A group of vape shops are suing the Food and Drug Administration (FDA) over what they argue is an unconstitutional rule that threatens their industry’s existence.
The Pacific Legal Foundation, which is representing shops from five states, filed three lawsuits in federal courts Jan. 30 targeting the FDA’s contentious “deeming rule,” calling it, “unconstitutional and illogical.” The rule allows the FDA to treat vaping devices like combustible cigarettes under the Tobacco Control Act despite the fact they do not contain tobacco, opening the industry up to onerous regulations that most manufacturers and retailers cannot afford.
The lawsuit argues the rule was unconstitutionally issued by a career bureaucrat at the FDA in violation of the Appointments Clause, which requires such regulations be issued by an agency head appointment by the president and approved by the Senate.
“The FDA is basically doing an end-run around advice and consent, around the requirement of the appointments clause, because they’ve given the associate commissioner for policy all the same powers that the FDA commissioner has,” Thomas Berry, an attorney with Pacific Legal Foundation, told The Daily Caller News Foundation. “If you have a rule that’s issued by someone who’s not an officer of the United States appointed by the president and confirmed by the Senate then that rule is null and void.”
The FDA “deeming rule” requires businesses to retroactively submit each individual product to the FDA for approval before it can be sold. Businesses will have to file applications for nearly every product they currently sell at a cost of $100,000 to $400,000 each.
While FDA Commissioner Scott Gottlieb rescheduled the product application deadline to comply with the deeming rule last summer from Aug. 8, 2018 to Aug. 8, 2022, other aspects of the regulation are already undermining the industry. Vape shops are barred from giving customers free-samples and face speech restrictions regarding what they can say about the impact of the products compared to smoking that Berry says, “flouts the First Amendment.”
“Even though some of the deadlines have been extended, some of them have gone into effect already, including a ban on free samples and the speech restriction, which is why our clients clearly have standing to sue immediately,” Berry told TheDCNF.
The lawsuits, filed in U.S. District Courts in Washington, D.C., Texas and Minnesota, represent a coalition of vape shops from California, Michigan, Minnesota, North Dakota, and Texas. The non-profit Tobacco Harm Reduction 4 Life is also part of the litigation against the FDA.
Steve Green, owner of Mountain Vapors, a shop in Sonora, Calif., which is part of the lawsuit, says the rule is making it harder to transition smokers from deadly combustible cigarettes to healthier alternatives. He notes the “deeming rule” is so broad that it bars him from sharing stories with customers about how smokers have quit with the devices.
“The advertising restrictions stop me from sharing my personal story,” Green said in a statement from the Pacific Legal Foundation. “For years I smoked two-and-a-half packs of cigarettes a day, and it nearly gave me emphysema. Vaping freed me from my addiction and the doctor says I’ve recovered.”
The most comprehensive review of existing research on e-cigarettes to date was released Jan. 23, concluding the products are a useful tool for smokers trying to quit cigarettes that greatly improves health outcomes.
The research from the National Academies of Sciences, Engineering and Medicine echos previous reports confirming the relative safety of vaping devices when compared to traditional cigarettes. The report found that smokers who completely switch to vaping largely eliminate their exposure to deadly carcinogens, tar and other harmful chemicals present in combustible tobacco.
Millions of former smokers in the U.S. are embracing the positive science on vaping and using the harm reduction tools to quit combustible cigarettes. Roughly 2.62 million former smokers were using a vape in 2016.
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