A small village in Wisconsin has put the Food and Drug Administration on notice over the agency’s controversial tobacco “deeming” regulation.
At issue is whether the FDA followed federal law which requires agencies to “coordinate” with state and local governments before implementing regulations to ensure minimal economic harm. The statute is part of the National Environmental Policy Act of 1976.
The “deeming” rule puts vaping products and their components such as flavors, nicotine concentration levels, e-cigarette batteries, and software under the purview of the Tobacco Control Act, even though the products contain no tobacco. The rule also requires a lengthy, expensive, and arbitrary pre-market approval process for each product on the market dating back to 2007.
Hartland, Wis., is home to vaping liquid manufacturer Johnson Creek Enterprises, a major economic driver in the community.
With a price tag of up to $1 million per application and more than 200 vaping liquids, the math alone would force Johnson Creek to either drastically cut back their product selection or close up shop altogether. In fact, vaping advocates predict the regulation is on pace to wipe out 99 percent of the industry across the country.
In turn, consumers would lose access to a product that’s been shown in studies to be 95 percent less harmful than combustible cigarettes, and helped more than 6 million people in the European Union quit smoking.
Hartland village leaders had no answers for Johnson Creek until leaders with the Electronic Vaping Coalition of America introduced them to the legal process of coordination and asked them to consider the process as a way to help the vaping industry.
Under the guidance of longtime attorney and coordination expert Fred Kelly Grant, a special board convened in late April to collect testimony from health and policy experts, industry advocates, vaping manufacturers, retailers, and people who said vaping saved their lives by helping them stop smoking. The evidence included sworn testimony by local government officials that the FDA never contacted them prior to implementing the rule in August 2016. The record also shows the regulation was implemented in breach of several other federal statutes.
On May 24, village president Jeff Pfannerstill, Administrator David Cox, and the leaders of EVCA personally delivered their findings to intergovernmental liaison officers with both the Environmental Protection Agency and the Department of Health and Human Services (which oversees the FDA), and spoke with officials of both agencies as well as the FDA. All documents have been sent to FDA Commissioner Scott Gottlieb and HHS Secretary Tom Price.
“We’ve done our delivery. Now we’ll let them go and do their work,” said Pfannerstill. “We trust that they are being honest and sincere, just as they seemed in the meeting, they were nothing but gracious.”
Now, Hartland waits.
“The next steps are to wait to get a response in one fashion or another,” Pfannerstill explained. “Either a status report that says ‘We need more time to look into this’, or that says, ‘Hey, we need to talk. Here’s what we have to do. If we don’t get that, we will reach back out.”
If the FDA admits it did not coordinate with Hartland, the deeming regulation would be nullified nationwide.
If not, the matter would head to court.
Grant says in his 30 years and 80-plus cases of batting back federal agencies through coordination, none faced a legal challenge. He sees no reason the FDA will be any different. Nor does he believe the agency will let the findings languish.
“The FDA, having received the findings and conclusions, have the obligation to at least review the decision under NEPA’s mandate as well as the Council on Environmental Quality regulation mandate,” said Grant. “If they ignore the findings we petition the Council on Environmental Quality in the White House to hold a hearing and demand that they reply. The FDA won’t do that. They will not risk offending the White House.”
In the meantime, Congress is taking steps to replace the deeming regulation. Rep. Duncan Hunter, R-Calif., introduced a bill in April that would remove vaping devices from the tobacco regulation, and set up a separate regulatory framework.
The bill, known as the Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017, is currently before the House Subcommittee on Health.
Grant says while the legislative process will take time to play out, the coordination process, spearheaded by EVCA, deserves credit for quick action and results.
“Right now, as to the deeming regulations, the Hartland folks are the only show in town for getting relief,” he said. “And they are doing it for the whole people of America who are trying to quit smoking. Our hope is that everyone who has any sense of urgency for the vapers of America will support them.”
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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