New FSA Guidelines Bring Clarity To CBD Market
Despite CBD’s ubiquitous status, the CBD market is largely unregulated. While this has allowed innovation to explode, it has also led to concerns about the quality and purity of sold products. Now, the FSA has released its guidelines for registering CBD consumable products.
Despite rising sales of CBD products, no consumable product has actually been approved in the UK yet. This has raised safety concerns, as several studies have found that products often have less CBD than advertised or, even worse, more THC—the psychotropic compound found in hemp that gives people the feeling of “high.”
UK’s Food Standards Agency (FSA) sets a deadline of one year
In one notorious case, a high-street pharmacy product retailing for £90 contained no CBD at all. Thankfully, the lack of regulation concerning CBD, or cannabidiol, consumables has now come to an end. In mid-February 2020 the UK’s Food Standards Agency (FSA) clarified how it will regulate products for consumption containing CBD.
The FSA has given a deadline of one year for CBD producers to apply for a so-called “novel food authorization.” Failure to do so will result in the removal of their CBD products from the market.
The FSA justified the tight deadline by arguing that CBD producers had been slow to submit their products for approval.
“The CBD industry must provide more information about the safety and contents of these products to the regulator by March 2021, or the products will be taken off the shelves.”Emily Miles, FSA Chief Executive
The FSA had been waiting for individual companies to voluntarily produce their product information. However, none of them provided enough documentation, so the regulator raised the stakes. The new deadline produces a strong incentive to do so for any CBD company angling for a slice of the UK’s multi-million pound CBD industry.
The FSA’s deadline will apply in England, Wales, and Northern Ireland. Scotland is covered by Food Standards Scotland, which has yet to announce its policy on CBD consumables.
It should be stressed that FSA’s deadline only concerns products for consumption. CBD cosmetics, vaping products, and cannabis used for medicinal purposes are subject to different rules.
The FSA guidelines
To meet the FSA guidelines, producers of CBD consumable products in the UK need to submit novel food authorisation applications with the FSA by March 31, 2021.
Until then, CBD producers are allowed to sell their existing CBD products, as long as they are correctly labelled, safe for consumption, and do not contain THC or any other substances that fall under drugs legislation. However, CBD producers may not market any new CBD extracts or isolates until they have registered them with the FSA.
As per the new guidelines, retail distributors are now responsible for ensuring the accuracy of CBD products’ labels. This creates a headache for many of them, as they are usually not involved in the production of the CBD products they sell.
Retailers can only test a limited number of CBD products for purity and concentration. Instead, they may prefer to only sell CBD products from bigger producers, as these can provide Certificates of Authenticity (CoA). So, don’t be surprised if smaller CBD brands disappear from the shelves long before the FSA deadline.
The sale of CBD products in the UK is regulated by the FSA. The FSA itself will follow EU regulations set by the European Food Safety Authority (EFSA) until at least December 31, 2020.
As the EU is a big market for CBD products produced in the UK, this makes sense: UK producers will not be able to sell to European countries any CBD products failing to meet European criteria.
It comes as no surprise, therefore, that the FSA also made it clear that CBD producers should apply to the European Commission for authorisation of their CBD extracts and isolates.
What is Novel Food?
According to the EU’s “Novel Food Regulations,” any food without a history of EU consumption before May of 1997 is considered “novel.”
Novel foods must be approved by the European Commission before they can be sold in Europe. The approval process follows a comprehensive safety audit.
Other novel foods include traditional products from countries outside the EU, for example, chia seeds. They also include food that has undergone a new processing treatment, for example UV-treated milk and bread. Finally, they cover new sources of food, such as insects.
Last January, the EFSA classified CBD as a “novel food” for the purposes of the EU Novel Food Catalogue.
Novel foods need to complete an EU process known as a consultation application process. This applies to CBD producers who can demonstrate a significant history of consumption for their CBD products from before May 1997.
As CBD consumables were illegal before 2019, the EU also provides an alternative route, known as a pre-market safety assessment and authorisation process. However, this could take up to 18 months from the submission of an application.
Given the regulatory hurdle this creates for CBD producers, they have asked the EFSA to review its classification of CBD as a novel food. While the EFSA has agreed to consider the petition, the agency hasn’t yet changed its position.
Are CBD health claims stretching the truth?
Importantly, the FSA also issued new advice on CBD use. Specifically, it stressed that CBD should not be used alongside other medications without a doctor’s approval.
An estimated 1.3 million people in the UK regularly use CBD oils, drops, foods, and supplements to help them with medical problems, even though CBD products are not actually allowed to make any health claims. Given the range of ailments and conditions CBD is supposed to alleviate, many of these people will be taking CBD alongside other medicines.
The FSA also warned healthy adults to “think carefully” before taking CBD. It also suggested a top dose of 70mg a day—or about 28 drops of 5% strength CBD oil. Finally, it advised pregnant or breastfeeding women not to use any CBD products at all.
The CBD industry welcomes the news
The Association for the Cannabinoid Industry (ACI) welcomed the new guidance.
“We believe that this will elicit the safety studies that are vital to build consumer confidence and help develop a socially responsible and sustainable industry.”Steve Moore, ACI’s Strategic Director
The ACI has made it clear that the FSA guidelines provide much-needed clarity for market participants, investors, and consumers. It is in the CBD industry’s interest to ensure that CBD products are subject to quality assurance and product safety standards.
The FSA guidelines are also great news for consumers, who can be certain of the quality and purity of their CBD products. Importantly, the regulation also helps clarify the legal grey area surrounding CBD consumables.
Also, the UK now has a clear pathway to legal CBD food products sales. This makes it easier for large, non-cannabis food and drink brands such as Unilever and Coca-Cola to try out CBD-infused products.
If you thought the CBD market has exploded, wait until CBD-infused colas hit the shelves!
Update: March 15, 2021
The Food Standards Agency provided in March 2021 an update on the criteria for the sale of CBD products in England and Wales. All products on sale on 13 February 2020 and linked to an application submitted before 31 March 2021 that is subsequently validated meet the criteria set by the FSA.
UK CBD producers should submit novel food applications via the new Regulated Products system. The Northern Ireland Protocol outlines the EU law that applies in this region.
The Association for the Cannabinoid Industry (ACI) welcomed the news. Shomi Malik, ACI’s External Affairs Director, said: “Today’s update from the FSA is a welcome one. The 31 March deadline is now for submission, rather than validation.”