FDA Looking for ‘Alternative Approaches’ to CBD Regulation

FDA Commissioner Scott Gottlieb said that the FDA is looking at “possible alternative approaches” to CBD regulation on Tuesday. The commissioner reiterated that the agency has oversight of hemp and its derivatives according to the 2018 Farm bill. However, the agency wants to talk with “stakeholders” and Congress about creating a regulatory framework for CBD products. At the same time, he said it might take time, which may worry hemp producers and consumers alike.

FDA Commissioner Says Agency Exploring ‘Alternative Approaches’ to CBD Regulation

At a conference for the National Association of State Departments of Agriculture on Tuesday, FDA Commissioner Scott Gottlieb said the agency is investigating “possible alternative approaches” to regulating CBD.

Recently, the state departments of agriculture and health in Maine, New York City, and Ohio have banned the sale of CBD products, citing FDA regulations as the source of the bans.

In his speech, Gottlieb reminded his audience that while the 2018 Farm Bill legalized hemp, it also retained the FDA’s authority to oversee products containing cannabis and its derivatives.

“We’re concerned when products not approved by the FDA make unproven claims of therapeutic benefit. Marketing unproven treatments raises public health concerns, because it could keep patients from accessing approved therapies to treat serious diseases. We’ll continue to warn consumers and take enforcement action to protect public health,” said Gottlieb.

Currently, the FDA prohibits the interstate commerce and marketing of food products and dietary supplements that contain CBD.

However, Gottlieb said the agency was “interested” in talking with stakeholders and Congress about creating a legal pathway for CBD in food products and dietary supplements.

In response to the CBD bans in various states, a bipartisan group of Congress members sent the FDA commissioner a letter last week asking if the FDA was creating such a pathway for CBD food products and dietary supplements. The Oregon senators from Congress also asked the FDA in January to revise its “outdated” regulations on CBD.

The commissioner’s speech may be a response to these letters.

Gottlieb later added in his speech, “it’s important to note that CBD isn’t risk free. There are potential risks associated with its use.”

He did not specify what those risks may be.

Gottlieb also said that the process of collecting information about CBD “could take time,” which likely has hemp producers and consumers worried.

The letters from Congress members called for “swift” action to clear up the confusion for both parties.

The commissioner finished by reminding companies they “could seek approval from the FDA to market human or animal drugs derived from cannabis.”

He cited Epidiolex as one such FDA-approved, CBD-based medication.

h/t Marijuana Moment