US Court Upholds FDA Authority to Regulate E-Cigarettes
On June 25, the U.S. Supreme Court dismissed a lawsuit claiming the FDA had been unconstitutionally authorized to regulate e-cigarette products, thereby upholding the agency’s authority over these products. On August 19, 2019, Big Time Vapes Inc. and the
On June 25, the U.S. Supreme Court dismissed a lawsuit claiming that the U.S. Food and Drug Administration (FDA) was unconstitutionally authorized to regulate e-cigarette products, upholding the agency's authority over the products.<\/span><\/div>
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On August 19, 2019, Big Time Vapes Inc. and the American Vaping Association Inc. filed a lawsuit against the FDA in the federal district court in Mississippi, claiming that the Tobacco Control Act (TCA) authorizes the FDA to regulate tobacco products, especially e-cigarettes and vaping products, is unconstitutional and therefore invalid.<\/span><\/div>
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The plaintiffs requested the court to declare Section 901 of the TCA unconstitutional and to issue an injunction prohibiting the FDA from enforcing the TCA against electronic nicotine products. The district court ruled in favor of the plaintiffs, and the plaintiffs then appealed to the U.S. Fifth Circuit Court of Appeals.<\/span><\/div>
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Subsequently, the appellate court upheld the authority of the TCA, stating that if Congress "establishes understandable principles for individuals or entities authorized [to exercise authority] to comply with," then the congressional authorization is constitutional. "If Congress clearly delineates the general policy, the public agencies to which this policy applies, and the scope of authorization, this is constitutionally sufficient."<\/span><\/div>
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Trump supports removing FDA authority over tobacco products<\/div>
Interestingly, earlier this year, President Trump also proposed removing tobacco regulations from the FDA's jurisdiction. In a budget request released in February last year, Trump called for the establishment of a new agency under the Department of Health and Human Services to regulate tobacco products, including e-cigarettes. Before proposing this change, lawmakers seemed uninterested in making such a shift, but in 2019, Joe Grogan, the director of Trump's Domestic Policy Council, did express that he did not believe tobacco should be regulated by the FDA.<\/span><\/div>
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The FDA regulates drugs, which helps people... it regulates devices that help people. Tobacco has no redeeming qualities," Grogan said last November. Meanwhile, the budget request indicated that this change would allow the FDA commissioner to "focus on ensuring the safety of the nation's food and drug supply."<\/span><\/div>
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According to the proposal, the commissioner leading the proposed tobacco regulatory agency would be a person similar to the FDA commissioner, requiring Senate confirmation, "to increase direct accountability and respond more effectively to this critical public health issue." Currently, the head of tobacco regulation is the head of the Tobacco Products Center, and since this is an FDA department, the position does not require Senate confirmation.<\/span><\/div>
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