U.S. Sen. Ron Wyden (D-OR) has introduced a bill aiming to build frameworks for regulating hemp-derived cannabidiol (CBD) as a food additive and dietary supplement.
The Hemp Access and Consumer Safety Act (S.2451) represents another attempt by lawmakers to regulate CBD in food and dietary supplements since the FDA announced in January it would not pursue its own rulemaking around the issue. Instead, the agency called for a “new regulatory pathway,” adding it would work with Congress to balance CBD access with regulatory oversight.
“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back,” Wyden said. “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”
Wyden’s bill seeks to amend the federal Food, Drug and Cosmetic Act by including “other than hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” in a clause that prohibits incorporating substances that have been approved as new drugs in dietary supplements.
Additionally, the bill aims to exempt hemp and hemp-derived ingredients, including CBD, from a section of the act that prohibits adding approved drugs to food intended for interstate commerce.
In addition to the potential for long-term health effects, the FDA has taken issue with using CBD in food and dietary supplements since the drug Epidiolex uses high doses of CBD to treat certain seizure disorders.
The bill would also allow the Secretary of Health and Human Services to establish labeling and packaging requirements for dietary supplements and food containing hemp or hemp-derived ingredients.
The U.S. Hemp Roundtable endorsed the bill, calling it a “crucial piece of legislation that addresses the pressing need for FDA regulation of CBD.”
"This bill provides a much needed pathway for FDA to establish a clear and consistent framework for the production, marketing and sale of hemp-derived CBD to ensure consumer safety while fostering a thriving, regulated market,” said Jonathan Miller, general counsel of the U.S. Hemp Roundtable. “We look forward to supporting his efforts and appreciate his longtime commitment to unlocking the full potential of the hemp industry.”
This bill follows the March reintroduction of two bills in the U.S. House of Representatives that seek to regulate CBD in food and dietary supplements. The bills, originally introduced in 2021, have been referred to the House’s Health subcommittee, but no action has been taken since.