In October 2016, the UK's Medicines and Healthcare products Regulatory Agency (MHRA), adopting its usual test for borderline products, stated that products containing cannabidiol (CBD), if advertised for medical purposes, must be licensed.
This created a problem for the CBD industry, as many of the products that were already on the market in 2016 claimed to have medical benefits.
The MHRA gave manufacturers, whose CBD products were advertised as capable of treating certain conditions, until 31 December 2016 to change their marketing or withdraw their products from sale.
Although most complied with these instructions, and the MHRA has taken issue with some companies for not following its rules, in general, the regulator's position has not been strictly policed or enforced.
This puts compliant companies at a disadvantage and jeopardises public trust in both the medical and non-medical sides the CBD industry, as it creates confusion over what is a medicine and what is a food supplement.
According to the results of a YouGov poll on the CBD industry published in October 2019, 47% of people questioned said they would not consider using products that contained CBD, against 28% of respondents who said they would consider it.
Of those questioned who said they already used CBD, 61% said they use the products for medicinal purposes, with pain relief the primary use, at 71%, and another 38% using products to treat anxiety and depression. This suggests that assertions about the medicinal benefits of CBD, whether authorised or not, have penetrated public conscience.
To build trust in the sector and avoid criticism from the regulator, it is therefore important for CBD developers to understand the relevant legal parameters before commencing product development.
CBD products require a licence, referred to as a marketing authorisation, before they can be legally sold, supplied or advertised as medicines in the UK. There is an exception for products categorised as 'specials', which can only be prescribed and supplied to meet the particular needs of an individual patient and cannot be advertised.
To obtain a marketing authorisation, a manufacturer must submit clinical trials data to demonstrate the quality, safety and efficacy of their product. Gathering this data is a long and expensive process. Some medicinal cannabis products, such as Epidiolex, have successfully been authorised by the European Medicines Agency (EMA) about a year after submission of its clinical studies. So far, however, very few other cannabis-based medicines have received marketing authorisation for use in the UK.
In addition to Epidiolex, Nabilone, a synthetic cannabinoid, is licensed for use with some patients with chemotherapy-induced nausea and Nabiximols (Sativex) is licensed for multiple sclerosis-related muscle spasticity. Once authorised, medicines then face the National Institute for Health and Care Excellence (NICE) appraisal process before they are reimbursed by the NHS.
The time, cost and regulatory scrutiny involved in applying for a marketing authorisation has prompted many CBD product manufacturers to abandon or modify claims to their products' medical/health benefits in favour of finding another route to market as a food supplement.
While this initially looked like an easier way to sell CBD, last year saw the erection of new regulatory hurdles for non-medicinal cannabis products.
In January 2019 the European Commission classified all synthetically obtained extracts of hemp and derived products containing cannabinoids (including CBD) as 'novel foods'.
Although not legally binding, authorities can refuse to permit supply of foods and food supplements containing CBD, pending formal approval by the European Food Standards Agency (EFSA) under the Novel Food Regulation ((EU) 2015/2283).
A novel food is one that had not been widely consumed by humans in the EU before May 1997, when the first Regulation on novel food came into force.
Hemp seeds, hemp seed oil and hemp flower oil are not considered novel, as these have a sufficient history of consumption in the EU.
The UK Food Standards Agency (FSA) accepted this clarification and has said it will work to achieve compliance in the market place in a proportionate manner.
In February 2020, the FSA announced that it was giving the CBD industry a deadline of 31 March 2021 to submit valid novel food authorisation applications. After this deadline, only products which have submitted a valid application will be allowed to remain on the market.
As of February 2020, EFSA had received around 20 novel food applications, two of which have been validated and entered the risk assessment phase, but so far none have been granted the status of approved novel foods.
Obtaining approvalThe novelty status of CBD was a blow for the industry, which had hoped that by not making medical claims, manufacturers would be free to sell their products as supplements without significant regulatory constraints.
The reality of getting authorisation for a novel food from the FSA and EFSA is burdensome and involves a dossier of scientific data that may seem similar to getting a medicine authorised.
The FSA website offers detailed guidance on the steps manufacturers need to take to compile the information required to make an application for novel food approval.
Where medicines come with calculable dosage information, food manufacturers need to think about the effects of consumption and test for different scenarios, and develop appropriate labelling with recommended intake information.
The FSA has issued guidance, based on recent findings by the UK government’s Committee on Toxicity (COT), that those who are pregnant, breastfeeding or taking any medication not to consume CBD products. They also advise healthy adults to think carefully before taking CBD, and recommends taking no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction.
