1/12 @FDATobacco has failed as a regulator for vaping products. Given most products are similar, @FDATobacco FDA could have set up a standardised form. It could even have populated it with what is already known (a lot) and spared millions of hours of work and repetitive waste. https://twitter.com/VaperNt/status/1302338290230546432

2/ FDA could have provided guidance on what would meet the public health standard without having to prove it in every case. In order to have consistency between assessors, between products and over time, FDA must have its own standardising guidance. It could have published that.

3/ FDA could have published 'findings' - e.g. settled understandings on, say, nicotine or PG & VG. It could have created a reference vaping product and focussed assessment on variations from this, on novel technologies or on unusual or suspect ingredients. It chose not to.

4/ The guidance FDA did publish is absurd. It is like an open-ended wish-list of every conceivable test or study that could add to the chance of approval. But FDA does not state clear success criteria, so applicants never know how much is too much or how little is too little.

5/ FDA does not need a PMTA for every product and does not need detailed analysis for every product variant. These were all *choices* FDA made. It just needs Alex Azer to be satisfied that allowing the product onto the market is appropriate for the protection of public health.

6/ FDA could have recognised that population effects are impossible to know in advance and the effort to predict them is data theatre. Given *obviously* much lower risk of vaping to the individual, it could have relied heavily on *post-market surveillance* for population effects.

7/ Also, a decision to allow marketing is *reversible* so that if anything does go wrong, it can be addressed as quickly and retrospectively. Not like releasing a pathogen or GMO into the environment. This means a regulator need not be so afraid of minor residual uncertainties.

8/ FDA has committed the cardinal sin of regulators. It has failed to make its regime 'proportionate'. Given that it gives a pass to cigarettes, vaping regulation is *anti-proportionate*. FDA has failed to make its own role "appropriate for the protection of public health".

9/ In this field, so-called unintended consequences should be the dominant concern of a regulator - for example, regulation and regulatory decisions that increase cigarette consumption, create black markets or force users into dodgy workarounds. FDA has failed to grasp this.

10/ The regulatory impact analysis for the deeming rule is like a bad joke - it completely fails to look at the interaction between smoking and vaping. It provides absurd underestimates of the compliance cost and the likely, er, impact of the regulation. https://www.fda.gov/media/97875/download

11/ So, why is @FDATobacco so hopeless as a vaping product regulator? It comes from being a tobacco regulator. That means costs, burdens and waste are a *feature*, not a bug. The aim is to block innovation, not to enable it, even if, as with vaping, the innovation is pro-health.

12/12 All this has been carefully set out to:
...the White House @OMBPress:
https://www.iowaattorneygeneral.gov/media/cms/MillerOMB_follow_up__3_Oct_2019__Pu_AD6FE02B6AB9B.pdf

...HHS @SecAzar: https://www.iowaattorneygeneral.gov/media/cms/PMTA_letter__190724__headed_45164DED1A0BA.pdf

But @SteveFDA and @FDATobacco have *not even tried* to be competent regulators of vaping and other reduced risk nicotine products.