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A federal drug agency is taking another stab at regulating CBD. A Food and Drug Administration (FDA) official recently said the officials plan to make CBD and kratom regulation a top priority this year.
During an Alliance for a Strong FDA webinar held last month, FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak said the agency is working to find an “appropriate regulatory framework for CBD.”
Although CBD sourced from hemp is technically legal, thanks to the passage of the 2018 Farm Bill, federal law prohibits companies from selling over-the-counter supplements and foods containing any active ingredients found in FDA-approved pharmaceutical drugs. Since CBD is the active ingredient of Epidiolex, a drug that treats rare forms of epilepsy in children, companies aren’t allowed to make products with it that are meant for human consumption.
The only reason consumers can still purchase CBD is because the FDA decided to allow its sale as long as producers don’t print any health claims on their labels. And this leniency was only decided upon following public outcry over the legality revelation.
Nevertheless, consumers and federal legislators have been putting pressure on the agency to fast track special regulations for the cannabinoid since hemp was first legalized. The FDA even said it would be expediting the process way back in 2019, although it has repeatedly noted that the agency is concerned that CBD could be harmful to children and may cause liver damage.
Now, a mere five years later (and notably following a significant decrease in consumer interest), it looks like the agency is finally ready to pull the trigger and set up some regulations.
Trzeciak said CBD products sold in corner stores and gas stations probably don’t meet safety standards set by the FDA for food and dietary supplements. She said without a proper regulatory framework for CBD, authorities are unable to inform the public about the ingredients that are in products and ensure that kids don’t get a hold of them.
“How can we ensure that the Agency knows if there are adverse events that are being reported—so we can identify those trends?” she said.
Trzeciak said the agency has a lot of experience setting regulatory boundaries for food products and it needs to collaborate with industry stakeholders and federal legislators to determine “where those lines need to be drawn in terms of the safety of the products.”
That means the agency might be considering a much more stringent framework than anticipated. It also means these might be the final days of the Wild West for CBD. Depending on how harshly the agency chooses to regulate, buying CBD over-the-counter might be a thing of the past soon.