As CBD Oils Become More Popular, The FDA Considers Whether To Set New Rules | KCUR

As CBD Oils Become More Popular, The FDA Considers Whether To Set New Rules

May 31, 2019
Originally published on May 31, 2019 1:45 pm

The Food and Drug Administration is holding its first public hearing on CBD, the cannabis extract that has quickly grown into a billion-dollar industry. Today's hearing will help officials determine how to regulate CBD products.

The compound can be extracted from marijuana or from hemp. It's promoted as a way to ease anxiety and inflammation – and it doesn't get people high because it doesn't contain THC, the psychoactive component of the cannabis plant.

People are using oils with cannabidiol, or CBD, to help with everything from menstrual cramps to insomnia. While the hype around CBD has gotten ahead of the science, there are a growing number of small studies that do point to some health benefits. But the FDA has concerns over how these products are marketed, and is seeking more data about their safety.

"Questions remain regarding the safety considerations raised by the widespread use of these products," FDA officials wrote in a Federal Register notice about today's hearing. "These questions could impact the approaches we consider taking in regulating the development and marketing of products."

Regulators are expected to hear from many players in the CBD industry eager for the agency to step in and set some clear rules, because there's been a cloud of uncertainty over the legality of marketing and selling CBD products.

The 2018 farm bill lifted longtime restrictions on hemp, meaning that hemp would no longer be regulated as a controlled substance. The hemp industry saw this as a green-light to move ahead in promoting CBD products.

"When the farm bill passed last year, we were beyond thrilled. This ended a multi-decade prohibition on hemp," says Jonathan Miller who serves as general counsel to the U.S. Hemp Roundtable, a coalition of dozens of hemp companies. "It was a historic moment."

But the FDA quickly stepped in to make it clear that it has regulatory authority over CBD. The agency has said, for example, that cannabidiol products cannot be sold as dietary supplements.

So the industry is asking for a more definitive set of rules, and the FDA hearing is a first step.

"We really need the FDA to join in and help us lay a path toward a regulated legal product," Miller says. This is the main message he says he'll deliver during today's hearing.

But the FDA has a lot of questions for his industry, and researchers who study cannabis say there's still a lot to learn about cannabidiol.

"We're really in the infancy of understanding the physiological effects of cannabadiol right now," says Ziva Cooper, research director for the UCLA Cannabis Research Initiative.

Cooper says there are important questions to answer, such as: What doses are safe? And what happens when people use it for long periods of time?

The FDA has already approved one drug made of purified CBD, called Epidiolex, which is used to treat two rare and serious forms of epilepsy.

You need a doctor's prescription to get this medication, and it contains a much higher dose of CBD than what people typically get from the oils sold online or in dispensaries or markets.

Clinical trials of Epidiolex found that the high dose of CBD was generally safe but that it did cause side effects in some people, including lethargy and gastrointestinal distress. The FDA also pointed to concerns about possible liver injury.

"This is a potentially serious risk that can be managed when the product is taken under medical supervision in accordance with the FDA approved labeling for the product," agency regulators wrote in the Federal Register notice. "But it is less clear how this risk might be managed if this substance is used far more widely, without medical supervision."

One potential strategy to regulate CBD may be to set a threshold. High-dose products could be restricted and require a prescription, while low-dose products similar to many of the CBD oils currently on the market would be widely available.

The hemp industry has signaled its support for this approach. The lower dose products could be sold "over-the-counter in natural food stores, drug stores and grocery stores," says Miller of the U.S. Hemp Roundtable.

The FDA has set no timeline to regulate CBD products, and its evaluation is likely to continue over the coming months.

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