Public health expert blasts ‘bizarre FDA vaping retail restrictions’

The vaping community is abuzz over a recent announcement by the U.S. Food and Drug Administration (FDA) that its long-anticipated PMTA process is finally confirmed and slated to begin within months.  Manufacturers of vapor products released to market prior to February 15, 2007 must submit a Pre-Market Tobacco Application for FDA approval by a nearing date that is yet to be officially determined, but insiders expect the deadline to fall in the range of four to ten months. 

In hindsight, however, there were signs that this ramping up of regulatory actions was imminent and perhaps even growing more severe in months leading up to their rollout.  One such example occurred in early March 2019 when the FDA released its draft compliance policy which attempts to restrict the sales of flavored vapor products through conventional brick-and-mortar retailers.

While industry-specific vape shops would be excluded, gas stations, convenience stores, and pharmacies were not.  For consumers in more rural areas who are trying to quit smoking through vaping, their access to vapor products would be severely limited, leading many public health experts to question the true motives behind the new FDA guidelines. 

The FDA is caught in an ‘auto-induced moral panic about the teen vaping’

The United Kingdom’s Clive Bates is one such public health expert who firmly believes that the FDA is overstepping its bounds of authority.  In an op-ed published in April entitled Bizarre FDA vaping retail restrictions more likely to do harm than good, the former Director General of the Welsh Government and Director of the United Nations Environment Programme (UNEP) made his opinions clear.

“Caught in its auto-induced moral panic about the teen vaping epidemic, the FDA has decided that it would be better if certain vaping products were harder to get hold of than cigarettes, and the ones that were easiest to get hold of should be the ones most like cigarettes – tobacco and menthol flavour. This seems entirely mad to me and riddled with the potential for unintended consequences that would increase smoking in both adults and adolescents…”

Related Article:  NYU study shows FDA endorsement of vaping would save ‘millions of life years’

Yes, Bates suggests, no official of the federal government should ever endorse or promote teen e-cig usage.  That’s a given. But labeling teen vaping a national epidemic just because a few youngster are experimenting occasionally with e-cigarettes– rather than the combustible tobacco products of generations past – is no reason to incite fear, chaos, and “bureaucratic harassment” among the adult vaping community.

“The main effect will be on adults: it is the casual bureaucratic harassment of law-abiding adults while they try to obtain regular supplies of products they are using as alternatives to smoking.  It won’t take many to relapse to smoking to blow any conceivable case for these measure right out of the water.”

Former FDA Commissioner, Dr. Scott Gottlieb, is responsible for releasing the new regulatory proposal, and in all fairness, he also allowed the creation of a website to solicit feedback from anyone who might be interested, including medical personnel, anti-vaping activists, and pro-vaping business owners.  Still, Mr. Bates believes these vaping FDA retail restrictions are “entirely mad” and a complete waste of time, not to mention a great detriment to public health. 

Related Article:  Is vaping doomed? New PMTA deadline may be just 4-months away

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UK study involving 60,000 teens shows less than 0.5% become daily vapers

When public health agencies in the United States begin sounding the proverbial alarm over allegations that teen vaping has somehow become a national epidemic, other nations around the world tend to listen. The same can be said when the U.S. Food and Drug Administration (FDA) consistently makes claims that vaping is a gateway to future smoking addiction among teens.

Public health officials in the United Kingdom appear to have been curious if the same things were occurring across the pond.  So, a group of researchers led by Professor Linda Bauld of the University of Stirling set out to uncover the facts.

To be clear, the federal public health agencies of the United States and Great Britain have vastly divergent points of view when it comes to vaping.  For example, the UK’s Public Health England (PHE) published documented research as far back as 2015 indicating that electronic cigarettes are up to 95% less harmful than smoking.  E-cigs are also openly endorsed and promoted by UK public health officials as a smoking cessation tool.

Related Article:  NYU study shows FDA endorsement of vaping would save ‘millions of life years’

Meanwhile, the American counterpart to PHE – the U.S. Food and Drug Administration– has never officially recognized or validated the UK’s 2015 research nor does it officially endorse vaping as a stop smoking tool.  The farthest the FDA will go is to admit that e-cigs may be useful for “tobacco harm reduction.” 

