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

The U.S. Food and Drug Administration (FDA) finally released its updated guidelines for the Pre-Market Tobacco Applications (PMTA) process last week, and vapers are growing increasingly concerned.  Of the 401 applications submitted for approval in April 2019, only four received FDA approval, and each of those four applications were for Big Tobacco heat-not-burn technology.  Meanwhile, the deadline for applications submissions is still be battled out in the courts, but the judge overseeing the case sis indicating that a 4-month timeline is not out of the question.

As the threats from government officials, politicians on Capitol Hill, and now the judiciary branch continue to escalate, scientists and public health experts from around the country are also becoming more vocal.  A recently published study from New York University (NYU) researchers suggests that government endorsement of vaping as “substantially less harmful” than smoking would result in “millions of life years saved.”

“Under all but the most implausible scenarios, population simulation modeling estimates millions of life years saved by employing the principles of harm minimization and switching smokers to safer ANDS products.  Replacement of most cigarette use by e-cigarette use over a 10-year period yields up to 6.6 million fewer premature deaths with 86.7 million fewer life years lost. America and the world need a candid smoking control champion—a figure like C. Everett Koop, Surgeon General during the first eight years of the AIDS epidemic—to get out the latest accurate information about reduced harm ANDS products that could save millions of smokers’ lives. Ethics and integrity in responsibly interpreting the scientific evidence with rigor and with common sense, demand it.”

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

The NYU research is entitled Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine Use to Rapidly Save Lives (Annual Review of Public Health).  According to the paper’s co-authors, smoking-related illness and disease is a leading cause of death in the United States as well as globally.  Unfortunately, many average consumers and even many of the key decision-makers in Washington, DC are being deceived by massive amounts of misinformation being spread online and in mainstream media about the alleged dangers of vaping.

Nicotine is not tobacco, and vaping is not smoking

One of the core arguments that the anti-vaping establishment often makes is that teen vaping increases the risks of becoming an adult smoker in the future.  The public outrage really began to escalate when when former FDA Commissioner Scott Gottlieb labeled teen vaping as a national “epidemic.”  Yet, government agencies still refuse to release scientific data that supports these alarming claims.

Though current research on this topic is rather limited, many reputable public health experts in the private sector are now speaking out against these allegations.  Some are even suggesting that this widespread fear-mongering campaign may be a more devious attempt to kill the American vaping industry in favor of the very deep pockets of the Big Tobacco lobby.  In an interview with Regulator Watch, Dr. Brad Rodu of the University of Louisville in Kentucky, has even accused the FDA of “cherry-picking” the facts to create a “fake epidemic” that is “vastly overblown.”

“The Numbers that U.S. regulators are basing their claims on simply aren’t available to the wider research community.  The one thing we know for sure is that in 2017 vaping was increasing but at a modest rate.  And a lot of the current frenzy about the ‘epidemic’ has been based on 2018 data, and unfortunately, only the FDA, the CDC, and other federal authorities have access to that data.”

Related Article:  FDA deeming regulations update: PMTA approval process finalized

The NYU researchers take very special care to explain the differences between nicotine and tobacco, which evolves into a deeper discussion of the differences between vaping and smoking.  The co-authors indicate that nicotine alone and in small doses is not toxic to the human body nor is it highly addictive, especially when compared to smoking combustible tobacco products.  Furthermore, the e-liquids used in vaping are 100% tobacco-free, even though the FDA officially classifies them as “tobacco products.” 

“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.”

The NYU study appears to be very detailed, thoroughly investigated, and peer-reviewed by hundreds of public health experts.  The paper also contains a remarkable 144 resource references containing third-part documentation to support the co-authors’ claims.  While the study falls short of outright accusing public health officials of intentionally creating a fake news event surrounding teen vaping, it also makes very clear that “the mistaken public beliefs that nicotine is the cause of disease risk and cancer, rather than the smoke from combustion, must be dispelled.”

Related Article:   The ‘kill vaping’ conspiracy: Regulator Watch releases shocking video interview

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Is vaping doomed? New PMTA deadline for may be just 4-months away

It’s been an eventful week for the American vaping industry as the U.S. Food and Drug Administration (FDA) finally released its much-anticipated guidelines for the Pre-Market Tobacco Application (PMTA).  A crucial component of the 2016 FDA deeming regulations, the new regulations directly affect an estimated 99% of e-cigs and e-liquids currently on the market.

As the shock wave spreads across the vaping community after the FDA’s Tuesday announcement, vapor manufacturers were still missing one critical fact.   When, precisely, do these applications need to be submitted? 

