UK CBD industry given ultimatum to authorize products by March 2021

14 Feb 2020 --- UK Food Standards Agency (FSA) has set a deadline for cannabidiol (CBD) companies to provide more information about their products and their contents. The FSA gives industry by March 31, 2021, to submit valid novel food authorization applications. Beyond that date, only products with a valid application will be allowed to remain on the market. The process ensures that novel foods meet legal standards, including on safety and content. Moreover, the agency advises healthy adults not to consume more than 70 mg daily, while vulnerable groups, such as those who are pregnant, breastfeeding or taking any medication, should abstain entirely.

The March 2021 deadline applies only to England, Wales and Northern Ireland, as Scottish novel food regulations will be covered by Food Standards Scotland. Additionally, people who take medically prescribed CBD or cannabis will be unimpacted.

“The novel food legislation is being transferred from the EU into UK law. In terms of the health effects, there is still discussion around them and research needed. So far, there is no human data on reproductive toxicity (i.e. pregnancy), but there is human data for other toxicity effects, such as the effect on human livers,” Rachel Hodgson, Senior Communications Manager at FSA, tells NutritionInsight.

Local authorities are enforcing the novel food legislation, which has included CBD since January 2019. Businesses have been advised to sell their existing CBD products during this time provided they are not incorrectly labeled, are not unsafe to eat and do not contain substances that fall under drug legislation. 

A survey last year revealed that almost half of CBD products currently available on the UK high street contain cannabinol (CBN) or tetrahydrocannabinol (THC).

Click to EnlargeThe March 2021 deadline applies only to England, Wales and Northern Ireland, as Scottish novel food regulations will be covered by Food Standards Scotland.The latest health warnings on CBD are based on recent findings by the UK government’s Committee on Toxicity (COT). “'We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead,” says Professor Alan Boobis, Chair of the Committee on Toxicity.

Reinforcing the above, a study last year revealed that components of marijuana, including CBD and THC, can cause brain and facial birth defects if used during the first trimester of pregnancy.

Industry response
The FSA’s move has been welcomed by those in the industry, with the Association for the Cannabinoid Industry (ACI) stating that it establishes a clear trajectory toward the development of a safe and legally compliant CBD industry in the UK.

“A key challenge is that some products’ labeling is misleading to consumers. These need to be addressed via appropriate safety study design to ensure safe dose evaluation and standardization, as well as harmonization of testing methods for appropriate labeling of products so that consumers can have confidence in the product,” Dr. Parveen Bhatarah, Regulatory Lead, ACI, tells NutritionInsight.

“There are some gaps in legislation so far, due to lack of appropriate skill set in the cannabinoid testing and evidence-based science study behind it. This is compounded further by the Home Office not providing the licenses to these companies to develop these skills. It is evident from the limited analytical testing houses in the UK with a Home Office License,” he adds.

Dr. Andy Yates, Pharmacy Lead, ACI, also notes that the statement by the FSA is going to be welcomed by everyone connected with CBD in the UK, including consumers, retailers, manufacturers and health care professionals. This is because it sets a clear timetable for action and recommends a maximum daily dose and exclusions for use in vulnerable groups in the interim, he says.

The announcement has elicited a response from several CBD-related sources. “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,” notes Dr. Nick Horniman, Director of Regulatory Affairs, Sativa Group.

Stephen Mueller, Founder and CEO of Mile High Labs, says he “applauds” 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,” he adds.

By Kristiana Lalou, with additional reporting from Katherine Durrell

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