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(Washington, D.C.) – The Electronic Vaping Coalition of America (EVCA) wholeheartedly applauds today’s announcement by the Food and Drug Administration that it is putting the controversial tobacco “deeming” regulation on hold for five years as it looks to balance regulation and encouraging the development of innovative, less dangerous tobacco products.
The announcement came on the heels of a letter sent by Hartland, Wisconsin to the FDA yesterday (July 27) that the agency either begin coordination proceedings to align the federal “deeming” rule with local economic interests, or face a lawsuit. The letter included some 70 pages of evidence that the deeming rule would devastate a local vaping manufacturer and major economic driver.
“Today the FDA opened the door to coordination,” said Mark Block, EVCA founder and director. “What Commissioner (Scott) Gottlieb and Mitch Zeller laid out in their announcement today goes hand-in-hand with what Hartland demanded.”
The new FDA plan calls for delaying the timeline to submit product review applications for electronic nicotine delivery systems (ENDS) or e-cigarettes to Aug. 8, 2022. That time will allow the agency to develop public health standards and manufacturers to develop better, more complete applications. In addition, the FDA will actively work on gaining public input into its regulatory content.
“This is a total shift in agency policy from the bureaucratic “We will write it and you follow it” traditions at the agency,” Block said. “Hartland has insisted on public input starting with its third day of hearings back April. And pushing back the timeline for what would have been a very costly preapplication process shows the FDA clearly recognizes what Hartland has advised – it needs far more information from actual stakeholders before implementing such vague overreach.”
The July 27, 2017 letter to the FDA stated that coordination with Hartland can address and solve the following issues:
“EVCA will continue to support coordination efforts in Hartland, and what will undoubtedly be more communities who can now see for themselves why the coordination process has been so successful in standing up to federal agencies,” said Block. “Until we see a complete overhaul of this regulation – such as legislation introduced by U.S. Rep. Duncan Hunter – there’s always threat the rule will destroy the vaping industry and smokers’ options to quit.”
In a somewhat extraordinary and unexpected development Scott Gottlieb, the newly appointed head of FDA, has announced that the submission deadline for PMTAs is to be delayed until 2022.
This is a de-facto endorsement of the vaping industry and heads off the cataclysmic demise that was set in motion by the previous administration.
The grandfathering date from last year is not changed, so new products may not be introduced to the market, although it’s unclear what enforcement there is likely to be on that front.
This delay comes as part of a comprehensive anti-smoking plan which also involves the (controversial) denicotinisation of tobacco cigarettes which will start in 2021. In reality, this could be transformative for the vape industry, as smokers move to vape products to get their nicotine which is no longer available from smoking.
My intel suggests that the FDA’s interim focus will be on underage sales and “kid-centric” flavors, although it’s not clear in practice how the latter will manifest. The rulemaking process for setting standards for characterizing flavors will take at least three years.
In any case, this is huge news for vapers and for the vaping industry. Thousands will rest much easier tonight knowing that this life-saving movement can continue to grow and help fulfill the mission of the coercion-free end of smoking.