Cannabis Claims – Tread with Care?

Cannabis/Cannabis sativa persists as a headline news item.  Cannabis oil, cannabinoid oil, hemp oil are terms used interchangeably and confusion prevails. The regulatory status and claims vary dependent on whether it’s a medicine, a food supplement or a food.  Here at OTCExperts we like to keep ourselves abreast of this rapidly developing space. We present a small summary of our views.

Cannabis Sativa/Cannabis

Cannabis has been used as an illegal drug for many years and is classified as a Controlled Drug (Class B). Cannabis plants contain >100 cannabinoids, which have different effects on the body. The most well-known are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). CBD is not controlled under the Misuse of Drugs Act.

An industrial strain of Cannabis sativa, which has a low delta-9-tetrahydrocannabinol (THC) content (below 0.2%), is commonly known as hemp.  It has many industrial uses but has been consumed as hemp tea or hemp oil as foods for many years as a source of omega fatty acids. No health claims can be made for these food sources.

Medicines

In June 2010, Sativex Oromucosal Spray was authorized to GW Pharmaceuticals as a UK medicine. The product is derived from Cannabis sativa, each dose  contains 2.7 mg THC and 2.5 mg CBD.  Sativex is used as a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS).

On 25 June 2018 the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX® (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. EPIDIOLEX is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD).  This medicine is currently under review by the European Medicines Agency (EMA): a decision on whether to recommend approval is expected in the first quarter of 2019.

These medicinal treatment claims are heavily regulated.  These claims relate to the product and the evidence generated in clinical studies to support them.

Cannabidiol Oil

Cannabidiol (CBD) is an active compound which has no psychoactive effect. It can be sold as food supplement but has no authorised health claims. Indeed, CBD oil
should not be sold with any health claims.

In Oct 2016,the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance that CBD products, if advertised for the medical purposes,  needed to be licensed.

MHRA, Jan 2017

"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."

Our Opinion

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.

Cannabis Oil

Cannabis oil is illegal to possess, supply or use. Cannabis oil has a higher THC content, and so, unlike CBD oil, is not legal in the UK. Much
controversy has been documented in recent times by the campaign by the mother of Billy Caldwell looking for a legal solution for the supply of cannabis oil. On 18 June 2018, health secretary Jeremy Hunt said he backed the use of medicinal cannabis oil after an emergency licence was granted to a child with severe epilepsy who had previously had his medication confiscated.

OTCExperts View

Products that cross different regulatory categories or are borderline as to which is the correct category for the claim you wish to make, need careful consideration of the claims and the evidence you have to support them. It is misleading to sell a product with claims that are either unauthorised or cannot be substantiated. Here at OTCExperts we have experience in claims review and substantiation. We can help unravel the regulatory path . Please contact us via consultancy@otcexperts.co.uk.