What You Need to Know About the FDA Consumer Update on CBD
By Shawn Hauser, Partner; Corey Cox, Associate Attorney
Nov 27, 2019
Yesterday, the US Food and Drug Administration (FDA) issued a public update reiterating its position that CBD may not lawfully be added to food or marketed as a dietary supplement. As part of this update, FDA also issued 15 warning letters to companies marketing and selling unapproved CBD products.
FDA's consumer update entitled "What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD" reaffirms the agency’s current stance that CBD cannot lawfully be added to a food or marketed as a dietary supplement due to existing provisions of the Federal Food, Drug and Cosmetic Act, and outlines the data and potential safety issues it is considering as part of its ongoing evaluation of potential regulatory frameworks for CBD.
In the consumer update, the FDA goes into detail about the potential harms and risks of CBD, citing the data it received in public comments collected earlier this year. Significantly, FDA does not clarify the concentration of CBD at which potential harms and side effects have been found to exist, nor does the agency cite any data regarding the benefits and safety of CBD.
Also of significance, FDA states that it could not conclude based on available data that CBD is "generally recognized as safe" for use in human or animal food. While this statement is broad and may not be applicable in all instances, it nevertheless represents a shift by the agency in identifying legal barriers to CBD as an ingredient in food beyond the “drug preclusion rule” to more directly address the status of CBD as a food additive. The FDA illustrates this position in some warning letters where it notes that the inclusion of CBD in food would require a food additive petition.
Through this public update and warning letters, the agency appears to continue to focus enforcement efforts on what it considers significant public safety issues, including the use of improper claims that target vulnerable subgroups with the promise of unsubstantiated benefits. The update and warning letters also reiterate the heightened risks facing the manufacture, marketing and sale of ingestible CBD products, and emphasizes the need for congressional action to ensure the agency establishes a workable regulatory pathway for hemp-derived CBD ingestible products.
We encourage you to review FDA's latest guidance and determine the potential direct and indirect implications for your business. It is increasingly important that businesses understand the regulatory unknowns and how to position themselves for compliance in the wake of this current update.
Please do not hesitate to contact our Hemp & Cannabinoids Department at 303-860-4501 with any questions regarding this update and how it may impact your operations.