Wednesday, June 19, 2024

US Court of Appeals Upholds FDA Authority to Regulate E-Cigs


On August 19th 2019, Big Time Vapes Inc. and the United States Vaping Association Inc. filed a lawsuit against the FDA in a Federal District Court in Mississippi, saying that the Family Smoking Prevention and Tobacco Control Act (TCA) delegation of authority to the FDA to regulate tobacco products, more specifically e-cigarettes and vaping products, is unconstitutional and therefore invalid.

The plaintiffs requested the court to declare that Section 901 of the TCA violated the non-delegation doctrine under the U.S. Constitution, and requested that an injunction preventing the FDA from enforcing the TCA against electronic nicotine products is issued. The District Court ruled against the plaintiffs, who then proceeded to appeal to the U.S. Fifth Circuit Court of Appeals.

Subsequently, the Appeals Court upheld the TCA’s authority, saying that Congressional delegations of authority are constitutional if Congress “lay[s] down by legislative act an intelligible principle to which the person or body authorized [to exercise the authority] is directed to conform.” It is “constitutionally sufficient if Congress clearly delineates the general policy, the public agency which is to apply it, and the boundaries of th[e] delegated authority.”

Trump in favour of lifting the FDA’s authority on tobacco products

Interestingly earlier this year, President Trump had also proposed removing tobacco regulation from the FDA’s jurisdiction. A budget request by Trump issued last February had called for the creation of an entirely new agency that would fall under the Department of Health and Human Services, in order to regulate tobacco products, including e-cigarettes. Prior to this proposal, there didn’t seem to be much interest among lawmakers to make such a change, however in 2019, the director of Trump’s Domestic Policy Council Joe Grogan, did say that he didn’t see the point in tobacco being regulated by the FDA.

“FDA regulates drugs, which help people. … It regulates devices, which help people. Tobacco has no redeeming qualities,” said Grogan last November. Meanwhile, the budget request pointed out that this change would give the FDA commissioner to “focus on its traditional mission of ensuring the safety of the nation’s food and medical supply.”

According to the proposal, the commissioner leading the suggested tobacco regulations agency would be someone, who like the FDA commissioner, has to be confirmed by the Senate “in order to increase direct accountability and more effectively respond to this critical area of public health concern.” While currently, the person in charge of tobacco regulations is the director of the Center for Tobacco Products, and since this is an FDA department, the director role doesn’t need Senate confirmation.

Read Further: CSP

FDA Issues Warnings To E-Cig Retailers Selling Unauthorized Products

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