Thread by @AriCohn

1/ Though my work is on speech issues, those who know me well know that #HarmReduction is an issue I care deeply about. Both because keeping people healthier & alive is good, and because it highlights the danger of overly intrusive govt.

So I want to talk about #vaping & #ecigs.

2/ A section of @POTUS' State of the Union Fact Sheet that didn't make it into the speech addressed the harms of smoking, and the importance of cessation and prevention.

whitehouse.gov/briefing-room/…

3/ Prohibition has never worked. Instead of failing repeatedly to regulate vice out of existence (which will never happen, and shouldn't be the purview of govt anyway), we should be enabling ways to keep people safer when they do partake in less-healthy activities.

4/ The SOTU Fact Sheet *also* notes the importance of, and strides made in, harm reduction for opioid abuse--a critical issue that I am glad to see positive movement on.

But it doesn't mention it at all for smoking, and that's a mistake because improvements are sorely needed.

5/ While vaping isn't totally safe (of course, no amount of car driving is totally safe either), it is certainly--on the whole--safer than smoking.

And there's evidence that e-cigs are more effective at helping people quit smoking than other options: pubmed.ncbi.nlm.nih.gov/34519354/

6/ And smoking *has* decreased. In 2007, when vaping products hit the market, nearly 20% of adults smoked cigarettes: cdc.gov/mmwr/preview/m…

In 2022, that number is 12.5%: cdc.gov/tobacco/data_s…

Millions of Americans who used to smoke, now vape instead. That's a win itself.

7/ What about when all those people were hospitalized in 2019 after vaping?

Thanks to inaccurate reporting and moral panic, many missed that this was linked to black market *THC* vapes (also, notably, a byproduct of prohibition), not nicotine vapes: theguardian.com/society/2019/d…

8/ And of course, so much of this discourse revolves around "won't someone think of the children." And it is true: smoking and vaping are both bad for kids! But has vaping made the problem worse among youths so as to justify hindering harm reduction availability for adults?

9/ In 2000, 15.1% of middle school students, and 34.5% of high schoolers, smoked cigs: cdc.gov/mmwr/preview/m…

In 2022, *vaping* rates were 3.3% (middle school), and 14.5% (high school): cdc.gov/media/releases…

Together w/ other tobacco products, 4.5% and 16.5%, respectively.

10/ So youth use has decreased, despite widespread availability, AND adults benefit from a less harmful alternative to cigarettes.

It's a positive development, but that harm reduction has happened *in spite* of government, which has taken an increasingly prohibitionist stance.

11/ The obstruction of harm reduction innovation has taken many forms. USPS won't allow vape products to be shipped. The FDA banned some flavored products, which did nothing, because--again--prohibition never works: urmc.rochester.edu/news/story/ban…

12/ But the FDA approval process for new products stands out as a uniquely senseless obstruction. Since 2009, the FDA's Center for Tobacco Products (CTP) has been charged with regulating tobacco products, which now includes Electronic Nicotine Delivery Systems (ENDS).

13/ Pretty much nobody is happy with the CTP. Not the industry, not the anti-tobacco lobby. Nobody. It has an annual budget of over $700 million, but is seemingly a rudderless ship without clear goals or priorities.

14/ The discontent is so great that the Reagan-Udall Foundation for the FDA (a congressionally-created nonprofit) was brought in to produce a report on the CTP's problems and how to fix them: reaganudall.org/operational-ev…

15/ In order to sell any such product that was not on the US market prior to 2007, the manufacturer has to submit a Premarket Tobacco Product Application (PMTA) and receive authorization.

16/ The FDA *says* it approves products using the "Appropriate for the Protection of the Public Health" standard consistent with the TCA, which is supposed to balance harm reduction effects and public health impact.

But it sure doesn't effectively communicate how it does so

17/ The Regan-Udall Report notes that the CTP said it wants to help people move down to lower-risk products like vapes, but then decides without telling anyone that it didn't really mean that, or really explain what it meant at all.

18/ It's also important to note that the PMTA process has to be completed not just for each new product type, but separately for each additional flavor, even if that's the only difference. Oh, and also if you change any component or function.

19/ So if a manufacturer finds a better, safer, more efficient piece, even if it's tiny and not a tech overhaul, or adds a new flavor, they're back in the application queue.

That might not seem like a bad thing, until you consider how long it takes for CTP to decide on things.

20/ On paper, once a completed application is submitted, the FDA has a 180-day period to make a decision.

The reality is...different.

21/ Take these Philip Morris supplemental PMTAs for new versions of products authorized in 2019: fda.gov/tobacco-produc…

The applications were submitted on 12/14/2020. They were granted on 1/26/23.

That's not 180 days. That's 770 days. For a new version of an existing product.

22/ That insane wait time on an application means that by the time authorization is granted, the products are obsolete--and customers don't have access to new, innovative products that may reduce harm even *more*.

23/ It's simply government at its worst. And if a huge company like Philip Morris, with its vast resources to navigate the process, are facing this, just imagine how much innovation from smaller upstarts is being stifled. The Regan-Udall report notes this specifically:

24/ Nothing about the process is clear to anyone (seemingly even the CTP), because the agency has not put in the work to actually setting standards, clearly communicating them, and doing basic things that would make the process less of a trainwreck.

25/ Even worse, the way CTP is doing things actually benefits companies that break the rules. Under the current enforcement priorities, companies can market a product illegally, then submit an application to bump themselves down the enforcement priority list.

26/ You may not have much sympathy for tobacco companies, but this process is clearly broken, and it actively hinders harm reduction efforts. It's not absurd to think that companies *want* to put out safer--that would present a huge reputational benefit.

27/ We should encourage that innovation instead of clinging to the false hope that one day everyone will wake up and say "you know what, I'm not going to do anything that presents a risk to my health." That's just not going to happen.

28/ Fortunately, CTP today announced their response to the Regan-Udall Report: fda.gov/tobacco-produc…

It's a start, but only time will tell whether the CTP has truly taken it to heart and is committed to fixing its dysfunction and fostering non abstinence-only harm reduction.

29/ Bonus: @GregTHR of @VaporAmerican did a great event with CTP Director Brian King, asking incisive question about the FDA's messaging, processes & policies, and regulatory issues:

*safer products, that is