Supreme Court Vape Ruling Could Reshape FDA’s Regulatory Power
The Supreme Court heard arguments on Monday in a crucial case that could significantly influence the FDA’s ability to regulate not just vaping products, but a vast array of other goods it oversees. At the heart of the case are two e-cigarette manufacturers who challenged the FDA after their applications for flavored vape products were denied in 2021.
A lower court sided with the companies in January, expressing concerns that the FDA was disregarding its own guidance documents when making these decisions. This ruling sent ripples through various industries, raising questions about the FDA’s authority and the predictability of its regulatory process.
Sharper legal scrutiny could have far-reaching consequences for the FDA, impacting the way it regulates a multitude of products, from pharmaceuticals and medical devices to food and cosmetics.
"The court’s eventual decision could change the way the agency regulates not just vaping products, but a litany of other products under its purview," noted STAT’s Lizzy Lawrence.
The case hinges on the FDA’s use of guidance documents. These documents, while not legally binding, offer insight into the agency’s thinking and expectations for companies seeking approval for their products. The lower court’s ruling suggests that the FDA cannot simply depart from these guidelines without providing clear justification.
The outcome of this case will be closely watched by stakeholders across diverse industries, as it could fundamentally reshape the landscape of FDA regulation in the United States.
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