The market of cannabidiol (CBD)-containing products has been booming in Europe, Canada and the USA while regulations were clearly lagging behind. In January, the European Commission updated the Novel Food Catalogue regarding Cannabis sativa L., Cannabidiol and Cannabinoids. According to the Novel Food Catalogue, more or less all products consisting of or containing hemp extracts from plant parts other than seeds are considered novel foods and require a novel food application. The confusion in the industry around CBD persisted even after the update to the Novel Food Catalogue by the European Commission.
In order to bring some light and guidance to food business operators, a&r team of experts hosted two seminars on the CBD topic to help clarify the regulatory challenges that food business operators currently face, and explain the requirements for the submission of Novel Food applications for CBD in foods/supplements.
Despite the resistance of some players in the CBD industry, there seems to be consensus among National Authorities about the status of CBD products. The German “Bundesamt für Verbraucherschutz und Lebensmittelsicherheit” (BVL) published a clarification note and Q&A on CBD, THC and hemp extract, where it states that before placing products containing CBD on the market, either an application for authorization of a medicinal product or a request for authorization of a novel food must be submitted. In both procedures, the safety of the respective product must be demonstrated by the applicant.
Recently, the UK Food Safety Agency (FSA) evaluated an isolated CBD dissolved in MCT (medium-chain triglyceride) oil in the context of an Article 4-enquiry and classified the product as novel food .
Courts increasingly follow the view of the European commission and the National authorities. Very recently, one German court decision concluded that CBD is to be classified as novel food based on the absence of evidence of its consumption before 15 May 1997.
There is still a pending novel food application for trans-cannabidiol but this application only concerns food supplements and does not cover other food applications. No further information is publicly available on the status of this application or the exact composition of the extract. Just a few days ago, a second novel food application on has been submitted to EFSA.
On the other side of the Atlantic, the regulatory grey zone of CBD is also under scrutiny. Last month, the U.S. Food and Drug Administration (FDA) has informed the public that due to the lack of scientific information supporting the safety of CBD in food, CBD cannot be recognized as safe (GRAS) for its use in human or animal food. Meanwhile, the FDA has issued several warning letters to companies selling CBD-containing products for illegally selling various products containing CBD.
If you are considering to develop, import, or market cannabis-containing products as foods or medicinal products, we can guide you through the legal jungle on cannabis. Get in touch today!