Last week, FDA Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy released a series of tweets indicating that the agency is “expediting” its work towards addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Dr. Abernethy also stated that FDA plans to report on the agency’s progress around the end of summer or early fall.
1/3 FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders. pic.twitter.com/XQbXb0KspU
— Dr. Amy Abernethy (@DrAbernethyFDA) July 12, 2019
2/3 We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety. To understand the breadth of issues and gather data on safety we have conducted a public hearing, reviewed the medical literature, and have an open public docket.
— Dr. Amy Abernethy (@DrAbernethyFDA) July 12, 2019
3/3 Over 100 speakers presented at the May 31st public hearing. There are 3417 comments on the public docket with 4 days to go. Please submit comments & data by 7/16/19. We plan to report on our progress around end of summer/early fall. https://t.co/EK3FxsPq0F
— Dr. Amy Abernethy (@DrAbernethyFDA) July 12, 2019
As we have discussed before, FDA has been receiving pressure from Senator Ron Wyden (D-OR), among other members of Congress, to clarify a regulatory pathway for CBD. Senator Wyden’s position focuses on the economic opportunity associated with CBD, stating that “FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements [is] fully unacceptable.”
Senate Majority Leader Mitch McConnell (R-KY) has also exerted pressure on FDA to move quickly. “Congress’s intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement,” McConnell said in a statement.
On the House side, the House Appropriations Committee passed a measure that allocates $100,000 to FDA to evaluate and set a safe level for conventional foods and dietary supplements containing CBD.
And finally, today is the deadline to submit comments to FDA’s public docket on CBD. With over 3800 comments received thus far and stakeholder pressure mounting, one thing appears certain: FDA is facing a hot – and busy – rest of the summer.