FDA Public Meeting on Hemp Oil Comes at Time of Regulatory Uncertainty

ANCOR is sharing this article by Politico Pro as an update on this article from April. Questions over the use of cannabidiol (CBD) have started to cross over into disability supports, leading to providers’ confusion of how to operate between different federal and state frameworks. A summary of the ten hour plus FDA hearing, which has now occurred, can be found here and here.

As shared by Politico Pro:

“The FDA will attempt a step toward clarity on CBD, or cannabidiol, with what’s expected to be an exceptionally well attended public meeting on Friday. It will address whether CBD oil and other edible versions are food or medicine; and look at their known and suspected risks and benefits in various forms or combinations, according to Deputy Commissioner Amy Abernethy. Attendees hope to learn what the FDA’s next steps will be and how long they will take.

The confusion dates back to December when Congress’s farm bill threw a curve ball at regulators and state officials. It legalized hemp production nationwide, and with it the plant’s most profitable byproduct, the non-intoxicating drug cannibidiol. The chemical also is found in marijuana, which is still banned under federal law, though plentiful in 33 states that have legalized it for either medical or recreational use.

The FDA has reminded Congress that there was already one approved product containing CBD — a prescription drug for two specific forms of childhood epilepsy — but that it needed at least a year to make federal rules that reflected the oil’s safety and effectiveness, as a medical product or a low-dose additive for foods, ranging from lattes to waffles.

In the meantime, states are working on their own rules to handle the growing number of farmers and retailers hoping to cash in on CBD. It’s already a $1.5 billion market, and it should expand to $16 billion by 2025, according to Cowen analyst Vivien Azer.

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The Department of Agriculture, which would regulate hemp production itself, has promised to issue a framework this year. Other agencies, from the Drug Enforcement Administration to the Department of Transportation, have been thrust into the debate as states take aggressive steps to confiscate supplies or stop hemp-carting 18-wheelers from traveling across borders.

[…]

A coalition of multistate CBD manufacturers will make the case at the meeting that states have already laid the groundwork for CBD regulation. They have pathways for approving cannabis producers and retailers and in some cases are even requiring bar codes that allow tracking of products.

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But only 33 states have legalized marijuana in some form, and not all have built those frameworks that can translate to CBD.”