Small City Pushes Back Against FDA on E-Cigarettes
As previously promised, the village board of the city of Hartland, Wisconsin is going forward in its fight against the Food and Drug Administration to help save a local vaping company from potentially disastrous legislation. At issue is the FDA’s testing requirements, which will cost Johnson Creek Enterprises and all other vaping product manufacturers millions of dollars unless the rules are changed before they go into effect in August 2018.
In February, the Hartland village board voted unanimously to help Johnson Creek Enterprises fight the FDA rules. They won’t be alone in their fight: There are currently two pieces of federal legislation that aim to get the FDA to change their deeming rules that will make selling e-cigarettes and e-juice next to impossible for all but very wealthy corporations. A bipartisan bill wants to change the grandfather clause to allow current vaping products to remain available without the expensive testing, while another bill wants to change the definition of e-cigarettes altogether and put them in their own category instead of being labeled as tobacco products.
Hartland and Johnson Creek are getting help in their fight from an experienced legal expert. Fred Kelly Grant is a former federal prosecutor who knows all about taking on federal agencies, and beating them. In 1990 he discovered a little-known but very powerful law that he has successfully used more than 80 times in the past to fight federal agencies over various issues. The law says that federal agencies must coordinate with local and state governments when planning rules. There was no “coordination” involved in the FDA’s tobacco deeming rules as they pertained to e-cigarettes.
Johnson Creek Enterprises is a big company in its small city, and it is important to the local economics. By ignoring its own coordination law, which has existed since 1976, the federal government has endangered Johnson Creek Enterprises and Hartland’s economic health. Nationwide there are thousands of vaping companies at risk from the FDA’s overzealous e-juice requirements, which include, among other things, 24-hour a day video monitoring of manufacturing facilities.
The Hartland village board conducted three days of hearings in late April, during which it heard testimony from former smokers and policy experts. Lou Ritter, a 30-year smoker before he switched to e-cigarettes, says that the FDA does not have enough scientific evidence to declare e-cigarettes to be a danger. Ritter is the founder of the E-Research Foundation, a funding source for scientific research of e-cigarettes and vaping. Ritter is also the founder of the American E-Liquid Manufacturers Association, which aims to create safe production standards.
The FDA declined to send a representative to the Hartland hearings, but promised it will address the issue in writing. A full report on the hearings will be sent to the FDA.