How much of the cannabis extract is safe to consume daily, he asked at the jam-packed, all-day hearing at FDA headquarters in Silver Spring. How will it interact with other drugs? What if a consumer is pregnant? What is CBD’s effect on children? What happens if someone takes it over the course of years?
Acting Commissioner Norman “Ned” Sharpless said answers to most of those questions are still unknown despite the popularity of many CBD products.
“There are important reasons to generally prohibit putting drugs in the food supply,” Sharpless said. And cannabis extracts like CBD “are no exception.”
During the 10 hours of testimony that followed, hemp growers, start-up businesses, academic researchers and consumer advocates argued about how FDA should regulate the already booming CBD industry. Some demanded strict oversight. Others — especially companies with millions at stake — lobbied for looser regulation.
But the common theme among them all: FDA needs to figure out its rules sooner, rather than later.
Even though FDA’s regulations make adding CBD to food and supplements illegal, the CBD industry has exploded in recent years with thousands of unproven products flooding the market. Companies have trumpeted the compound’s alleged health benefits — claiming it can reduce anxiety, pain and insomnia and treat conditions from Parkinson’s disease to cancer. But almost all such claims lack rigorous scientific proof, prompting concern among health officials and scientists about safety and deceptive marketing.
Without clearly defined regulations, no one knows for sure how much CBD is in products available on the market, or how safely the chemical compound is being manufactured and incorporated into them.
“It’s a wild West kind of environment right now,” said Yasmin Hurd, a psychiatry professor at the Icahn School of Medicine at Mount Sinai in New York City, who has researched CBD for almost 10 years. “I’m inundated every day with patients wanting to know how much CBD they should take, which ones to buy. But we don’t know what’s in the stuff now being sold. . . . We’ve had this explosion without guidance to the public or regulation.”
How the FDA will choose to regulate the industry and how long it will need to figure that out remain unclear. Those prospective regulations have become a fierce battleground: More than 400 people and groups applied for a chance to speak at Friday’s hearing, with roughly 120 speaking slots parsed out.
CBD can be derived from the marijuana plant or hemp. Congress in December legalized hemp as part of the Farm Bill, clearing the way for industrial production of the nonintoxicating compound from that plant. But the FDA quickly made it clear to companies that while hemp was legal, CBD extract remained under government regulation. In recent months, the agency has sent warning letters to some companies that it said were “illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer.”
Billions are at stake in how the FDA decides to regulate the compound, with business analysts projecting the industry could grow to be worth as much as $22 billion in the next five years.
Market research firm New Frontier Data estimated that sales of CBD products in the United States more than tripled between 2014 and 2017, to $367 million.
At Friday’s hearing, hemp growers argued that the CBD market represented thousands of jobs and a booming source of growth for the economy. CBD retailers relayed anecdotal evidence of patients who found relief to longstanding medical problems in their products.
Health advocates spoke equally passionately about the dangers posed by an unfettered CBD market.
So far, the agency has approved only one CBD-based drug, Epidiolex, which treats severe forms of childhood epilepsy.
In a phone interview, Orrin Devinsky, a New York University researcher who helped develop the drug, said the government’s haphazard approach has been frustrating to scientists trying to help suffering patients.
“You have researchers having to struggle through enormous expense and obstacles to study CBD,” he said. “At the same time, you can walk down to your neighborhood bodega and buy a CBD soda off the shelf. The nation and marketplace are in a horribly confused state.”
So far, treating epilepsy is the only application for CBD supported by rigorous scientific data, Devinsky said. Though less rigorous, some promising findings have emerged for CBD’s possible effect on anxiety and inflammation.
“The thing we worry about is someone with cancer forgoing real treatment like chemo and taking CBD instead,” said Devinsky, a neurology professor at NYU.
At Friday’s hearing, scientists and consumer advocates also warned that for the thousands of CBD products being sold, there is little data to guide dosage levels, expiration dates, and manufacturing protocols to make sure they don’t also contain other elements like tetrahydrocannabinol, or THC, the main psychoactive component in marijuana, which has been found in some CBD products.
Whatever the FDA decides, many in the industry are pressing for it to move quickly.
“I’ve talked to beverage companies and they want to get into this space, but they are not interested in just throwing themselves headlong into an area without science and engagement with regulators,” said Coleen Klasmeier, a former FDA staff lawyer and now partner at law firm Sidley Austin.
“For years now, the agency’s position has been just to throw up their hands and say it’s a confusing issue,” said Daniel Fabricant, a former FDA official overseeing dietary supplements, who is now chief executive of the Natural Products Association representing the supplement industry.
In addition to Friday’s hearing, the FDA has set a deadline of July 2 for written comments on the issue. It also convened a working group led by Deputy Commissioner Amy Abernethy to explore ways CBD products might be sold legally, the impact of such products on public health, and whether new FDA rules or congressional legislation may be needed.
In a string of tweets on Friday, Abernerthy summed up main points she and FDA officials were hearing over and over at the meeting: “Key questions about product safety need to be addressed. Data are needed to determine safety thresholds for CBD...There are both positive supporters of cannabis-cannabis derived products including CBD and also concerned citizens worried that widely available products can be harmful.”