Sudworth, FSA Director of Policy reaffirmed the agency’s commitment to advancing CBD applications through risk management under the process for approving new or “novel” foods.
“While acknowledging delays caused by poor-quality applications and the retrospective nature of the process, the agency made it clear that applications are processed in the order they were received and based on quality,” the CTA said in characterizing the letter.
Five applications have moved through the FSA’s risk management phase since the start of 2025.
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.
THC limits in focus
The FSA is also preparing to publish safe upper limits for THC in CBD products, based on findings from its scientific advisory committees.
CTA has accused the FSA of misapplying a 10mg acceptable daily intake (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 a surprise 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.
A 12-week public consultation on the first batch of CBD authorizations is expected to launch in May. These initial authorizations are expected to set the template for how future CBD applications will be assessed. Regulators are likely to use them as benchmarks for key criteria, including maximum allowable THC levels, labeling requirements, and the specific formulations and conditions under which products can be legally sold.