Fighting for the Constitution and small business owners
Anyone who has tried to quit smoking knows that it’s one of the hardest things you can do. But when everything else has failed, thousands of Americans have found success turning to vaping. This new technology allows users to inhale vapor from heated nicotine-infused liquids, without the harmful tar released by burning tobacco. Because it offers one of the most effective alternatives to smoking (some studies suggest it is the most effective), it is not an understatement to say that vaping is a technological advance that could save thousands or even millions of lives.
Yet that progress was put in jeopardy in the summer of 2016, when the vaping industry was rocked by the federal government’s new “Deeming Rule.” Under this new rule, vaporizers and all other electronic nicotine devices are subject to the same burdensome regulations that the Tobacco Control Act places on cigarettes, even though vaping involves no tobacco. That means that every vaping shop in the country must now submit every new creation—no matter how minor—to the FDA for approval. This process was designed for multi-billion-dollar cigarette companies, not the small businesses that are the backbone of the vaping industry. For most of these mom-and-pop stores, the process is so time-consuming and expensive that innovation has had to cease altogether.
Today, however, Pacific Legal Foundation is taking the first step in not only striking down the Deeming Rule, but setting a precedent that will have enormous importance for the separation of powers. PLF, representing several vape shop owners across the country, has filed complaints in three separate federal courts, explaining that the Deeming Rule is void because it was issued pursuant to an unconstitutional delegation of power. Specifically, the FDA commissioner delegated the power to issue the rule to a career FDA bureaucrat named Leslie Kux, who then issued the rule under her supposed authority and in her own name.
This delegation was unconstitutional because Kux, as a civil-servant who has served under the last two presidents, was never appointed by a president or confirmed by the Senate. Rulemaking power, which can have an enormous effect on the lives of Americans, is a power that can only be exercised by constitutional “officers” who have undergone that process. This ensures that those who decide to issue rules are politically accountable, and that responsibility (and blame) for rules cannot be dispersed indefinitely throughout the federal bureaucracy.
In addition, PLF is also challenging the rule as a First Amendment violation. Remarkably, it bans the creators of vaping devices from telling their customers that their products are less harmful than cigarettes, even if such claims are undeniably true. The FDA requires that in addition, these creators must also somehow prove that being allowed to tell the truth will produce more good than harm across the entire population, a standard that is almost impossible to meet. For this reason, the rule is a “prior restraint” on truthful speech, which the First Amendment forbids the government from imposing.
If successful, our lawsuit will establish that rulemaking is an important power and privilege that should not be treated cavalierly. The livelihoods of thousands of small business owners, and potentially the lives of many thousands more of their customers, have been put in jeopardy by this ill-considered rule. It’s time for the federal government to start following constitutional rules for its own rulemaking.
To read the full complaints, and to see our full background materials explaining the case and introducing our plaintiffs, go to the case page here.
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Electronic nicotine delivery systems—vaping devices and e-cigarettes—first hit U.S. stores in 2007. It didn’t take long for vaping to jump from zero to a $5 billion domestic industry, as entrepreneurs quickly recognized a market hungry for an alternative to traditional cigarettes. In 2016, just as the burgeoning vaping industry was getting off the ground, the Food and Drug Administration (FDA) stepped in with a rule that deems e-cigarettes as tobacco products, and brand new, severe regulations that will only harm the industry and perhaps overall public health—contrary to the agency’s very mission. Using a unique legal theory, Pacific Legal Foundation is suing the FDA in three separate federal courtrooms—at the same time—on behalf of vape store owners and a harm reduction organization in several states who want to promote a more healthy alternative to smoking. The unconstitutional rule burdens these individuals and organizations in unique ways, but all are united in opposition to its continued enforcement. The FDA’s regulations are not only expensive and onerous, and prevent vaping entrepreneurs from fulfilling what they believe is a humanitarian mission of helping people, but the rule was illegal the second it hit the Federal Register.Read more
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