Small Town Pushing Forward The Fight Against The FDA
The village of Hartland, Wisconsin, is moving forward with their battle against the Food and Drug Administration, and Lou Ritter is lending his voice to the attack.
“I want to see people have the same opportunities to get away from tobacco that I had. And see if we can advance harm reduction,” he told the Hartland Board of Trustees on Thursday when the board met to discuss the FDA’s deeming rule on vaping regulation.
Ritter was a former smoker who quit the habit after 30 years when he discovered vaping. Seven years on, Ritter is still cigarette-free and one of the most prominent critics of the FDA’s deeming regulation on the habit in the state of Wisconsin. He’s also the founder of the American E-Liquid Manufacturers Association, a group dedicated to creating responsible and sustainable practices and standards for the vaping industry, and the E-Research Foundation, which is a 501(c)(3) nonprofit organization that is dedicated to funding independent scientific research on vaping.
The Washington Examiner is reporting that Ritter was one of two witnesses that kicked off the three-day hearing process on the FDA’s deeming rule. The bulk of his testimony dealt with the FDA’s relationship to both the deeming rule and independent research on vaping and how the agency is failing both the public and smokers by being narrow-minded in its approach to vape regulation.
Ritter’s testimony was followed by Jeff Stier’s contribution to the hearings. Steir, who’s a senior fellow at the National Center for Public Policy Research, has worked tirelessly for the past ten years focusing on tobacco harm reduction.
“Which is lowering tobacco use in the most deadly form, which is cigarette smoking, to some other form of nicotine use that is less harmful, or dramatically less harmful in the case of e-cigarettes,” he told the board. He went on to call the FDA rule, “a life or death issue for people, especially adults, who have not been able to quit smoking.”
The 2016 so-called deeming rule was passed into law in August of 2016 and stipulates that e-liquid and all nicotine vape products, including the software, mods, and batteries that run the process, are subjected to regulation under the Family Smoking Prevention and Tobacco Control Act, which was signed into law on June 22, 2009. The act, which readers can view here, granted the FDA the authority to regulate every aspect of the tobacco industry, from manufacturing to marketing and everything in between.
This means that when the FDA decided to classify vape products as tobacco products, it gained the ability to regulate the vape industry the same as the tobacco industry, including requiring vape businesses to undergo the arduous and expensive pre-market approval process for each individual product that they sell.
The deeming rule and the regulations put in place after it was made law is expected to wipe out virtually the entire vape industry, which is populated by small businesses, by the August 2018 deadline. This deadline is the date that all businesses must have submitted their applications to keep their products on the market.
But some vape businesses and the towns that support them aren’t taking this lying down.
Johnson Creek Enterprises, which is located in Hartland, is a major economic driver in the village, offering at least 50 jobs to residents, and it is at the heart of the town’s fight with the FDA.
The company has enlisted the help of the Electronic Vaping Coalition of America and Fred Kelly Grant; the former is a grassroots vaping advocacy group while the later is a former federal prosecutor. With all the voices heard at the series of hearings, the village board voted unanimously to take their fight with the FDA to court by using an obscure federal law known as “coordination.”
The law, which was put into place when the Federal Land Policy and Management and the National Environmental Policy Acts of 1976 were passed, states that federal agencies, such as the FDA, must coordinate with state and local governments when creating rules that affect them; if the agencies don’t coordinate or in any way fail this obligation, their rules and regulations are considered moot nationwide. This, of course, includes the deeming rule sanctioned by the FDA last year, which was met with criticism and was not widely debated before it became law.
Grant discovered coordination in the early 1990s after compiling a strategy for a case over a land-use issue in the state of Idaho and has since used it more than 80 times in court to beat back regulations and rules implemented by a variety of federal agencies. Some of the agencies that faced the coordination strategy and lost include the Departments of Interior, Agriculture and Homeland Security, the Army Corps of Engineers, and the Bureau of Land Management.
Now Grant says he’ll use the same tactic on the FDA, which is bound by its own rules to follow coordination procedures under the NEPA.
“The effort of the agency has to be to the fullest extent possible. It emphasizes that this is not just a cosmetic requirement. They have to go to the fullest extent possible to involve you,” Grant told trustees at the hearing.
The FDA, for their part, did not send a representative to the hearings to learn about the concerns the Hartland village has but did make a promise to “send a letter addressing the concerns of the village.”
The assurance from the FDA to address the concerns of Hartland is expected to go nowhere since the view of vaping has dramatically changed over the years. In fact, now that research has proven that vaping is 95 percent less dangerous than cigarettes, along with the knowledge that 6.1 million people in Europe have quit smoking with the use of vaping, along with an estimated nine million more who are currently vaping while reducing the use of traditional cigarettes, it seems less likely that the village will be swayed by anything that the FDA may say.
The Hartland legal battle is not the only war the FDA is fighting; Capitol Hill has begun making moves to eradicate the deeming regulation as well.
Representative Duncan Hunter, a Republican from California, announced on Thursday the introduction of his bill, “The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017,” that would repeal and replace the deeming regulation with a new, common-sense framework that would regulate the industry without destroying it.
Hunter also testified at the village hearing last Friday, albeit by phone.
The hearings in Hartland, along with a full report, is expected to make its way to the federal government as evidence that the FDA has neglected to comply with federal law, specifically the law of coordination, and therefore should be rendered moot.
This publication will continue to update readers as the legal battle continues.