Related Article:  FDA deeming regulations update: PMTA approval process finalized

The PMTA deadline has been a moving target from almost the very beginning.  In 2017, the original cut-off date of August 2018 was eventually moved forward by almost five years to August 2022.  This past March, it was moved back to 2021, perhaps due to the filing of lawsuits by American Pediatric Association (APA), the Campaign for Tobacco-Free kids, and other anti-vaping groups.

Then on May 15, 2019, Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ruled in the APA case that the FDA had acted illegally by delaying the PMTA deadline in the first place (Case No.: PWG-18-883).  In fact, Judge Grimm says the agency’s delay is “so extreme as to amount to an abdication if its statutory responsibilities” while also demanding that the PMTA review process begin within 30-days. 

Does the FDA’s PMTA process favor Big Tobacco over vaping?

Meanwhile, the judge also allowed the APA to submit a proposed remedial order outlining how the organization would prefer the FDA to proceed.  The APA recommended that the entire PMTA process be up and running within 120-days or just four months from the May 15 ruling.   Mitch Zeller, Director of the Center for Tobacco Products, a subsidiary agency of the FDA and overseer of all things related to the FDA deeming regulations, shot back immediately with a revised deadline of his own.

Zeller states that the 120-day deadline would “cause significant public health concerns as well as implementation challenges…It could suddenly clear the market of thousands of e-cigarette products, raising the risk that some former smokers addicted to nicotine might migrate back to conventional cigarettes, and is likely to flood the Agency with thousands of low-quality applications that would strain Agency resources and significantly delay processing… if the Court orders a deadline for the submission of premarket applications, it should set that deadline no sooner than 10 months.”

The FDA response went on to claim that of the 401 PMTAs already received as of April 2019, “more than 99% (369/373) were closed as insufficient to accept or file, largely for failure to include an environmental assessment.”  Only four applications were approved, and these were not for vaping products but for heat-not-burn technologies manufactured by Big Tobacco. 

Related Article:  Judge orders FDA to begin approval process for vaping devices immediately

 The FDA had previously announced that companies will be allowed to continue selling their products for one year after the submission of their application to give the agency enough review time to approve or deny the applications.  This guideline may also change depending on the final opinions of Judge Grimms. 

However, the expedited PMTA deadline is likely to be bad news for possibly thousands of  smaller “Mom and Pop” retail shops selling e-liquids and other vape products.  Along with the completion of an official PMTA form, which itself is highly detailed and complex, the manufacturer must also provide additional information, such as:

  • A detailed description and perhaps photographic imagery of the product packaging
  • The voltage, amperage, wattage, and battery chemistry
  • Battery testing certifications
  • Voltage protection methods and technologies for the prevention of overheating or “explosions”
  • “Chemical testing, applying existing scientific literature or analyses about similar products to the proposed new tobacco product, including multiple distinct products in a single submission and referencing tobacco product master files.”
  • E-liquids ingredients, if applicable
  • Proof that the products is an effective tool for tobacco harm reduction
  • And more

The FDA estimates that the cost of a single application would fall somewhere between $100,000 to $400,000, but most experts in the vaping industry expect the final price tag to be significantly higher.  And again, many of those Mom and Pop vape shops will have a very difficult time coming up with that amount of cash… per product.

Whether the PMTA process begins in four months or ten, the earth is now shaking under the collective feet of the American vaping community.  The time to stock up is now.

Related Article:   Beverly Hills snuffs sales of vaping & tobacco (except at posh hotels & cigar bars)

from VAPES – VAPES News Blog http://bit.ly/2KRQYUJ

Eye Roll Alert: Congress announces investigation into teen vaping ‘epidemic’

Rep. Raja Krishnamoorthi (D-Illinois) is only one among many politicians on Capitol Hill who continuously blast the American Vaping industry for alleged violations of underage sales.  While most people would agree that the same sorts of infractions occur at a much grander scale within the Big Tobacco market, Krishnamoorthi and his cohorts refuse to give up.

Now that the Democrats have won the majority in the House, the Illinois lawmaker has been promoted to Chairman of the Subcommittee on Economic and Consumer Policy.  With chairmanship comes the ability to conduct congressional investigations, and the teen vaping “epidemic” just landed a slot on the docket.  In a June 10 press release announcing the new probe, Chairman Krishnamoorthi makes the following statement specifically targeting Juul Labs.

“The safety and well-being of America’s youth is not for sale.  I am extremely concerned about reports that JUUL’s high nicotine content is fueling addiction and that frequent JUUL use is sending kids across the country into rehab, some as young as 15.  At 5% nicotine weight content, your products have nearly three times the nicotine by weight allowed in the European Union.”

