FDA threats Banning Flavored E-Cigarettes

JUUL

Unelected Bureaucrats Consider Banning Adults from Buying Flavored E-Cigarettes

| SEP 12, 2018 |

2018-09-12T145325Z_1_LYNXNPEE8B1HF_RTROPTP_4_USA-FDA-ECIGARETTES

REUTERS/Mike Segar

FDA threats Banning Flavored E-Cigarettes

The Food and Drug Administration (FDA) is strongly considering banning all flavored e-cigarettes.

E-cigarettes, such as Juul, have become a popular alternative to smoking. The smoking alternative came under FDA control in 2016, when the administration placed an age requirement of 18-years-old on the product.

Now, the FDA wants to crack down on flavored products. FDA Commissioner, Scott Gottlieb, an appointee of President Donald Trump, stated, “We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion.”

The unelected officials at the FDA are now requiring private businesses, like Juul, to provide a detailed plan for how they will attempt to limit access of their product to those under 18.

Juul detailed their extensive plan on their website. Their plans include investing $30 million in educational materials for young people, ID match and age verification technology for online sales, age exclusive social media marketing, and support for legislation restricting access to those under 18.

Juul e-cigarette starter pack is seen in this picture illustration taken July 16, 2018. REUTERS/Martinne Geller/Illustration

Despite this extensive plan, some of the unelected bureaucrats at the FDA would still like to ban flavored e-cigarette products.

While the health risks for e-cigarette smoking are still being conducted, there are decades worth of studies on traditional cigarettes highlighting the horrible side effects of smoking.

One Harvard study found that e-cigarettes, while not good for you, are much less toxic than traditional cigarettes. Another study found that e-cigarettes are “no more or no less” effective than nicotine patches when used to help stop smoking.

A Juul spokesperson, Victoria Davis, argued in a statement to Reuters that “appropriate flavors play an important role in helping adult smokers switch.”

Although Gottlieb conceded that e-cigarettes may help adults stop smoking, it seems as though he won’t be swayed by Juul’s work to prevent kids from accessing the product.

U.S. Food and Drug Commissioner Scott Gottlieb attends an interview at Reuters headquarters in New York City, U.S., October 10, 2017. REUTERS/Eduardo Munoz/File Photo

“While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids,” said Gottlieb.

Instead of cracking down on enforcement to ensure that teens aren’t getting the product, it seems as though the FDA is leaning toward banning the product for everyone.

Despite the fact that not one person casted a vote for Gottlieb, his board at the FDA has the future of flavored e-cigarettes in their hands.

News Article from IJR.com

Direct Link to IJR article

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FLAVORED VAPOR: IN RESPONSE TO FDA ANPRM

VTA LOGO

VTA SUBMITS FULL SCIENTIFIC DEFENSE OF FLAVORED VAPOR
IN RESPONSE TO FDA ANPRM

July 21, 2018 –  On July 19, 2018, the Vapor Technology Association submitted VTA’s Comments on the FDA’s Advanced Notice of Proposed Rulemaking on Flavors, Docket No. 2017-N-6565.  VTA put itself in a position to present to FDA a scientific defense of flavors in ENDS products after engaging scientific experts to review, assess, and analyze all of the peer-reviewed scientific research on flavors and vapor products.

This intensive analysis – which had to be completed in very short order – required a significant amount of resources, a decision that was made by VTA’s Board of Directors which understood the importance of making the strongest possible case based on science to defend flavors in vapor products.  VTA wants to thank its regulatory counsel, Eric Heyer, Thompson Hine, LLC for his and the firm’s extensive work on VTA’s comments to the flavor ANPRM.  The professionalism, responsiveness, and attention to detail by counsel enabled us to present a thoughtful, clear, balanced, and forceful defense of flavors in vapor products.

SUMMARY OF COMMENTS

First, VTA framed the issues for FDA’s analysis explaining that the uniqueness of ENDS products in the overall discussion of this ANPRM requires that FDA examine vapor products differently and impose on itself a higher standard of scientific certainty before taking any action to regulate flavored vapor. As part of that analysis, VTA reviewed the well-known conclusions about the relative safety of vapor products, the unique position that vapor products occupy on the risk continuum, and the unique attributes of vapor products that distinguish them – and any policy related to flavors – from combustible tobacco products.

Second, VTA presented the scientifically based arguments for how and why flavors are helping adult smokers reduce and quit smoking combustible cigarettes.  VTA presented the key studies and surveys demonstrating that flavors are a key factor in cessation and, as importantly, VTA demonstrated the many scientific failings of the only studies that try to deny that flavors assist with cessation, explaining to FDA why those studies can carry no scientific weight.

