Vaping Litigation

The Constitution going up in vapor

Cases > Separation of Powers > Vaping Litigation
Lost: The court said the FDA commissioner ratified the rule which cured any Appointments Clause violation.

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.

  • In the U.S. District Court for the Northern District of Texas, PLF represents Joosie Vapes, owned by Denissa Moore and her husband, Larry Moore, Jr. Denissa used to smoke two packs a day, and tried to quit by using Chantix, nicotine patches, and even hypnosis. None of these were successful. She then turned to vaping and quit smoking after just a year. She founded Joosie Vapes with her husband in 2013 as a way to help others quit smoking.
  • In the U.S. District Court for the District of Minnesota, PLF represents five clients: Jen Hoban (pictured above), owner of Masterpiece Vapors, the Plume Room, J.H.T. Vape, Lakes Vape Supply, and Tobacco Harm Reduction 4 Life (THR4Life), a nonprofit organization.
  • In the U.S. District Court for the District of Columbia, PLF represents four businesses in three states:
    • Steve Green, owner of Mountain Vapors (California), was a 2+ pack a day smoker for 30 years who doctors warned was developing emphysema. A few years ago, his wife was given a vaping pen from a friend, which he tried and quit smoking that same day.
    • Kimberly Manor founded Moose Jooce in Michigan, after her late husband passed away from lung cancer.
    • PLF also represents Rustic Vapor in Michigan and Dutchman Vapors in North Dakota.
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What’s at stake?

  • Rule-makers need to follow the rules: Under the Constitution, issuing regulations is the job of appointed officials who answer to the democratic process, not unelected career bureaucrats. This vaping rule was issued by such a bureaucrat in violation of the Constitution.
  • The vaping edict flouts the First Amendment by forcing businesses to run a daunting regulatory gauntlet in order to advertise truthful information. The government can’t require pre-approval for truthful speech, and it especially can’t shift the burden of proof to the speaker to prove the benefits of his speech will outweigh any harms the government perceives may result.
  • Beyond violating the Constitution, the vaping rule is horrible public policy: it threatens to shut down thousands of small businesses that provide potentially life-saving products and creates a public safety hazard by making it very difficult to improve and repair products.

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