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article imageCBD rules process in U.S. could take three years or longer

By Karen Graham     Mar 21, 2019 in Politics
The outgoing head of the Food and Drug Administration (FDA) suggested on Tuesday that it would take several years for the agency to come up with rules around allowing hemp-derived cannabidiol (CBD) in food products—unless Congress steps in.
Speaking at a Brookings Institution event on Tuesday, FDA Commissioner Scott Gottlieb shared some updates regarding the status of hemp-derived CBD at the national level.
Gottlieb said he recognizes there is strong interest in the cannabis industry and among lawmakers in getting a regulatory framework in place so that CBD from hemp could be extracted, sold and introduced into the food supply. He said the problem is that “CBD didn’t previously exist in the food supply, and it exists as a drug under the statute.”
Gottlieb added that even though the 2018 Farm Bill legalized hemp when it comes to CBD, the law only allows the FDA to contemplate putting a substance in the food supply if it goes through a rule-making process.
The process of adding anything to the food supply can take up to three years, Gottlieb said, and with CBD, it could well be even longer. “It can’t just be put into the food supply,” he said, explaining that CBD is more complex than conventional products.
The FDA has already put together a "working group" to identify “some potential legislative pathways might be to create a framework for allowing CBD into the food supply," Gottlieb said. He expects the group to release some recommendations by the summer, as Business Insider first reported.
“I think you need to come up with a framework that defines concentration levels, where you would create some kind of cut off, and that would be up to the agency to do,” he said. “Congress would obviously give directions to the agency to do that.”
“CBD in high concentrations isn’t risk-free, and in low concentration, it probably is safe—I don’t want to make a declaration here. It’s also a question of whether it’s providing any kind of therapeutic benefit in those concentrations, although people seem to believe that it has some value. But this is a process that the agency would have to work through. I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation that would specifically address CBD.”
Gottlieb also said the Drug Enforcement Administration (DEA) would have to “formally de-schedule” hemp-derived CBD before the regulatory process could move forward.
“I think the prevailing view is that the plain language of the statute [of the Farm Bill] intended for that, but I’m not sure that DEA has done that yet,” he said. “But that’s another step that would have to take place. DEA would have to formally de-schedule CBD derived from hemp.”
“Then, there’s also, of course, the question of how you differentiate between CBD derived from hemp versus CBD derived from marijuana.”
More about CBD, Regulations, Food supply, Fda, congressional action
 
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