Industry’s urgent plea: ‘Save Our CBD’ campaign calls on UK Home Office for legal clarity

28 Aug 2023 --- The UK consumer cannabinoid industry has initiated an urgent plea to the Home Office to put a legal framework to sell cannabidiol (CBD) products, upholding its 2021 commitment. The campaign, Save Our CBD, seeks legal clarity for these products, which have been sold online and commercially for ten years without formal regulation.

“The lack of a defined legal limit for trace levels of controlled cannabinoids has left the entire industry in limbo. It has stalled product research and development because companies are not certain on what levels of cannabinoids their products can contain,” Tom Risby, campaign researcher, tells Nutrition Insight.

“Furthermore, investors are unwilling to support companies that are producing and selling products that technically should not be on the market. Until this issue is resolved, businesses have no clarity, cannot innovate and cannot raise the capital required to expand their enterprise.”

According to the campaigners, the uncertainty in the industry puts at least 400 CBD suppliers in jeopardy of closure and threatens a market worth around £690 million (U$S868 million). Additionally, they state that the lack of legal clarity prevents the Food Standards Agency (FSA) from granting Novel Food authorizations, restricting business operations and innovation in the sector.

Campaign pushes for legal framework
The Save Our CBD campaign, officially launched today, requests that the UK Home Office provide urgent clarity about establishing a legal framework for businesses to operate “securely, safely and responsibly.”

It states that CBD products have become a vital part of the lives of millions of consumers, about 18 million, with more than 12,000 products permitted for sale by the FSA, which regulates over-the-counter CBD products in England and Wales. A maximum daily dose of 70 mg is recommended.

Steve Moore, a representative of the campaign and lead counsel for The Association for the Cannabinoid Industry (ACI), says: “We understand the complexities the Home Office faces, but businesses have consistently acted responsibly throughout this period. There is no valid reason why it cannot provide the much-needed legal clarity the industry urgently seeks.”FSA’s silence on providing a clear legal framework for CBD use and sales has prompted the industry to form a consortium to push for a decision to be taken.

Risby notes that the lack of legal clarity costs the industry “many millions” of pounds. “The FSA demanded toxicology data to prove that CBD was safe for ingestion at the rates that consumers would typically take these products. This data is expensive to produce.”

Some companies generated their own toxicology data, while others in the industry reacted innovatively by forming consortiums through groups of companies to spread the cost of this data.

Nutrition Insight reached out to the Home Office for a response, but they had yet to respond at the time of going live.

Earlier this year, CBD was 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 green light from the FSA. 

The move came after ACI received formal notification from the FSA that its CBD distillate and isolate applications are within the scope of authorization as a novel food.

Ripe for a response
In February 2020, the FSA unveiled detailed plans to regulate CBD as a food product. Millions have since been invested in research by industry to meet the highest food safety standards mandated by the Novel Foods process, the campaigners emphasize.

In January 2021, the Home Office sought advice from the government’s Advisory Committee on the Misuse of Drugs (ACMD) to amend the Misuse of Drugs Act to accommodate the sale of CBD products. 

“The Home Office needs to respond to the ACMD’s report on consumer cannabidiol products. The Home Office solicited a response to these legal questions from the ACMD, who submitted its recommendations in December 2021,” laments Risby.

“Twenty months on, and the Home Office is yet to formally act on these recommendations.” 

“We are finally nearing the end of the regulatory process, but the FSA cannot authorize products for sale until legal limits for trace levels of controlled cannabinoids are established. It is thus critical that the Home Office acts as soon as possible to resolve this issue and allow the regulatory authorities to resume the novel foods authorization process.”The Save Our CBD campaign consists of many UK industry leaders and businesses. 

After a year of public consultation, AMCD submitted a report outlining recommendations for an appropriate legal framework for CBD sales; however, the Home Office still needs to take further action or provide legal clarity.

CBD industry support for campaign
The ACI set up the consortium to conduct studies that would answer the safety concerns and data gaps cost-effectively, ethically and timely. The consortium bases its stance on studies that feature four major tests.

“The first is a genotoxicity test that assesses the mutagenic potential of chemical compounds, or whether CBD causes mutations in DNA,” Risby explains.

This followed the 471 guidance of the Organisation for Economic Co-operation and Development (OECD) and produced a negative result. 

“The second was an in vitro micronucleus assay, or a test for detecting micronuclei in the cytoplasm of mammalian cells. This is a test to see if CBD is absorbed and stored within the cells.” This followed OECD 487 guidance and again was negative.

The third major test was a 90-day rodent toxicity study following OECD 408 that informs whether a health hazard is likely to arise from exposure to CBD via oral administration. 

“It produced results that align with the existing scientific literature and support the FSA’s current daily CBD intake recommendation of 70 mg/day,” Risby notes.

“We also conducted an additional relative bioavailability study that shows a significant margin between the current recommended daily intake and the no observed adverse effect level in rodents, which supports the current recommendations of 70 mg per day or 1 mg per kilogram,” he concludes.

By Inga de Jong