A 2016 ruling by the Food and Drug Administration effectively banned new vaping products from the market unless they undergo an extensive, and expensive, approval process that was designed for traditional cigarettes. The so-called "deeming rule" also prevents e-cigarettes from being marketed as safer alternatives to traditional cigarettes or as a way to help smokers quit.
Lawsuits filed Tuesday in federal courts in Minnesota, Texas, and Washington, D.C., ask judges to overturn that ruling on that grounds that such regulations must come from Congress, or at least from presidential-appointed agency heads.
The decision to force electronic cigarettes and other vaping products to comply with the 1997 Tobacco Control Act is a head-scratcher for a number of reasons—not least of which being that e-cigarettes contain no tobacco. Forcing e-cigarettes to comply with a regulatory scheme devised for cigarettes, one that predates the introduction of e-cigarettes into the marketplace, has hurt vaping businesses and made it harder for smokers to switch from combustible cigarettes to the relatively safer electronic variety, which use a heating element and nicotine-laced liquids. Under the terms of Tobacco Control Act, vaping manufactures and sellers cannot market their products as a more healthy alternative to cigarettes that help smokers quit, despite the fact that study after study has shown that they are.
Steve Green, owner of California-based Mountain Vapors and one of the plaintiffs in the lawsuit filed Tuesday in federal court in Washington, D.C., says the FDA's rule-change has damaged his business and his customers. Worse, it's stopped him from being able to share his personal story of using e-cigarettes to kick his smoking habit.
"For years I smoked two-and-a-half packs of cigarettes a day, and it nearly gave me emphysema," says Green. "Vaping freed me from my addiction and the doctor says I've recovered."
Vaping businesses in Michigan and North Dakota are also part of the lawsuit launched in D.C. Separately, a lawsuit was filed in federal court in Minnesota by a group of four small vape shops in the state and the Minnesota-based nonprofit Tobacco Harm Reduction 4 Life. Joosie Vapes, a vape shop in Mesquite, Texas, filed a federal lawsuit in the state. All three challenges are being backed by the Pacific Legal Foundation, a libertarian law firm, and all three make the same basic argument about the legality of the Food and Drug Administration's decision to apply the Tobacco Control Act to e-cigarettes.
"Rules that affect the American people must be issued by officials who are answerable to the political process, not by bureaucrats who have no political accountability," says Thomas Berry, an attorney with PLF. "The Constitution requires that regulations with the force of law must be approved by agency executives nominated by the President and confirmed by the Senate."
By contrast, the FDA's deeming rule was issued by Leslie Kux, an associate commissioner for policy, a career civil service employee at the FDA.
The consequences of that rule are significant. Bringing any new e-cigarette products to the market will now require an application to the FDA and the administration's approval. That process will cost from $182,000 to $2 million for e-liquids and from $286,000 to $2.6 million for e-cigarettes themselves, the FDA estimates. That's a prohibitively high expense for many potential products, and it leaves bigger companies in control of the e-cigarette market.
Berry says the FDA's rule also flaunts the First Amendment by forcing vaping businesses to "run a regulatory gauntlet" before being allowed to speak openly about their products. Under the Tobacco Control Act, which prohibits unapproved "modified risk" claims, e-cigarette companies are not allowed to advertise the main advantage of their products—that they are healthier than traditional cigarettes.
The deeming rule survived an earlier court challenge that sought to overturn the 2016 rulemaking on the grounds that it exceeded the FDA's authority.
While the lawsuits seek the repeal of the FDA's decision to force e-cigarettes into the Tobacco Control Act's regulations, the Trump administration could reverse course on its own without input from the courts.
The FDA has an opportunity to recognize that distinction by granting a Modified Risk Tobacco Product application for e-cigarettes, allowing those products to be sold as a better alternative to smoking. As Guy Bentley, a research associate with the Reason Foundation (which publishes Reason.com) noted recently, it's the "deadly smoke caused by setting tobacco on fire sucking into the lungs that are responsible for the deaths of 480,000 Americans each year—not nicotine."
Here's more on PLF's new lawsuits: