Everything You Need to Know About the FDA’s Hearing on CBD
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After a marathon ten hours of testimony, the US Food and Drug Administration’s public hearing on the use of cannabidiol (CBD) products concluded on May 31 with one clear, unified message: the status quo must be challenged.
However, perhaps unsurprisingly for a public hearing in which a wide range of views were represented, there were an equally large number of suggestions on how to improve the current state of affairs.
The hearing featured more than 100 speakers from a diversity of backgrounds and perspectives who testified before a panel of the FDA’s officials. The purpose of the hearing was for the FDA to discuss how CBD products should be regulated and marketed, as well as hearing additional information, data, and opinions from stakeholders and members of the public on the topic.
Despite the diversity of viewpoints represented by the contributing speakers, there were several broad points that raised support from across the board.
To save everyone ten hours of watching the entire of the hearing, Analytical Cannabis has gathered together the biggest talking points of the day and collected them below.
1. The CBD industry needs quality oversight and operating guidelines
Whether the speakers considered themselves for or against CBD products, most agreed that at a minimum the current CBD market needs to be subject to more oversight from experts.
The first hearing speaker of the day Peter Pitts, the president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, made this point in his speech before the FDA panel:
“The absence to date of advanced regulatory thinking relative to CBD has resulted in a maelstrom of false claims and shoddy quality standards.” He also called out some current CBD marketing campaigns for being “aggressive and misleading” with the claims being made about their products.
“It’s time for the proponents of CBD, including many highly vocal patients, physicians, pharmacists, manufacturers and distributors, to become part of the solution. Quality must always trump corporate convenience.”
Later on in the hearing, a number of stakeholders reportedly also brought forth laboratory evidence showing bottles of CBD oil claiming to contain 300 mg of CBD that in actuality contained far less, or in some cases no CBD at all. Speakers urged the FDA to do more to regulate these “junk products” out of the CBD market by introducing quality assurance requirements. Dietary supplement lobby groups made statements in support of further regulating the CBD industry, saying that it was unfair of the FDA to continue along this path of allowing an underregulated CBD market to compete with the much more tightly regulated dietary supplement market.
Jonathan Miller is the general counsel of the US Hemp Roundtable, which represents many top CBD producers. He also welcomed suggestions for introducing better regulation, saying, “there is an urgent need for an efficient regulatory framework.” He added that his association would be willing to work with FDA officials “to help the agency establish measures of quality safety and transparency for the entire industry.”
2. Research into CBD needs more support
Further research into the potential effects, risks, and benefits of CBD, and a need for science-forward policies were also topics that cropped up frequently at the hearing.
Elise Weerts, a professor of psychiatry and behavioral sciences at the John Hopkins University School of Medicine, spoke at the hearing on the behalf of the College on Problems of Drug Dependence, an international expert group which promotes research into addiction and provides education to legislations and policy officials.
“We need science to inform policy. Is cannabis good or bad? The answer is actually a little bit of both. It can have medical benefits in some cases, and also have problematic use,” Weerts said. “We’re in a vacuum right now.”
Speaking on behalf of the Alzheimer’s Association, Dr Keith Fargo, the director of the association’s scientific programs and outreach activities, also backed further research into CBD’s effects on health conditions, such as Alzheimer’s and dementia.
“Research findings to date have been inconclusive and contradictory,” said Fargo. “Although the chemical components of cannabis have been studied in relationship to Alzheimer’s and dementia, most of this research has been conducted on animal models, not in people.”
“And like any untested drug, [cannabis-based medicine] cannot be responsibly recommended for human use. Only large randomized, controlled clinical trials can provide reliable evidence in efficacy in the drug for human use.”
3. New proposals should not disadvantage people who rely on CBD medicinally
One other important point was raised by Dr Jaqueline French, a professor of neurology at the New York University School of Medicine and the chief medical officer of the Epilepsy Foundation.
For people with epilepsy, CBD has been proven to be effective in treating seizures even in rare drug-resistant forms of epilepsy. So effective is CBD, that last year the FDA approved its first CBD-containing medicine for the treatment of two severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
“Epilepsy, make no bones about it, is a serious and potentially life-threatening disease. And unfortunately, despite all of the therapies that are available right now, one-third of people with epilepsy do not have control of their seizures,” explained French to the expert panel.
“I think that I speak in a unique position because CBD, we’ve been told, is not a drug,” she continued. “But we in the epilepsy community obviously know it is a drug and it is a lifesaving drug. It has been proven in randomized controlled trials of Epidiolex (a drug that contains CBD), that in high enough concentrations it can stop seizures.”
“People who are in my community know that. They’ve heard that. They understand that. And they are looking for answers for their uncontrolled seizures.”
At one point in the hearing a suggestion was made that the FDA take all CBD products, except for those containing very low concentrations of CBD, off the shelves. French challenged this proposal, saying that the move could be detrimental to many people who are currently treat their epilepsy with commercially available CBD products.
“As much as I’m afraid of what we have now, I am more afraid, as a representative of my community, of losing it.”
4. Some people still don’t know the difference between CBD and cannabis
While the focus of the hearing was exclusively geared towards discussing CBD, time and time again speakers slipped into discussing the risks and benefits of cannabis as a whole.
For example, Professors Weerts, as she spoke about the needed for better CBD research, also illustrated her point with reference to cannabis use disorder. CBD is just one chemical constituent of cannabis, and has actually been proposed as a treatment for cannabis use disorder.
Several people also came before the FDA panel with anecdotal stories about recreational and medical marijuana. According to Leafly, it was during these anecdotes that “those of us covering the hearing left the room to refill our coffee mugs,” as such stories were usually dismissed by the FDA who would ask for follow-up evidence, research, and high-quality data.
For people who were unable to submit testimony during the hearing, the FDA has established a docket for public comment on the topic. Electronic or written comments can be submitted to the FDA until July 2, 2019 for consideration. The FDA’s acting commissioner, Dr Normal Sharpless, has said that these docket comments will help to inform the FDA as it considers future policy directions related to regulating CBD and CBD products.