As we mentioned in a previous Alert, FDA held a public hearing on May 31, 2019 “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”1 A wide-ranging group of industry stakeholders, including consumers, doctors, retailers, manufacturers, researchers, industry groups, lawyers, and patients attended the hearing. With over 400 applicants vying to present their viewpoints, over 100 individuals were permitted to voice their interests and concerns over the regulation of cannabis plants and derivatives (including cannabidiol (CBD)), and their uses in both products and foods.
Reed Smith’s Cannabis Law Team closely monitored the hearing and has the following key takeaways. In short, while many presenters touted the benefit of cannabis during the hearing, FDA did not seem ready to commit to potential rules and regulations regarding cannabis or cannabis-derived products until it has more data regarding the ingredients’ safety; in fact, during the hearing, the agency repeatedly asked the presenters to submit available data on that point. Throughout the hearing, industry members requested federal regulation and standardization over the use of these ingredients, and the hearing made it clear that FDA will continue to lead the discussion on the use of cannabis and cannabis derivatives in FDA-regulated products.