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.

In May 2016, the Food and Drug Administration issued its so-called “Deeming Rule,” which added vaping products to the list of items covered by the Tobacco Control Act of 2009—even though they contain no tobacco—and subjects them to costly, burdensome and ultimately unconstitutional regulations. The Deeming Rule, by the way, applies to all vaping products dating back to 2007—every flavor, mixture concentration, and equipment component are subject to this prohibitively expensive approval process.

For small businesswomen like Skip Murray, whose son owns JHT Vape in Minnesota, this regulation could be devastating. Not only could the compliance costs force them out of business, but they’re not allowed to label ingredients or talk about the products’ effectiveness to help quit smoking without FDA approval.

That’s right—they cannot even talk to their own customers about vaping products’ potential life-saving benefits as an alternative to traditional tobacco cigarettes unless they first prove to the FDA their statements are true and that the benefits of the message outweigh the harm to the population as a whole.

This means Skip Murray is afraid to tell customers how, after smoking two packs of cigarettes a day, her health turned around after she switched to vaping—unless she first proves to the FDA that her claims about vaping are true.

This is unconstitutional. Restricting truthful, non-misleading speech, and shifting the burden of proving the net value of speech from the government to speakers clearly violates the First Amendment.

To add insult to injury, the very rule that muzzles what these entrepreneurs can say about the products they sell went on the books illegally.

The power to issue a rule that has the force of law and binds members of the public is reserved under the Constitution only to principal “Officers of the United States,” that is, only people appointed by the President and confirmed by the Senate.

The final rule published in the Federal Register, however, contains only the name of an FDA employee, not a principal officer of the FDA (such as the Health and Human Services Secretary or FDA Commissioner.) Therefore, under the Appointments Clause, the Deeming Rule is constitutionally invalid.

On behalf of small vape business owners and harm reduction clients, PLF has taken the bold and unique step of filing three lawsuits in three different federal courts—at the same time—asking the courts to find the Deeming Rule unconstitutional under the Appointments Clause and the First Amendment, and to stop the rule’s enforcement.