The vaping industry is launching an appeal against a federal rule it charges does a “massive disservice to public health” by threatening to wipe out businesses.
Nicopure Labs LLC filed a Notice of Appeal Wednesday challenging the July 21 ruling by Judge Amy Berman Jackson upholding the deeming rule from the Food and Drug Administration. While the FDA recently rescheduled the deadline for companies to comply with the costly rule from Aug. 8, 2018 to Aug. 8, 2022, it still looms as a major threat to the future existence of the industry.
The deeming rule requires businesses to retroactively submit each individual product to the FDA for approval before it can be sold. Businesses will have to file applications for nearly every product they currently sell at a cost of $100,000 to $400,000 each. Many vaping retailers anticipate closure under the rule because they simply cannot afford to comply.
“We believe in helping millions of adult smokers battle tobacco addiction through vaping products,” Jeff Stamler, CEO and co-founder of Nicopure Labs, said in a statement Wednesday. “We believe the FDA is doing a massive disservice to public health and we will keep fighting for the vaping industry to ensure these products will continue to help a growing number of people quit tobacco and start a new, smoke-free life.”
FDA Commissioner Scott Gottlieb announced new plans for tobacco regulation July 28, which included the deadline extension for the deeming rule. The FDA will also attempt to reduce the levels of nicotine allowed in traditional cigarette products as part of its overall tobacco strategy.
The extension was welcomed news for vaping companies, but industry experts say it does not change their long-term outlook. The deeming rule is also causing short term headaches for vaping companies. Since the rule was implemented on Aug. 8, 2016, businesses have not been able to release new products, hampering the technological innovations coming out of the industry.
“The deeming rule as a whole still does not change and it still does not take into consideration the harm reduction potential of e-cigarettes,” Patricia Kovacevic, general counsel and chief compliance officer of Nicopure Labs, told The Daily Caller News Foundation in July. “The grandfather date stays the same, and we still cannot launch new products or improve on existing ones to keep up with advances in technology. So, while grateful, much more needs to be done and the entire regulatory framework needs to be reevaluated and changed.”
Advocates argue the FDA must ultimately ditch the rule entirely if the vaping industry is going to survive and thrive in the future.
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