FDA and Cannabis: Striking the Balance between Protecting the Public Health and Consumer Demand

Presented By:

Frederick Ball, Partner, Duane Morris LLP; Seth Goldberg, Partner, Duane Morris LLP

The 2018 Farm Bill allowed the interstate sale and transportation of industrial hemp-derived CBD grown and derived in compliance with state programs approved by the USDA, DEA to deschedule CBD that meet the Bill’s requirements; but maintained FDA’s jurisdiction for industrial hemp-derived CBD products. In May, FDA held a public hearing to obtain information and data on the safety, dosing, and routes of administration of cannabis, after which it noted the significant desire for meaningful regulation with appropriate and clear safety standards, including on quality and consistent terminology. Rule making by FDA may include regulation on the manufacture, distribution, marketing and sale of CBD products. We will detail different potential pathways available to regulate these products—drugs, botanicals, dietary supplements, food additives, or a hybrid—and provide insight into how FDA is setting about balancing the public desire for CBD products and its goal of protecting the public health.