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.
Chief of Legal Policy and Strategic Research, and Director, Center for the Separation of Powers