CCSS Calls for FDA Action on CBD

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Washington, D.C.—The Collaborative for CBD Science and Safety (CCSS)—which provides a forum for industry, researchers, academia, healthcare practitioners, and regulators to exchange information and respond to policies and practices affecting cannabidiol (CBD) research, safety and quality—is calling on stakeholders to accelerate both research and the development of a federal regulatory framework for CBD and products that contain CBD.

A press release from CCSS notes that, since 2016, cannabis research funding has grown from $115 million to $189 million—an increase of nearly 65%. But, the group maintains, that is not enough to keep up with public demand for CBD-containing products, which have been projected surpass $20 billion in sales by 2024.

CCSS points out that a year has passed since the Food and Drug Administration (FDA)’s May 2019 public hearing on “Products Containing Cannabis or Cannabis-derived Compounds,” which aimed to assist the agency in gathering scientific data and related quality, marketing and labeling information for CBD and related products for the purposes of developing a robust regulatory framework. By reopening the public docket and “extending it indefinitely,” CCSS says, “FDA signaled that regulatory oversight and continued evaluation remain stymied by the dearth of existing scientific data and information on cannabis or cannabis-derived compounds.”

Related: CBD Public Hearing: “FDA Does Not Have the Luxury Of Time” (May 2019)
FDA Reopens Comment Period for CBD Hearing (March 2020)

“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. “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.”

The release points out that FDA’s actions against illegal actors have spiked over the last 12 months, and the Agency has issued 30 CBD-specific warning letters since the public hearing, which is a 50% increase compared to pre-hearing statistics going back to 2015. While CCSS says these are important steps, it stresses that “more needs to be accomplished to protect public health and safety and remain on par with other national regulatory bodies, such as the United Kingdom, Sweden and Australia, addressing CBD
for their consumers.” Looking to the future, CCSS would like to see the FDA “continue its effort to drive evidence-based decision making such that the regulatory environment shifts away from warning letters and towards promotion of safe, high-quality products on the market.”

Steve Mister, President & CEO of the Council for Responsible Nutrition (CRN) and CCSS Steering Committee Member, added, “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. 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.”

Related: NPA Invites FDA to Brief Industry on CBD Regulatory Process, Progress
CBD – When it stands for Cannot Be Denied

 

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