Related Article:  Dear Sen. Durbin: Research shows vaping acts as roadblock (not gateway) to smoking

The press release also includes a link to a special letter sent to Juul where Krishnamoorthi asks the Vaping Giant to produce a variety of documents dating back as far as 2013, examples of which include:

  • Verification of Juul’s “earliest indication” that underage purchases “comprised a substantial share” of its social media engagement.
  • Documentation of company research into successful marketing tactics of the past previous employed by Big Tobacco and their possible relevance to the future potential profitability of similar advertising strategies later employed by Juul
  • Social media analytics information
  • Social media hashtags histories
  • Documentation regarding research conducted by Juul-employed behavior scientists as related to on-house marketing and advertising tactics
  • Information regarding “every celebrity, influencer, and marketing agency”

For now, the congressional investigation seems to be focusing almost entirely on Juul Labs, but the outcomes will likely affect the vaping industry as a whole.   Furthermore, Krishnamoorthi’s fundamental reasoning behind the need for a congressional probe in the first place appears to be almost entirely based on anti-vaping rhetoric originating from the U.S. Food and Drug Administration (FDA).

Related Article:  Big Pharma conspiracy deepens; FDA considers ‘drug therapy’ for teen vapers

Just last year, Former FDA Commissioner Dr. Scott Gottlieb labeled teen vaping as a national “epidemic,” even though numerous public health experts have refuted these claims repeatedly.   In fact, many of the experts often quote statistical data compiled by none other than the U.S. Centers for Disease Control and Prevention (CDC) as proof that the “epidemic” conspiracy theories are just plain wrong.

But there may be more to the story.  In April, nearly a dozen Democratic senators also sent a letter to Juul, but this one demanded information behind it’s deal with Altria, the Big Tobacco company which recently purchased a 35% share of Juul Labs. 

Is there a teen vaping epidemic conspiracy?

What’s so strange about this whole thing is that Krishnamoorthi and his congressional cronies always seem to ignore the fact that Big Tobacco is a significantly much greater threat to public health than an e-cigarette company ever could be.  And what’s more, Big Tobacco has been guilty of selling to teens for decades and with comparatively little political or regulatory repercussions.

So, why are politicians continuously demonizing and trying to eradicate an industry that literally saves millions of people’s lives?  The answer to that question may lead to another political conspiracy theory involving Big Pharma.  And the plot thickens.

Related Article:  The ‘kill vaping’ conspiracy: Regulator Watch releases shocking video interview

(Image courtesy of C-SPAN)

from VAPES – VAPES News Blog http://bit.ly/2IcM4QC

FDA deeming regulations update: PMTA approval process finalized

Earlier today, the U.S. Food and Drug Administration (FDA) issued a press release announcing the completion of its guidelines for the Pre-Market Tobacco Application (PMTA) process.  Though the FDA deeming regulations of the 2016 regarding federal oversight of the e-cigarette and vaping industries is nothing new, the PMTA process itself has remained only partially defined.

With no definitive PMTA pathway for approval clearly detailed within the original multi-page document of the FDA deeming regulations, vape retailers and wholesalers around the world have been left largely in the lurch.  The original verbiage only states that any vaping companies wanting to sell vapor products in the USA to submit an application for approval on all products originally released to market after February 2007.

However, numerous questions immediately began to surface regarding the FDA’s initial demands for supporting documentation that would accompany the PMTA, and FDA officials didn’t know how to answer most of them.  So, the FDA began issuing a series of deadline extensions, which enraged anti-vaping activists and eventually, a whole lot of politicians on Capitol Hill.

Related Article:  Vaping cheers as Gottlieb extends FDA e-cig regulations to 2022

The initial deadline for PMTA submission of August 2018 has been extended at least twice by the former FDA Commissioner Scott Gottlieb.  The current deadline is August 2022, which seems to be still intact. Gottlieb’s replacement, Acting FDA Commissioner Ned Sharpless, issued the following statement which does not specifically identify a new or revised submission date.

“The FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death. The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health…” 
 
“The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product. There are no authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications. At the same time, the public can be assured that the FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren’t being marketed to, sold to or used by kids.”
 

The release of the completed guidelines arrives about one month after a Maryland District Court judge ruled against a lawsuit filed against the FDA by the American Academy of Pediatrics and other public health advocacy groups.  Judge Paul W. Grimm’s ruling document (Case No.: PWG-18-883) essentially says that the FDA acted illegally by allowing vapor and e-cigarette products to remain on the market until March 2022 without an approved PMTA.  The judge also gave the plaintiffs 14-days to propose recommended remedial actions to the FDA, and less than 30-days later, the FDA published its updated PMTA guidelines.   

Related Article:  Judge orders FDA to begin approval process for vaping devices immediately

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