The regulator announced that the UK CBD industry has taken a major step in the right direction. It could be the Spring of next year before the first CBD products are officially approved.
The Food Standards Agency has not seen a precedent like this before.
The Food Standards Agency and Food Standards Scotland are now set to begin an eight-week period of public consultation early in the new year. This will be followed by a final decision to ministers.
This period of consultation offers stakeholders a unique and much-needed opportunity to hear their concerns. In addition, it could be a way for both the FSA as well as business owners to mend a broken relationship.
What has happened?
Thomas Vincent, FSA Policy Team and CBD Policy Team released a report last week on the status of novel food application processes.
The FSA provided a timeline of three possible applications that would reach the last stage in the approval process. At this point, the FSA makes recommendations to the government ministers.
According to the FSA, “Subject Ministers approval, authorisation is written in legislation and laid down as statutory acts which are under Ministerial review before authorisation becomes effective.”
According to the recent report from the FSA, it is ‘on track to make recommendations to ministers on our first CBD applications in the Spring/Summer of 2025′.
The FSA board will decide on key principles for these recommendations early in the next year.
These recommendations, which are a significant change in the rhetoric of the FSA after repeated criticisms of lack of transparency from industry, will include recommendations from that sector based upon an eight-week period of consultation.
The event is scheduled to occur in 2025. It will give stakeholders the opportunity to voice their concerns and make recommendations about what they feel to be a flawed regulatory system. This has led to an industry contraction over the past few years.
Please read the following recommendations
The FSA Board is invited to adopt five principles that will guide the management of CBD risk.
- Advice on CBD safety for consumers
- Balance public safety, consumer choice and the industry’s viability with proportionality
- Only CBD-authorized novel foods are allowed on the market
- Supporting enforcement: Facilitating retailers and enforcement colleagues efforts to prevent noncompliant products
- Keep the consumer’s trust: Renewing their faith in FSA and food safety
Once these principles have been established, potentially with the industry’s input, they will be used to ‘guide the FSA’s approach to the risk management of CBD’ in two key areas.
THC is a content that contains the following:
First and foremost, the FSA has suggested that it would align itself with the Home Office’s position on THC.
Home Office guidelines confirm that any THC level in a drug makes it a misuse of drugs act controlled substance. When THC is at low levels, and is difficult to obtain in quantities that are likely to be misused, the substance is exempt from drugs laws and is free for trade.
The ‘Exempt Product Criteria’ (EPC) is a key element of this debate, and has already played a crucial role in seeing the Home Office admit to acting unlawfully in banning a CBD company from importing products to the UK.
This year has been a busy one for the earliest part of this decade. MEDCAN24 The case of Jersey Hemp was reported. It was a story centered on EPC, an EPC-related regulation to the Misuse of Drugs Regulations of 2001.
CBD isn’t a controlled drug, but it is almost impossible to prevent traces of THC from being present in products containing full spectrum CBD. However, under these regulations, a product containing THC is considered ‘exempt’ if it meets three criteria.
It must contain less than 1 milligram of THC per product component, THC must not be easily extracted from the product ‘in a yield that poses a health risk’, and it must not be ‘designed for administration of the controlled drug to any human or animal’.
Josh Normanton is a Trinity Chambers barrister who advised Field Fisher’s Jersey Hemp legal team on this case. He explained that there has been much debate in the past about whether or not the exemption criteria apply to CBD products and food items. This is something that I’ve dealt with many times. This is definitely applicable.
The CBD product should be used for CBD administration to humans or animals, not for THC administration. THC can sometimes remain in products as traces after the manufacturing process. The criteria of an exempt product is therefore met.
The FSA adds that it intends to make recommendations to minsters on CBD products containing CBD where they ‘meet the Home Office exempt product definition’.
However, it stipulated that it will need to ‘carefully consider the legal and operational implications of regulating a product that is considered both a food and a drug’.
The FSA’s other main goal is to protect those who are vulnerable, such as children under 18.
It proposes that mandatory labeling be required, with information about the Acceptable Daily Intake and warnings specific to certain groups as well as limitations on marketing for those under 18. It will also establish collaborations with the industry, local authorities and retailers to inform consumers of risks and ensure compliance.
ADI is still a very contentious topic in the industry, especially since it was reduced abruptly from 70mg a week to just 10mg.
In its latest report, the FSA notes that ‘scientific assessment to date shows that CBD does not pose an acute safety risk at 10mg a day for a healthy adult’.
The FSA Board meeting will take place in London Wednesday 11th Dec., and the next steps of this process are likely to be discussed.
Participants can attend online or in person. They may also submit questions.