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FDA to issue ‘discretion policy,’ interim rule on CBD in dietary supplements

U.S. Sen. Ron Wyden on Tuesday urged top federal health officials to announce a “formal enforcement discretion policy” by Aug. 1 regarding CBD as a food additive or dietary ingredient in supplements.

Without such a policy, “hemp producers and their customers will continue to be left in a regulatory gray zone,” Wyden, a Democrat from Oregon, wrote to the leaders of FDA and the U.S. Department of Health and Human Services (HHS).

In a letter to HHS Secretary Alex Azar and FDA Acting Commissioner Ned Sharpless, M.D., Wyden also urged FDA to publish an interim final rule to ensure CBD can be lawfully sold in food and dietary supplements, pending the agency’s publication of a final rule.

Congress in 2018 removed hemp from the federal Controlled Substances Act (CSA), but lawmakers preserved FDA’s authority to regulate cannabis-derived products.

FDA has maintained CBD cannot be lawfully added to conventional food or marketed as a dietary supplement because essentially the compound was first studied as a drug. The agency, however, has authority to create an exception, and it hosted an all-day public hearing May 31 to examine issues around its regulation of cannabis-derived products.

Wyden characterized as “fully unacceptable” a suggestion by FDA that publishing a final rule authorizing the use of hemp-derived CBD in dietary supplements could take three to five years.

“The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,” the senator wrote.

Wyden also urged FDA to streamline the process for reviewing safety-related notifications for hemp-derived CBD ingredients and dedicate staff to the process.

“I feel strongly the FDA must undertake a process to make lawful a safe level for conventional foods and dietary supplements containing hemp-derived CBD,” Wyden said.

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