Lawmakers Push FDA to Regulate Cannabidiol as Dietary Supplement

Lawmakers and hemp advocates urged the Food and Drug Administration to promptly regulate cannabidiol products as dietary supplements under its existing authorities at a House subcommittee hearing Thursday.

CBD products currently can’t be sold or regulated as dietary supplements, given CBD’s inherent risk profile and the limited risk-management resources that exist under the food ingredient and dietary supplement pathways, according to the FDA.

The consumer safeguards in the Federal Food, Drug and Cosmetic Act would apply to CBD products if regulated as dietary supplements, including good manufacturing standards, adverse event reporting, strict labeling with warnings, and potential child-proof packaging requirements, advocates said.

Under the Controlled Substance Act, marijuana and delta-9-tetrahydrocannabinol (THC) are Schedule I substances, which are not approved for medical use and have a high potential for abuse. The US Agricultural Improvement Act of 2018 excluded hemp-derived CBD from the CSA, legalizing cannabis plants and derivatives containing up to 0.3 percent THC on a dry weight basis.

However, the law doesn’t address the explosion of a new, intoxicating compound, delta-8 THC, which is being sold unregulated, sometimes to minors.

“This could be fixed if the FDA regulated CBD as a dietary supplement. That would mean that the FDA would have enforcement authority to enforce labeling requirements and keep Americans safe and healthy,” said Rep. Lisa McClain (R-Mich.) during the hearing before the House Oversight’s Subcommittee on Health Care and Financial Services.

The FDA said in June that it intends to collaborate with Congress to devise a harm-reduction approach to potential regulatory pathways for CBD products to protect consumer safety. Such a framework would allow inhalable hemp products such as vapes to meet the definition of an FDA-regulated product type that receives FDA oversight.

However, some say a new regulatory regime for CBD products is “unnecessary and burdensome” as the agency could use the authority it already has to regulate CBD products as dietary supplements.

“We don’t think a new regulatory pathway is needed, but we would be happy to support additional regulatory safeguards above what’s currently under the law. But the FDA has not specified those in a way that’s allowed members of Congress to draft legislation to accommodate that,” said Jonathan Miller, general counsel of the U.S. Hemp Roundtable, a hemp business advocacy organization.

Rep. Morgan Griffith (R-Va.) and Rep. Angie Craig (D-Minn.) introduced the Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 (H.R. 1629) in March. The bill would require the FDA to regulate hemp-derived CBD as a dietary supplement, establishing labeling, dosage, and testing requirements to protect consumers in the currently unregulated market. Sen. Ron Wyden (D-Ore.) introduced a companion bill (S. 2451) on July 20.

Regulating CBD products through the existing food and dietary supplement regulatory pathway would not fully address safety concerns, because it wouldn’t cover inhaled or combusted products, limit contaminants, or provide labeling based on route of administration beyond food and supplements, said Gillian Schauer, executive director of Cannabis Regulators Association. The group’s members are regulators and representatives from relevant government offices.

While states are creating their own regulatory frameworks for hemp-derived CBD products to protect consumer safety, federal regulation is still needed to provide uniform oversight across states given the gaps created by interstate commerce and online sales, she added.

“We need a holistic regulatory approach that really accounts for what’s coming out of the plant,” Schauer said in an interview. “If we have too narrow a regulatory framework, it will leave gaps in regulation and those gaps will be exploited by people at the risk of consumer safety and public health.”

Meanwhile, the House Energy and Commerce Committee announced Thursday a bicameral Request for Information (RFI) about FDA regulation of CBD products. Comments are due to the committee Aug. 18.