FDA Will Not Regulate CBD
Instead, the FDA is asking Congress to create a regulatory system that balances “risk” with access to CBD products.
This announcement hasn’t changed the status of CBD products, which are legal but not regulated as food or dietary supplements.
Some businesses were disappointed to hear that the FDA will not regulate CBD. Many people associate the federal bureaucracy with consumer-friendly standards and practices.
2018 Farm Bill
CBD, or Cannabidiol, is one of the major cannabinoids of the cannabis plant. Although technically psychoactive, you can take CBD and stay clearheaded. Consumers like CBD for its anti-inflammatory effects, as well as its neuroprotective properties.
CBD is also popular among cannabis connoisseurs for its ability to attenuate THC‘s effects. Some say cannabinoids work better when they’re all present, a process called the entourage effect.
CBD’s popularity in the United States grew after President Donald Trump signed the 2018 Farm Bill, which legalized cannabis production so long as the plants were below 0.3% of THC.
According to a report by CannIntelligence, the U.S. CBD market is expected to reach $1.9 billion this year, with a projected value of well over $3 billion by the decade’s end.
However, a lot of those projections depend on how the FDA and Congress decide to regulate CBD.
FDA Only Approves Patented-CBD
The announcement that the FDA will not regulate CBD as a dietary supplement or food-based product leaves many wondering: what’s next?
So far, the FDA has only approved one CBD-based product: Epidiolex.
Approved in 2018 for treating seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, Epidiolex was given the thumbs up for patients as young as two-years-old.
The FDA approved Epidiolex based on clinical trials they claimed showed its efficacy and safety in treating these forms of epilepsy. Of course, other studies show CBD’s efficacy with epilepsy. One doesn’t need Epidiolex, per se.
But, of course, Epidiolex is patented. GW Pharmaceuticals developed and marketed it. That’s how they justify the high cost of the drug.
(There’s also been issues around misrepresenting their clinical trial data on Epidiolex and long-term side effects like liver issues. Note that none of these cost, safety or side effect issues are present in the raw form of cannabis).
FDA on CBD: Passing the Buck to Congress
The FDA expressed concern about “CBD exposure” to “vulnerable populations” like pregnant women and children.
Ergo, they’ve passed the buck to Congress. Currently, nothing has changed. And if Congress’ reputation holds, nothing will likely change. At least not in the short term.
There is talk about classifying CBD as a dietary supplement in the 2023 Farm Bill, but nothing has come of it so far.
That said, the states of Colorado, Oregon, Washington, Maryland, and Virginia already have regulations concerning CBD products.