FDA to Clear a Path Within Four Months To Lawfully Market Hemp-Derived CBD Products

26 Sep FDA to Clear a Path Within Four Months To Lawfully Market Hemp-Derived CBD Products

Back in March, former Food and Drug Administration (“FDA”) Commission, Scott Gottlieb, explained it would take several years for the agency to come up with rules that would legalize the use of hemp-derived cannabidiol (Hemp-CBD) in food products, unless Congress stepped in.

Last week, both chambers showed they are not interested in waiting around for the FDA to go through the traditional rulemaking process and pressured the agency to proceed with the federal legalization of these products.

House of Representatives

Last Thursday, a collation of twenty-six House members sent a letter to the FDA, urging the agency to develop a path for the lawful marketing of Hemp-CBD products.

The letter provides that while lawmakers appreciate the FDA’s “proactive approach” towards pursuing a legal pathway for the production and sale of Hemp-CBD products, the agency’s current regulatory posture on the matter has created significant regulatory and legal uncertainty for stakeholders.

Specifically, the signatories explained that:

Given the widespread availability of unregulated CBD products, growing consumer demand, and the expected surge in hemp farming in the near future, we believe that FDA must quickly act to provide legal clarity and to establish a regulatory framework that supports this exciting new opportunity.”

Moreover, the lawmakers are hoping that regulatory certainty will provide stakeholders access to banking services and open up new economic opportunities for the industry while at the same time protect consumers.

Lastly, the House members pressed the FDA to consider issuing an interim final rule to establish clear regulatory framework for Hemp-CBD as a dietary supplement and food additive and asked the agency to clarify that while it is developing its rules it is limiting its enforcement discretion towards CBD companies that are making egregious medical claims about their products.

Senate

On the same day the coalition’s letter went out to the agency, Senate Majority Leader Mitch McConnell convinced the Senate Appropriations Committee to incorporate provisions into an agriculture spending bill that directs the FDA to issue enforcement guidelines for Hemp-CBD products.

The spending reports mandates the FDA to clear a path for the lawful marketing of these products within 120 days. This “policy of enforcement discretion” towards CBD products is believed to clarify rules so banks will provide banking services to CBD companies.

According to the language of the provisions, the FDA would be required to submit a report to the Senate Appropriations Committee within 90 days, detailing its “progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products.”

Once approved, these provisional guidelines would remain in effect until the agency finalizes the regulatory process to enable Hemp-CBD manufacturers to share safety data through existing FDA notification procedures to be fully compliant with federal law and policy.

Overall, both of these effort by U.S. lawmakers show promise in soon forging a path for the lawful sale and marketing of Hemp-CBD products. In pressuring the FDA, both houses acknowledge that the limitations on the marketability of Hemp-CBD has been an ongoing source of frustration that must come to an end to enable the crop and its derived products to meet their economic potential.