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FDA faces new lawsuits over e-cigarette rule

FDA faces new lawsuits over e-cigarette rule
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The Food and Drug Administration (FDA) is facing a new wave of legal challenges over its rules for electronic cigarettes.

The Pacific Legal Foundation filed lawsuits on behalf of vaping businesses in district courts in the District of Columbia, Minnesota and Texas on Tuesday.

In the lawsuits, the foundation argues the FDA’s so-called deeming rule, which brings e-cigarettes under the same regulatory scheme as traditional cigarettes, violates the First Amendment because it allows the agency to treat many nontobacco vaping products as if they were tobacco products regulated by the Tobacco Control Act.

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“Thanks to the Deeming Rule, anyone who manufactures or sells a vaping product must obtain FDA’s preapproval before engaging in truthful speech concerning that product’s health and related effects,” attorneys for the legal group argue in court documents.

“Moreover, it is the would-be speaker who must bear the burden of convincing the agency that the truthful speech will improve public health. Such restrictions on truthful speech are presumed unconstitutional under the First Amendment, and it is the government—not the speaker—which must bear the heavy burden to overcome that presumption. The Deeming Rule unconstitutionally shifts that burden from the government to speakers.”

Manufacturers have long claimed e-cigarettes are less harmful and can help people quit smoking. 

A report from the National Academies of Sciences, Engineering, and Medicine, however, found that e-cigarettes, while safer than traditional cigarettes and a useful tool for helping people quit smoking, are not necessarily “safe.” The report also found e-cigarettes put teens at a higher risk of trying cigarettes. 

The lawsuits also allege the rule is unconstitutional because Leslie Kux, the career FDA employee who issued it, had no authority to do so.

“Because the issuance of a rule is final, because a rule binds the government and the regulated public, and because a rule cannot be easily reversed, only a principal officer of the United States—one who has been nominated by the President and confirmed by the Senate—may exercise such authority,” the foundation wrote.

In July, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia upheld the FDA’s rule against a challenge from Nicopure Labs LLC. The e-liquids manufacturer had argued that the FDA overstepped its legal authority under the Tobacco Control Act in subjecting e-cigarettes to the same federal laws as traditional cigarettes.

“Congress gave the FDA broad authority to deem new products to be ‘tobacco products’ subject to that existing statutory regime, and the Court finds that it was not arbitrary and capricious for the agency to decide to take that action with respect to e-cigarettes,” she wrote in her opinion.