Silver Spring, MD—In response to accusations of lack of movement on the cannabidiol (CBD) front, FDA has released a statement titled “Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products.” The Council for Responsible Nutrition has dismissed it as an “excuse” for FDA’s inaction.
Written by Stephen Hahn, M.D., Commissioner of FDA, and Amy Abernathy, M.D., Ph.D., Principal Deputy Commissioner, the article states that while interest in and availability of CBD products has increased, “we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds, including potential safety risks for people and animals. At the U.S. Food and Drug Administration, we see these knowledge gaps as an opportunity to develop new ways of building the science to inform public health decisions.”
The article adds that FDA still doesn’t have clear answers regarding adverse reactions and risks of long-term CBD use. However, the article does not state that FDA intends to invest in research. Rather, it notes that this may be an opportunity to use “novel sources of data and rigorous analytical methods to build a more robust base of scientific evidence on the safety profile and use of CBD products.” The source of data in question: “We think that real-world data on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding.”
The article goes on to detail FDA’s work on CBD.
In response, the Council for Responsible Nutrition issued a statement from President & CEO Steve Mister. Mister writes in the statement: “Today’s notice, late in the day, late in a week that has seen a national crisis, is nothing more than an end-of-Administration desk-clearing exercise from an FDA that has failed to lead in this crucial policy area. Today’s announcement tries to excuse the agency’s inaction by decrying a lack of data—even as FDA has blocked the New Dietary Ingredient (NDI) route for CBD supplements by declining to review them, and done little that might incentivize data to be presented or invested in research of its own.”
Mister adds that this “essay on data” misunderstands DSHEA: “As a botanical, under DSHEA, the presumption in the law actually runs the other way. Put plainly, consumers should have access to CBD dietary supplement products absent some reason shown why they should not.”
In CRN’s view, FDA could immediately begin exercising its lawful authority to regulate CBD products as dietary supplements. FDA’s failure to act exposes the public to harm from “a wild-west market that continues to expand without meaningful regulatory bounds.” And, of course, responsible manufacturers face a wildly uneven playing field.
Mister concludes: “CRN looks forward to working with a new Administration and a new Congress and continuing to advocate strongly for a legal pathway to market for CBD dietary supplements. The public deserves better, and CRN intends to deliver.”