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 vape juice 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.