Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.

Description: The development and regulation of cannabidiol therapeutic products is a complex process given the wide range of unapproved products being marketed for numerous indications. The extensive marketing of unapproved cannabidiol products complicates the regulation of these products, providing a desperate need for understanding the regulatory framework that addresses unique issues related to cannabidiol, including its safety. Given cannabidiol’s toxicity profile, and the wide use of misbranded and/or low-quality products, there are many warranted concerns about the safety of consumers who use these misbranded and/or low-quality products. The toxic effects of unapproved products may be unique to those products, as well as exacerbate known toxicities of cannabidiol itself. In this context, preclinical and nonclinical data related to cannabidiol’s pharmacology and toxicology represents one type of data that can be reviewed and integrated to understand the potential therapeutic as well as toxic effects of these unapproved products in humans. This symposium will consist of three individual talks: First, a review of the US and Canadian regulatory and product quality challenges related to the development and use of cannabidiol-containing products that are either botanicals or highly purified drug products; Second, an examination of preclinical data that presents both the potential therapeutic and adverse effects of these products; and Third, a discussion on leveraging these data to understand approaches that would lead to a better framework to regulate the safe and effective use of these products