There are other differences of opinion, too.  A significant point of contention revolves around how each nation defines a “teen vaper.”  In the United States, FDA scientists usually make no differentiation between a youngster who may have experimented once or twice with an e-cig and an older 17-year teenager who vapes every day.   UK scientists, on the other hand, tend to pay closer attention to these types of details. 

And these details matter, especially when a federal public health agency like the FDA is making outlandish claims that teen vaping is now a national epidemic.  Details matter even more when these same officials are implementing a series of regulatory actions on the American vaping industry that are so severe that they threaten its very existence.

Overview of the teen vaping study

The University of Stirling paper is entitled Young People’s Use of E-Cigarettes across the United Kingdom: Findings from Five Surveys 2015-2017 (NCBI).  Dr. Bauld and her research team began by compiling extensive data collected from over 60,000 teenagers ages 11 to 16 residing throughout Great Britain and Scotland.  Surveys conducted by five highly reputable third-parties include “(t)he Youth Tobacco Policy Survey; the Schools Health Research Network Wales survey; two Action on Smoking and Health (ASH) Smokefree Great Britain-Youth Surveys; and the Scottish Schools Adolescent Lifestyle and Substance Use Survey.”  What the Bauld team discovered includes the following highlights.

  • 11% to 20% of teen respondents self-identified as “ever smokers,” meaning that they had tried a combustible tobacco cigarette at least once in their young lives.
  • Comparatively, 7% to 18% of respondents self-identified as “ever vapers.”
  • 1% to 4% self-identified as “regular smokers,” meaning that they had histories of smoking combustible tobacco products at least once per week.
  • Comparatively, 1% to 3% of respondents self-identified as “regular vapers.”
  • Of the 80% to 89% who self-identified as “never smokers,” only 0.1% to 0.5% (one-tenth to one-half of a percentage point) also self-identified as “regular vapers.”

According to the University of Stirling report, recent claims by the FDA regarding both the gateway theory and an alleged “epidemic” rise in teen vaping are grossly exaggerated at minimum and outright false at maximum.  In an interview with The UK news organization The Telegraph, Dr. Lind Bauld states, “Our analysis of the latest surveys from all parts of the United Kingdom, involving thousands of teenagers shows clearly that for those teens who don’t smoke, e-cigg experimentation is simply not translating into regular use.”

Related Article:  Public health expert says ‘Fear Profiteers’ are behind FDA push to kill vaping

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Public health expert says ‘Fear Profiteers’ are behind FDA push to kill vaping

“I started noticing all these media stories about Juul and adolescents, and I started wondering. Where is this coming from, because the research data wasn’t showing an epidemic? It was showing a very small percentage of teenagers experimenting with e-cigarettes, but it didn’t – in my mind – nowhere near rising to the level of the panic that I was seeing in newspapers, on blogs, etcetera.”
#FDADeming #PMTA #vape #Juul #ecigs
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Public health expert says ‘Fear Profiteers’ are behind FDA push to kill vaping

As the U.S. Food and Drug Administration (FDA) continues to ramp up its anti-vaping regulatory actions over the past few years, many within the vaping community appear to be living in a state of denial.  Mistakenly assuming that, ultimately, good always triumphs over evil, many vapers refuse to believe that the American vaping industry could be essentially regulated out of existence.  Unfortunately, it may be happening right before our very eyes as the FDA officially released its long-awaited PMTA guidelines last week which could go into effect within the next four months. 

Senior Fellow Michelle Minton of the Competitive Enterprise Institute in Washington, D.C. is an expert in FDA and other government regulatory strategies. She’s often a guest on shows like Fox News and has been asked several times to testify in congressional hearings, as well.  But it’s Minton’s rather controversial research paper which alleges a sort of anti-vaping conspiracy occurring at a national scale that is currently garnering increased attention.

FDA Chief Scott Gottlieb claims teen vaping is a national ‘epidemic’

According to an interview conducted by Brent Stafford of Regulator Watch, Ms. Minton was immediately taken off-guard when the former Commissioner of the FDA, Dr. Scott Gottlieb, released a press announcement last year labeling teen vaping as a national epidemic.  As reports of the FDA statement began surfacing in the Wall Street Journal, the New York Times, CNN, and elsewhere, she could not understand where these allegations were coming from. 