Third, VTA presented the scientifically based arguments for why the concern of a “gateway” to cigarette smoking is entirely misinformed – emphasizing that there is no reliable science which could justify limiting flavors because of youth or adult initiation.

Fourth, VTA explained that the existing toxicological evidence on flavors and vapor products is simply underdeveloped and does not provide a basis for regulating flavors.  This is especially true when FDA is required to balance the interests of the potential adverse consequences, such as the real likelihood of smokers relapsing, the continued sale of unregulated products on the black market or the rapid expansion of an unregulated DIY market.

Finally, VTA encouraged FDA to consider the fact that we have many tools that can be deployed and strengthened to continue the rapid decline in youth vaping and emphasized the importance of the VTA Marketing Standards being adopted to further that goal.  In contrast, VTA noted that, other than vapor technologies, we simply do not have meaningful tools to help adult smokers quit, especially given the poor track record of existing NRTs that have had every marketing and regulatory advantage.  In other words, FDA cannot take any precipitous action to limit flavors in vapor products since that would simply remove what is proving to be an important tool in the smoker’s arsenal for reducing or quitting cigarettes.

HIGHLIGHTS OF VTA QUOTES
AND CONCLUSIONS

A review of the Table of Contents provides a full overview of the arguments and conclusions presented by VTA, but here are a few highlights from the lengthy submission from VTA.

FDA HAS NO SCIENTIFIC BASIS TO LIMIT FLAVORED VAPOR; VAPOR UNIQUENESS DEMANDS SCIENTIFIC CERTAINTY BEFORE REGULATION

“Based on VTA’s review of the peer-reviewed research on the role of tobacco and non-tobacco flavors in ENDS, FDA does not have a sound scientific basis upon which to issue a product standard or otherwise restrict the sale or distribution of any ENDS flavor.”

“For the sake of both individual and public health, FDA must examine the role of flavors in ENDS products differently than any other product under consideration and why FDA should impose on itself the highest standard of scientific certainty before it acts to regulate or limit ENDS flavors in any way at this time.”

“In light of the predictable harms that would result to former, current, and future smokers if access to non-tobacco flavored ENDS were restricted, FDA should demand of itself the highest level of scientific evidence before considering potentially restricting access to ENDS products.”

“Because the proven health risks associated with ENDS products are so low and the potential benefits of such products are so high, FDA should demand of itself the most rigorous scientific standard of certainty before considering any product standard or other restriction on the sale of flavored ENDS products.”

FDA MUST EXAMINE AND TREAT VAPOR PRODUCTS DIFFERENTLY THAN COMBUSTIBLES

“FDA must resist the temptation to lump together ENDS products with combusted tobacco products since doing so serves no meaningful scientific or policy objective when evaluating completely different types of products – one, an organic agricultural product that is combusted, and the other a consumer electronic that delivers a vapor which contains zero tobacco – the only common attribute of which is nicotine.”

“In addition to taking into account the accepted scientific conclusions that vapor products are demonstrably safer than combustible cigarettes, FDA also must take into account the place that ENDS products occupy on the opposite end of the risk continuum from combustible cigarettes – a place occupied by the products that deliver nicotine without combustion and in the absence of any tobacco.”

“Although ENDS are encompassed in the Tobacco Control Act’s broad legal definition of “tobacco products,” they differ markedly from virtually every other product covered by that definition in multiple meaningful ways and so must also be treated differently as a matter of FDA policy.”

“It is clear that ENDS products cannot be viewed through the same policy prism as characterizing flavors in other tobacco products, including cigarettes.”

“If nothing else underscores the fundamental difference between ENDS products and tobacco products, it is the fact that the naturally occurring flavor of e-liquids prior to the introduction of flavorings is NOT tobacco because ENDS e-liquids do not contain tobacco. […] This distinction is important because many of the presumptions that FDA may have in connection with why flavors are added to combustible products do not apply to ENDS products.”

“As noted in various studies, and as is obvious from a cursory review of the marketplace, there is a wide selection of ENDS products on the market with varying levels of nicotine.  This empowers the ENDS user with the ability to choose the amount of nicotine at which they start and, most importantly, choose lower levels of nicotine – including zero nicotine – as they mature in their use of ENDS.  This fact makes ENDS products entirely unique from all of the other products subject to this ANPRM and again requires FDA to be circumspect about limiting its availability.”

