Public opinion on cannabis changed dramatically in 2019, and companies are seeing its effects—both in the workplace and in the marketplace. FDA’s reaction has been slow and steady as it gathers scientific and medical data on cannabidiol (CBD), the active ingredient in cannabis derived from the hemp plant. The regulatory landscape continues to shift for companies selling CBD foods and supplements, as FDA reacts to the public and political pressures to find a viable pathway for CBD products.
We also saw a shifting regulatory landscape for e-cigarettes, which not long ago FDA considered to be safer alternatives to traditional combustible cigarettes. FDA changed course in 2019 and reacted quickly to the outbreak of lung illnesses associated with vaping by enforcing against companies manufacturing and selling kid-friendly e-cigarettes.
Finally, we saw the agency take an innovative approach to regulating medical device software powered by artificial intelligence (AI). Realizing that its current framework is ill-equipped to handle machine learning and other AI, FDA introduced a white paper positing an approach that would accommodate the continuous learning nature of AI-driven medical software.
Looking ahead to 2020, drug pricing will continue to be a priority, as FDA reacts to clear demands from the White House to lower prescription drug prices. We also likely will continue to see scrutiny on the global supply chain.