Lou Ritter wants to see people stop dying from smoking cigarettes.
“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, Wis., Board of Trustees Thursday night.
Ritter was one of two witnesses to kick off a three-day series of hearings on the Food and Drug Administration’s so-called “deeming” regulation of vaping products.
Ritter testified that he smoked for 30 years before discovering e-cigarettes. Not only has he been smoke-free for seven years, he’s become a fierce advocate for the vaping industry. Ritter founded the American E-Liquid Manufacturers Association (AEMSA) to create safe production standards, and the E-Research Foundation to fund sorely needed science.
It’s science Ritter says the FDA does not have, even though the 2016 rule adds liquid, all-nicotine products to tobacco regulations — down to the batteries and software that enable nicotine delivery — and subjects each component to an expensive pre-market approval process that vaping advocates say will wipe out 99 percent of the industry.
This prognosis alarmed Hartland, home to Johnson Creek Enterprises, a vaping company and major economic driver in the community. With help from the Electronic Vaping Coalition of America, a grassroots vaping industry advocacy group, and Fred Kelly Grant, a former federal prosecutor and founder of the Stand Up and Fight Club, a property rights advocacy group, the village board voted unanimously to take the FDA to task under a little-used, but extremely powerful federal law known as “coordination.”
First embedded in the Federal Land Policy and Management and the National Environmental Policy Acts of 1976, the provision requires federal agencies to coordinate with state and local governments when planning their rules.
If it’s proven agencies fail this obligation, their rules become moot — not just in a local community, but nationwide.
After discovering coordination in the early 1990s over a land-use issue in Idaho, Fred Kelly Grant has used coordination more than 80 times to beat back an alphabet soup of federal agencies. Among them, the Bureau of Land Management, Environmental Protection Agency, Forest Service, Fish and Wildlife Service, the Departments of Interior, Agriculture and Homeland Security, and the Army Corps of Engineers.
Kelly says the FDA is bound by its own rules which require the agency to follow coordination under 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,” he told trustees.
The FDA declined to send a representative to the hearings, but promised to “send a letter addressing the concerns of the village.”
In addition to Ritter, Thursday’s hearing included testimony from Jeff Stier, a senior fellow with the National Center for Public Policy Research, a free-market think tank that has challenged the FDA for ignoring the health benefits of e-cigarettes. Stier told the board his work over the past 10 years has increasingly focused 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 said, calling the FDA rule, “a life or death issue for people, especially adults, who have not been able to quit smoking.”
The Centers for Disease Control and Prevention has pegged the number of cigarette-related deaths in the United States at 480,000 premature deaths per year. And research has found e-cigarettes are 95 percent less harmful than cigarettes, and have helped 6.1 million people in Europe quit smoking.
In addition to the legal challenge, the FDA is also feeling the heat on Capitol Hill. Rep. Duncan Hunter, R-Calif., on Thursday introduced “The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017,” to essentially repeal and replace the deeming regulation through a new regulatory framework for vaping products.
Hunter is expected to testify at the village hearing Friday via phone.
In addition, Sen. Ron Johnson, R-Wis., has strongly criticized the regulation, and has demanded the agency to repeal the rule to “spare the growing e-cigarette industry unnecessary and avoidable compliance costs that it currently faces.”
The hearings continue today and tomorrow, and a full report will go to the federal government as evidence of the FDA’s neglect to comply with federal law.
Kathy Hoekstra (@khoekstra) is a contributor to the Washington Examiner’s Beltway Confidential blog. She is freelance writer who formerly worked for Watchdog.org.
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