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New FDA Statement On Vape Products: Nice Rhetoric, No Substance

New FDA Statement On Vape Products: Nice Rhetoric, No Substance

Carl V. Phillips | Contributor

In a new document entitled, “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap,” the FDA lays out its goals for nicotine policy among other topics. On its face, it reads like good news for vaping. A deeper read, along with background knowledge about FDA policy and practice, suggests that this interpretation may be too optimistic.

The document states, “the Agency must also take a fresh look at products that can deliver satisfying levels of nicotine to adults who want access to it without burning tobacco.” It continues, “With appropriate product regulation, new technology, and product innovation – including new medicinal nicotine products and electronic nicotine delivery systems (ENDS) – could present an opportunity for more smokers to quit combustible tobacco and stay quit.”

That sounds good, apart from the hint that the FDA thinks of vapor products as basically being medicines. However, the FDA has been trying to sound good about low-risk alternatives to smoking since it gained authority over tobacco. But every policy decision has gone in the opposite direction. This includes denying multiple applications from smokeless tobacco manufacturers who wanted to tell consumers those products are less harmful than smoking, and banning new flavors of one smokeless product that were clearly aimed at smokers. There is also the deeming of e-cigarettes itself, which unnecessarily triggered a doomsday countdown for all products (now delayed from 2018 to 2022, but still counting).

The deeming already prohibits innovation and product upgrades in the vapor product market. The only new products allowed — and the only products allowed as of 2022 — will be standardized closed systems, mass produced on a scale that justifies the millions of dollars that new product approval costs. Thus, the “appropriate regulation” necessary to achieve “new technology and product innovation” must include ending these restrictions. The FDA’s document does not suggest they have any such intention.

Even apart from the Orwellian “safer families” (there is nothing about families in the document), the document is mistitled. It is not actually a roadmap — not unless you consider a page with a starting point and destination marked, but nothing but blank space in between, to be a roadmap. It is more of a wishlist.

There are a few vague points under the heading “Actions.” In the nicotine section, most of these are either busywork (“Initiate a public dialogue surrounding nicotine”), about the FDA’s main goal of forcing cigarette manufacturers to reduce nicotine content, or about increasing anti-vaping restrictions and propaganda (banning “kid appealing e-liquid flavors”; “expanding FDA’s public service programs aimed at reducing youth use of tobacco, including ENDS”).

There are two points about making regulations more conducive to the stated goal of encouraging smokers to switch, but they are exceptionally vague. The first reads:

Establish an appropriate regulatory framework for new product innovations that could serve as less harmful alternatives to combustible tobacco, for adults who want to get access to satisfying levels of nicotine. Create a framework to properly evaluate their safety and potential benefits.


Tobacco 21 Advocates are pushing the debunked gateway vaping narrative



Tobacco 21 Advocates Are Pushing The Debunked ‘Gateway’ Vaping Narrative

Steve Birr | ContributorAnother state is mulling a hike to the minimum tobacco purchasing age, relying primarily on the debunked claim that e-cigarettes are a “gateway” to smoking for teens.

Officials are using alarmist tactics, pushing misinformation on the effects of vaping, in order to secure a tobacco purchasing age hike in Idaho, that will also apply to all vapor products. Proponents of the Tobacco 21 agenda in Idaho make the unsubstantiated claims there is little proof the devices help smokers quit, instead arguing the majority of e-cigarette users are teens, reports WTVA.


Philip Morris vows to give up smoking for the new year!

Philip Morris vows to give up smoking for the new year: Tobacco giant plans to stop selling cigarettes as they turn to trendy vaping

  • The big tobacco company launched an advertising campaign in the UK  on Wednesday, promising to ween its business and customers off of cigarettes
  • It claims to be investing in smokeless tobacco and launched a quitting informational website 
  • Philip Morris’s move is the latest in a series of big tobacco companies’ attempts to reshape their businesses for an anti-smoking world
  • But recent file dumps and investigations into research methods suggest the companies may not be as good as their words 

Tobacco giant Philip Morris International aims to stop selling cigarettes in the UK, it announced on Wednesday in a new advertising campaign.

The Marlboro-maker’s move is the latest in a wave of big tobacco companies’ – including the unaffiliated Philip Morris USA – efforts to re-brand themselves in an increasingly anti-smoking world.

Philip Morris International (PMI) also launched a new website, smokefreefuture.co.uk to inform and encourage its UK customers to quit.