I started noticing all these media stories about Juul and adolescents, and I started wondering.  Where is this coming from, because the research data wasn’t showing an epidemic?  It was showing a very small percentage of teenagers experimenting with e-cigarettes, but it didn’t – in my mind – nowhere near rising to the level of the panic that I was seeing in newspapers, on blogs, etcetera.”

Related Article: Judicial Watch sues Feds over secret emails linked to FDA vaping regulations

These initial thoughts of alarm are the basis for her provocative white paper entitled Fear Profiteers: How e-cigarette panic benefits health activists.  While many within the vaping advocacy community firmly believe that either Big Tobacco or Big Pharma (or both) are somehow conspiring to eradicate vaping, Minton alleges that a third and perhaps even a fourth player may also be involved in the diabolical plot – anti-smoking advocacy groups and the mainstream media itself.  

“Yes. The misleading media response is the result of an orchestrated effort meant to create confusion and public panic over electronic cigarettes—part of a strategy to pressure governments to restrict or eliminate these alternatives to traditional cigarettes. As this paper will explore, the individuals and groups behind this fear campaign are those most likely to profit from it: anti-smoking and health advocacy groups.”
“For public health regulation to do more good than harm, regulators need to base decisions on an objective analysis of sound research and a thorough examination of the potential unintended consequences of policy proposals. They should not make decisions based on assumptions, blind fear, or political pressure.”

Related Article: Public health experts ask: Should ‘stupid kids’ be allowed to kill vaping

In short, Ms. Minton believes that “anti-smoking and health advocacy groups” are making money when they use widespread fear-mongering tactics to demonize vaping.  Even though these types of organizations are often listed as non-profits, they can boost their international profiles and professional reputations considerably by promoting intentionally falsified public scares.  As their reputation soars, they tend to appear higher on the lists of government agencies looking to award research grants and other forms of financial support.

“The air of authority these health charities seek to cultivate is heightened by the fact that they often function as an extension of government, sometimes as paid contractors of public health agencies. Not only do these health advocacy organizations receive government endorsement, they also receive financial support. Government entities are prohibited from lobbying. Instead, they route funding to health advocacy non-profits, either as direct grants or through programs sponsored by local health agencies. In this way, health advocacy nonprofits work as subcontractors for government entities, legally executing their shared Health advocacy nonprofits work as subcontractors for government entities, legally executing their shared political agenda. Fear Profiteers political agenda. Often, a centerpiece of that agenda includes lobbying to protect or increase access to public funds.”

In her research paper, Minton further illustrates her theories with a very relatable example involving TV commercials from the 1950s. Back then, it was very common for movie and television stars to appear in these televised advertisements promoting their favorite brands of tobacco cigarettes.

Lucille Ball and Desi Arnaz, for example, were regularly featured in TV commercials for Phillip Morris and Lucky Strikes which ran during their famous I Love Lucy sitcom.  In 1952 alone, well before the invention of cable TV or Internet video streaming, that single TV show captured a whopping 67.3 percent of the viewing audience.  

1950’s ‘I Love Lucy’ and its TV commercials hawking cigarettes

Then in the 1960s, the medical community began releasing data showing the significant health risks of smoking.  A few anti-smoking advocacy groups began to sprout up, but by the 1990s, there were thousands because more and more people began learning just how much money the federal government was willing to dole out in order to prevent smoking addiction.

While a noble endeavor in the 1990s, Ms. Minton suggests that the same thing is now happening to the vapor industry even though e-cigarettes are proven to be as much as 95% less harmful than smoking.   Through the intentional creation of misinformation campaigns demonizing e-cigs, anti-smoking advocacy groups like the notorious Campaign for Tobacco-Free Kids are essentially raking in millions of American tax dollars in the process.

Related Article: Public health expert: FDA is ‘overblowing the argument’ against vaping

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NYU study shows FDA endorsement of vaping would save ‘millions of life years’

“When nicotine is decoupled from the deadly toxins in inhaled smoke, it is substantially less harmful. Most of the harm is due to the inhalation of combustion products [about 70 human carcinogens and other toxins in particulate matter (sometimes called ‘tars’) and carbon monoxide]. E-cigarette aerosol is very different. E-cigarettes do not contain any tobacco and do not produce carbon monoxide.”
#NYU #vaping #Juul #FDADeeming #PMTA
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