THE FSA’s plans to regulate CBD as a Novel Food and cautions over its potentially harmful health effects have prompted a mixed reaction in the industry.
Most businesses have welcomed the clarity it will provide, highlighting the further investment it will encourage, although there is still much resistance to the FSA’s stance.
To summarise, on Thursday February 13, U.K. regulators the Food Standards Agency warned the country’s CBD industry to comply with Novel Food rules or face having their products taken off their shelves.
It gave the industry a little over a year to comply with its new guidelines – and also issued a health warning to mums-to-be and those taking medication not to use CBD.
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Cannabis Trades Association
While welcoming aspects of the statement The Cannabis Trades Association (CTA) – the largest association of its kind, with over 1,200 members in 35 countries – raised some concerns.
It said: “Although the Cannabis Trades Association duly welcome a route to compliance for the industry and its members, we are still of the opinion that natural – not isolates or synthetic forms – CBD products do not fall under the scope of the Novel Food schedule.
“The CTA fully supports regulation as it ensures consumer safety and gives clarity to the processes required for its members’ products to remain in stores across the country.
“We are continuing a full review process including legal aspects and avenues into the current and proposed regulations for CBD in the U.K., whilst maintaining close relationships with relevant authorities and stakeholders. In reality, not all members will be affected by the proposed legislative changes.
“Further to the highlighted safety concerns, the CTA agree that CBD as a food supplement should not be administered in high daily doses (above 200mg as approved in 2016 by the MHRA), and consumers should always seek approved medical guidance if taking other medications or during pregnancy.
“We also maintain our position that CTA members products are compliant and continue to pose no safety concerns to those consuming within the set guidelines.
“In summary, although we do not agree in full with all that is being proposed, we believe it is a positive step towards ensuring consumer safety and that “CBD will be on the shelves for many years to come.
“As an association, we will continue to work tirelessly to maintain relationships with all the official agencies to ensure our members, their products and the entire industry maintains a route to compliance and will issue further statements and guidance outlining the steps the CTA are undertaking.”
European Industrial Hemp Association
The European Industrial Hemp Association (EIHA), which has over 250 members in over 26 countries, said it welcomes the clarity the FSA announcement has provided the industry.
Although, it went on to say it would have preferred a higher recommended daily dose and expressed disappointed at the FSA’s failure to acknowledge that CBD in whole plant extracts have been used in Europe for hundreds of years and are therefore, not novel.
Ms Lorenza Romanese, Managing Director of the EIHA, said: “We support the rationale behind FSA’s statement and look forward to our discussions early next month to discuss the EIHA consortium application in detail.
“The sector indeed needs standards and I can assure you that we will lead this process.
“However, that being said, we are disappointed that the FSA does not appear to support EIHA’s position that for many centuries cannabinoid rich hemp foods and hemp extracts containing CBD have been extensively consumed across Europe and therefore low concentration CBD products should not be considered as Novel based on FSA’s own definition.”
“EIHA’s members agreed last year to submit a joint consortium application and will submit a range of CBD extracts to both the U.K. FSA and the European Food Standards Agency (EFSA).
“Considering the substantial cost of an application, this is the optimum solution for industry and EIHA is receiving new membership applications on almost a daily basis from businesses wishing to benefit from our knowledge and expertise.”
The Association for the Cannabinoid Industry (ACI) welcomed the new FSA ‘regulatory and precautionary advice’.
In said: “We believe it establishes a clear trajectory towards the development of a safe and legally compliant CBD industry in the UK.
“Today’s update will be welcomed by consumers, the industry, and retailers alike. It will generate significant levels of industry investment in research and product quality which will place the sector on a sustainable path.
“Until now, it had grown in the shadows of the necessary regulation any such industry requires, perpetuating a lack of consumer confidence and business confusion.
“The whole industry is now on notice and we are confident it will respond with urgency to the new clarity the FSA have provided.
“The foundation goal of the ACI is to facilitate the creation of an ethical, high-quality and innovative cannabidiol industry in the UK. With the publication of this new guidance, we are emboldened in this mission. We will now intensify our work with the FSA, trading standards other Government departments to make this a reality.”
Dr Nick Horniman, Director of Regulatory Affairs, U.K firm Sativa Group, said: “Sativa Group wholeheartedly welcomes the FSA’s groundbreaking statement which outlines a clear path towards a safe and legal CBD industry in the UK. We believe this will position the UK as world leaders in this sector. Sativa is fully engaged with the process of novel food approval, with the support of ACI, to ensure legal compliance.”
Stephen Mueller, Founder and CEO of U.S. firm Mile High Labs, said:
“We applaud FSA for recognizing the demand for CBD in the UK, and for taking the necessary steps to protect consumers. We are committed to filing our novel foods application and welcome the agency’s progressive focus on CBD compliance.”
Peter Reynolds, founder of industry trade body CannaPro, says it will be seeking another meeting with the FSA to question why it sees the need to regulate CBD as a Novel Food.
Mr Reynolds believes the FSA’s reference to ‘CBD extracts’ demonstrates a lack of understanding of the issues as its members sell only ‘whole plant extracts’.
He said: “We don’t sell CBD extracts. What we do sell is something that has been taken from the cannabis plant for hundreds of years.”
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