Ask Our Experts: U.S. Federal Guidelines for CBD Research

 

Q: What are the U.S. federal guidelines for CBD research?

 

By William Sumner, Hemp Content Manager, New Frontier Data

A: Passage of the 2018 Farm Bill ushered in a significant increase among academic institutions and clinical researchers seeking to investigate a range of CBD’s potential medical applications. However, though CBD has been federally legal since the end of 2018, the rules governing its research have been nonexistent, with federal regulators essentially quiet on the issue before the Food and Drug Administration (FDA)’s newly issued guidelines.

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research,” said FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D., in a statement. “As that body of research progresses and grows, the FDA is working to support drug development in this area.”

So long as their hemp plant sources contains no more than 0.3% THC by weight,  CBD researchers will no longer have to rely on samples provided only by the University of Mississippi as the sole federally authorized cannabis manufacturer.,

In the memo, the FDA stresses that the guidance provided does not “establish legally enforceable responsibilities,” unless specific regulations or laws are cited. Click here for the FDA’s CBD research guidelines.