UK CBD businesses with applications on the Food Standards Agency’s (FSA) Public List are being strongly encouraged to reformulate products in line with recently lowered safety limits.
The FSA’s advice, published yesterday, requires businesses to make the necessary changes to meet the safe upper limit for THC of 0.07 mg per day and the provisional acceptable daily intake (ADI) for CBD of 10 mg per day, a reduction from 70 mg set in October 2023.
The new CBD ADI came to the dismay of the industry at the time as it signaled major reformulations would be needed. Most CBD drinks on the market, for example, contained 12.5mg of CBD per can.
But manufacturers weren’t told to reformulate; instead the FSA advised consumers to check labels and monitor daily intake limits.
In its latest statement, the FSA said the change to guidance urging reformulation prioritizes public health.
“Allowing businesses to reformulate their products at this stage will make the authorization process more efficient, while consumers will benefit from safer CBD products on the market,” it stated.
Thomas Vincent, deputy director for innovation policy at FSA, added: “Our pragmatic approach allows businesses to do the right thing for consumer safety while progressing towards full regulatory compliance. This flexibility creates a clearer path forward for CBD businesses while ensuring products meet our safety standards.”
What manufacturers need to do
Businesses with products on the list do not need to contact the FSA if reformulation doesn’t affect product details on the list. If updates are required, businesses must provide their application number, necessary updates, and confirmation that changes are safety related.
The FSA advises all CBD food businesses to review product labelling to display the recommended CBD acceptable daily intake limit and include key safety information such as age restrictions and warnings for those who are pregnant or taking medications.
It continues to advise that under-18s, people taking medication, and those who are breast feeding, pregnant or trying to conceive do not consume CBD.
Vulnerable used ‘as a shield’ to suppress safe CBD dosages
Voicing his disappointment at the FSA’s guidance, Dr Mark Tallon, Managing Partner of the food law consultancy Legal Foods, argued the assessment of CBD novel foods dossiers has not been done on a case-by-case basis.
“The FSA have used the opinion of [the FSA’s Committee on Toxicity], which is not evidence on individual submissions, to make an opinion on what is a provisional ADI.”
He added that many companies will have provided warnings or are willing to add warnings to protect any vulnerable groups that “the FSA use as a shield to suppress safe CBD dosages above 10mg/d”.
“Foods are aimed at the healthy population and not those with disease states, vulnerable groups (young) or on medication. We already have mandatory labelling for vulnerable populations such as those with allergies, those with hypertension or even by age for the case of food supplements. Where is such application and parity for CBD as a novel food?”
He added: “The FSA have ignored this least harmful measure of labelling and instead implement a de facto ban for products above 10mg ADI. We need to view this in the context of applications that have been assessed and, in our case, peer reviewed to provide evidence that they are safe above 10mg.
“The FSA continue to refuse to accept a higher dose and have not considered at this point the labelling requirements. This can only be challenged once the novel foods and risk assessment for each product is completed and that includes possible labelling resulting in a higher CBD does to be permitted.”
“There’s been too much noise, misinformation, and wasted money.”
Cary Holmes, founder and CEO at Nootro Group
Cary Holmes, founder and CEO at Nootro Group, which supplies CBD ingredients and has three dossiers currently in the risk assessment phase, echoed frustration that the ADI has been hampered by “some atrocious operators and dossiers”, but acknowledged the FSA’s efforts.
“They’ve gone further than EFSA and are working hard to push things forward. Albeit a protracted process laden in ambiguity,” he said.
“We’re ready and well-placed to support brands with reformulation, especially those who’ve been let down by manufacturers lacking the necessary data.
“There’s been too much noise, misinformation, and wasted money. I hope to use the strength of our data and work with genuine industry leaders to help build a stronger, more credible sector.”
