On Tuesday, members of the U.S. Senate’s Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies backed legislation penned by Senate Majority Leader Mitch McConnell, which aims to urge the FDA to adopt a lenient framework for hemp-derived CBD products.
The move is a response to the regulatory landscape unfurled by the 2018 Farm Bill, which removed hemp from the Controlled Substances Act, but preserved the FDA’s authority over CBD under the Federal Food, Drug and Cosmetic Act. Currently, the FDA maintains that food additives and dietary supplements containing CBD are illegal because the cannabinoid is the active ingredient in the epilepsy drug, Epidiolex.
As a means to lift the business obstacles posed by the FDA’s current guidance, Senator McConnell (R-KY) introduced language on the 2020 Agriculture Appropriations Bill, which would require the FDA to:
• provide Congress with a report outlining its efforts to develop an “enforcement discretion policy” on hemp CBD within 90 days
• issue its formal enforcement discretion policy on hemp CBD within 120 days
• keep the enforcement discretion policy in effect “until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product.”
McConnell’s efforts are in line with those of Representatives James Comer (R-KY) and Chellie Pingree (D-ME), who asked all members of the House of Representatives to co-sign a letter urging the FDA’s Acting Commissioner to issue a formal “enforcement discretion policy” on hemp CBD products. According to the Representatives, such a policy would enable the authorities to target “bad actors, while eliminating uncertainty for responsible industry stakeholders and consumers.”
In their missive, Comer and Pingree note that the FDA has taken steps towards establishing a legal pathway for the production and sale of hemp-derived products, including holding a public hearing earlier this year and creating a Cannabis Working Group. However, the agency has indicated that a formal rulemaking process could take three to five years to complete. For Comer and Pingree, this projected timeline is “untenable, especially in light of the fact that the Department of Agriculture (USDA) is expected to greenlight the legal production of industrial hemp for the 2020 crop year any day now.”
The primary policy challenge facing the hemp-derived CBD industry, the lawmakers add, “is guidance issued by FDA, opining that it is illegal for CBD to be introduced into interstate commerce as a food additive or dietary supplement.” Therefore, they also request that the FDA issues an “interim final rule” to regulate CBD as a dietary supplement and food additive. Though the FDA classifies CBD as a drug, Comer and Pingree argue, the agency “has the authority to also classify lower doses as a food additive or dietary supplement.” A “two-track regulatory approach,” they add, “could enable lower dosed products with limited health risks to enter the market as a dietary supplement, while requiring higher dosages in drugs, such as Epidiolex, to be prescribed by medical professionals.”
In an interview with Cannabis Wire, Jonathan Miller, General Counsel to the US Hemp Roundtable—which supports both efforts in Congress—said that the trade association worked closely with Senator McConnell to craft changes that can “help lift the cloud” cast by the FDA guidance.
On Tuesday, the U.S. Senate’s Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies carried out a markup of the 2020 Agriculture Appropriations Bill. During the meeting, Senator Jeff Merkley (D-OR) noted that, “this year in Oregon, the hemp industry may well be a billion dollar crop.” This, he told Cannabis Wire, “is an incredible addition to income for our agricultural community.”
With the subcommittee’s support, the bill now moves forward and will be considered by the full committee on Appropriations on Thursday.
