Suing FDA over CBD would face procedural, substantive hurdlesPosted by On

The prospect of a lawsuit against FDA has grown after the agency rejected three citizen petitions that requested a pathway to market for CBD in dietary supplements, though some trade groups said their focus is on a legislative solution.

The petitions were filed in recent years by three trade associations, following FDA’s determination that CBD is excluded as a dietary supplement because it was first authorized for investigation as a new drug and the subject of substantial clinical trials made public.

Trade groups and litigation prospects

Dan Fabricant is president and CEO of the Natural Products Association (NPA), which filed a CBD citizen petition in February 2022 and sued FDA in December 2021 over a separate ingredient called N-acetyl-L-cysteine (NAC).

“We couldn’t be more disappointed [with FDA’s decision on CBD] and will look for relief with every branch of government and will need the help of our members to right the wrong,” Fabricant said in a Jan. 26, 2023 statement.

The Council for Responsible Nutrition (CRN) also criticized FDA’s response to its own CBD petition filed in June 2020. However, CRN is among the trade groups focusing their efforts on Capitol Hill. Craig Muckle, a spokesman for CRN, said his group is pursuing legislative options for CBD but not a lawsuit.

Meanwhile, U.S. Hemp Roundtable General Counsel Jonathan Miller said he had not heard members express interest in suing FDA.

“The lack of regulatory certainty has significantly…

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