Because food supplements tend to have much longer consumption periods than medicines, manufacturers need to have data to prove that their product is safe for routine consumption.
They also need to consider what happens if someone outside the product's target population consumes the product and include instructions for what to do if this happens.
This is especially pertinent to CBD products, many of which are in the form of gummies or chocolates, which are very attractive to children.
All ingredients used in a CBD product need to be clearly labelled with information on allergens and any other active ingredients that could pose a risk to some consumers.Manufacturers also need to think about the stability of a product – i.e., what happens to active ingredients when they exposed to extreme temperatures or pH levels – and provide appropriate storage instructions.
Finally, it is important to demonstrate a controlled production process that will result in the same product every time.
Legal limitsCannabis remains a controlled Class B drug in the UK, meaning it is illegal to possess without a prescription or licence. Tetrahydrocannabinol (THC) is the psychoactive cannabinoid in cannabis that gets recreational users 'high' (CBD does not have this effect).
CBD manufacturers must therefore comply with the 1971 Misuse of Drugs Act and Home Office stipulations that a product can contain a maximum THC content of 0.2%, and that the THC must not be easily separated from it.
At present, there are no limits on CBD content; in fact there is more concern about manufacturers overstating CBD percentages than exceeding specified thresholds. However, there are also no standard tests for verifying CBD content and different laboratories have been shown to give different concentration results for the same products.
This is a problem when it comes to accurate labelling products and, until it is rectified, manufacturers should ensure they have the highest possible quality control processes in place to deliver consistent products.
Clear, compliant labelling is how industry wins the trust of consumers and regulators. When deciding what information to put on labels, CBD manufacturers need to be aware of certain regulations and labelling standards. Any product destined for sale in the EU will need to comply with EU rules on labelling.
Regulation (EU) No 1169/2011 places an obligation on food manufacturers to provide nutrition information to consumers. EU rules on what nutrition and health claims manufacturers are permitted to make are set out under Regulation (EC) No 1924/2006. These rules are designed to ensure that any claim made on a food's labelling, presentation or advertising in the EU is clear, accurate and based on scientific evidence. It is unclear how the FSA will proceed in terms of alignment with EFSA processes after the end of the Brexit transition period.
As things stand, to avoid the risk of being penalised for failing to adhere to regulatory positions on CBD, manufacturers should be aware of EU rules and continue to adhere to these until the situation is clarified, especially if they have plans to export products in the future.
Common mistakesDevelopers of novel food products routinely underestimate the amount of time it takes to gain regulatory approval. How long it takes for dossier preparation and testing will depend on the time and effort put in, but also access to labs and turnaround times.
Once the dossier has been submitted to EFSA, the regulator will decide whether or not to accept it. If the dossier is validated, the regulator then has nine months to perform a risk assessment. One of the reasons why novel food applications fail to make it to the risk assessment stage is that they lack sufficient data on manufacturing controls; or, do not have enough analytical data, or the data they do have is not good enough quality.
Typically, there is overreliance on existing literature, in place of data on the manufacturer's own product.
Another common mistake is including data designed to illustrate the efficacy of the product. EFSA is not concerned with whether or not a product "works" and including this information may distract from the key objective, which is to demonstrate safety.
In addition, any attempt introduce health claims into a novel food application will almost certainly result in the application being knocked back straight away.
Finally, applicants should not submit incomplete dossiers and expect the regulator to come back with queries.
A far more likely outcome is the application becoming stuck in the system for several months, before being rejected in its entirety without any guidance on what areas require improvement.
Both medicinal and non-medicinal cannabis CBD products face significant hurdles to obtain regulatory approval.
While these may be frustrating, it should be remembered that the rules are set in the interests of public safety, and that attempting to side step or antagonise regulators could have serious consequences for individuals, companies and the CBD industry as a whole.
Medicinal CBD products have a fairly well worn, albeit lengthy and expensive, path to approval, however these also have the stigma of cannabis to contend with and still face the need to demonstrate cost effectiveness to ensure reimbursement on the NHS.
The novel foods issue is complicated as it requires many products that are already on the market to seek retrospective approval – something which is proving difficult to enforce. For new and would-be market entrants to the novel foods arena, there are issues around the lack of available data on CBD, inadequate testing infrastructure and a lack of standardisation across the industry.
This article was originally published in The Life Sciences Lawyer magazine, Issue 2, 2020.
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