A “fool’s game.”
That’s how FDA’s top official described any attempt to keep CBD products from the American people.
“We’re not going to be able to say, ‘You can’t use these products,’” said Stephen Hahn, M.D., who began serving as FDA’s commissioner in December 2019. “Even if you did, it’s a fool’s game to even try to approach that.”
Hahn made the remarks Wednesday at the NASDA (National Association of State Departments of Agriculture) Winter Policy Conference, which the advocacy group Vote Hemp recorded.
Eric Steenstra, president of Vote Hemp, said Hahn understands CBD is “everywhere” and “not going anywhere too.”
Hahn prefaced his remarks above with observations that highlighted the prevalence of CBD.
“There is a huge—and I mean huge—stand for CBD products” at Reagan National Airport, Hahn said. “We know one thing from the American people: They are using CBD products.”
He also mentioned receiving a recent text from a lung cancer patient who was using CBD oil to supplement her chemotherapy. Hahn previously served as chief medical executive at The University of Texas MD Anderson Cancer Center.
While Hahn suggested it would be futile to tell Americans to stop using CBD, he said the agency needed to “fill the information gaps” and understand where CBD could be beneficial beyond its medicinal value.
FDA in 2018 approved a CBD-containing medicine known as Epidiolex to treat seizures associated with two rare and severe forms of epilepsy.
“We know that there’s some medicinal value there,” Hahn said. “What about on the other side of the fence? Where could it be a benefit?”
CBD ‘everywhere’
Non-FDA-approved CBD products—including dietary supplement hemp extracts—have flourished on the U.S. market. Hemp-based CBD in supplements alone generated $623 million in 2019 sales, up from $148 million in 2017, according to Nutrition Business Journal.
The growth was partly fueled by passage of the 2018 Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA).
But some large corporations wanting to enter the market have remained on the sidelines. FDA has maintained CBD cannot be lawfully sold in a food or dietary supplement because it was first studied as a drug by GW Pharmaceuticals plc. The hemp industry has long criticized the agency’s position, arguing FDA has failed to distinguish Epidiolex from the full-spectrum hemp extracts marketed as dietary supplements, for example.
FDA officials “are equating whole-plant extracts from hemp as being apples to apples with pure CBD from marijuana,” Steenstra of Vote Hemp said in an interview. “That’s the only basis for them to claim that this is somehow not legal to sell because it’s been removed from the Controlled Substances Act.”
“Epidiolex is out there,” Steenstra added, “but it’s not the same.”
FDA has discretion to allow for the sale of CBD in food and supplements through a rulemaking. Agency officials, though, have raised safety concerns about the use of CBD, such as the risks of liver injury, drug interactions and male reproductive toxicity.
FDA is “trying to formulate” its position on CBD, said Hahn, who noted the importance of communicating to Americans the risks and what his agency would like to further study.
FDA must be “open to the fact that there might be some value to these products, and certainly Americans think that’s the case,” Hahn conceded, “but we want to get them the information to help them make the right decisions.”
Steenstra expressed hope FDA’s top official would send a message to his staff: “Stop the charade. Let’s start regulating this and … let’s research it as fast as we can.”
Addressing gaps in data or safety concerns raised by FDA, Streenstra said the industry would be pleased to work with the agency.
Asked whether he perceived anything in Hahn’s speech to suggest FDA plans to move more swiftly on a rulemaking, Streenstra responded he was “hopeful.”
“Am I expecting the FDA to pivot this morning to 180 degrees and say, ‘OK now, everything’s cool and we’re going to regulate CBD,’” Steenstra said. “No.”
But Hahn’s statement, he concluded, acknowledged CBD “products are everywhere,” Americans are benefiting from them, and the products are “not going anywhere.”