A lawsuit filed in federal court on Thursday challenges the FDA’s new regulations for electronic cigarettes.
It’s the return volley in what could be a legal battle for the survival of the electronic cigarette industry in America.
New regulations finalized last week by the Food and Drug Administration would make e-cigarettes subject to the same federal rules as traditional cigarettes, despite the obvious differences between the two products. Some in the industry worry that the new rules could ban 99 percent of all electronic cigarettes from the market.
“The government’s role is not to regulate for the sake of regulation,” said Patricia Kovacevic, general counsel for Nicopure Labs, which filed the lawsuit against the FDA in the U.S. District Court for the District of Columbia.
“Regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals,” she said.
The lawsuit argues that during the rule-making process the FDA violated the Administrative Procedure Act, which governs how the federal government’s agencies can make regulations, and that the final rules violate the First Amendment of the U.S. Constitution.
The new rules from the FDA include a lengthy list of expensive changes, such as mandatory warning labels and limitations on advertising and sales similar to those already in place for tobacco products like cigarettes and cigars.