President’s Budget Contains Funding for CBD Regulation and Proposal to Create a Separate Tobacco Agency

The President’s Budget, released on Feb. 10, 2020, is intended to signal the direction of the Administration’s legislative and regulatory agenda for the coming year. There are two provisions in the budget request related to issues in which CDA is engaged.

First, the explanation of the budget contains $5 million for regulation of CBD at the U.S. Food and Drug Administration (FDA). The agency requests this funding for enforcement and regulation of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives. It goes on to say that the funding will support development of policy, and will be allocated to the FDA to continue to perform its existing regulatory responsibilities, including review of product applications, inspections, enforcement and targeted research.

Additionally, the budget proposes to move tobacco regulation away from the FDA's Center for Tobacco Products (CTP) and under a new stand-alone agency under Health & Human Services (HHS). The agency would be led by a Senate-confirmed political appointee and would have responsibility for all aspects of tobacco regulation. The Budget says, “(a) new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity of new tobacco products. In addition, this reorganization would allow the FDA Commissioner to focus on its traditional mission of ensuring the safety of the Nation’s food and medical products supply.” In order for this to be implemented, not only would Congress have to approve the Budget, but would also have to amend the Tobacco Controls Act in order to set up this new agency - a move that has been universally panned by the public health community.