Two members of Congress on Friday introduced a bill that would create a legal pathway for marketers of hemp-based CBD in dietary supplements, eliminating a monstrous hurdle that has stymied the sector’s growth in recent years.
The legislation would create an exception to a current provision in the law, which bars an article like CBD from being marketed in a dietary supplement if it was first the subject of substantial clinical investigations instituted and made public.
Under the bill, CBD and other ingredients from hemp would become lawful for use in supplements if the products comply with current legal requirements for new dietary ingredients, as well as all other requirements applicable to dietary supplements under federal law.
Subject to meeting the above provisions, hemp-based CBD would be lawful for use in a dietary supplement beginning 90 days after the legislation took effect.
“Enabling CBD to be lawfully marketed as dietary supplements and mandating that manufacturers comply with the entire existing regulatory framework for dietary supplements, would create immense confidence in hemp and CBD products, and would provide great opportunity for hemp farmers across the nation,” Jonathan Miller, general counsel to the U.S. Hemp Roundtable, a coalition of companies and organizations, said in a press release.
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 was introduced by Reps. Kurt Schrader, Democrat of Oregon, and Morgan Griffith, Republican of Virginia. Griffith and Schrader both sit on the House Committee on Energy and Commerce, which has jurisdiction over FDA.
“Hemp was historically an important crop for Virginia farmers, and dietary supplements made from it do not possess dangerous addictive qualities,” Griffith said in an emailed statement through a spokesperson. “Nevertheless, the current state of regulation creates confusion about its legal uses. I joined this bipartisan bill to provide certainty for hemp farmers that their crop may find legal uses.”
Schrader hails from the same state as Sen. Ron Wyden, a Democrat who also has been a supporter of the hemp industry and recently expressed hope that FDA would release a sensible CBD guidance related to a policy of enforcement discretion.
In a joint press release, four dietary supplement trade groups applauded introduction of the bill in the House of Representatives. The release was issued by the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN) and United Natural Products Alliance (UNPA).
“While the 2018 Farm Bill changed the law to allow hemp farming, regulatory uncertainty remains about the inclusion of hemp and hemp-derived CBD in dietary supplements,” the groups stated. “This lack of regulatory clarity along with insufficient oversight around hemp and hemp-derived CBD exposes consumers to potentially unsafe products and lack of consistency in product quality.”
On May 31, 2019, FDA held a public meeting on cannabis-derived compounds largely devoted to CBD. While FDA has been exploring whether to issue regulations for the CBD market, the hemp and dietary supplement industries have grown inpatient with the lack of a national regulatory framework.
“Over one year has passed since FDA held its public meeting to better understand hemp-derived substances, and almost two years have passed since the Farm Bill was enacted, legalizing hemp-derived CBD,” said Julia Gustafson, vice president of government relations with CRN, in a separate news release. “During this time, the agency has taken no action to legalize this ingredient, facilitating an unregulated marketplace. CRN urges Congress to pass this critical legislation and open the marketplace to CBD dietary supplements, providing FDA enforcement authority over the category to assure consumers have access to safe and beneficial products to support their health and wellness.”