FLAVORED VAPOR HELPS ADULTS QUIT

“[A] strong trend in the scientific literature supports the proposition that the availability of a wide variety of non-tobacco flavors in nicotine-containing e-liquids used in ENDS products further bolsters smoking cessation and promotes larger numbers of smokers to permanently transition to less harmful ENDS products.  Rather than merely help sell more products, the availability of non-tobacco flavors in ENDS products actually advances the public health goals of reducing reliance on harmful combustible cigarettes and improving smoking cessation rates.”

“The existing reliable scientific literature on flavors and ENDS products-including longitudinal analyses, survey data, and experimental studies-trends strongly in favor of the conclusion that access to a wide variety of flavors-and particularly non-tobacco flavors-plays a critical role in encouraging cessation among existing smokers and preventing relapse.”

THERE IS NO GATEWAY TO SMOKING ASSOCIATED WITH FLAVORED VAPOR

“There is no reliable literature that concludes that the availability of non-tobacco flavors in ENDS products makes more likely any gateway effect of progression from ENDS to cigarettes.  In the end, as Dr. Rigotti clarified from the NASEM Report, the “enormous amount of ecological data” makes it “hard to argue that there is a gateway there.”

“Any regulatory action that would restrict access to non-tobacco flavors on the basis that they attract youth to ENDS would be premature and any such action undertaken on the theory that such flavors promote a gateway effect to combustible cigarettes would be entirely without any scientific basis.”

“The predictable adverse public health effects of limiting access to non-tobacco-flavored ENDS products would far outweigh any speculative public health benefit.  Consideration of the health effects associated with flavors in ENDS products also weighs against any product standard that would limit access to such products.”

ON BALANCE, FDA MUST PROTECT ENDS AND PROMOTE FLAVORED VAPOR

“The balancing of interests with respect to flavored ENDS products is relatively easy for FDA:  FDA must prioritize helping the adult smoker desperately trying to switch to noncombusted products like ENDS.  The short term individual benefits of ENDS have been recognized by NASEM, the relative safety when compared to deadly combustible cigarettes has been heralded by public health experts in the U.S. and around the world, and the potential long-term benefits are so critical to the public health of our nation that these considerations dramatically outweigh the speculative concern about initiation, no matter how much it may be sensationalized.”

“Never before has a revolutionary consumer technology offered an alternative pathway to cessation. […] Moreover, it is clear that ENDS products are so uniquely situated amongst all other “tobacco products” that FDA must recognize the ground-breaking tool that they offer FDA to achieve one of its biggest public health missions: eliminating cigarette smoking.  With that goal at the forefront of all considerations, the balancing of interests in favor of ENDS products and flavors is easy.”

If you have any questions regarding the VTA’s defense of flavors, please feel free to reach out.

Thank you for all you do to defend vapor, and let’s fight this fight together!

Tony Abboud

Executive Director
Vapor Technology Association

 

JULY2018 Vapor Calls To Action

JULY2018 Vapor Calls To Action

All CTA posted by date below

We hope you find this page helpful. Please let us know. We welcome feedback on CTA and/or VapeSling® products.

Reach us anytime on the contact page or custinput@vapesling.com, or vapersarmy@vapesling.com.

Also, Reach out to your state or local area Reps is asking your for HR1136 support. Unite to fight for our right to VAPE!

Write, call or both to your lawmakers

Here are some materials you can share on social media and as flyers around town.

VSLLC /VapersArmy Daily Updates

VSLLC conducts daily research for new CTA’s (Calls to Action) to publish and alert the community.

On occasion, one of the esteemed #2018VapeFight .org’s may publish a CTA later in the day. It may pass us till the next day. Help this page—> ON IG, we have received several CTA Alerts from concerned Vapers (#VapeWarriors). We appreciate this and please continue or join in this practice. We will publish your handle when you tag us for the alert. Thank you VapersArmy!

The Vape Community is family…being part of a family means doing your part. Please advocate for Vapor as Harm reduction for you and future vapers.

Posted 7/21/18 (Thank you @luv2vape on IG for the alert)

Posted 06.22.18

Today, the Vapor Technology Association (VTA) & Consumer Advocates for Smoke-Free Alternatives Association (CASAA) announced a nationwide campaign to submit Declarations to the U.S. Food & Drug Administration (FDA). These will be submitted regarding the Advanced Notice of Proposed Rulemaking regarding the regulation of flavors in tobacco products.

