UK FSA Finalizes Public CBD List Comprising Almost 12,000 Products

The UK Food Standards Agency has published the final update to its public CBD list following what Canna Consultants' Matt Lawson describes as a regulatory “baptism of fire.” There are now 11,908 products permitted to remain on the UK market once those classed as “removed” are taken into account. These products will either progress to the “validated” stage of the UK's novel food process or also be removed.
 

An additional 6,000 cannabidiol products have been added to the UK Food Standards Agency’s public list, taking the total to almost 12,000.

The list, which represents those products that are allowed to remain on the market while their respective novel food applications are being assessed by the regulator, is now complete, the FSA says.

“The list is now closed and further requests to have products put on the public list or evidence sent are no longer being accepted,” the agency states on its website.

Companies can still apply to bring new CBD products to the market via the UK’s new “regulated products” process – the country’s post-Brexit European Union novel foods equivalent – but these new applications “will not be eligible for the public list and should not be put on sale until they have been authorized,” the FSA clarified.

“This has been a long and complex process and we are grateful for the help and cooperation of the CBD industry as we reach this important milestone on the path to bringing CBD products into compliance and protecting consumers,” commented the FSA’s policy director Rebecca Sudworth.

“The only changes we envisage being made to the list now will be to reflect the status of products as we move to authorization, and any routine corrections,” she continued.

Sorting Process

So far, no products have been authorized. Only 82 have been validated, which means they have progressed to the risk assessment phase, with the remaining classed as “awaiting evidence” or “removed.”

The 11,908 products now on the list will either be validated or marked as “removed,” in which case marketers are responsible for taking these products off the shelves.

Despite the until now incomplete nature of the list, enforcement by local Trading Standards authorities has already begun, the FSA recently revealed. (Also see "CBD Supplements Safety: EU Two Years Behind UK" - HBW Insight, 21 Jun, 2022.)

The list has “grown considerably” since March when it was first published, the FSA said, because it “prompted a number of companies to come forward with new evidence linking large numbers of individual products to existing applications.”

“This is why we made a final call for evidence to support businesses in achieving compliance for their products,” the regulator commented.

“We think it is important we get this right,” it added, “and it is encouraging that so many companies want to get their CBD products on the path to authorization.”

Baptism of Fire

CBD expert Matt Lawson described the FSA’s CBD regulatory journey so far as a “baptism of fire.”

Nevertheless, Lawson, who is co-founder of The Canna Consultants, was pleased to see signs of “considered, independent policy” emerging from the chaos.

However, while the FSA has had an “unenviable task” in identifying the products for the Public List, Lawson questioned whether the increase from 3,536 to 11,908 products can really be the result of market participants failing to supply the data on time

Lawson pointed to a “number of drivers, including changes in policy” as the real reason – an analysis which is supported by the FSA’s own admission that it could have “better anticipated” the last-minute surge in applications before the 31 March 2021 deadline. (Also see "UK FSA Admits It Could Have ‘Better Anticipated’ CBD Application Bottleneck" - HBW Insight, 2 Mar, 2022.)

Lawson’s colleague Steve Oliver also raised an eyebrow with regards to whether some of the 11,908 products were genuinely on sale on 13 February 2020 – one of the criteria for inclusion on the public list.

“Evidence must have been provided to the FSA to support the claim,” he acknowledged. “There is little that the FSA can do if provided with fabricated documents – they are not an investigative organization. But it does little to increase faith in the probity of some market participants.”

Think Carefully

The FSA ended its most recent update with a warning to consumers that they “should continue to think carefully before consuming CBD products because we don’t know a lot about them.”

“People should refer to the FSA’s precautionary consumer advice which states that those who are pregnant, breastfeeding or taking any medication should not consume CBD products,” it explained.

The FSA is here pointing to its “pragmatic” safety advice, published alongside the 31 March 2021 deadline, which included of an upper limit of 70mg a day (about 28 drops of 5% CBD) unless under medical direction. (Also see "UK CBD Firms Given Deadline For EU Compliance" - HBW Insight, 13 Feb, 2020.)

This upper limit was based on advice from the government’s Committee on Toxicity, which in 2020 reviewed the evidence on CBD food products, concluding that observable adverse effects from CBD exposure in humans included liver injury at a dose of ≤ 5mg/kg body weight (bw)/day, as well as reproductive toxicity observed in laboratory animals treated with CBD as well developmental effects in the offspring.

COT anticipated by about two years the conclusions of the European Food Safety Authority, which last month paused all CBD novel food applications on the back of a literature review by its panel on Nutrition, Novel Foods and Food Allergens (NDA).

In its review, the NDA identified “significant” potential adverse effects relating to a number of human systems, including liver, gastrointestinal tract, endocrine system, nervous system, psychological well-being and reproduction. (Also see "EU CBD Novel Food Applications On Hold As EFSA Considers Health Risks" - HBW Insight, 15 Jun, 2022.)

However, both COT and EFSA noted that the data is merely inconclusive and does not necessarily suggest that CBD is unsafe as food.