Cannabis-derived products (CDP) and other emerging substances present unique challenges to one of the U.S. Food and Drug Administration’s (FDA) core responsibilities: to protect public health by ensuring that products such as human and veterinary drugs, human and animal foods, dietary supplements, and cosmetics meet required safety and quality standards. To best protect the public health, FDA needs robust information about potential safety problems or adverse events associated with FDA-regulated products, including CDPs. FDA also needs information about general patterns of product use and emerging trends—and it needs this information in close to real time, so that the FDA can deploy its limited resources quickly and effectively. The FDA believes that new approaches to detecting safety signals and other insights using diverse data sources and rigorous analytical methods can contribute significantly to FDA’s ability to respond to emerging and rapidly evolving product areas, like the CDP market.
Enhancing the FDA’s safety surveillance and signal detection capabilities is critically important to understanding current and emerging CDP market segments. The FDA needs a suite of modern, flexible tools and processes that can be used across cannabinoids and other emerging substances to complement existing safety monitoring capabilities.
The Cannabis-Derived Products Data Acceleration Plan (DAP) is a portfolio of pilot initiatives and partnerships focused on advancing data-driven safety signal detection and building advanced technology capabilities. The DAP’s primary goal is to leverage novel data sources and advanced data analytics to identify current and emerging safety vulnerabilities in the CDP market. The DAP is also focused on forging government data partnerships and championing scientific research to evaluate safety and consumer vulnerabilities.