Earlier this week, as part of the Senate Appropriations Agriculture Subcommittee meeting, Senator Mitch McConnell (KY) submitted language concerning hemp-derived products and the FDA’s lingering uncertainty concerning the same as a potential proposal to be included as part of forthcoming budgetary legislation. The forthcoming proposed budget provides $2 million to the FDA for research, policy evaluation, issuance of an enforcement discretion policy, and regulation development for hemp-derived CBD products. As part of that appropriation to FDA, McConnell’s language seeks to more firmly establish FDA’s long-practiced enforcement discretion, which FDA has continually utilized for the past several years. To date, FDA’s enforcement discretion has targeted companies making disease claims regarding their products.
While the report language would not have the force of law, if it is included in the Committee’s report, it would move the needle in the right direction when it comes to hemp-derived products and federal direction. A formal, written enforcement discretion policy from FDA within 120 days after budget adoption would provide some clearer guidance for companies regarding FDA’s CBD priorities. Perhaps even more importantly, with several state-level agencies across the country citing FDA’s position as a reason to adversely treat hemp-derived products at the state level, such a formal policy could compel many states to walk back their adverse treatment of such products. Such a formalized FDA policy is at least some needed progress during a time when the nation anxiously awaits FDA to complete its long, drawn out process of developing hemp-derived CBD regulations. How long that will take is a popular question these days, but expect a few years for robust regulation given FDA’s track record.