The strange debacle over whether hemp-derived cannabidiol (CBD) can be used as an additive in food and beverages will get some much needed attention starting month. The U.S. Food and Drug Administration announced earlier this week that it would conduct its first hearing on the matter at the end of May. But while the cannabis industry is hoping for a quick solution to this regulatory snag, the sentiment of outgoing FDA commissioner Scott Gottlieb is that it could take years to find a resolution.
Nevertheless, the FDA wants to dig into the situation relatively soon. Gottlieb initially said the issue would be dealt with in April, but that was before he decided to resign from his post with the Trump Administration and make a move back to Connecticut. There was a point when it seemed that Gottlieb’s departure from the agency would put the end game for all of this CBD confusion on the back burner for an indeterminant amount of time. However, the agency is now looking to collect all the data possible on the substance in hopes of coming to terms sooner rather than later.
“It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products — especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods,” Gottlieb said in a statement Tuesday.
Although CBD has become one of the hottest new trends in the realm of American wellness, no one really has any idea if it comes packed with the medicinal wizardry that many companies purport. There is little evidence that this compound has the all-healing powers to treat conditions ranging from anxiety to chronic pain, but that hasn’t stopped them from telling these tales in their marketing spiels. But then again, the compound has proved to have some medicinal function. Last year, the FDA puts its stamp of approval on the nation’s first CBD-derived medication(Epidiolex) as it showed it could be useful in the treatment of certain kinds of epilepsy.
Aside from it, though, most of the other claims behind this drug are based on anecdotal evidence and hearsay.
But the situation reached new heights of chaos last December when Congress legalized industrial hemp production. The law, which was designed to eliminate hemp from the Controlled Substances Act, essentially allows hemp-derived CBD to be sold as long as it contains no more than 0.3 percent THC.
This, of course, caused a veritable uprising in the CBD sector. But the FDA stepped in and put the kibosh on it to some degree, asserting that for the CBD compound to be added to food and drink it would first need to go through the agency’s approval process. Many states and local jurisdictions used this as an opportunity to swoop in and pull the plug on many operations selling edible forms of the drug. Everyone has just been waiting for the FDA to give them permission to continue.
But since CBD also comes from marijuana itself, the FDA commissioner argues that establishing regulatory controls for the substance is a complex issue. “This is a complicated topic and we expect that it could take some time to resolve fully,” he said. “Nevertheless, we’re deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward.”
But just how much time to resolve? Possibly years.
Last month, during a Bookings Institution event, Gottlieb told those in attendance that if Congress doesn’t step in and clarify the law, it could take somewhere around three years before CBD regulations are finished.
Although his final day is Friday, Gottlieb has appointed Principal Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller to oversee a working group that will assemble a list of recommended pathways to solve the problem. These findings will then be presented to boy and girls on Capitol Hill in hopes that they will pick up the issue. If they don’t, it will be entirely up to the FDA to handle the workload, and that’s going to take a while. Even Gottlieb believes Congress is the best way to make the quickest progress. “I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation that would specifically address CBD,” he said.
One way or another, something has to be done.
Just this week three companies — Advanced Spine and Pain’s Relievus, Nutra Pure and PotNetwork Holdings — received warning letters from the FDA advising them to stop telling customers that their CBD products could treat cancer and Alzheimer’s. The agency says this is false advertising, as these products have not been given clearance under the agency’s approval process. “The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today,” Gottlieb said in a statement.
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