ACI’s novel food application validation set to move CBD from “product to ingredient”

15 Mar 2023 --- CBD is on track to be integrated into bread, cereal, ice cream and other common foodstuffs to create a whole new functional food and supplement market, following a greenlight from the UK’s Food Standards Agency (FSA).

This follows the Association for the Cannabinoid Industry (ACI) receiving formal notification from the FSA that its applications for cannabidiol (CBD) distillate and isolate are within the scope of authorization as a novel food – a designation that could affect up to 320 brands sold in Great Britain.

The applications will now move to the risk assessment phase of the application, which, once complete, 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, tells NutritionInsight. “This will increase consumer confidence, de-risk the category for investors and create the important foundations that will lead to increased product innovation in the coming years.”

“We hope that 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.”The ACI believes that CBD will pass from product to food and supplement ingredient status in the near future.

Opening new markets
ACI submitted the completed toxicological packages along with bioavailability data to support its applications in 2022, including dose range findings and rodent toxicity study with “no observable adverse effect level” findings.

The organization states that following final approval, it expects CBD to become a common ingredient within the ingredients and supplement industries as its applications account for 30% of products that the FSA permits to remain on the market, under the current novel foods authorization process.

“The current consumer cannabinoid market primarily consists of CBD oil tinctures, gummies and capsules,” explains Risby. “However, we see this as simply being the start of the category. In the future, we imagine that rather than being a product, CBD will become an ingredient, similar to Omega-3.” 

“We expect to see CBD being integrated into bread, cereal, ice cream and other common foodstuffs to create a whole new functional food market. Integrating cannabinoids into products that consumers already regularly use will broaden the scope of the market, engaging consumers that would perhaps never go and buy a specific CBD product but instead are looking for alternatives to their daily routine that can offer some small health benefits.”

A model for other countries?
Recently, the US Food and Drug Administration (FDA) rejected three petitions by the Consumer Healthcare Products Association to allow CBD products to be labeled as dietary supplements. The administration has also been accused of perpetuating confusion in CBD regulation.

“The UK’s regulatory experience also offers a number of critical insights for regulatory bodies and companies operating 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. 

“As more jurisdictions see the progress the UK is making in this space, we will start to see a global push for safe and regulated CBD markets.”The organization states that the FSA’s validation could act as a model for regulation in the US and EU.

“In the longer term, given our team’s expertise and success in dealing with the challenges posed by the UK regulator, the ACI will also be assisting companies in their applications to the European Food Safety Authority. We believe that we have a full tox package that will facilitate product authorizations in the EU too.”

Next steps in the process
Risby further explains that the ACI will continue to monitor the FSA’s public list of affected products under the validation in order to see “the true impact of this notification.” Once the FSA’s list is fully updated, he 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. “However, every consortium members’ applications ride on the back of those, so the success of those two is crucial to every other validation. In total, that means around 4000 products and 320 brands could potentially be moved to the validated category in the coming days.”

“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,” Risby concludes.

By William Bradford Nichols