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Cannabidiol: Is CBO in Medicinal Products, Novel Food, and Cosmetics Welcomed or Simply “The Devil” If Used at All?

Cannabidiol: Is CBO in Medicinal Products, Novel Food, and Cosmetics Welcomed or Simply “The Devil” If Used at All?

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The Supreme Court of Cassation in Italy has recently rendered a decision that products containing Cannabidiol (CBD) shall be prohibited from being marketed on the Italian market, even if they contain less than 0.2% of the psychoactive substance Tetrahydrocannabinol (THC). The sale of such products had previously been permitted based on an amendment to the law regulating hemp production that removed the requirement to obtain a permit for “cannabis light.” This led to a “cannabis light boom.” The change was triggered based on the opinion of the Highest Italian Sanitary Council that even such “cannabis light” products could conceivably endanger human health. Following the Supreme Court of Cassation’s ruling, only products specified as medicinal products or certain agricultural varieties may be sold.

Similarly, in December 2018 the Austrian Federal Ministry of Labor, Social Affairs, Health and Consumer Protection (Bundesministerium fuer Arbeit, Soziales, Gesundheit und Konsumentenschutz) issued a binding order heavily restricting the use of CBD in cosmetics, food, and food-supplements, and as liquids for electronic cigarettes. And the guidelines of the German Federal Office of Consumer Protection and Food Safety (Bundesamt fuer Verbraucherschutz und Lebensmittelsicherheit) take a similar path with respect to how CBD should be classified in the various product categories. Both the Germans and the Austrians also took the fact that products containing THC often exceed the permissible threshold into account. All three countries have heavily limited the use of CBD in products which can be freely marketed without specific authorization (unlike, for instance, medicinal products). 

Cannabis sativa undoubtedly constitutes a narcotic substance under the Single Convention on Narcotic Drugs and has a pharmacological effect – including, among other things, an anti-psychotic, neuroprotective, or anti-inflammatory effect. This means that products containing cannabis sativa can only legally be marketed if they have obtained a marketing authorization in accordance with the Human Use Directive if the THC content is above 0.2 % (in Germany) or 0.3 % (in Austria). Products containing CBD as an active substance are already approved as medicinal products – in Germany, for instance, such products can only be obtained via a prescription. Not only can the pharmacological properties trigger the application of the Human Use Directive, but also the presentation of the product per se. If the product is advertised using diseases related claims, the product would qualify as a medicinal product even if the THC content is below 0.2%. Austrian authorities are increasingly checking homepages advertising CBD products. 

According to the EU Novel food catalogue, synthetically obtained Cannabinoids are considered novel food, thus require authorization in accordance with the Novel Food Regulation. Even if extracted in a natural way, CBD is classified as a novel food, as it is when added to traditional hempseed products, under the wording “this applies to both the extracts themselves and any products to which they are added as an ingredient.” Therefore, only traditional food such as hempseeds, hempseed-oil, hempseed-flour, or fat free hempseed proteins can be legally marketed within the European Union. The use of CBO in veterinary food supplement products is also not permissible for the German authorities, which also pursue companies sending such products via mail order to Germany. 

For CBD in cosmetics there are some differences – and the Austrian Ministry strictly prohibits use in cosmetics altogether simply for the listing of cannabis in the Single Convention. 

In various countries CBD is used as a liquid for electronic cigarettes as well. The Austrian Ministry states that such liquids are not permissible at all (even if the THC content is under 0.3%) out of a concern that consumers could be misled into believing that CBD liquids have a positive health effect due to the pharmacological effects. The Austrian Tobacco and Non-Smoker Protection Act does not allow any claims going into this direction. This opinion of the Ministry is triggered more by the political position that CBD products should not be on the Austrian market at all. 

What can be derived from the Austrian, German, and Italian approaches? These three countries currently consider CBD products as the devil and are of the opinion that products containing CBD should not be marketed for human/veterinary consumption until scientifically valid data is available, either gained during a clinical trial or during an evaluation in accordance with the Novel Food Regulation supporting the safe use of such products.

By Karina Hellbert, Head of Life Sciences / Pharmaceutical Law, Polak & Partner Rechtsanwalte 

This Article was originally published in Issue 6.6 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.

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