Notably, the FSA aims to harmonize CBD product safety with Home Office standards, enforcing strict THC thresholds and labeling requirements.
According to legal experts, the updated regulatory framework represents both an opportunity and a challenge.
Luca Bucchini, managing director at Hylobates Consulting Srl, says the latest update is a further step towards full legal recognition of CBD in the UK, with the FSA moving towards regulating the industry with more certainty.
“There are legal challenges pending; however, the alignment of the FSA with the Home Office is the most important piece of news,” Bucchini told NutraIngredients.
“The Home Office’s views are not ideal for the industry but do provide a way forward with more legal uncertainty.”
The Home Office’s position on cannabis, CBD and other cannabinoids reflects a highly regulated approach, he said.
While this stance is not entirely favorable to the burgeoning cannabis industry, as it imposes significant restrictions and legal hurdles, it does offer a path for legitimate operations under specific conditions, Bucchini explained.
Slipping timelines
An eight-week public consultation is set to launch in early 2025, inviting stakeholders to contribute feedback on the proposed regulations, and final recommendations to ministers across Great Britain are expected by Spring/Summer 2025.
The current novel foods assessment process has been slow-moving, and Dr. Mark Tallon, CEO of Legal Products Group Ltd, also predicted legal action against the FSA, citing delays and inconsistencies.
“It is now expected to drag into 2025 where I expect legal action to have started against the FSA over the handling of novel foods and current assessment process,” he wrote in a recent LinkedIn post.
He noted that labeling should play a more prominent role in the regulatory approval process for novel foods, particularly in addressing concerns about higher doses of certain substances.
“The consideration of labeling is key to ensuring higher doses are accepted but are currently being ignored by the Advisory Committee on Novel Foods and Processes (ACNFP) and FSA in the assessment of novel foods submissions,” the post stated.
CBD legal background
All CBD food products must apply for novel food authorization before they can be sold legally in Great Britain. This involves providing toxicity data for products.
The FSA introduced the public list as a public record of products linked to credible applications going through the authorization process.
The authority published consumer advice in February 2020, which recommended healthy adults not to take more than 70 mg of CBD per day. However, this was significantly dropped to 10 mg in October last year.
Since the updated regulation, three applications have received positive safety assessments and are undergoing risk management to address broader factors like labeling and THC content.
Voicing frustration
Stakeholders have expressed dissatisfaction with the Acceptable Daily Intake (ADI) limit of 10 mg/day, arguing that available data supports higher intake levels, which was announced in October 2023.
This issue, along with labeling requirements, has become a focal point of contention, as stakeholders seek adjustments that better align with scientific findings and consumer needs.
Cefyn Jones from the Hemp Hound Agency criticized the Home Office’s decision to uphold a 1 mg THC limit per product in a LinkedIn comment, arguing that it disregarded expert recommendations for more practical thresholds.
“What was the point of asking for the ACMD to provide an opinion on controlled cannabinoid levels and to then say they ‘we agree in principle’ if the Home Office is only going to ignore that that has happened and reinforce the 1 mg rule?” he wrote.
Advice for CBD brands
Breaking down the details of the announcement, Stephen Oliver, co-founder of MAST Consulting Advanced Food Regulation, stated LinkedIn post that companies must take note of the revised guidance.
He wrote that the Home Office asserts that CBD products authorized by the FSA and Novel Food/Regulated Products will have a 1 mg threshold per container (e.g., a bottle of oil) for each controlled cannabinoid, not based on a typical dose.
Additionally, testing laboratories must hold ISO/IEC 17025 accreditation from a relevant body to ensure validated methods, quality management and independent assessment. In the UK, United Kingdom Accreditation Services (UKAS) is the accrediting body.
Finally, detection levels must be sufficient to avoid vague claims like “less than 0.2% THC“ or certificates of analysis (COAs) stating ”0.0% THC.”
“Obtaining a license for manufacturing compliant produces will now be possible once a company can evidence that their output is lawful and authorized by the FSA,” he wrote.
“This creates a new chicken and egg but... it is workable.”
Oliver recently spoke to NutraIngredients about the challenges faced by start-ups whose products fall under the EU’s Novel Food regulations.
He warned that the EU lacks specific regulations and inconsistent rules across member states, creating confusion. This means there is now a ‘graveyard’ of innovative companies ill-prepared for the hurdles they must jump.
In a comment on LinkedIn, one user noted that while the timeline for approval of the first three CBD novel food applications has been delayed until some point in 2025, enforcement will soon come into play.
“Anyone who has a product in the UK market that isn’t manufactured from CBD that is sourced from one of the three approved CBD product suppliers are at risk of removal from the market,” wrote Adam George, founder of Psi Pharmaceuticals Ltd.
“As for those who have invested substantial sums in toxicology and safety studies, it does at least look like payday is on the horizon.”