Assessment of the enforcement and regulatory impact on cannabinoids with the recent Food and Drug Administration's (FDA) ordinance over cannabidiol (CBD) and the new Drug Enforcement Administration (DEA) Controlled Substance Act (CSA) scheduling.

Cannabidiol (CBD) has been widely recognized for the beneficial results achieved in multiple pre-clinical and clinical trials. However, the use of marijuana-derived products is still very controversial. This thesis evaluates the impact resulting from the DEA scheduling and FDA approval of Epidolex (Cannabidiol) with respect to regulatory, enforcement, economic and marketing areas. Similarly, it compares the different perspectives of the FDA and DEA. The document also summarizes the FDA regulatory requirements for Epidiolex (Cannabidiol). The assessment revealed the new status of imports and exports for those products containing CBD (21 CFR 1308 and 21 CFR 1312). Analysis of clinical trials revealed that eight new medical indications using CBD are currently being studied. Lastly, the study demonstrated that using CBD as a therapy is significantly more expensive than a conventional treatment using Stiripentol and Clobazam for Dravet syndrome.