It does not, however, make the argument that its full spectrum hemp extracts are legal dietary ingredients because they are a different article to the isolated CBD used in drug trials, a case recently made by supplement brand Diamond CBD and something CV Sciences execs have argued in other settings (notably the May 2019 FDA hearing).
Instead, CV Sciences focuses on more basic legal arguments, arguing first and foremost that federal pre-emption applies: “Plaintiffs cannot escape the preemptive effect of the Food, Drug and Cosmetic Act.
“Their claims arise solely from the alleged failure of the product to meet the Act’s statutory definition of a Dietary Supplement… As a result, all of the state law claims Plaintiffs assert here are preempted.”
Moreover, its attorneys note: “Neither plaintiff was harmed by the product, nor did the product’s label misrepresent its actual contents; plaintiffs paid for a CBD product and received exactly that product… Plaintiffs [also] lack standing to seek injunctive relief. Therefore, any claim that seeks such a remedy must be dismissed as a jurisdictional matter.”
‘Until the agency establishes the rules that will govern CBD products, the court should stay this litigation’
Finally, echoing arguments made by multiple CBD firms hit with lawsuits, they say the case should be stayed (put on hold) on primary jurisdiction grounds given that the FDA is actively considering how to regulate the CBD marketplace (ie. it would be unwise for courts to make local determinations now as the relevant federal agency is poised to act).
“Until the agency establishes the rules that will govern CBD products, the court should stay this litigation… While Plaintiffs allege that the FDA has sent warning letters to companies selling CBD products about labels pertaining to the designation as a dietary supplement, those letters are not final agency action, and the FDA’s final position is not yet established.”
Hemp-derived CBD: Navigating the regulatory minefield
The FDA has promised to provide more clarity over CBD “in the coming weeks.” But how should brands navigate the regulatory minefield in the meantime, and what options does the agency have?
WATCH our video with PSL Law Group partner Jeni Lamb Rogers.
Charlotte’s Web – another leading player in the hemp-derived supplements arena to be hit with a lawsuit – not yet filed a motion to dismiss, but several other players have cited a recent court ruling in Florida that stayed a CBD-related class action (Snyder et al v Green Roads of Florida**) on primary jurisdiction grounds.
*Colette and Shaw el at, v CV Sciences 2:19-cv-10227
***Snyder et al v Green Roads of Florida LLC 0:19-cv-62342