"Dagger-blow to the whole of the UK industry" as FSA slashes CBD daily limit
The authority says this is based on new evidence from the industry and updated advice from its independent scientific committee - the Advisory Committee on Novel Foods Processes (ACNFP) and the Committee on Toxicity (cot) published today.
It states the updated advice, which amounts to 4-5 drops of 5% CBD oil a day, has been based on the average lifetime exposure to food products containing CBD.
To give a picture of the impact of this recommendation, most CBD drinks on the market contain at least 12.5mg of CBD per can.
Keeping advice vague in terms of what brands and retailers should do next, the FSA states: "Some products available on the market will have a higher dose of CBD per serving than 10mg a day, therefore consumers should check labels and consider their daily intake in light of this updated advice."
It adds: "We encourage consumers to monitor their daily consumption of CBD by checking the CBD content of the product and consider if they wish to change it in light of this updated advice."
The authority says it will update advice "if new evidence indicates a change is needed".
Response to poor data
Marc Burbidge, founder of the premium white label CBD products manufacturer B3 Labs, said the news would come as a huge shock to the industry and would primarily cause concern over reaction from retailers.
His only explanation for this sudden change of tact from the FSA could be their reliance on ‘bad data’ coming from toxicity results from full spectrum distillates which contain many ‘contaminants’ such as flavonoids and terpenes.
“I can only think that they’ve reviewed results from the first six dossiers in their novel foods applications, basically found the worst one, and released a recommendation based on that.”
He warned that if this recommendation spooks retailers, it could lead to a huge number of brands being culled from shelves.
“This is only a recommendation. They aren’t telling retailers to pull products from shelves and they aren’t telling companies to change their formulations or recommended dosages but we don’t know how retailers will respond.”
Explaining how this impacts B3 Labs, and other manufacturers, he says that companies base their dosages on the recommended daily limit of 70mg so re-formulations and new serving sizes will be required.
B3 Labs has already revised its serving size guidelines for clients based on the amount of CBD per drop, as opposed to per quarter of a pipette. The manufacturer has also removed its 40% oil from sale until further clarification.
“The regulatory goalposts just keep changing. We were supposed to be a few months out from some clarity in the market and now this could be an extra hurdle that brands can’t surmount,” Burbidge adds.
CBD business experts at The Canna Consultant (TCC), have released a statement informing this will do "collateral damage to the whole of the UK CBD industry".
The position paper proposes the new guidance is in response to "one poor study" within its Novel Foods dossiers applications.
It states: "When regulatory scientists are provided with data by an applicant who asserts the quality and accuracy of the data, then they cannot fail but act upon it. It is to be noted that we do not criticize the FSA for acting upon the data with which they have been provided – what else can they do?"
The paper refers to this as a "dagger-blow to the whole of the UK industry".
It adds that whilst the FSA says it will keep the recommended daily limit under review, there will be no swift reversals adding that "the industry should accept that this will be the applicable figure for years to come".
After gaining some clarity from Paul Tossell, head of regulated products at the FSA, the TCC advise that no products will be removed from the novel foods public list simply because they are single-consumption units at a dosage of greater than 10mg.
The consultants advise via their website: "With that, manufacturers should not immediately react and change the formulation or packaging of their products - to do so in an unstructured manner would breach the FSA’s “New to Market” Policy and lead to removal from the Public List.
"The FSA recognize the anomaly that were you to seek to follow their safety guidance and change a product’s formulation, you would be voluntarily removing yourself from the Public List via their existing policy. They intend to conduct a review of how the Public List will operate."
"...Following the review of the operation of the Pubic List going forwards the FSA will engage with market participants and set a realistic timescale for the implementation of any consequent changes."
Mile High Lab reveals safety data
Mile High Labs has also released a statement taking issue with the fact the recommendation is based on just three novel food applications and it has publicly discussed its own safety data which claims 70mg CBD per day is more than safe.
The company has stated: "Mile High Labs’ application and proprietary data set was not considered in this assessment. The opinion takes into account several uncertainties in these three applications which lowers the derived ADI (by 300 fold from that derived in safety studies).
