Last week, the FDA heard ten hours of testimony and comments at a public hearing designed to obtain information about cannabis-derived products with the ultimate goal of improved regulation of, among other things, popular wellness supplement CBD oil. Of the more than 400 people who applied to speak, 120, ranging from hemp growers to business reps to researchers, shared their insight.
“Ultimately, this is the opportunity for academia, industry, consumers, and medical professionals to voice their experience, their research findings, their anecdotal experience using the products, to the FDA and hoping that the FDA will kind of take this coagulation of input and issue some guidance on how the overall industry should behave,” said Derek Thomas, Vice President of Business Development of Veritas Farms.
“Overall, it's been fascinating to hear from everyone from Johns Hopkins research professionals to farmers to manufacturers, and everyone's experience has been so well thought out, incredibly displayed, very passionate," he continued. "It’s just an exciting day to watch.”
The public hearing was webcast live, but if you missed it, here are five major takeaways.
1. Time is of the essence.
One common theme that emerged from all sides was that the FDA needed to make a decision sooner rather than later when it comes to regulation.
Jonathan Miller, general counsel at U.S. Hemp Roundtable, was one of the first to speak, noting that there is “an urgent need for an efficient regulatory framework for CBD.”
“It's really important for the FDA to act judiciously here,” he told Organic Authority. “That we embrace federal regulations, but that it both needs to be fair and speedy. We're in a cloud right now, because of uncertainty in terms of the way that FDA is going to treat CBD products, and we need them to lift the cloud and come up with a fair and just resolution.”
Dr. Yasmin Hurd, director of the Addiction Institute at Mount Sinai in New York and a cannabis researcher, echoed these sentiments in an email to CNN.
"The market and the public have already let the genie out of the bottle and it will be difficult to put it back in without the FDA and government showing clear proof that there is evidence showing a negative health impact," she wrote.
Waiting too long to come up with a nationwide regulatory protocol could have a host of negative repercussions, including individual states making their own regulations, as the industry saw when Vermont attempted to regulate GMO labeling in 2014.
The FDA has already taken some steps to expedite the regulatory process for CBD, setting a deadline of July 2 for written comments on the issue, but calls for even faster decisions were widespread during the public hearing.
2. Regulations are needed to help guide CBD oil consumers.
The current market for CBD products is a bit all over the place: some brands are clean and transparent; others are a bit more reticent to share what's in their oils and tinctures. But perhaps one of the biggest blind spots consumers have is how much CBD is in any given product.
“The 2018 Farm Bill was signed into law on December 20th, and since then, the CBD industry has been holding its breath for clarity from the FDA," said Dr. Duffy MacKay, Senior Vice President, Scientific and Regulatory Affairs for CV Sciences, who presented at the hearing. "The central question is whether, and how much, CBD can be included in food and beverages in the U.S. Considering that many products violating FDA regulations are currently on the market, now is the right time to answer that question.”
“It’s a wild West kind of environment right now,” Hurd told the Washington Post. “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.”
The FDA will not only need to establish guidances to ensure that CBD oil products contain an appropriate amount of active ingredients; it will also have to decide how much CBD constitutes an over-the-counter dietary supplement, and how much constitutes a medicine.
Orrin Devinsky, a New York University researcher who helped develop Epidiolex, an epilepsy treatment that is currently the only currently-approved CBD drug on the marketplace, expressed another worry to the Washington Post.
“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.
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Once thresholds are set, there will be a clear divide between dietary supplements, which will not be allowed to sport medical claims, and FDA-approved drugs, which will.
“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.”
3. Funding is desperately needed for CBD research.
The issue raised by Devinsky is two-fold: not only does the public need to be made aware of the clear divide between an OTC-strength CBD oil product and a medication, but researchers need to be given the tools to test and derive further drugs from the plant.
CBD oil has been touted by many as having a variety of health benefits; we analyzed the ongoing research in our CBD oil guide, 7 Potential Benefits of CBD Oil, and also answered some of your burning questions about the product in our FAQ guide on CBD (we also rounded up for you 9 Best CBD OIl Products Vetted by Our Editors). But researchers shared during the hearing that they did not have the tools they needed to continue testing new drugs.
Acting Food and Drug Administration Commissioner Ned Sharpless pointed out during the hearing that, prior to a reclassification of hemp in the 2018 Farm Bill, much of the research into cannabis looked at the plant as a whole, rather than specific components including CBD.
"When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD's broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation," he said.
Experts including Sue Sisley, an internal medicine physician at the Scottsdale Research Institute, called for the DEA to process applications to increase the number of authorized manufacturers for research-grade cannabis in order to pave the way for such developments.
“Sadly, because of the limitations with the current drug supply, we are forced to import study drugs from a Canadian manufacturer and that is disappointing to us,” she said. “We would like to see our own domestic variety of domestic manufacturers. The point is that researchers need access to options. Scientists need options when it is to embolden scientific freedom.”
This desire was echoed from representatives for associations researching cures for diseases like Alzheimer's, Parkinson's, and Epilepsy.
4. FDA officials remain skeptical.
The Washington Post cited Sharpless' comments that answers to many of his CBD-related questions remained unknown following the hearing, and Abernethy Tweeted about the “lack of information about dosing guidelines” given by the experts who spoke.
“Several experts who testified were unable to give clear answers to the FDA panel when asked about what the proper doses are in different contexts, and what their affects (sic) on consumers are.”
This may have contributed to stock in CBD products falling yesterday. Despite analysts projecting that the $1 billion industry could grow to be worth as much as $22 billion in the next five years, during the hearing, major cannabis companies like Tilray, Cronos, and Aurora Cannabis traded down by more than 3 percent, according to Business Insider.
5. There’s more to be done.
Perhaps the biggest takeaway of the meeting is that this is only the beginning.
“I am confident that we're going to have a positive resolution; the question is, how quickly," said Miller. "We would like to see this happen within a 12-month period; some people fear it might be as long as three years.”
Thomas also noted that there is a “great chance” that whatever resolutions are made “won’t be perfect for everybody.”
“You have growers, manufacturers, brands who have different operating intentions and different ideas of how the products should be used and discovered and talked about, as well as consumers and their experiences... so it's really hard to say what the FDA took away from today,” he said.
“The good thing is that, by and large, a lot of the input was very well thought out, very well presented, and very forthright, so the FDA was presented with a lot of good material.”
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