Food law experts concerned about CBD novel foods process as FSA reveals first products list
The FSA has published its promised list of CBD products that can remain on sale until it decides whether to authorise the products.
The list contains 22 products from just three companies: Chanelle McCoy Health (Pureis), CANNABIS Pharma s.r.o, and Health Innovations (UK) ltd.
Companies in England and Wales had to submit their novel foods dossiers to the FSA by March 31st if they wanted their CBD products to be able to legally remain on the market.
The FSA promised that it would provide the industry with a list of products this month, associated with applications which either: have been validated in the initial stage of the process before going on to the safety assessment; or are ‘on hold’, with applicants having set out robust plans to complete the risk assessment but yet to supply all the information needed to continue on in the process.
Local authorities will need to use the lists in order to enforce the law and ensure only legal products are being sold.
Emily Miles, Chief Executive of the Food Standards Agency, says companies who didn't submit a dossier to the FSA by March 31st should remove their products from the market, adding: "Products on the list that have been linked to a validated or on hold application will now undergo a full safety assessment so that a final decision can be made.
"When complete, the list can be used by suppliers and retailers to confirm the status of particular products and to help local authorities inform their enforcement decisions.
"The FSA is not endorsing the sale of any of these products, regardless of whether they are on the list or not and inclusion on the list is no guarantee of eventual authorisation; that will be determined on the strength of evidence of safety submitted by the companies."
Mark Tallon, Managing Director at Legal Foods Ltd, tells NutraIngredients that he knows novel foods applicants who have been given application numbers in the high 700’s, suggesting the FSA has probably received 800-1,000 applications. He says he has serious concerns about the whole process and continuing delays.
“Those companies submitting their application prior to March 31st - a date put in place by the FSA are now disadvantaged as it may be perceived they have not submitted a relevant dossier,” he says.
“Likewise unless the list is updated with a rejected or withdrawn list, those products will likely continue to remain on the market until at least June when the full list is published. The effect on consumers and businesses is they will have no way of knowing if a product they are purchasing is legal for sale.”
“The submission of dossiers will now make the FSA aware of those products that are not pure CBD. Thus, the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) have provided a view that “only” CBD is a low health risk substance over a short period of time, they provided no such safety assessment about other substances present in cannabis extracts such as CBG, CBN, THC.
“Without any risk assessment equivalent to that carried out by COT on CBD then the FSA may be allowing unsafe substances and / or a wide range of novel products to remain on the market until at least June.”
The FSA has advised that any product brought to market after Feb 13th 2020 is considered illegal until they are given novel foods authorisation. However, products on the market prior to this date and linked to novel foods applications which are making initial progress through the novel foods authorisation should be allowed to stay on the market until a decision on their authorisation has been made.
Mr Tallon takes particular issue with this, saying: “The FSA continues to support this notion of a threshold date of 14th February 2020 as a date permitting products can remain on the market. This is not enforceable in law in our view. You may have companies right now with a submission that will be rejected or contains no toxicology study on their ingredient yet because it was sold pre- 14th Feb can remain on the UK market.
“This maybe in stark contrast with a businesses with full suite of toxicological data on their products yet not be allowed to be sold if placed on the market post 14th Feb. This is nonsense and is wide open to judicial review as is the continuing extension of the deadline for the removal of products from the market without any open consultation of visible ministerial approval.”
In response to Mr Tallon's comments, a spokesperson for the FSA has said: "The clarification of CBD as a novel food was 26 months ago so all businesses have had the opportunity to submit an application. We decided to set a deadline to ensure that the industry began to move towards compliance. No CBD products on the market, including those on the CBD list, are authorised novel foods. The list reflects the products associated with companies that have taken the time to provide sufficient information to demonstrate the safety of their products.
"It is a food business’ responsibility to ensure any product they put on the market is safe. All products with a validated application will progress through a full risk assessment as part of the novel foods process. There is an independent view on the risk assessment conducted by the Advisory Committee on Novel Foods and Processes, who are very experienced at dealing with a wide range of novel foods.
"All novel foods should have been through the risk assessment process before they were put on the market. Any new products after the announcement date will be treated as any other novel food would be. Local authorities have the legal powers required to enforce against non-compliant novel foods. The CBD list can be used as a guide for local authorities to inform their enforcement decisions and by retailers to know the status of their suppliers."
Sarah Ellson, Co-Head of Regulatory at the law firm Fieldfisher with specialist knowledge of the cannabis market, says the small size of the list is 'worrying'.
"Looking at the list it is surprising and perhaps worrying for the current state of the UK CBD market to see only three companies got their dossiers in and validated."
Providing advice for stockists concerned about what products they can keep on their shelves, she adds: "According to the FSA's CBD novel foods list, technically products not on the list should not be sold – they are not compliant with food safety law and should not remain on the market.
"In reality of course many have been being sold and the press announcement hints at the enforcement reality being that trading standards will focus on products about which there are safety concerns or which have made no efforts to step into compliance.
"It seems that there must be a good number of suppliers who are in the process of submitting applications or having them validated (and eventually authorised). The list is going to be updated weekly until the end of June so in many ways it seems that there is a three month grace period where is it unlikely any action will be taken against leading brands who have applications in train."