While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions. Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012. We have today written to the manufacturers of CBD to make them aware of the timeline for engagement. It is vital that medicines meet safety, quality and efficacy standards to protect public health.
An MHRA spokesperson said:
An MHRA spokesperson said:
Update 1 November 2016
We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine. Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health. If you use CBD and if you have any questions, speak to your GP or other healthcare professional. We have written to UK CBD stockists and manufacturers to inform them of our view. We can provide regulatory guidance to any company who may wish to apply for a licence.
Our primary concern is patient safety and we wish to reiterate that individuals using cannabidiol (CBD) products to treat or manage the symptoms of medical conditions should discuss their treatment with their doctor. MHRA will now work with individual companies and trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Regulations 2012.
Update 30 December 2016
Be careful when researching online. Sadly, we’ve seen brands duping consumers by buying recommendations – if you see the word ‘advertorial’ on an article, it’s a paid for advert, not an independent opinion!
But the real understanding of how CBD and THC (and since, other cannabinoids and terpenes besides) interacts with the human body first came to light when the first endocannabinoid, Anandamide, was found in the 1990s, quickly followed by the discovery of an unknown molecular signaling system: the endocannabinoid system. A totally transformational moment in cannabis study.
Third-party testing and lab reports that are available for you to read are a must. If they’re not available on the website, ask for them. If a brand says they don’t have them or won’t pass them over for you to look at, walk away!
Although regulations surrounding CBD in the UK are pretty firm, there has been a lot of movement in the industry and, undoubtedly, more change is yet to come. However, what that will look like is anyone’s guess.
The CBD industry is still maturing
There have been movements in recent years which have seen regulations changing – the 2018 introduction of cannabis derived pharmaceutical drug Sativex, containing a 1:1 CBD and THC potency, now means multiple sclerosis patients in the UK have some access to medical marijuana. And in November 2019, The Guardian reported that up to 20,000 patients in the UK were to be given medical cannabis over a two-year period as a study into the potential medicinal use of the drug.
After this date, only consumable products (like CBD oil) that are linked to a validated application will be allowed to stay on the shelves.
When a CBD company submits Novel Food Application, their products must be sent for full analysis, including:
So, where does CBD come in?
However, while this has been going on, the drug class of cannabis has bounced up and down between being a Class B and Class C drug and the largest hemp (cannabis sativa) farm in the UK, largely used for home-grown CBD products, was ordered to destroy its crop without having their license renewed due to confusion over cultivation and harvesting guidelines.
At the moment, there are many CBD products available in the UK which contain little to no CBD at all (despite stating they do), as well as products which contain higher than legal levels of THC and toxic substances.
NOTE: A soft stance on enforcement by the UK authorities is the reason why we see prohibited products such as CBD flowers and unlicensed CBD foods without novel food application openly sold in shops in the UK.
Who should read this
“The hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9-tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9-THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel”
The Novel Food Catalogue
The entry for CBD in the catalogue confirms that CBD foods are by definition a Novel Food and should be subject to Novel food regulation whereby a novel food application is required.