FDA Will Hold April Meeting to Discuss CBD Product Regulation

02/28/2019
The FDA headquarters sign

SILVER SPRING, Md. — The Food and Drug Administration (FDA) is putting cannabidiol (CBD) products on its agenda.

In testimony during a House Appropriations Subcommittee hearing on Feb. 27, FDA Commissioner Scott Gottlieb said the agency will meet in April to explore new pathways for hemp-derived CBD to be sold legally in the food and supplement markets, while protecting research into future pharmaceutical applications.

Cowen & Co. reported the meeting in an analyst note.

The meeting comes on the heels of the passage of the 2018 Farm Bill in December. The legislation declassifies industrial hemp as a Schedule I substance, but it does not change the FDA’s oversight authority over CBD products, according to Cowen & Co.

At the time, Gottlieb said the FDA will continue to step in when certain health claims are made. Additionally, since there is now an FDA-approved drug with CBD as an active ingredient, current law stipulates that CBD can’t be added to food products sold across state lines or marketed as a dietary supplement, the firm noted.

According to Cowen, some states like California have chosen to follow FDA’s stance banning hemp-derived CBD in food and dietary supplements — even though recreational cannabis is legal in California. Other states like New York initially said they would allow CBD to be sold as a dietary supplement, but have since taken a more aggressive stance on CBD added to foods.

On Jan. 15, U.S. Sens. Ron Wyden (D-Ore.) and Jeff Merkley (D-Ore.) sent a letter to the FDA urging the agency to update federal regulations governing the use and interstate sale of certain hemp-derived ingredients in food, beverages or dietary supplements.

The two senators, who authored the 2018 Farm Bill’s Hemp Farming Act provision, indicated that it was “Congress’ intent to ensure that both U.S. producers and consumers have access to a full range of hemp-derived products, including hemp-derived cannabinoids.”

They requested feedback from FDA within 30 days on the agency’s specific plans regarding implementation of the 2018 Farm Bill, Cowen & Co. reported.

“In our view, Gottlieb’s statement and testimony indicate that he is willing to take a flexible regulatory approach to foster the development of hemp products such as CBD. However, those actions will have to fit under the confines of current law and further legislation may be needed,” Cowen & Co. analysts Eric Assaraf and Vivien Azer wrote in the joint note.

“We continue to believe there will be a period of regulatory uncertainty over CBD products at the state and federal level for at least the next six months to a year,” they added.

1 comment so far ↓

#1 Tom on 05.11.19 at 1:18 AM

This will be interesting to see how the FDA protects the pharmaceutical companies.

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