FDA Is Inaccurately Using Incomplete Safety Data On CBD To Refuse Regulation, Says Hemp Non-Profit

The hemp industry’s national advocacy organization, the U.S. Hemp Roundtable is not pleased with the recent Food and Drug Administration's presentation of a potential CBD framework. The coalition's general counsel, Jonathan Miller, wrote to key congressional leaders notifying them that the FDA based its refusal to regulate CBD as a dietary supplement or food additive on inaccurate use of incomplete safety data. 

What happened: Last week, the administration held a virtual panel “A New Way Forward for Cannabidiol and Other Hemp Products” for stakeholders. The panel came some four months after the FDA stated that it will not regulate CBD as a food and dietary supplement ingredient and that it intends to collaborate with Congress to establish "safeguards and oversight to manage and minimize risks related to CBD products."

In summary, the FDA found “important safety concerns” with CBD’s potential to negatively affect the liver, and male reproductive system, and potential for drug interaction. It also restated that the ball is in Congress's court and that it's willing to collaborate. 

US Hemp Roundtable Responds 

Miller called out the FDA’s reliance on studies, such as one published in April, that use high-dose, pharmaceutical-grade CBD formulations, while ignoring the growing body of evidence demonstrating the safety of CBD at lower amounts, such as those typically found in CBD dietary supplements and foods sold at retail.

“There are multiple toxicity studies published between 2020 and 2023 demonstrating the safety of CBD at these lower amounts, as well as other studies we expect to be published soon,” Miller wrote. “Combined with the low number of adverse events associated with CBD products and real-world, observational data that also points to the safety of CBD, the totality of the evidence paints a much different picture than what is presented by the FDA.” 

In the letter addressed to the chairs and ranking members of the Senate HELP, Bernie Sander and Bill Cassidy, and House Energy & Commerce committees, Cathy McMorris Rodgers, and Frank Pallone, Miller wrote: “We are also concerned that CBD is being held to a much higher standard than other dietary supplement ingredients. The existing regulatory framework for dietary supplements is intended to ensure these products do not pose an unreasonable or significant risk of illness or injury, and includes the necessary risk management tools to achieve this purpose including mandatory GMPs, new dietary ingredient notification requirements, and mandatory serious adverse event reporting – contrary to the FDA’s claims that its current authorities ‘provide only limited tools for managing many of the risks associated with CBD products.’ “

Miller correctly pointed out that there are many other beneficial dietary supplements that pose high safety risks if taken at high doses, such as Vitamin D. “As Congress develops plans to ensure the regulation of hemp extracts such as CBD, it should focus its attention on how these products are typically used, and not be distracted by studies that imagine their gross over-consumption which is not a realistic concern,” Miller concluded. 

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