In a new report sent to Congress this week, the U.S. Food and Drug Administration (FDA) said that it is still working out its policy regarding the use of CBD in dietary supplements.
CBD or cannabidiol was legalized in the U.S. via the 2018 Farm Bill. However, due to a lack of research on the non-psychoactive compound found in cannabis plants, the agency has been unwilling to greenlight products containing it.
Still, pressure has been mounting on the agency to issue guidance on the use of CBD as a dietary supplement.
In January, House Agriculture Committee Chairman Collin Peterson filed a bill to address the gridlock facing CBD manufacturers and consumers waiting for the FDA’s approval to safely enjoy products containing the ingredient.
The bipartisan bill would have allowed the FDA to “regulate CBD that comes from hemp as a dietary supplement, providing a pathway forward for hemp-derived products,” while the compound would still remain illegal in conventional food products.
Now, after missing last month’s deadline for submitting a report on its progress regarding CBD, the agency said that it is still evaluating its policy as it continues to gather information.
“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions,” the FDA wrote to lawmakers.
“Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway,” says in the letter.
The FDA previously warned companies about making unsubstantiated claims regarding their CBD products in December. FDA officials have also acknowledged their inability to acquire sufficient research as CBD was still illegal up until 14 months ago.
The regulator underlined this fact in its new report once again, writing that “limited systematic data exist to inform our approach.”
“As more data on CBD become available, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches.”
But as the FDA still works on tackling this complex issue, the agency did certify one over-the-counter topical drug containing CBD in January.
Elixicure’s CBD-based pain drug is the first to have been certified by the FDA, and remains the only for the time being.