UK FSA sets a March 2021 deadline for novel food applications

The UK’s Food Standards Agency (FSA) today set 31st March 2021 as a deadline by when the industry players must submit their novel food application. After this date, only products which have submitted a valid application will be allowed to remain on the market, the announcement published on the authority’s website explains.

According to the FSA chief executive, Emily Miles (pictured), all CBD products currently available on the high street are not properly authorised. Miles added that the industry must provide more information about the safety and contents of these products to the regulator before 31st March 2021, or the products will be taken off the shelves.

“The actions that we’re taking today are a pragmatic and proportionate step in balancing the protection of public health with consumer choice. It’s now up to industry to supply this information so that the public can be reassured that CBD is safe and what it says it is.”

Products available on the market can continue to be sold during the transition period provided they are correctly labelled, safe for consumption and free of “substances that fall under drugs legislation”. We understand that the agency implies here that the products must not contain THC, which is a scheduled substance.


Evidence indicates ‘adverse health effects’


In the announcement, the FSA recommends that people should not to take more than 70 mg of CBD a day (about 28 drops of 5% CBD) unless under medical direction, while those who are pregnant, breastfeeding or taking another medication should not be taking CBD at all.

The advice is based on the recent findings by the government’s Committee on Toxicity (COT) – a UK independent scientific committee that provides advice to the FSA, the Department of Health and other government departments and agencies on matters concerning the toxicity of chemicals – whose chair, Alan Boobis, said that the committee has reviewed the evidence on CBD food products and found potential indications of adverse health effects from the consumption of these products.

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    The COT’s review was based on data from GW Pharmaceuticals’ clinical trials for Epidiolex/Epidyolex. These revealed some side effects including lethargy, sedation, drooling, tremors, diarrhoea and vomiting – with the most serious being potential damage to the liver.

    However, there remains significant debate about how applicable these clinical trials are to CBD products commonly found on the high street.

    “We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead,” Boobis said.

    Today’s announcement by the FSA on CBD extracts applies in England, Wales and Northern Ireland. Novel food regulations in Scotland are covered by Food Standards Scotland.


    What This Means: This is the first time any country that is treating CBD as a novel food sets a clear enforcement path. It could be that others will follow a similar route – most likely beginning with Scotland and the Republic of Ireland, both of which often take a joined up approach on these issues with the FSA.

    Whether the approach carries across the Channel is harder to say given that significantly more enforcement action has already taken place on the continent.

    It is also unclear what impact Brexit will have on novel food assessment. It seems likely that the FSA will continue with the EU system rather than set up a parallel one of its own, but it is impossible to conclusively say until negotiations are complete.

    – Marija Obradovic CBD-Intel staff

    Marija Obradovic

    Senior legal analyst
    Marija is responsible for legal analysis in the UK and the Balkans. Marija is an international regulatory specialist. She has worked in Spain and Serbia on a broad range of national and cross-border policy issues, dispute resolution and rule of law. She holds an LLB law degree from the University of Belgrade and a Master’s in International Security from Institut Barcelona d’Estudis Internacionals.