New EU regulations on cannabidiol (CBD) – UPDATE
Support the European Industrial Hemp Association (EIHA) in its work to create meaningful and uniform regulation.
Sensible regulation of cannabidiol (CBD) in food, cosmetics, as a natural medicine and drug urgently needed
The European Industrial Hemp Association (EIHA) has published a position paper on the patchwork of EU regulations on CBD.
Cannabidiol (CBD is one of the non-psychotropic cannabinoids of industrial hemp. In 2016, 30,000 hectares of the plant were cultivated in the European Union. Interest in CBD has increased in recent years. Cannabidiol not only has a wealth of health-promoting properties, but also no relevant side effects, even in high doses. CBD is increasingly being used as and in food supplements and cosmetics, creating new investments and new jobs in hemp cultivation, hemp processing and the resulting products. Pharmaceutical products with CBD as an active ingredient have also been developed.
At the moment, there is only a meagre patchwork of CBD regulations. Here are just two examples from the last few weeks:
On October 4, the Medicines and Healthcare products Regulatory Agency (MHRA) began sending letters to CBD suppliers informing them that CBD is intended as a medicine and that the sale of CBD products must therefore be stopped within 28 days – effectively a ban on the sale of CBD from November 1. The letters imply that suppliers will need either a “marketing authorization” or “traditional herbal registration” from the MHRA to sell CBD in the future. Most of the affected businesses contacted by the MHRA say they have stopped selling, but several of the largest CBD suppliers have said they have not received a letter from the MHRA and will continue to trade until they are informed of a change in the law. The UK Cannabis Trade Association (UKCTA) will meet with the MHRA on November 3rd.
In Germany, medicinal products containing CBD have been subject to prescription since October 1, 2016, without any restrictions on dose or route of administration. This was done by amending the Ordinance on the Prescription-only Use of Medicinal Products (AMVV) following a recommendation by the Federal Institute for Drugs and Medical Devices (BfArM). Unfortunately, the fact was overlooked here that no significant effects can be observed in adults for orally administered CBD in doses below approx. 200 mg per day and that CBD is also very well tolerated in much higher doses. The opportunity to benefit from the many health advantages of CBD in different doses is thus wasted.
The European Industrial Hemp Association (EIHA) advocates the development of consistent legislation in this area that ensures consumer protection, supports the industry’s double-digit growth rate, attracts new investors and leads to increased product development. The legislation should not impose restrictions on CBD and should clarify that extracts and preparations made from industrial hemp are not considered narcotics in the EU.
EIHA strongly opposes the attempt by some pharmaceutical companies to make CBD subject to prescription. This only serves the self-interest of a few companies and harms the young CBD industry. Such regulations would also restrict access to CBD for many citizens who already benefit from cannabidiol in food and cosmetics. EIHA expects European and national authorities not to limit the use of CBD to pharmaceuticals (medical products). There is also no reason to regulate access to CBD too tightly with its wide range of beneficial physiological effects and positive safety profile.
Therefore, EIHA recommends a three-tiered regulation for different doses and uses of CBD: At high doses, CBD can be a medical product and should be regulated accordingly. In physiological doses, CBD can be considered an over-the-counter drug or dietary supplement. This approach is already used for a variety of substances, such as valerian, glucosamine, chondroitin (sulphate), ginkgo biloba, some vitamins and iron products. Low doses of CBD should be allowed in foods without further restrictions.
Additional aspects such as the type of administration, indication area, maximum single/daily dose and pack size can be used to further fine-tune the regulations. The BfArM already uses these aspects to differentiate between prescription-only and, for example, pharmacy-only substances and to draw dividing lines.
The full position paper of the European Industrial Hemp Association (EIHA), “Reasonable regulation of cannabidiol (CBD) in food, cosmetics, as herbal natural medicine an das medicinal product” (October 2016, can be read, signed and supported at: www.eiha.org/cbd-support
EIHA calls on all patients and citizens who benefit from CBD products to sign the position paper.
Responsible in terms of press law:
Dipl.-Phys. Michael Carus (Managing Director)
European Industrial Hemp Association (EIHA)
Executive office:
nova-Institut GmbH
Chemical Park Knapsack
Industriestrasse 300
DE-50354 Huerth (Germany)
Internet: www.eiha.org
Email: info@eiha.org
Phone: +49 (0) 22 33-48 14 40
The “European Industrial Hemp Association” is the association of the European hemp processing industry. It represents the common interest of farmers and producers at national and European level. EIHA is the only European association in the industrial hemp sector. This sector includes, among others, the use of hemp fibers, shives, seeds and cannabinoids. Originally founded as a purely European association, today a quarter of its 130 members come from countries outside Europe.
This post was translated from DeepL.