"If exactly the same criteria as set out in by the Joint Committee is applied to Mile High Labs’ CBD proprietary data set, an ADI of 35mg would be derived for Mile High Labs’ CBD. From a scientific perspective, the standard 100-fold uncertainty factor was applied to the 150mg/kg body weight ('bw')/day point of departure ('POD') alongside the additional uncertainty factor of three, giving an overall uncertainty factor of 300-fold which, when applied to the POD, would result in a putative ADI of 0.5 mg/kg bw (150 mg/kg bw/day POD / (10 x 10 x 3)). For a 70kg adult, 0.5 mg/kg bw x 70 kg would lead to an ADI of 35mg.
"However and importantly, this set of criteria does not take into account the fact that Mile High Labs also conducted pharmacokinetic studies to assess bioavailability, which is considered an uncertainty factor. As an uncertainty is resolved, Mile High Labs’ CBD can be accordingly increased to an ADI of 70mg or more."
CBD drinks brand stands firm
Eoin Keenan, co-founder and CEO for the CBD brand Goodrays, which sells drinks with 25-30mg CBD per can, says it will continue to sell its product in the knowledge they are still legal and with the expectation that guidance will change as new evidence is assessed.
He says: "The FSA has changed the daily intake guidance based on tests from three early market brands that have shown that repeated daily usage of those specific products over a lifetime period carries some risk of adverse impacts. However, it’s imperative to recognise that not all CBD is created the same and the guidance is not based on our products or those of many other market leaders.
"We work with the market-leading CBD supplier who has a recommended daily intake of 70mg per day, which is over 2 cans per day, and we’re sure that the guidance will soon take this research into account. As an industry, we need to get to a place where that quality and safety is recognised and we’re not being led by the worst-quality applications.
"There’s no change to the legality of our products and there’s loads of other categories that sell products which have a higher recommended daily intake, such as alcohol, soft drinks, vitamins and supplements. It’s in no way unusual. We’ve got incredible relationships with all our retailers who have been really positive and supportive during this update as they understand the difference between our products and the rest of the market."
What will retailers do?
The Canna Consultants point out the legality of products on shelves in the UK has been made murkier than ever, creating a dilemma for retailers.
"The FSA is not banning products which have greater than 10mg of CBD in a single serving, but it is advising consumers against their use. This means that retailers of such products are now faced with a dilemma – stock something which is not only unlawful - which has a quasi 'get out of jail free' card with it - but something which the food safety regulator says is potentially harmful to the consumer in the dosage at which it is being sold by the retailer.
"If retailers continue to sell single-use products which breach the FSA’s recommended daily safety limit, then they as the retailer are exposed to any Consumer Safety litigation risk...
"Now, any reader of this document will appreciate that the actual health risk to consuming 10mg or 30mg or 70mg per day of CBD is less than negligible, but reality has nothing to do with the perception of litigation risk that may be held by the legal departments of these retailers or, more pertinently, by the legal and underwriting departments of the insurers of those retailers."
The background
All CBD food products must apply for novel foods authorisation before they can be sold legally in Great Britain. This involves providing toxicity data for products.
The FSA has introduced the public list as a public record of products linked to credible applications going through the authorisation process.
The authority published consumer advice in February 2020 which recommended healthy adults not to take more than 70mg of CBD per day. The FSA now says this level was based on limited evidence where CBD was studied as a medicine, and where the dosage is determined by balancing the benefit of the drug with the potential side-effects.
Since this initial advice, the FSA asked its independent scientific committees - the Committee on Toxicity (COT) (Opens in a new window) and the Advisory Committee on Novel Foods and Processes (Opens in a new window) - to assess data received via novel foods dossiers.
This new assessment led to the sudden drop in limit recommendation.
Professor Robin May, Chief Scientific Advisor at the Food Standards Agency said: “Our independent advisory committees have reviewed the safety assessments submitted by the industry as part of their novel food applications and we are advising that healthy adults should take no more than 10mg of CBD a day.
“The more CBD you consume over your lifetime, the more likely you are to develop long-term adverse effects, like liver damage or thyroid issues. The level of risk is related to how much you take, in the same way it is with some other potentially harmful products such as alcoholic drinks.
“We encourage consumers to check the CBD content on the product label to monitor their overall daily consumption of CBD and consider if they wish to make changes to how much they take based on this updated advice.”
