WASHINGTON — Those hoping for a quick resolution to the confusion surrounding the U.S. Food and Drug Administration’s oversight over cannabidiol (specifically food and beverage products), might want to think again. While speaking at a Brookings Institution Event last month, outgoing FDA Commissioner Scott Gottlieb warned it will take years—not months—for the FDA to create a regulatory pathway for cannabidiol (CBD) products, those products made with the nonpsychoactive chemical in hemp or marijuana.
Gottlieb went on to suggest that a legislative intervention by Congress would be a quicker alternative to getting edible CBD products to market.
He acknowledged the current pressure to create a legal framework for CBD. The issue facing the agency is that “CBD didn’t previously exist in the food supply, and it exists as a drug under the [current] statute,” he said.
It’s also unlike any other chemical the FDA has dealt with before; it's a hemp-derived substance that is also associated with the cannabis plant and tetrahydrocannabinol (THC), the psychoactive chemical that gets a user high. “We’ve never done this before,” said Gottlieb.
A Three-Year Process?
Even with less complicated substances, like tobacco or nicotine, the FDA rulemaking process takes years. Three years is typical, Gottlieb estimated.
Patrick Goggin, a senior attorney specializing in cannabis at the San Francisco-based Hoban Law Group, agreed that three years is about the average for FDA regulations. “If the FDA acted with urgency, they should be able to do it sooner,” he said.
Goggin pointed out that the U.S. Department of Agriculture (USDA) is attempting to finalize its hemp regulations in just nine months. “While the regulatory process might be more involved on the FDA side, if the USDA can expedite its regulatory process, the FDA can as well, enabling it to shorten three years to perhaps 18 months.”
Next Steps
Gottlieb said the FDA is assembling a team to review other legislative options that would get CBD foods to the market before that three-year time frame, and again suggested that the fastest option would be for Congress to get involved.
“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 said.
The question is how likely the current Congress is to pass such a law. Scott Sinder, NACS general counsel and a partner at Steptoe & Johnson LLP, said it’s “hard to say.”
“There will be very little movement on big issues, but there is a real need for something here given how pervasive CBD is,” he said. “You could see something get done on a must-pass bill like the end of the year omnibus or flood insurance [bills]. The issue at the moment is that I am not aware of any actual proposal; they obviously will need a solution before they can try to enact it.”
Goggin agreed that a standalone bill is unlikely, saying the process might mirror what we saw with the Farm Bill, the bill that made growing industry hemp legal, last year.
“Remarkably, we have re-legalized hemp in the U.S. without ever having hemp-specific committee hearings. Rather, we advanced U.S. hemp policy through the Farm Bill and spending legislation,” he said. “I'm confident that if the Senate is motivated by the FDA's slow movement, it will find the legislative vehicle to solve this significant economic and human issue and hasten the process.”
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