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s2smodern

Harry Shapiro Director DrugWise

Now that he has been confirmed as the new FDA Commissioner, the heat is on Scott Gottlieb to torch the FDA deeming regulations that themselves threaten to set a match to America's vaping industry. (OK enough of the inflammatory metaphors). As a consequence of the new appointment, the industry has won a significant reprieve in the administration's decision to delay implementing the new FDA regime.

The Washington Post reported, “ While the administration has not indicated what it will ultimately do about the 2016 rule, the decision to side with the industry in delaying the rule represents a sharp policy shift from the previous administration. Industry officials are optimistic that they will get a favorable hearing from the administration, especially considering that a large number of lawmakers are on their side”

“What we’ve got to do is rein it back in,” said Tobacco Vapor Electronic Cigarette Association president Ray Story, referring to the 2016 rule. When it came to the administration, he added, “I certainly think that they are going to curb regulation, just to curb regulation, because it’s bad for business.” But he added, “I certainly don’t think they’re going to lift the veil and say, ‘Here you go, e-cigarettes, you can do whatever you want to do”.

No doubt this latest development has put the anti-vaping lobby on the back foot coming after the conflict of interest concerns surrounding Gottlieb (which haven't gone away) and the fact that there are those in the Trump administration with ties to the tobacco industry. For example, acting assistant-attorney general Chad Readler represented R J Reynolds before joining the Justice Department.

Meanwhile Judicial Watch has filed a lawsuit against the Health and Human Services department seeking to obtain internal records from the FDA, CDC and the Office of the Surgeon General pertaining to the claims about the carcinogenesis of e-cigarettes against traditional cigarettes. Judicial Watch are aiming to publicly expose why the FDA sought to impose tough restrictions on e-cigarettes having publicly declared they didn't have adequate data

http://www.vapingpost.com/2017/05/16/lawsuit-against-hhs-over-records-pertaining-to-fda-deeming-rule/

Now I'm quite prepared to admit that I don't get this, but Nature published what read to me a very confused editorial headlined “The United States must act quickly to control the use of e-cigarettes”. Just from that headline, it looks like another anti-vaping diatribe; it highlights the boom in vaping and mentions some of the key research questions that still need to play out, but then says “But studies suggest that e-cigarettes are considerably less harmful than cigarettes, and that they may help smokers to substitute a safer habit for a deadly one.”

It then bemoans the fact that while many other countries have regulations in place, the FDA only finalised its proposals last August and then the author goes into hand wringing mode over the new delays to implementation, although s/he does acknowledge that both those in the industry and “many public health officials...are concerned that the regulations are so onerous that they will squash the industry.”

The point of the editorial seems to be that the FDA needs to move quickly to put something in place even if not the whole deeming regulations red in tooth and claw. “Ideally, regulations would maintain safety standards and restrict marketing aimed at children and adolescents, while ensuring that e-cigarettes remain available to wean smokers off cigarettes.”

However in praising the speed of regulation elsewhere, the editorial overlooks the key issue that like the FDA proposals, most of them need tearing up and rewriting.

https://www.nature.com/news/the-united-states-must-act-quickly-to-control-the-use-of-e-cigarettes-1.2198

The Surgeon General's tip sheet for parents suggested they avoid answering the question 'I thought e-cigarettes were safer than ordinary cigarettes' - by doing what exactly? “Hey Chuck, look over there. A skunk with a gun”.”Phew, Mildred. I think we got away with it this time”. Meanwhile back in the real world where young people have access to Google, they might come across reference to a new study published in the Annals of Internal Medicine.

The research was conducted at University College, London where they tested the saliva and urine of 181 volunteers representing five groups: current smokers, current smokers who also use e-cigarettes, current smokers who also use nicotine replacement therapy (NRT) products such as gum or patches, former smokers who have switched to e-cigarettes, and former smokers who have switched to NRT. The researchers found all five groups were receiving similar amounts of nicotine, but as lead researcher Lion Shahad said the switchers showed "substantially reduced levels of measured carcinogens and toxins."

The differences between vapers and smokers were dramatic, ranging from 57 percent reductions in three volatile organic compounds (ethylene oxide, acrylonitrile, and vinyl chloride) to 97 percent reductions in acrylonitrile (another VOC) and in a tobacco-specific nitrosamine, a potent carcinogen. The levels for vapers were at least as low as those for NRT users and in some cases lower, which is striking because NRT is widely accepted as a safe alternative to cigarettes.

http://annals.org/aim/article/2599869/nicotine-carcinogen-toxin-exposure-long-term-e-cigarette-nicotine-replacement

http://reason.com/archives/2017/02/15/study-confirms-health-advantages-of-vapi

But the week wouldn't be complete without another bad news vaping story. Try this for size – vaping causes bladder cancer:

http://www.prnewswire.com/news-releases/studies-raise-concerns-for-the-bladder-cancer-risk-of-e-cigarette-smokers-and-show-intensity-of-traditional-smoking-increases-mortality-rate-of-bladder-cancer-patients-300456707.html

One simple response comes from Dr Farsalinos who makes the point that if nicotine caused bladder cancer, how come it hasn't shown up in either users of snus or any NRT product?

Alex Brill from the American Enterprise Institute is warning that as tax revenues from cigarette smoking decline, the governments should not be tempted to try and claw some of this back by onerous taxation of HNB technologies. He writes: “taxing e-cigarettes has not proven to successfully address budget woes. Based on actual experience with taxing e-cigarettes, it is reasonable to conclude that these taxes may actually do little to address government budget challenges. Minnesota (a US state with a population similar to Finland or Slovakia) collected just over $5 million in e-cigarette taxes in fiscal year 2014, or roughly $1 per capita. By comparison, annual revenue from all cigarette and tobacco taxation in Minnesota recently totalled nearly $660 million. A similar picture appears to have emerged in Italy and Portugal – the two European countries with the highest e-cigarette taxes. The e-cigarette markets in both countries contracted dramatically following the introduction of the tax, likely making it difficult to achieve revenue targets”.

The important point is not so much that e-cigarette tax revenue will ever seriously compensate for lack of tobacco revenue which will continue to flow into treasury coffers for a long time to come. It is that taxation could be used not just to increase income from HNB technologies but simply to put people off using. James I of England absolutely hated tobacco and published his famous 'Counterblaste to Tobacco' in 1604, but with 7000 tobacco outlets in London at the time, he needed tax revenue to fight endless European wars. His response was to the set a high tax rate not just to earn cash, but to dissuade all but “the better sort” from smoking. Result? Smuggling exploded and tobacco became so adulterated that the king had to introduce legislation to protect the very product he despised. It would be a public health disaster if regulators took advantage of the still small global market for e-cigarettes and taxed them out sight to the extent that only “the better sort” could afford them.

https://www.euractiv.com/section/health-consumers/opinion/dont-thwart-an-ally-in-the-war-on-tobacco/

And finally, we are all aware of the crimes and misdemeanors of the tobacco industry, but this article is worth reading simply because it attaches real personalities to the conveniently vague moniker Big Tobacco.

https://www.policyalternatives.ca/publications/monitor/%E2%80%9Ci-foresee-serious-criminal-liability-problems%E2%80%9D .