“We don’t want any longer to be ruled by the bureaucrats in Washington,” President Trump said Friday at the National Rifle Association’s group leadership forum in Georgia.
Neither does Hartland, Wis.
That’s why the village of 9,200, located about a half hour west of Milwaukee, is forging ahead with a legal gambit in what’s believed to a first against the U.S. Food and Drug Administration.
With Johnson Creek Enterprises, a vaping manufacturer and one of the community’s major economic drivers facing a federal rule that could drive it out of business, the village launched a hearing board to collect evidence that the FDA broke federal law and thus its e-cigarette “deeming” regulation is illegal.
Federal statute requires the feds to “coordinate” with state and local governments before implementing regulations, to measure economic and other effects the rules may have on local communities.
Village leaders contend the FDA did not do this prior to enacting its e-cigarette “deeming” regulation in August 2016. The rule subjects all products related to liquid nicotine, including the batteries, software and cotton components of e-cigarettes, to a pre-market approval process for each product that hit the market after February 15, 2007.
At a cost of $330,000 to $1 million per application, the rule would devastate Johnson Creek, which makes and sells more than 200 vape liquids at around 70 stores throughout Wisconsin and online.
“If we were to pare down our 43 flavors, even down to, say five, we’d only be reaching that audience who only liked those five flavors,” Tom Pangborn of Johnson Creek told the village board Friday, the second day of hearings to collect evidence of the FDA’s failure to coordinate with the village.
Stephen Moore, a senior fellow with the Heritage Foundation painted a grim picture in written testimony, estimating the loss of Johnson Creek and its 50 jobs would cost the community nearly $1.5 million in economic activity per year.
Small businesses, he wrote, “are the financial spinal cord of any community.”
Worse, according to Johnson Creek President and COO Heidi Braun, the FDA application requirements would take five people to complete and have no clear direction.
“They have not provided any manufacturing standards. None,” she testified. “It feels like it’s a moving target.”
Village Trustee Ann Wallschlager had a harsher assessment.
“It seems the FDA can just throw whatever s—t they want up against the wall and see if it sticks,” she said after the second day of fact-finding. “The bureaucrats are unaccountable. It doesn’t make any sense.”
“Procrustean,” according to Greg Troutman on the deeming rule’s hurdles. Troutman is a lawyer who testified about his fight in Indiana over the deeming regulations. Procrustes. In Greek mythology, Procrustes stretched or amputated the limbs of travelers to fit the length of his bed. “That is a perfect example of what these regulations are.”
Other testimony included Hartland Village Administrator David Cox, who initiated the hearings at the behest of the Electronic Vaping Coalition of America, a grassroots advocacy group. Cox played a voicemail from an FDA official, saying the agency would not be sending a representative to testify, but would instead respond to village concerns in a forthcoming letter.
Hearing officer Fred Kelly Grant has used the coordination hearing process to successfully fend off the Bureau of Land Management, Environmental Protection Agency, Forest Service, Departments of Interior, Agriculture and Homeland Security, among others over the past 25 years.
He posed the possibility that in failing to coordinate with local governments, the FDA may have violated due process rights afforded by the U.S. Constitution.
“And this is why [newly-confirmed Supreme Court Justice Neil] Gorsuch is good,” agreed John Dunn, a toxicologist and health policy researcher who also testified Friday. “Laws need to be applied to allow people to live their lives, and not be in violation of the law because some bureaucrat decided [to make law].”
The village board will hold one more day of hearings Saturday, and will vote on the findings Monday evening. If approved, the findings then go to the FDA Commissioner Stephen Ostroff and Secretary of Health and Human Services Tom Price.
Admission that the agency did not follow federal coordinating rules would negate the deeming regulation altogether.
Wallschlager welcomes the opportunity to be the small town to turn the tables on the big-government FDA.
“Maybe we should regulate them out of existence,” she said.
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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