The agency has itself held similar safety concerns for more than two years that have not been deemed significant enough to shift the safety needle against some 5,980 FSA-registered CBD offerings transitionally permitted on British brick and click shelves while it engages in its own assessments of around 900 industry-submitted safety dossiers.
“The information available does not provide sufficient evidence of a safety risk to determine that an immediate product removal is appropriate, based on the legal balance that must be made,” FSA Senior Communications Manager, Lisa Nelson, told NutraIngredients.
“So while we do not have evidence of harm relating to CBD products, there is also no evidence to show they are safe. The independent Committee on Toxicity has reviewed the existing CBD evidence and from that we have developed consumer advice on consuming CBD.”
That advice continues to be that healthy adults should consume a maximum of 70mg of CBD per day and vulnerable groups like pregnant and breastfeeding women and those on medications should not take it all.
Nelson added: “If we find credible evidence to say that CBD isolates or synthetic products in general, or specific products containing CBD, risk harm to the public, they will be removed from sale.”
Support for EFSA's work
The European Industrial Hemp Association (EIHA), which has submitted dossiers to the FSA representing more than 100 of its full-spectrum and isolate CBD-manufacturing members, supported EFSA’s work and publication.
“EFSA did this to help applicants improve their chances,” EIHA Managing Director, Lorenza Romanese, told us. “So we support that. There are no surprises here really whether it is for isolates or full-spectrum CBD – the gaps have been known for a long time.
"When EFSA says a NOAEL (no-observed-adverse-effect level) for CBD does not exist, they are right. It doesn’t exist for THC (tetrahydrocannabin) either! So we support this clarification. EFSA is doing what it is supposed to be doing.
“It shows how poor some of the toxicology data has been which is a shame for the sector.”
Plugging data gaps
EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) applied the Novel Foods brake after scrutinising just 19 of 150 Novel Foods dossiers, performing a data appraisal that included a systematic review of human CBD studies, and collating the resulting data gaps into its opinion.
Novel Foods specialist Dr Nigel Baldwin, of UK-based Baldwin Advice, said there were “no surprises” in the toxicology data requirements within the European Food Safety Authority’s opinion, which are similar to those being requested by the US Food and Drug Administration (FDA) in regard to CBD products.
“The opinion will provide more support for enforcers in the EU where these ingredients are anyway not approved yet,” Dr Baldwin said.
Some are concerned the opinion could be used by those who seek to have CBD withdrawn from the food supply altogether, as looked to be the case with the European Commission pursuing a narcotic route for CBD before the European Court of Justice (ECJ) in November 2020 ruled CBD was not in fact a narcotic.
UK-based nutritionist, food law expert and Managing Director of Legal Foods, Dr Mark Tallon, questioned the effect of defining safety data gaps essentially derived from a pharmaceutical CBD to treat epilepsy – Epidyolex – which the NDA acknowledged featured heavily in the 19 dossiers it assessed.
“The report assesses dosages that are multiple that of those proposed as safe in the Novel Food applications which are in the range of 20-50mg/d,” said Dr Tallon.
“As an example the liver data is over 15 times that proposed in most applications. This has little relevance when companies are submitting data specifically on their product at a specified dose and that dose is shown to be safe based on models EFSA have accepted as fit for purpose.”
Dr Tallon said EFSA’s opinion made it starkly clear that ‘paper submissions’ that draw predominantly from existing published literature but did not feature fresh and specific toxicological data, “are not fit for purpose and those businesses sold that dream by consultants should understand they were misled".
Evolving data needs
The UK-based Association for the Cannabinoid Industry (ACI), whose consortium is responsible for around 70% of the first batch of submitted dossiers to the FSA, said a recently completed toxicology study it commissioned had been sent to the agency.
“The FSA in the UK made it known a long time ago that they would require toxicology data to be submitted under a CBD novel foods application,” said Dr Paul Duffy, ACI toxicology associate.
“Hence why the ACI consortium came together, so that our members could facilitate a new, original study which would support their novel food applications. We don't anticipate any market authorisations until 2023.”
The EIHA consortium would update its FSA CBD isolates dossier with fresh toxicology data in August, Romanese said. The same would happen for its full spectrum dossier before year-end.
She urged companies to join consortiums or work together to gather the necessary data in the coming years “to save resources and rats.”
Mark Tucker, CEO of UK CBD player, TTS Pharma, said he expected the FSA and EFSA CBD positions to align in the long term, even if not bound legally, post-Brexit.
“Despite the need to be seen to be independent and separate I still expect both organisations to learn from each other’s experiences without being bound to each other’s decisions,” he said. “If 'Mutual Recognition’ on fully authorised dossiers is to be achievable across both jurisdictions I would expect both organisations to cooperate on key issues rather than seek major variations.”
Data gaps highlighted by the NDA included psychological function, liver, gastrointestinal tract, endocrine system and the nervous system.