Hemp Derived CBD – Regulatory Overview
Whether you’re in the US or the EU, the regulatory / enforcement picture for CBD products isn’t clear. Commerce is running ahead of regulations on both sides of the Pond. What is clear is that, as the market rapidly emerges, various vested interests are jockeying for position. Big Pharma would like to sew the market up with approved CBD based drugs. Meanwhile, every man and his dog wants unfettered access to CBD as an ingredient or supplement. Who knows how things will play out? One view is that ultimately an accommodation will be found, whereby CBD as a plant-based ingredient or supplement is permitted and regulated, without undermining the drug approval process or diminishing incentives for further clinical study.
USA – Legal & Political
The Farm Bill declassified Hemp as a Schedule 1 substance. This is significant. However, the US FDA retains oversight of CBD products. As the market has proliferated, the FDA has issued various positioning statements (alongside written warnings to producers marketing CBD too aggressively).
The FDA is committed to engaging with industry. A process to clarify uncertainty and develop a pathway for bringing legal CBD products to market is underway. Senators have stated that the intention of Congress in passing the Bill was to ensure that U.S. consumers have access to a full range of hemp-derived cannabinoids.
USA – Marketing & Positioning
Currently, without FDA approval for an intended use, a Hemp derived CBD product cannot claim therapeutic benefits, or purport to treat any medical condition. CBD products cannot claim in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Further, it is unlawful under the FD&C Act to introduce food containing added CBD into interstate commerce, or to market CBD products as, or in, dietary supplements. This is because CBD is an active ingredient in FDA-approved drugs: the compound has been subject to certified clinical investigations before ever being marketed as a food or dietary supplement.
EU – Legal & Political
Last year CBD was added to the EUs Novel Food Catalogue. This would have led to a regulatory framework for the EU. However, in March 2019, the EFSA (European Food Standards Agency) stated that it was reviewing that decision. A product is defined as a novel food if it cannot be shown to have been in long term and safe use before 1997. CBD producers have vociferously argued that CBD (via Hemp Oil) has been in use since 1220!
In Jan 2019, the UK FSA announced that it plans to investigate CBD products for consumer safety. It is expected that the FSA will later provide requirements for authorization. This may take up to 18 months. Although enforcement action is unclear, some CBD products have been removed from the shelves.
EU – Marketing & Positioning
CBD products are available across the UK, primarily sold in boutique shops, cafes, health stores and online. Holland and Barrett listed CBD products way back in 2017. Some restaurants already offer CBD cocktails or hot drinks.
So long as CBD products are not authorized by the MHRA (Medicines and Healthcare products Regulatory Agency), medical claims on labeling and packaging cannot legally be made. However there are also no enforced regulations for testing or packaging, and many CBD products are readily marketed as health supplements or wellness products.