A little-known rule from the FDA has the potential to gravely harm dozens of North Dakota small businesses and limit access to smoke-free options for consumers. The FDA used its “deeming rule” in 2016 to extend the agency’s regulatory authority to e-cigarettes, vape pens, and e-liquids.
While common-sense regulation in the vaping industry is needed, the new FDA rules would be an unnecessary burden, especially to small business owners, by requiring all products that were not on the market before 2007 to retroactively go through the FDA’s complex, expensive, and lengthy premarket approval process.
With application costs ranging from $350,000 to $500,000 per product, these new rules would likely result in the shuttering of most manufacturers of e-liquid and vapor devices. This will remove smoke-free options from store shelves at gas stations, vape shops, and other retailers throughout the country.
Federal regulations should prioritize options for smokers who are trying to quit. Instead, despite evidence that vaping is an effective tool for helping people kick their smoking habit, our current regulatory framework is working against smokers who want to switch to vaping. One study last year from the British Medical Journal looked at American smoking rates and quit attempts, and found that smokers who used e-cigarettes and vapor products tried to quit smoking more often, and were more successful in quitting, than those who didn’t. Studies also show that the rise of the use of e-cigarettes is correlated to the decline of traditional smoking in the United States.
Fortunately, a bipartisan group of lawmakers in Washington have crafted legislation to balance these concerns from manufacturers, retailers, and consumers with common-sense regulation. The Cole Bishop Amendment, named for the two congressmen leading the charge, Reps. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., would modernize the cut-off date for product re-approval to 2016 and instead direct the FDA to establish clear products standards for all vape products.
The bill would also extend the current regulations to further safeguard consumers and keep vapor products out of the hands of minors. This includes banning any advertising to children, prohibiting self-serve options like vending machines so that retailers must sell face-to-face and ID, and requiring labeling of nicotine content.
Government policies and regulations should be supporting safety and innovation in the vaping industry, leading to safer batteries, better labeling, and other improvements for consumers. Instead, our current regulatory framework is at best hindering progress and at worst putting an entire industry, and the consumers that rely on its products, at risk. The Cole Bishop Amendment puts in place the common-sense reforms we need.
I hope that Sen. John Hoeven, Sen. Heidi Heitkamp, and Rep. Kevin Cramer add their support to this important legislation to help small business owners, preserve the availability of smoke-free products, and ensure smart regulation and safer products for vapor consumers.