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June 24, 2019
The Food and Drug Administration says it knows there’s demand for cannabis products, but says it’s taking a “science-based” approach to determine their safety and efficacy as it considers how to handle their legality.
The FDA recently opened a public docket on cannabis and cannabis-infused products and held its first-ever hearings as it starts the process of figuring out if, and what, it will regulate in the cannabis space.
In a message posted on the FDA website, the agency signaled an open-mindedness to the potentially beneficial effects of cannabis and cannabis-derived substances. Cannabidiol, or CBD, is the principal ingredient in one FDA-approved drug, seizure drug Epidiolex, already. But the agency urged the public to understand its interest in analyzing evidence.
“We recognize that there is significant public interest in these products, for therapeutic purposes and otherwise,” the FDA said. “At the same time, there are many unanswered questions about the science, safety, and quality of many of these products. As we approach these questions, we do so as a science-based regulatory agency committed to our mission of protecting and promoting public health.”
Among the potential issues the FDA wants to know more about is whether cannabis causes liver problems. The agency is also interested in whether cannabis-derived substances can be beneficial in veterinary medicine.
But the FDA also signaled its clear understanding that many in the health community think the plant may have therapeutic value.
“It is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis,” the FDA said.
The FDA is currently reviewing written comments submitted to the public docket which is open until July 16.
While the FDA has approved GW Pharmaceuticals’ Epidiolex, the agency looks at substances on two parallel tracks – one for drugs and one for food and dietary supplements. Currently, it is illegal to sell foods to which CBD has been added, or to market it as a supplement.
The FDA memo also said it’s serious about its consideration of CBD in food and other non-drug products.
“The Agency is committed to science-based decision making when it comes to CBD, while also taking steps to consider if there are appropriate regulatory pathways for the lawful marketing of CBD, outside of the drug setting,” the FDA said.
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