New FDA Commissioner Won’t Ban CBD
In his first speech at a policy conference as the FDA’s new Commissioner, Dr. Stephen Hahn spoke plainly and gave a boost to the burgeoning CBD industry, saying “People are using these products. We’re not going to be able to say you can’t use these products. It’s a fool’s game to try to even approach that.”
His measured but positive response is good news for CBD users and the CBD industry. Hahn acknowledged the need for more information, and to date, the FDA has not issued any guidance on what CBD could be used for, what dosage levels are appropriate or how it should be sold and distributed. That guidance will help solidify the industry and give reassurance to users of CBD around the country. Hahn’s comments reinforce the inevitable truth that the time for CBD has come, it is useful for many people, and the FDA is finally getting on board with recognizing CBD as a mainstream therapeutic treatment.
“What we need to do is we need to fill the information gaps,” he said. “We need to understand what it helps with because we have some evidence on the drug side that it may be beneficial. We know there is some medical value there.” After waiting and hearing nothing since it became legal by passage of the Farm Bill of 2018, Hahn finally said, “It’s an important time for the FDA to really communicate with the American people about what we think is the risk and what we’d like to study further. We have to be open to the act that there is some value to these products. And certainly, Americans think that’s the case.”
The previous FDA chief Scott Gottlieb had said previously that it could take years before the FDA establishes rules for allowing use of CBD in food products unless Congress takes specific action in developing regulations on how CBD is extracted, used and sold. Currently, the FDA has only approved CBD for use in the drug Epidiolex for treating epilepsy. Although CBD products are now technically legal because FDA has no guidance on specific uses or therapeutic benefit, producers are unable to make any specific claims on the label; and it is still not allowed to be used as a food ingredient. Gottlieb had said that a framework to define concentration levels has to be put in place.
Hahn may be seeing some pressure from tobacco-growing states, where many farmers are eager to switch to growing legal hemp. Senate Majority Leader Mitch McConnell (R-KY) pressed Hahn early on about the need to establish a regulatory framework, stating after Hahn was first nominated to lead the FDA, “Like many Kentuckians who are taking advantage of hemp’s legalization, I am eager for FDA’s plans to create certainty for CBD products.”
With no finalized rules in place yet, the FDA’s enforcement activities are in a grey area but mostly limited to obviously unsupportable claims and irresponsible marketing tactics. The FDA is within its scope to do so, and some less reputable CBD vendors have made claims that clearly go beyond the norm, misleading some users into thinking it can be used to treat very serious illnesses like cancer. To be clear, CBD can be useful for cancer patients seeking relief from nausea resulting from their cancer treatments, but it is not a cure for the disease in any way, and reputable CBD vendors are not claiming it to be so. Former Commissioner Gottlieb had stated that while the agency has limited resources for enforcement, it will focus on taking action against companies that make “over-the-line” claims” that could be misleading.
Because to date, the FDA has failed to take action on issuing guidelines on CBD outside of a single product, Epidiolex, the CBD available on the marketplace occupies a grey area between being legal but still being mostly unregulated. As such, consumers of CBD must rely on peer reviews and are advised to purchase CBD products from reputable manufacturers and retailers. CBD does have a wide range of potential uses and delivery formats, ranging from tinctures to gummy bears, and even CBD for pets.
Hahn’s positive comments underscore the need for the FDA to finally take action on CBD and quickly issue regulatory clarity and industry standards and consumer protections. Ultimately, if the FDA issues guidelines sooner rather than later, this will be good for all parties concerned. For the CBD industry, FDA action will provide the framework necessary for CBD companies to produce, distribute and market CBD products responsibly. For consumers especially, swift action will mean they will have access to products they know are safe and effective, and with more specific guidance as to dosage and therapeutic use.