President Trump’s budget proposal for the 2021 fiscal year, which is set to be presented to Congress next year, should he gain re-election, includes $6.2 billion in overall funding for the Food and Drug Administration (“FDA”). This proposal includes a $5 million-line item for FDA to continue enforcement actions as well as to develop regulatory pathways for cannabis and its derivatives, including CBD.1The budget request states that the new funding will, “enable FDA to continue regulating the usage of cannabis-derived substances, such as CBD, in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives.”2 The proposal further details boosting regulatory activities, including creating policy, reviewing product applications, inspections, enforcement, and targeted research.
The $5 million is a mere 0.0807% of the overall FDA budget, and is proposed to be distributed across four FDA departments – $2 million to the Office of Regulatory Affairs (“ORA”), $2 million to the Center for Food Safety and Applied Nutrition (“CFSAN”), $500,000 to FDA Headquarters (“FDA HQ”), and $500,000 to the Center for Veterinary Medicine (“CVM”). The budget emphasizes the necessity for the integrated efforts of the departments across various FDA initiatives and provides a snapshot of the totals for overlapping responsibilities. FDA calculates that $1,088,881,000 is proposed for the combined efforts of CFSAN and ORA across the agency. $4 million of this amount is dedicated to the regulation of CBD, while “no less than $15 million” is proposed to be dedicated to inspections of foreign seafood manufacturers and field examinations of imported seafood. The funds that are proposed to be allocated to CFSAN and ORA for CBD equates to approximately 26% of what is suggested to be spent on foreign seafood inspection. Further, when evaluating the overall CVM budget request of $237,741,000, the $500,000 requested for CBD is about 0.002% of this total.
No matter how you crunch the numbers, given the dollar amounts allocated to other matters, it is clear that the requested budget to deal with CBD is far from sufficient. The CBD industry is a novel and largely unregulated industry, deserving of dedicated time and efforts for well-crafted regulatory structures and policies in order to avoid miscommunications to consumers, misunderstandings in enforcement actions, and heavy burdens for industry. Steve Mister, President and CEO of the Council for Responsible Nutrition, stressed that the $5 million budget request is much welcomed, but is not enough and comes more than a year late. “The time to act was a year ago when the Farm Bill went into effect,” Steve commented. “In the meantime, there is a price for FDA’s inaction.”
Some organizations are upset by the $5 million budget, but they are far more concerned with the language and aim of the funds in the proposal. “The President’s budget request suggests that FDA will continue to regulate the use of CBD-containing products. The language uses the phrase ‘continue to support’ and ‘continue to regulate’ throughout, but this misses the mark. Enforcing on label claims alone does not go far enough. Instead, we encourage the FDA to use this new funding to move on to the next phase of enforcement and establish a safe level or threshold of CBD,” said Daniel Fabricant, President and CEO of the Natural Products Association (“NPA”). This lack of guidance in the U.S. is especially uncalled for as countries around the world begin to develop regulatory structures at a pace that makes more sense for the movement of the market. Across the pond, the Chief Executive of the UK Food Standards Agency (“FSA”) recently recognized a daily limit of 70mg of CBD for healthy adults, advising vulnerable populations to steer clear of the substance completely. This decision was based on the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment’s (“COT”) scoping paper on the potential adverse effects of CBD products. This paper is not meant to be finalized research, but an overview of a topic COT is planning to research in more detail. This sort of acknowledgement and progression is exactly what U.S. industry and consumers need to move forward confidently in the world of producing and consuming CBD products.
So, is the $5 million budget proposal enough? Are the funds directed to the right departments? Does FDA realize the urgency of policies, research, and a regulatory structure? Does FDA truly believe they are doing enough? These are all questions the CBD industry continues to ask as the U.S. government continues to brush aside one of its most rapidly developing industries. In our opinion, the answer is a resounding “NO.”
1 https://www.fda.gov/media/135078/download at 13.