CCSS urges stakeholders to accelerate CBD research, and FDA to develop regulatory pathway

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The Collaborative for CBD Science and Safety (CCSS; Washington, DC) is calling on industry, researchers, academia, healthcare practitioners, and regulators to accelerate research and the development of an appropriate federal regulatory framework for cannabidiol (CBD) and CBD-containing products. One year after the May 2019 U.S. Food and Drug Administration (FDA) public hearing on “Products Containing Cannabis or Cannabis-derived Compounds,” the public docket has been extended indefinitely, signaling that regulatory oversight and continued evaluation remain stymied by the lack of existing scientific data.

“We must ensure consumers can trust the safety and quality of CBD-containing products and can rely on the product’s claims where appropriate,” said Sally Greenberg, executive director of the National Consumers League and CCSS Steering Committee Member, in a press release. “The importance of a separate regulatory pathway for CBD-containing products is underscored by the current spread of the coronavirus and the false, dangerous claims and misinformation about CBD that have accompanied the pandemic. In all cases, consumers remain at risk. FDA must continue to take action towards developing a regulatory pathway for CBD and begin mitigating threats posed by poor-quality products.”

Since 2016, there has been a nearly 65% increase in cannabis research funding, from $115 million to $189 million, but that amount remains insufficient to keep up with public demand for CBD-containing products, says CCSS. In the last year, since the public hearing, FDA issued 30 CBD-specific warning letters, which is a 50% increase compared to pre-hearing statistics going back to 2015. Clearly, more work needs to be done to protect public health and safety to be on par with other national regulatory bodies such as the UK, Sweden, and Australia.

“FDA has adopted a cautious approach to addressing the use of CBD in dietary supplements – it still does not consider CBD a legal dietary ingredient, nor recognize it to be ‘generally recognized as safe,’ or GRAS in food,” noted Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC) and CCSS Steering Committee member, in a press release. “FDA should continue to advance efforts that address the research gaps it has identified around CBD and establish a clear evidence-based path forward for their regulation of CBD-containing products as they are already widespread on pharmacy, grocery and convenience store shelves nationwide absent of a federal regulatory framework.”