Its campaign is also pushing PMI’s smokeless products, such as e-cigarettes, as healthier alternatives – an initiative that backfired against Philip Morris USA earlier this year when the legitimacy of its internal studies on e-cigarettes was called into question.

Philip Morris International's new advertising campaign promises that it is now dedicated to switch from cigarettes to safer alternatives, along with its customers

Philip Morris International’s new advertising campaign promises that it is now dedicated to switch from cigarettes to safer alternatives, along with its customers

PMI placed advertisements in a number of UK-based newspapers today, with the abbreviated ones stating simply, in the company’s signature shades of blue that ‘Our New Year’s Resolution’ is that ‘we’re trying to give up cigarettes.’

Its full-page advertisement details the actions that PMI has taken and plans to take to ween itself and its customers after the cigarettes it ‘is known for.’

Recent events indicate that big tobacco companies around the world are finally accepting that cigarettes, their bread and butter, may finally be on their way out amid irrefutable evidence that cigarette smoking is the leading cause of early death.

Instead, tobacco companies are embracing anti-smoking messaging – albeit, a bit late in the game – and the international trend toward e-cigarette use.

Between 2014 and 2015, sales of battery powered, smokeless vaping devices surged by 14.4 percent across the US as cigarette sales slowly continued to peter out, declining by 1.4 percent

In an effort to join the growing e-cigarette industry, Philip Morris USA sought Food and Drug Administration (FDA) approval for its iQOS device last year.

The FDA has not yet issued its decision on the product, but reports of inconsistencies and low quality research that surfaced last month do not bode well for the company’s foray into the vape market.

Several countries, including the UK have passed laws requiring cigarette cartons to be devoid of appealing advertising, and, in some places, to feature graphic health warnings instead.

This sort of legislation was met by outrage and concern by big tobacco companies and lobbyists, but recent research has suggested that, at least among teenagers at risk of taking up smoking – the warnings may have the opposite of the desired effect.

But in the face of this change, PMI is taking a different approach with today’s announcement.

In its full-page advertisement, the company said that its ‘ambition is to stop selling cigarettes’ to the 6.7 million smokers in the UK, because ‘the best action they can take is to quit smoking.’

The big tobacco company laid out its new initiatives in full-page advertisements in several UK newspapers, but anti-smoking organizations are dubious of its claims


The big tobacco company laid out its new initiatives in full-page advertisements in several UK newspapers, but anti-smoking organizations are dubious of its claims

For those that will continue to smoke, the company wants to ‘replace cigarettes with products, such as e-cigarettes and heated tobacco which are a better choice.’

PMI claims to have already invested the equivalent of $3 billion USD in developing the products in Europe.

The company promised to back government quitting campaigns and to seek approval for quitting and ‘switching’ informational inserts to put in its cigarette packs.

PMI’s own anti-smoking website, smokefreefuture.co.uk, is curiously ‘only intended for UK and Ireland residents,’ and is not accessible from people seeking information from ‘restricted’ countries, including the US.

‘You might wonder if we really mean it. We do,’ PMI assured readers in the advertisements.

But anti-smoking organizations like the Truth Initiative are not so quick to buy the company’s proclamation that it’s changed its ways.

In a press release, the Truth Initiative wrote that ‘Philip Morris International’s claims are inconsistent with its current behavior.’

In the first three financial quarters of 2017, PMI shipped 20.5 billion units of its purportedly safer heated tobacco products – more than 5 times as many as it distributed the previous years.

But that number still pales next to the 565.6 billion units of cigarettes it sent out in the same period of time.

The Truth Initiative argues that if it were seriously anti-smoking now, PMI would cease sales and production of cigarettes altogether, but evidence suggests that the company may not be in such a hurry to make that happen.

Beginning in July, Reuters published a series of PMI documents that reveal the company’s correspondences and meetings with delegates from various countries, in secret efforts to undermine the World Health Organization’s global anti-smoking Framework Convention on Tobacco Control (FCTC).

The Truth Initiative points to these activities as well as ad campaigns like PMI’s ‘Be Marlboro’ promotions, which, it says are aimed at teenagers and young people.

Quoting previous statements made by Philip Morris executives, claiming that they would stop selling cigarettes if they knew they were harmful, Truth Initiative said that today’s announcement ‘isn’t the first time Philip Morris has stated a commitment to ending cigarette sales, but every prior announcement was nothing more than a smokescreen to enable it to continue business as usual.’


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