Reed Smith Client Alerts

The U.S. Food and Drug Administration held a public hearing last week to obtain scientific data about the safety and sale of products containing cannabis or cannabis-derived compounds, including CBD. It was clear from the hearing that FDA will continue to play a key role in shaping cannabis policy federally and that the agency needs more research and data to do so. Presenters from a variety of stakeholder categories pressed for some form of FDA regulation over the myriad products that have already flooded the market and those that are likely to do so in the future. The FDA regulation will not come quickly and the status quo therefore remains in place – companies will continue to sell and introduce new cannabis and cannabis-derived products and FDA will continue to issue Warning Letters to companies making health claims on cannabis products or using cannabis in food products. 

Authors: Rachael G. Pontikes Cori Annapolen Goldberg Claudia Z. Springer Emily L. Hussey Sung W. Park

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.