With Popularity of CBD Oils, The FDA is Considering New Rules
The first public hearing will be held by the Food and Drug Administration to discuss CBD, the extract from cannabis, which has grown quickly into a billion-dollar market. Officials will figure out how to regulate CBD products in today's hearing.
Promoted as something that can reduce inflammation and anxiety, the compound can be extracted from hemp or marijuana. This compound does not get people high since it does not contain the psychoactive component of the cannabis plant, THC.
People now use CBD or oils with cannabidiol to treat almost everything, including insomnia and menstrual cramps. Even though the intensive promotion of CBD is overshadowing the science behind it, a growing number of small studies point to some health benefits. The Food and Drug Administration is worried about how these products are marketed and is looking to obtain more information about the safety of the products.
"Questions remain regarding the safety considerations raised by the widespread use of these products," FDA officials wrote in a Federal Register notice after today's hearing. "These questions could impact the approaches we consider taking in regulating the development and marketing of products."
Given the uncertainty over the selling and legality of marketing of CBD products, regulators expect to hear from CBD industry stakeholders who are eager for the agency to come in and set the rules.
The longtime restrictions on hemp was lifted by the 2018 farm bill, which saw hemp removed from the list of regulated controlled substances. As a result, the hemp industry took this as an opportunity to start promoting CBD oils.
Jonathan Miller, who serves as general counsel to the U.S. Hemp Roundtable, which is an alliance of many hemp companies, said, "When the farm bill passed last year, we were beyond thrilled. This ended a multi-decade prohibition on hemp. It was a historic moment."
But the FDA has stepped in to clarify that it has the authority to regulate CBD. It stated that cannabidiol products cannot be sold as dietary supplements.
This is why the industry stakeholders want a clear set of rules, and this hearing by the FDA will kick off the process.
"We really need the FDA to join in and help us lay a path toward a regulated legal product," Miller says. During today's hearing, this is the key message he said he'll deliver.
There are a lot of questions the FDA has for this industry, and researchers studying cannabis say that the surface is yet to be scratched when it comes to cannabidiol.
The research director for the UCLA Cannabis Research Initiative, Ziva Cooper, said, "We're really in the infancy of understanding the physiological effects of cannabidiol right now."
The director said that important questions such as what dosage is safe and the effect of prolonged usage are yet to be answered.
Epidiolex, which is a drug made of purified CBD, has already been approved by the FDA. This drug is used to treat two serious and rare forms of epilepsy.
To use this medication, a doctor's prescription is required. The drug contains a higher dose of CBD compared to what people usually get from the oils sold on the internet or in markets or dispensaries.
After some clinical trials of Epidiolex, it was found that the high doses of CBD was safe. Notwithstanding, it had side effects in certain individuals, such as gastrointestinal distress and lethargy. The FDA was also concerned about the chances of liver injury.
Agency regulators wrote in the Federal Register notice, "This is a potentially serious risk that can be managed when the product is taken under medical supervision in accordance with the FDA approved labeling for the product. But it is less clear how this risk might be managed if this substance is used far more widely, without medical supervision."
One way to keep CBD usage in check is to set a threshold. For products that have a high dose of CBD, restriction should be placed on those products and prescription would be required, while low-dose products, such as the many CBD oils now on the market, would be available to just about anyone.
The hemp industry has backed this method of regulating CBD dosage. Miller, who is a member of the U.S. Hemp Roundtable, said that “Lower-dose products could be sold over the counter in grocery stores, drug stores, natural food stores."
There is no timeline set by the FDA regarding when it will start regulating CBD products. It’s likely the FDA will continue with the evaluation process for some months.