UK- The Food Standards Agency formally notified the Association for the Cannabinoid Industry (ACI) that its applications for cannabidiol (CBD) distillate and isolate are within the scope of authorization as a novel food.
The FSA assessed the toxicology safety data ACI submitted in 2022 and confirmed that it is an appropriate study addressing the safety concerns held by the FSA and Committee on Toxicity (COT).
The submission included the dose range-finding study and the OECD408 rodent toxicity study to determine a ‘No Observable Adverse Effect Level’ (NOAEL) to cover the safety implications of CBD and minor cannabinoids, and other plant matrices present in these plant-derived products.
ACIs applications will now move to the risk assessment phase, after which the ingredients will receive full authorization for sale in the UK.
“The validation of thousands of products is a major milestone for the industry,” Tom Risby, business R&D manager at ACI, commented.
This development will likely lead to increased product innovation in the future within the regulations set by bodies like FSA..
“We hope this will cement the UK as a world leader in consumer cannabinoid research and development. We expect product authorizations to come in Q4 or Q1 next year,” Risby added.
Opening new markets
Once approved, it will be possible to integrate CBD into bread, cereal, ice cream, and other common foodstuffs to create a whole new functional food and supplement market.
CBD applications account for 30% of products the FSA permits to remain on the market, under the current novel foods authorization process. This designation could affect up to 320 brands sold in Great Britain.
“This is a key milestone for the sector and the ACI. The new consumer cannabinoid sector has been set as an important regulatory challenge. Today’s outcome suggests that by collaborating, they are both progressing towards market authorization for thousands of products but also delivering the safety data regulatory authorities have been crying out for,” Steve Moore, ACI co-founder, and strategic counsel said.
The integration of cannabinoids into products that consumers already regularly use is bound to expand the scope of the market, attracting consumers who may never go out of their way to buy a specific CBD product.
“The current consumer cannabinoid market primarily consists of CBD oil tinctures, gummies, and capsules,” explains Risby. “In the future, we imagine that rather than being a product, CBD will become an ingredient, similar to Omega-3.”
A framework for other jurisdictions
While ACI’s progress is a significant milestone in the utilization of CBD in the UK, this compound is still controversial in other countries, including the USA, even though ACI states that the FSA’s validation could act as a model for regulation in the US and EU.
Although several states in the US have passed laws to legalize CBD, products containing this compound, including CBD dietary supplements, CBD-infused sodas, sparkling water, and cold brew coffee, are essentially illegal at the federal level.
The US Food and Drug Administration (FDA) recently rejected three petitions by the Consumer Healthcare Products Association to allow CBD products to be labeled as dietary supplements.
Under federal law, once a substance is an active ingredient in an approved drug- or undergoes substantial clinical investigations as a medication- foods and dietary supplements containing this substance can’t be introduced into interstate commerce.
Despite the conflict between federal law and state laws concerning CBD, the U.S. market for cannabis beverages in 2022 was an estimated US$752 million, thanks to consumer interest in these products.
There is, however, some hope after the FDA states that it is “actively working to learn more about the safety of CBD and CBD products.”
According to Risby, as more countries see the progress the UK is making, there could be a global push for safe and regulated CBD markets.
“The UK’s regulatory experience also offers critical insights for regulatory bodies in other jurisdictions, which is especially valuable given the FDA’s recent announcement that they will be developing a specialized pathway for cannabis products in the US,” Risby stresses.
“Given our expertise and success in dealing with the challenges posed by the UK regulator, the ACI will also assist companies in their applications to the European FSA,” Risby added.
Once the FSA’s list is fully updated, Risby says the organization will have a more comprehensive understanding of how it can best assist its members in gaining product authorizations.
“The ACI’s applications only directly relate to 20 or so products,” he elaborates. “In the meantime, we will be assisting our members with their commercial goals, informing the public on what regulation means and how it benefits them, and investing in programs to help the sector reach its full potential.”