CBD-containing consumer/food products
CBD-containing products sold directly to consumers via shops or online. Such products include CBD-oils, sprays, supplements, gummies/confectionary, vape juice, creams, etc
Clinical data supporting use
These products are not marketed as medicines, and should not have associated medical claims.1These products do not have comprehensive and rigorous pre-clinical and clinical data supporting their use in specific patient populations and conditions, or marketing authorisation from medicines regulators.2
Safety data and monitoring
There is no statutory oversight of manufacturing practices for CBD-containing consumer products.3 This raises potential patient safety concerns, particularly regarding contamination with impurities, including contamination with THC,2 the primary intoxicating substance found in cannabis.4 One study in 2019 tested 67 CBD-containing consumer products available in Germany, and found 25% of them contained >2.5 mg THC, a level sufficient to cause adverse events.5 As these products are not approved by medicines regulators, they are not subject to the pharmacovigilance system that routinely monitors the safety of authorised medicines and it is not required that adverse events are reported.6
Manufacturing
Requirements for product quality, consistency and manufacturing good practices are unclear for these products.3,7 A consequence of this is lack of consistency in product contents. The levels of CBD advertised on the product label may not match the levels within the product itself.2,8 One study of 29 products available in the UK found that only 11 contained CBD levels within 10% of the amount advertised on the label.8
Access and legality
These products are typically available for purchase by consumers online or in high-street shops.9 The regulations governing the status of these products varies from country to country, and also on the intended use of the product, e.g. as a food,* a cosmetic product or as an e-liquid for a vaping device. Where Novel Food* regulations are enforced, safety data for CBD products is required for the application.10,11
*In the EU, CBD-based food products classify as novel food products, defined as those not consumed to significant degree before the date of the 1997 EU Food Regulations, and for which pre-marketing authorisation is required.11
References:
- European Parliament and the Council. Regulation of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (EC No 1924/2006). 2006
- Chesney et al. Ther Adv Psychopharmacology 2020;10:2045125320954992
- CBD-Intel. Business Briefing: The trouble with GMP – and why EU producers are at a disadvantage. 2020. https://www.cbd-intel.com/the-trouble-with-gmp-and-why-eu-producers-are-at-a-disadvantage/. Accessed February 2022
- Morales et al. Prog Chem Org Nat Prod 2017;103:103–31
- Lachenmeier et al. F1000Res 2019;8:1394
- European Monitoring Centre for Drugs and Drug Addiction. Medical use of cannabis and cannabinoids: questions and answers for policymaking. December 2018. Available at: https://www.emcdda.europa.eu/publications/rapid-communications/medical-use-of-cannabis-and-cannabinoids-questions-and-answers-for-policymaking_en. Accessed February 2022
- Pavlovic et al. Molecules 2018;23:1230
- Liebling et al. Cannabis Cannabinoid Res 2020;doi:10.1089/can.2019.0078
- European Monitoring Centre for Drugs and Drug Addiction. Low THC cannabis products in Europe. December 2020. Available at: https://www.emcdda.europa.eu/publications/ad-hoc-publication/low-thc-cannabis-products-europe_en. Accessed February 2022
- FoodNavigator. CBD and novel foods: a guide to who, what and when. May 2020. Available at: https://www.foodnavigator.com/Article/2020/05/05/CBD-and-Novel-Foods-A-guide-to-who-what-and-when. Accessed February 2022
- European Parliament and the Council. Regulation of the European Parliament and of the Council of 25 November 2015 on novel foods (EU No 2015/2283). 2015. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015R2283&from=en. Accessed February 2022
