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Clifford Chance

Clifford Chance

HEALTHCARE & LIFE SCIENCES

Talking Tech

Cannabis based food products

Got the munchies?

Healthcare & Life Sciences 16 July 2019

As a variety of CBD infused food stuffs hit the market across Europe, we ask, is it strictly legal in the eyes of the law?

The Green Rush

Cannabis-based products have been commercialised in Europe for a number of years. Generally, the focus has been on food supplement and nutritional products containing Cannabidiol (CBD) extract such as oils, capsules or balms. It is believed that these have certain therapeutic benefits. CBD is one of at least 113 cannabinoids that can be extracted from cannabis plants. Unlike the infamous (and controlled) cannabinoid Tetrahydrocannabinol (THC), CBD has no reported psychoactive properties, nor is it associated with the illegal 'high' connected with using cannabis.

As the CBD market grows, businesses have been looking to diversify their CBD product portfolio in order to commercialise on the 'green rush'. Food products and supplements are next on the shopping list. The growing CBD food product trend is not limited to small businesses prospecting and looking to make a quick buck. For instance, Anheuser-Busch InBev, the manufacturer of Budwesier beer, recently announced that it had partnered with Tilray, a Canadian-based cannabis company, to commercialise a non-alcoholic beverage infused with THC and CBD. In addition, Coca Cola has also announced plans to develop and launch a "wellness beverage" containing CBD.

In light of the above, consumers will have noticed their local health and food stores offering a larger number of CBD infused food and food supplement products, including, among many other things,  CBD infused chocolates, jelly sweets, jam, honey, milk, water and nutritional supplements. However, despite the widespread commercialisation of CBD in food products  across Europe, is it strictly legal in the eyes of the law?

Legal Background

Controlled Substances: THC vs. CBD

The general position across Europe is that THC is classed as a "controlled substance" (i.e. a drug identified as being harmful or dangerous). Accordingly, THC is subject to strict controls and restrictions, including a general prohibition concerning any cultivation, manufacture, import, distribution, use, supply or marketing. Unless any of these activities fall within specific exemptions or licensing regimes, it will be unlawful to undertake or facilitate activities in connection with a product containing THC in the EU.

In contrast, CBD (as a pure isolate) is not a "controlled substance". Accordingly, it will not be unlawful to market products containing CBD and 0% THC content. That being the case, the competent authorities across Europe are tolerant towards the marketing of products that contain very low-levels of THC (i.e. no more than 0.2%). Consequently, CBD products with THC levels below 0.2% may be marketed in the majority of Europe subject to meeting other product specific regulations and obtaining the necessary licences or authorisations.

Food Regulations: Novel Foods

There are strict laws and requirements in place to ensure that food marketed in Europe is safe for human consumption. Under the Novel Foods Regulation (No. 2015/2283), "novel" foods are required to have pre-market safety assessment and authorisation before they can be sold on the European market. A "novel food" is defined as being a food that has not been widely consumed in the EU before May 1997 (i.e. foods without a history of consumption) and fall within a pre-defined food category set out in the regulation (e.g. minerals; micro-organisms; plants).

It is unlawful to market a food that (i) has not been authorised; or (ii) is used / marketed in a manner inconsistent with the conditions and requirements laid out in its approval.

Are CBD Food Products a "Novel Food"?

Following the introduction of cannabis-based food products into the European market, there was some initial confusion over the classification of CBD extracts. However, earlier this year, the European Commission declared that most CBD food products are "novel" and therefore their marketing requires EU authorisation in accordance with the Novel Foods Regulation. Despite this, some domestic food agencies consider that CBD derived from certain "traditional" extraction methods may be lawful, and so not subject to a novel foods assessment.

Is it lawful to market CBD Food Products in the UK?

In the UK, the Food Standards Agency (FSA) has confirmed that food products containing CBD oil extracted by certain "traditional" methods do not require a Novel Food EU authorisation in order to be marketed in the UK. In contrast, it would be unlawful in the UK to market a food product containing CBD oil extracted by other extraction methods without having first obtained EU authorisation.  At the time of writing (July 2019), no CBD products have been authorised as a "novel food" (although applications have been submitted).

That being the case, there are a huge variety of CBD food products on the shelves in the UK. Most of these are unlikely to meet the requirements under either the "controlled substance" regime (e.g. THC content over 0.2%) or the Novel Foods Regulation (e.g. CBD extracted by non-authorised means). The marketing of such products is therefore currently unlawful but enforcement has been patchy at best.

In a recent statement, the FSA confirmed that it is aware of the fact that many CBD products have been placed on the UK market without the requisite authorisation. Further, the FSA has warned that such products are not permitted for sale and that their status on the market will be addressed. At this stage, it is unclear what level of enforcement the FSA or Trading Standards may take against non-compliant businesses (e.g. fines/penalties; seizure of goods), however, careful thought should be given to:

a)       penalties, fines or sanctions arising under relevant trading regulations;

b)      reputational damage arising from products being taken off the shelf;

c)       liability arising under agreements with distributors / retailers; and

d)      criminal sanctions.

Businesses should therefore be extremely cautious before launching a CBD food product in Europe without having first taken specialist legal advice to assess wider potential liability. In addition, careful consideration needs to be given to the relevant advertising, marketing and consumer regulations and codes that govern the food industry. For example, businesses should avoid using medical or health claims (e.g. "for the treatment of joint pain") on product labels in order to lower the risk of their CBD product being regulated under the stricter Medical Regulations Regime.