At the end of February 2019, as well as concurrent with the passage of the 2018 Farm Bill in late December 2018, Food and Drug Administration (“FDA”) Commissioner Dr. Scott Gottlieb made numerous public statements which offered hope to those waiting for the FDA to take affirmative leadership on hemp and cannabidiol (“CBD”) regulations. But, since then, further uncertainty has arisen as to what FDA’s position is and what happens next.
Before the House Appropriations Committee, Dr. Gottlieb stated, “We heard Congress loud and clear with respect to [the 2018 Farm Bill]… I understand Congress wants there to be a pathway for CBD to be available.” For many in the cannabis industry, Dr. Gottlieb’s words signaled an important shift in the FDA’s rhetoric regarding CBD, one of many cannabinoids that may now be lawfully derived from hemp pursuant to the newly-passed 2018 Farm Bill. Dr. Gottlieb promised an April meeting to discuss what FDA regulations in the hemp and CBD space could look like and offered a few hints of the same.
Dr. Gottlieb’s statements were encouraging to many because, previously, the FDA had sent mixed messages regarding how the agency would treat CBD moving forward. The 2018 Farm Bill remained silent as to the FDA’s regulatory authority, leaving untouched the FDA’s oversight in regulating hemp and hemp derivatives in various types of products. As of today, FDA remains unwilling to commit that CBD may be an allowable dietary or food ingredient for a number of reasons, including the investigation of a drug (Epidiolex) which recently received FDA approval. FDA’s written rhetoric, juxtaposed with its seeming inaction enforcing its positions, has led to significant confusion around the country, forcing state and local jurisdictions to take matters into their own hands with regard to whether hemp derivatives, such as CBD, could be permissibly added to foods, supplements and other product types, often to inconsistent effect.
In clarifying these exact concerns, Dr. Gottlieb added in his testimony, “… for CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing… We’re planning to seek broad public input on this pathway, including information on the science and safety behind CBD. But we know that this process could take time… So we’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.”
Without giving any concrete commitments on what the FDA would do on these issues, Dr. Gottlieb and the FDA finally appears to be warming on the future of hemp-derived CBD. In an unexpected turn of events, however, on March 5, 2019, Dr. Gottlieb announced his resignation in the comings weeks, leaving open the door for his successor to change course.
What, if any, effect Dr. Gottlieb’s resignation as Commissioner of the FDA will mean for hemp and CBD moving forward is unclear. It is not immediately apparent whether the FDA will continue to shift its position in the way that Dr. Gottlieb’s pronouncements suggested or whether the FDA will still host the planned April listening session on such regulations. While there stands a chance that his successor could change course – just as Attorney General Sessions did with the Cole Memo; the hope, and belief, remains that Gottlieb’s successor will hear Congress just as “loud and clear” as Gottlieb himself did. As these developments transpire, and as an eventual replacement for Commissioner Gottlieb is chosen and placed in the role, the cannabis industry will be closely watching.
For now, though, the needed clarification of policy that this industry wants and needs from the FDA will remain the elusive subject of speculation.
Darren Kaplan is an associate attorney at Hoban Law Group in Denver, Colorado. Darren has worked on several legal issues in the cannabis space, specializing thus far in industrial hemp, regulatory compliance (hemp and marijuana), and civil and commercial litigation
Garrett Graff is a senior attorney at Hoban Law Group in Denver, Colorado, nationally recognized as a Cannabis Law Trailblazer by National Law Journal. Garrett specializes in representation of both the marijuana and industrial hemp industries. His practice involves corporate and M&A, real estate, regulatory/compliance, FDA/FTC compliance, intellectual property protection, and civil and commercial litigation.
This article has been prepared for informational and general guidance purposes only; it does not constitute legal or professional advice. You should not act upon the information contained herein without obtaining specific professional advice. No representation or warranty (express or implied) is made to the accuracy or completeness of the information contained in this publication. Hoban Law Group, its members, employees, and agents accept no liability, and disclaim all responsibility, for the consequences of you or anyone else acting, or refraining to act, in reliance on the information contained in this publication or for any decision based thereupon.