Sylvester Comments on FDA Warning Over CBD

27 November 2019 Food Navigator-USA News

Special Counsel Brian Sylvester was quoted in a FoodNavigator-USA article, “The FDA issues a stern warning on CBD…but does it signal a change in approach?” about the recent wave of FDA warning letters issued to 15 CBD companies targeting products ranging from oils and dietary supplements to food (including gummies and water). A key question is whether the recent warning letters indicate a shift in FDA’s enforcement posture. 

In a recent interview with Food Navigator-USA, Sylvester commented that “practically speaking” the recent wave of FDA warning letters do not signal a change in FDA’s enforcement posture. He explained that the warning letters all targeted CBD companies making claims that purport to prevent, diagnose, mitigate, treat or cure serious diseases. Such claims are only authorized for drugs.  Thus, in Sylvester’s view, the warning letters simply re-emphasize the Agency’s longstanding position that “it is currently unlawful to add CBD to food or dietary supplements.”

FDA concurrently published a revised Consumer Update detailing safety concerns about CBD products more broadly. In the Consumer Update, FDA states that it is investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC). In a press release, FDA noted that it could not currently deem CBD to be “Generally Recognized as Safe”. When asked by Food Navigator-USA whether that pronouncement effectively closed off the GRAS pathway for CBD, Sylvester said, “Not exactly. FDA simply stated that it is not currently aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. It’s not inconceivable that, in the future, data could be brought to bear before the FDA to support GRAS status.”

 

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