Pacific Legal Foundation (PLF), a donor-supported organization that has successfully litigated for limited government, private property rights, and free enterprise, announced Tuesday that it would be representing several small vape shop owners in lawsuits filed against the U.S. Food and Drug Administration. The filed complaints object to the FDA “Deeming Rule” that requires the nearly impossible Premarket Approval (PMTA) hurdles for vapor products.
Skip Murray, a vape shop owner and advocate in Brainerd, Minnesota, filed a challenge in the U.S. District Court for Minnesota, along with three other vaping businesses in that state. They are joined by the nonprofit Tobacco Harm Reduction 4 Life. Additionally, four businesses from California, Michigan, and North Dakota filed a federal challenge in the U.S. District Court for the District of Columbia. Finally, a vape shop in Mesquite, Texas, filed a challenge in the U.S. District Court for the Northern District of Texas. All are represented “pro bono” by PLF.
The lawsuits primarily argue that the deeming rule and its requirements are both burdensome and unconstitutional, banning truthful speech and thereby violating the First Amendment’s free speech protections. The complaints also argue that Leslie Kux, FDA Associate Commissioner for Policy, does not have the authority to issue rules like the Deeming Rule, and such rules are reserved by the Constitution for “Officers of the United States.”
“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,” said attorney Thomas Berry in PLF’s press release. “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.”
“In contrast, the vaping edict was imposed by a career civil service employee,” he said. “It also flouts the First Amendment by stopping businesses from advertising truthful information unless they run a regulatory gauntlet.”
In 2009, under the Family Smoking Prevention and Tobacco Control Act, Congress granted the FDA “new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products,” defined in the Act as “Modified Risk Tobacco Products (MRTP).”
Unfortunately the requirements for MRTP status are even more difficult to achieve than PMTA.
“The bar for gaining a modified risk order is excessively high,” said Alex Clark, CEO of CASAA. “Arguably, the process is inherently cynical and prejudiced against any company in the tobacco or nicotine space.”
Not only must companies demonstrate that the product significantly reduces harm and the risk of so-called ‘tobacco-related disease’ to individual users, it must also show a benefit to the health of the population as a whole, taking into account the impact on both users and nonusers. The requirements are so unclear and ambiguous that it is unlikely that such a standard could ever be proven.
“And before a company even gets to that point,” Clark explained, “the cost of producing an application is beyond the means of the small to medium manufacturers who were driving innovation. Ironically, the market approval process favors protecting the market for the most harmful products, cigarettes.
“Both premarket approval and the MRTP standards create unnecessary barriers to consumer access of lower risk tobacco and nicotine products,” Clark said, “and they are effectively a de facto ban on truthful speech that is vital to saving lives.”
More information about the lawsuits may be found at https://pacificlegal.org/case/vape-litigation.