FOOD STANDARD AGENCY CHIEF EXECUTIVE’S REPORT TO THE BOARD
(8TH DECEMBER 2021)
The FSA Chief Executive has updated the FSA Board on:
- their progress with the assessment of CBD Novel Food applications;
- how they intend to proceed with their further assessment of those applications;
- their intention to maintain two “lists” (one for already Validated and one for what appears to be “heading in the direction of Validation”;
- their intention to target “stakeholder retailers” (i.e. national and larger regional chains) retailers and advise them of the status of products which they say (by reference to the above lists); and,
- their intention to advise Trading Standards to direct enforcement against rejected products (rather than products on either of the above two lists).
The full text of the Report is reproduced here (emphasis added by ourselves):
I wanted to give an update on the CBD applications in particular. As the Board know, the FSA has been concerned for some time about CBD food products which are on sale but have been concerned for some time about CBD food products which are on sale but have not yet been through the formal novel foods market authorisation process. CBD products are unusual, in food regulatory terms, for three reasons:
-
-
- Confirmed as a ‘novel food’ after many on sale. After some time discussing the novel food status of CBD extracts, in January 2019, the European Commission confirmed that CBD is a novel food (i.e., with no significant history of consumption before May 1997). By that time, however, a substantial number of products had already been placed on the market. Our consumer research in 2020 told us that of the 60% who said they had heard of CBD, 13% said they had used it in the past year.
- A food but could be a drug or a medicine. CBD is in the nexus of regulatory regimes between drugs, medicines and food. Some CBD products are classed as medicines and are therefore regulated by the MHRA (Medicines and Healthcare products Regulatory Agency). CBD is widely associated with general health benefits; these claims have not been substantiated by the relevant bodies. Further, if there is THC (tetrahydrocannabinol, the psychoactive compound in cannabis) in the product – which is a risk as it is derived from the Cannabis plant – it becomes an illegal drug. A product cannot, legally, be both a food and an illegal drug.
- A dearth of existing research. There is little existing scientific evidence about the safety or effect of CBD on the body. The Committee on Toxicity (COT) identified in July 2019 that CBD can have a number of adverse side effects and that there were numerous data gaps and uncertainties. Further data are needed to fully assess its safety. It is a basic principle of food law that the food business which sells the product is responsible for making sure it is safe for the consumer.
-
Since 2020, the FSA has been taking a proactive and phased approach to bringing this part of the food industry into compliance with the law. The approach balances legal compliance, consumer safety, the interests of consumers who take CBD products, and the desire to support innovation in the food industry.
In the interests of consumer safety, in February 2020 we offered consumer advice, highlighting that none of the products currently for sale had been formally safety assessed. Further, if consumers were going to eat them, they should limit themselves to a maximum of 70mg a day, and we advised vulnerable consumers not to eat CBD products on a precautionary basis. We understand we were the first food regulatory agency in the world to do this.
To encourage the industry to become compliant, at the same time we set a deadline of 31 March 2021 for applications to be registered with the FSA so that CBD products could be taken through the usual novel foods assessment process. The responsibility for novel foods market authorisation assessments transferred from the EU to the FSA on 1 January 2021.
We received a large number of enquiries and applications by our deadline but after filtering only around 210 applications were viable for further consideration, connected to several thousands of products.
Since April 2021 we have therefore been working progressively to give more clarity to the market, local authorities and to consumers about the likelihood of those applications getting market authorisation. So far, we have looked at almost all of the applications to see if they have provided enough scientific data to enable us to do a scientific risk assessment for safety. The quality of applications was lower than we anticipated, so this work has taken longer than we thought it would. Where necessary, we have had to ask for additional scientific information from applicants. Once we are confident we have sufficient information, we ‘validate’ the application and it then goes formally into the scientific assessment process. Currently, four applications have passed through the validation stage. We have made this list public.
