The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.
24. I’ve seen cannabis products being marketed for pets. Are they safe?
 Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71.
8. Is it legal for me to sell CBD products?
We also take into account the applicant’s ability to satisfy the requirements of other relevant regulatory bodies (such as the Medicines and Healthcare Products Regulatory Agency (MHRA), Food Standards Agency (FSA) and Trading Standards) when deciding whether it would be appropriate to grant a licence, where they are relevant to the risk-based licensing assessment process we operate.
Against this background, the presumption has to be one of caution – that is, that a CBD containing product would be controlled under the MDA 1971 / MDR 2001 as a result of its other cannabinoid content.
General licensing principles and interaction with other agencies
It is accepted that other countries may operate differing control regimes to the UK (which is outlined above). These alternative control regimes do not override UK domestic legislative requirements.
Cannabidiol (CBD) and its control status
“Cannabis-based products for medicinal use in humans” (“CBPM”) – a defined category of cannabis, cannabis resin, cannabinol and cannabinol derivatives – are listed in Schedule 2 to the MDR 2001 and removed from designation under the 2015 Order. Home Office licensing requirements relating to these products are outlined below. The explanatory memorandum to the legislative changes can be found on legislation.gov.uk.