In December 2018, Congress passed the 2018 Farm Bill, a landmark legislation that legalized the cultivation and sale of industrial hemp and it’s derivatives after decades of prohibition. Cannabidiol, a hemp extract with medical capabilities, quickly grew in popularity, resulting in an unregulated market worth millions of dollars in sales. For months, advocates, stakeholders, and some lawmakers have urged the U.S. Food and Drug Administration (“FDA”) to create a comprehensive regulatory structure for the industry.
On Tuesday, the agency finally released draft guidance on developing cannabis-based drugs, weeks after the White House announced that it had finished reviewing the draft guidance. The published document states that the guidance is “limited to the development of human drugs and does not cover other FDA regulated products.” As the FDA is still developing guidelines that would allow CBD to be marketed and sold as a food item or supplement, the draft document is meant to provide guidance for drug manufacturing.
“A range of stakeholders have expressed interest in the development of drugs that contain cannabis and other compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area,” says FDA Principal Deputy Commissioner Amy Abernethy. The legislative change she refers to is the 2018 Farm Bill which legalized industrial hemp with less than 0.3% THC. Thus, researchers can use industrial hemp from any source as long as it doesn’t have excess THC, not just from the University of Mississippi, the country’s only federally authorized marijuana manufacturer.
The new document stresses on THC testing, stating that sponsors and investigators may find it useful to calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain insight into the potential control status of their product. “Regardless of whether cannabis or a cannabis-derived compound meets the definition of hemp, sponsors and applicants should work with reliable laboratories for analytical testing.”
It also gives step by step guidance on how to test for THC on a dry weight basis according to the FDA’s standards. In a Federal Register notice accompanying the new draft guidance, the agency asked for comments from the public on their recommended approach to testing for THC. The FDA has opened a 60-day comment period for stakeholders to offer their opinions on the proposed research guidelines.
It would be great to hear what the initial reactions of entities like VIVO Cannabis Inc. (TSX.V: VIVO) (OTCQX: VVCIF) are regarding the research guidelines published by the FDA.
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