FDA Questions Safety And Marketing Of Cannabidiol, Known As CBD

May 31, 2019
Originally published on May 31, 2019 9:19 am
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The Food and Drug Administration is going to hold a hearing today to help determine how to regulate CBD. CBD is an extract of the cannabis plants, which is said to help relieve anxiety and inflammation. NPR's Allison Aubrey reports.

ALLISON AUBREY, BYLINE: CBD can be extracted from marijuana or from another strain of the cannabis plant, hemp. And last year, the hemp industry got some big news. The 2018 farm bill lifted long-time restrictions on hemp and the industry viewed this as a green light to sell a product that won't get people high but could have lots of benefits. Here's Jonathan Miller, general counsel to the U.S. Hemp Roundtable.

JONATHAN MILLER: When the farm bill passed last year, we were beyond thrilled. This ended a multi-decade prohibition on hemp, but it also raised a whole bunch of questions.

AUBREY: The Food and Drug Administration stepped in quickly to make it clear they still have regulatory authority over hemp-derived CBD. The agency sent warning letters to some companies, alerting them that it was illegal to market CBD as a treatment or cure for any specific medical condition. Miller says the legal uncertainty has left the industry in limbo.

MILLER: We really need the FDA to join in and help us lay a path towards a regulated legal product.

AUBREY: That's the message that Miller will deliver at the hearing today. But his industry will also face a lot of questions. At a time when people are using CBD to help with everything from menstrual cramps to anxiety, the FDA has a list of concerns it wants addressed. For starters, the agency wants more data to assess the safety of CBD.

Ziva Cooper is research director for the UCLA Cannabis Research Initiative. She's reviewed some studies on CBD, which is also known as cannabidiol.

ZIVA COOPER: So unfortunately, we're really in the infancy and understanding the physiological effects of cannabidiol right now.

AUBREY: There are studies underway, but she says there are still some basic questions to answer such as...

COOPER: What doses are safe? Or what are the impacts of accumulated exposure over time?

AUBREY: The FDA has already approved one drug made of pure CBD, which is used to treat seizures. You need a doctor's prescription to get this medication, and it's a much higher dose than what people typically get from the CBD oils sold online or in dispensaries or markets. The high-dose CBD has led to some side effects, including GI distress and feeling lethargic.

Ziva Cooper says another concern is how CBD interacts with other drugs that people take.

COOPER: We know that cannabidiol does interact with certain medications that could be dangerous - medications like chemotherapeutic agents or antiseizure medications.

AUBREY: When it comes to CBD edibles or foods that are infused with CBD, the FDA's position has been that it is not legal in interstate commerce to sell them. Nonetheless, they've popped up in lots of places.

COOPER: From, you know, the cannabidiol-infused hamburger that was offered at Carl's Jr. on April 20 to the cannabidiol that's in your hummus that you can buy at your local organic market.

AUBREY: CBD is quickly becoming a multibillion-dollar-a-year industry, and regulations are coming. The hemp industry says one approach it supports is to set a threshold. High-dose products could be restricted and require a prescription and low-dose products like supplements or foods would be more widely available.

Here's Jonathan Miller of the U.S. Hemp Roundtable.

MILLER: Sold over the counter in natural food stores and drugstores and grocery stores.

AUBREY: FDA regulators will likely weigh these options in the coming months.

Allison Aubrey, NPR News, Washington. Transcript provided by NPR, Copyright NPR.