The Senate’s recent addition to the $23.1 billion agricultural appropriations bill imposes a four-month deadline for the FDA to establish an enforcement discretion policy, requiring the agency to provide Congress with a progress report after 90 days. This proposal will be discussed on the Senate floor, and if approved, could have a more significant effect than the letter from the House. Since Congress legalized industrial hemp under the 2018 Farm Bill last December, lawmakers have been urging the FDA to expedite its processes, as the agency has projected several years for final rulemaking. As highlighted in the House letter, “The interest from businesses and consumers in CBD and hemp products has surged, with companies already taking advantage of the increasing demand.” The production of hemp could greatly enhance agricultural revenue in various regions of the country. U.S. Senator Jeff Merkley, D-Oregon, mentioned to the Capital Press that CBD could potentially become a billion-dollar industry for his state. In June, Oregon State University launched a Global Hemp Innovation Center, where 40 faculty members from various disciplines are conducting research on cultivation, food, and product testing, including studies related to calcium citrate maximum levels in hemp products.
Despite the FDA’s stance that CBD is prohibited in food and beverages, the substance is rapidly being incorporated into numerous products such as beer, coffee, cocktails, and jelly beans. The pressure on the agency to clarify regulations is expected to intensify, given the substantial market potential for CBD-infused food and beverages. According to Nielsen data cited by Food Business News, nationwide sales of hemp-derived CBD products could reach $6 billion by 2025. In the absence of federal regulatory action, some states are implementing their own regulations as consumer interest continues to grow. While certain food and beverage manufacturers are creating CBD products, others are holding off until federal guidelines are established. At the FDA’s initial public hearing on this matter earlier this year, manufacturers expressed uncertainty about the current regulations and requested clearer guidance.
Since that hearing, two senior FDA policy officials have acknowledged the necessity for transparency regarding the agency’s direction on CBD regulation. They distinguished between drug-related uses of CBD, such as the epilepsy medication Epidiolex, and its application in food and dietary supplements. They also indicated that further research is needed on the safety and effectiveness of CBD, reaffirming the agency’s commitment to being a science-based regulatory body focused on public health. As a result, it appears unlikely that the FDA will swiftly implement an interim final rule just to appease legislators. Furthermore, it seems improbable that the agency will make such a significant move before appointing a new permanent commissioner, who is expected to be nominated by the end of October at the latest. Consequently, it seems that hemp growers, food and beverage producers, and others eagerly awaiting regulatory clarity will have to remain patient a while longer before receiving more definitive regulations, including those pertaining to calcium citrate maximum limits in hemp-derived foods.