Special Counsel Brian Sylvester was quoted in the Food Navigator article, “FDA says it’s made ‘substantial progress’ on CBD regs; CV Sciences weighs in on food vs pharma path; man sues CBD firm after failing drug test,” which provided a round up of hot legal and regulatory topics facing the CBD industry.
Sylvester discussed several topics with Food Navigator including the need for the FDA to define a regulatory pathway for CBD in non-drug products. “Back in March, FDA acknowledged increased interest in drug development from CBD, and asked manufacturers and other stakeholders to submit information on processes for deriving full and broad hemp extracts, and on how those extracts’ contents compare to CBD isolates,” he said.
The key will be “for FDA to define a suitable regulatory pathway for use of CBD in non-drug products that would not impede its continued development in pharmaceutical applications.”
Sylvester also discussed with Food Navigator a recent lawsuit in Missouri where an individual claimed he failed a drug test test and lost his job after he consumed CBD oil drops. While the lawsuit provides scant details about the individual’s consumption and the product, Sylvester said it highlights the challenges that businesses face operating in the CBD space. Sylvester noted that businesses have been sued for claims ranging from dosage levels to selling illegal ingredients.
“For CBD products that may contain trace levels of THC, and in the interest of defending against such challenges, manufacturers could do well to consider adding disclaimers to the potential presence of trace levels of THC,” Sylvester said “Of course, if CBD manufacturers opt to add a ‘THC free’ claim to product labels and advertising, they should have adequate documentation to back it up.”