A surprise shift in policy by federal officials on electronic cigarettes is giving a beleaguered industry a chance to “reduce their costs” while leaving the devices available for former smokers.
The U.S. Food and Drug Administration announced July 28 they are delaying costly requirements for product approval by four years to avoid financially upending the industry. Commissioner Scott Gottlieb said he wants the FDA to encourage the development of innovative technologies that can improve public health while leaving products currently helping smokers quit on the market.
Ultimately, the decision reschedules the deadline for companies to comply with the FDA’s “deeming rule” from Aug. 8, 2018 to Aug. 8, 2022. The rule requires retailers submit individual applications to the FDA for approval, costing between $100,000 and $400,000 for each product they sell.
“It’s really the first truly common sense thing we’ve seen out of the FDA in the last few years,” Jan Verleur, CEO of VMR and co-founder of V2, told The Daily Caller News Foundation. “They got things right. By abandoning the one size fits all approach to regulating the products the industry can provide choice. It’s nice to see that it was embraced at the top level. It’s massive.”
Verleur notes the decision is beneficial to both the economic health of the industry and general public health. The FDA is now giving the vaping industry recognition and admitting the rule “would have put 60 to 70 percent of the industry out of business, which is most small vaping companies.”
“There is a continuum of risk with vaper products and its important to embrace that, because if you overreach to the point where you can stifle any form of innovation you end up in a situation where you force people into higher risk products,” Verleur said. “Having those extra four years can help businesses reduce their costs. It’s a massively different hit to the corporation.”
Millions of Americans now rely on a vape product, many using the device to quit smoking or reduce their daily intake of combustible cigarettes. A study from the University of California released July 26 showed that a record number of Americans are ditching cigarettes with the aid of vaping devices, bolstering the image of e-cigarettes as an important tool for improving public health.
“Often times things are so political in Washington we don’t always get the decisions that are in the best interest of the consumer and users of the product, and I think this really is,” Verleur told The DCNF. “You may have 7 or 8 million people now who are using vaper products but at least 4 million are using them exclusively over combustible tobacco, so you’re looking at a degree of harm reduction of about 80 percent.”
Researchers found the rate of Americans quitting smoking jumped from 4.5 percent between 2010 and 2011 to 5.6 percent between 2014 and 2015. That means roughly 350,000 smokers gave up the habit between 2014 and 2015, which the researchers largely attribute to the rising popularity of vaping.
A spokesman for the White House told TheDCNF on July 31 that President Donald Trump “supports the FDA’s new initiative,” and noted it as an example of his administration’s efforts to give relief to small businesses across the country.
While vaping advocates agree that a delay of the “deeming rule” is welcome news, they note that the FDA must ultimately overhaul the policy if the industry is going to thrive in the future. The FDA will also attempt to reduce the levels of nicotine allowed in traditional cigarette products as part of their overall tobacco strategy.
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