Updated 12 October 2021 – Please note in light of FSA Announcement 12 October we are currently in the process of reviewing the information presented below.
In light of the FSA’s announcement, relating to CBD regulation and precautionary health advice, ACI’s experts have compiled the following FAQ covering the questions consumers, retailers, manufacturers or health care professionals may have concerning CBD.
What is a Novel Food?
A Novel Food is defined by the European Food Safety Authority (EFSA) as food that had not been consumed to a significant degree by humans in Europe before 15 May 1997, when the first regulation on Novel Food came into force.
Why are CBD products on the market without Novel Food authorisation?
CBD products have seen a massive growth in recent years with many consumers claiming they gain therapeutic value from, with sparse evidence showing negative side effects. This led to incredible growth in the UK CBD market.
A policy report from the Centre for Medicinal Cannabis in June 2019 indicated a market size in excess £300 million with forecasted growth of just short of £1 billion by 2025 and a market larger than the Vitamin C (£119 million) and Vitamin D (£145 million) industries combined.
The FSA has been consistent in their stance that companies should be going through the Novel Foods process to ensure safety of the compounds within their products on the market.
Given the popularity of CBD this provides a difficult situation for the FSA, and trading standards, to police effectively. This has led to them allowing products to remain on the market providing they are engaged in the Novel Foods application process.
What does the statement from the FSA on 13 February 2020 mean for the UK CBD industry?
All stakeholders in the UK CBD industry need to begin looking at their products and processes to see how they conform to Novel Foods and wider regulations.
Products that were on the UK market prior to 13 February were given a grace period of until 31 March 2021 to submit a novel foods application. They were allowed to stay on the market unless their application is rejected.
Products that were not on the UK market prior to 13 February 2021 must have a validated novel foods application by the FSA before they can sell their products in the UK.
Any product that has not submitted a novel foods application by 31st March 2021 is expected to withdraw their products from the market.
Raw material manufacturers must gather appropriate safety and stability data, with appropriate standardised testing methods to submit a Novel Food’s authorisation process.
Manufacturers of finished products must ensure their suppliers are engaging with the Novel Foods process and making a Novel Foods application and they have appropriate stability data on finished products.
Brand owners using a 3rd party manufacturer must begin a consultation process with their suppliers to ensure they are using raw materials which will be going through the necessary authorisation.
What has the ACI done to address Novel Foods authorisation?
We have drawn on our vast expertise in the regulatory environment to put all the necessary plans in place to begin the Novel Foods authorisation process for our members.
This includes;
- Engagement with regulatory bodies to determine regulatory pathways and support companies create the necessary dossier.
- Equivalency work with validated testing laboratories to ensure flawless validation of any analytical results to be presented within the dossier.
- Constant engagement with leading toxicological experts and testing houses to put in place the necessary studies to smoothly gain Novel Foods authorisation.
- Launched a CBD safety study consortium to address gaps in the existing safety data relating to CBD.
What does the dosing requirements and guidance for pregnant and breastfeeding women stipulated by the FSA mean to brands and consumers?
Brand owners must ensure their labelling adheres to the advice given around maximum daily dose. They must also indicate pregnant, breastfeeding women and children must not consume CBD products. They need to indicate that those taking prescribed medication must consult their doctor before consuming CBD products.
Consumers should also heed the advice given the recent release of information from the Committee Of Toxicology (COT) indicating at certain doses CBD can be harmful to the liver. They recommend that anyone taking medication must not consume CBD.
Whilst there is evidence to show the products used in the Committee on Toxicity (COT) report, which was used as a basis for FSA’s guidance, are not equivalent in formulation to the foods supplements currently on sale in the UK, this is the only data available to the FSA to date and they had to take this into consideration when advising consumers.
It is important to note, the ACI is in the process of performing our own study with our members to accurately define safe doses of CBD within commonly used edible CBD products.
How should Retailers react to the announcement?
Retailers should be in constant communication with their suppliers to ensure they are aware of the announcement from the FSA and are adhering to these recommendations.
Should retailers have any fears or concerns they should not hesitate to contact the ACI for guidance.
How can the ACI support your business?
Raw Material Manufacturers
We can support you with the Novel Food application process from start to finish. We can assist in putting together your dossier. Our team of experts can advise you on the necessary data collection and analytical requirements for your application.
Finished Product Manufacturers
We can provide all the necessary information relating to best practice processing of raw materials going through the Novel Foods application process. We will guide you through the necessary information around your process and quality management to ensure legal compliance.
Brand Owners
We can advise on the steps needed in the consultation process with your 3rd party manufacturers to ensure they are taking the necessary action to ensure compliance.
In addition, we can support and advise where necessary to accurately label and market your products to adhere to FSA and MHRA requirements regarding dosing, warnings and any therapeutic claims.
Retailers
The FSA’s statement provides clarity for retailers to gain a broader understanding of the regulatory framework which will come into place. The ACI can advise retailers on the steps they must take to ensure they are only stocking products which will be legally compliant in the future.
What impact does the ACI expect this to have on the CBD sector?
It will standardise the testing methods and initiate safe dose evaluation. This is the best outcome for consumers as well as the suppliers. Responsible suppliers are already working on this, this clear guidance from the FSA means that companies are now rewarded for ensuring their products are safe.
Any more questions?
Please do not hesitate to contact the ACI. One of our experts will be in touch. This FAQ will be updated as more questions arrive.
