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FDA Commissioner Scott Gottlieb delays FDA’s vapor PMTA application deadline and vapor prohibition date from November 8, 2018 until August 8, 2022, vaguely endorses THR, calls for FDA to develop a new comprehensive plan for tobacco, nicotine, vapor and flavor product regulation 


FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
FDA's New Plan for Tobacco and Nicotine Regulation

Scott Gottlieb’s special announcement on tobacco/nicotine/vapor policy is at
Center For Tobacco Announcement

Gottlieb also said FDA CTP intends to:
- maintain Deeming Rule’s sales ban on all new vapor products since August 8, 2016,
- maintain Deeming Rule’s ban on truthful health claims by vapor manufacturers,
- reevaluate Deeming Rule’s policies on vapor products, cigars and OTP,
- promulgate regulations and final guidances for PMTA, MRTP and SE applications,
- promulgate rules on "kid-appealing" flavors in tobacco/vapor products (after FDA and its funding recipients falsely claimed, since 2009, that flavorings are marketed to youth),
- promulgate more rules and standards for ENDS (vapor products), and
- mandate low nicotine cigarettes (which would increase harms for many/most smokers, and would create an enormous black market for cigarettes).

News articles on FDA Commissioner Scott Gottlieb’s announcement are at
FDA unveils plan for major changes to tobacco product regulations
FDA aims to lower nicotine in cigarettes in bid to get smokers to quit
Tobacco Shares Plunge After FDA Proposes Cut to Cigarette Nicotine
FDA aims to cut nicotine in cigarettes, shift toward e-cigarettes
British American Tobacco not surprised by FDA move to cut nicotine

Altria responds to Scott Gottlieb’s announcement
Press Release

Clive Bates: Huge FDA announcement on future tobacco and nicotine strategy
Huge FDA announcement on future tobacco and nicotine strategy

Reposted from Bill Godhsall's post over on ECF. 

 

This doesn't mean everyone should start popping bottles, PMTA is still greatly in effect. This just means that deeming regulation has been pushed forward. 

Posted

Doesn't it look like no new products will be allowed? Maybe I read it wrong. I do wish we could hurry and find out what's good and bad in vaping as I quoting smoking April 22 and although I sometimes feel better other times my lungs do hurt but I chain vape at 6 mg on sub ohm tanks.  I need to exercise of self control

Posted

That is correct. That's been the case since last year (though not too many vendors are actually following the rule). 

What this does is give vendors (and vapers at least) some breathing room over the next few years and potentially even some time to lobby against certain aspects of PMTA. (Though honestly, I feel it's probably here to stay). I know of a few large vendors who had exit strategies in place for next year. At least for now, those are sidelined.

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