Follow this link – actnow.io/saveflavors – to learn more and submit your sworn declaration to FDA today.

Posted 6/25/18

Posted 06.16.18

Posted 06.02.18

NY – Stop a Flavor Ban before it Starts!

Posted 05.31.18

 

Posted 05.23.18

VT – Help stop a tax on vaping!

Posted 05.17.18

IL – Three bills would deny adult access to life-saving vapor products!

Posted 05.14.18 Thanks to IG’s @hell_wolfie for the alert.

VT – Help stop a tax on vaping!

Posted 05.10.18

 

Posted 05.04.18

The FDA is Coming – Vapor Business

Posted 05.0.18 —>Thank you @afcarmona & @jenbergercoleman from IG. Also Les Leung for the alert

Last day May 1st: A Survey just for Users of Vapor Products.

This study is performed for research purposes only, with the purpose of publishing the findings in scientific journals, presenting them in conferences and informing FDA regulators. Your replies will be used solely for the stated purpose and for no other study for which you have not previously been informed and give your consent.

Posted 04.24.18

NJ – Gov. Murphy is proposing a MASSIVE tax on vaping starting in FY 2019

Posted 04.20.18

MN – Stop an outrageous tax hike on vaping!

Posted 04.13.18

CASAA notice on FDA (ANPRM) Vapor Flavors. Click here to learn more plus take action.

Posted 04.09.18

FL – Stop an Anti-Vaping amendment in the state’s constitution!

Posted 04.03.18 —>Thank you @afcarmona & @jenbergercoleman from IG for the alert

A Survey just for Users of Vapor Products.

This study is performed for research purposes only, with the purpose of publishing the findings in scientific journals, presenting them in conferences and informing regulators. Your replies will be used solely for the stated purpose and for no other study for which you have not previously been informed and give your consent.

Posted 4/2/18

Posted 03.21.18 –>Thanks to @jenbergercoleman & @a.billion.vapers for the Heads Up!

 

Posted 03.12.18

MN – St. Peter – Stop tobacco AND vapor 21!

Posted 03.6.18

There is a deadline in Congress that is quickly approaching! A federal spending bill is being discussed NOW that could also include language that protects your right to vape and tightens restrictions on youth access! But to make sure the language stays in the spending bill, you should act now and spread the word!

We need to make sure that the final appropriations bill in the Senate has the “Cole-Bishop provision” that the House of Representatives has in its version of the bill. This crucial provision protects your right to vape, keeps your favorite products on the shelves, AND includes common-sense regulations that restrict underage access to vapor products.

Even if you have already reached out to your Members of Congress to Stop the Vape Ban, it is imperative that you reinforce your previous message! They need to hear YOUR story.

Visit the Stop The Vape Ban site now and let your Members of Congress know TODAY how important this issue is to you by tweeting them or sending an e-mail!

Click to Email Click to EmailThank you for your continued support!

Stop the Vape Ban
http://www.stopthevapeban.com/

 

From CASAA:

The word around Capitol Hill is that this week is the final week for lawmakers to make their decisions on final language for the US budget appropriations bill. We have until Friday, March 9th to urge officials to support a predicate date change for vapor products (section 753).

We need your help in humanizing the tobacco harm reduction movement and your story is central to this effort.

Please visit August8th.org and click on the phone icon.

Click on “Call Me” and we’ll connect you with your senators.

Points to discuss on your call with your senators:

  1. Briefly, share your story about how switching to vaping has helped you.
  2. Politely tell staff that you would like your senator to support modernizing the predicate date for vapor products.
  3. Make sure you thank staff for taking the time to listen to your comments.

If you get a recording, please leave a message.

Also remember to follow up with an email and a tweet. Just like making a call, we’ll connect you at August8th.org.

Thank you for your participation and support,

Alex Clark

CEO, CASAA

Posted 03.5.18

IL – Bolingbrook – Stop Tobacco and Vapor 21!

Posted 03.2.18

VTA: TELL CONGRESS TO WORK AS HARD AS YOU ARE TO KEEP E-CIGS AWAY FROM MINORS! CLICK HERE TO SEND THAT MESSAGE! 

Misinformation on vapor use and marketing to youths, is everywhere.

Your concerns should be your lawmakers concerns. TAKE ACTION NOW: CLICK HERE TO SEND THAT MESSAGE!

For Details, please click here.

Posted 02.19.18

 

Posted 02.15.18

 

Posted 02.08.18

Your support is making a difference, and your voice is being heard – but we need you to keep encouraging your Congressional officials to support this modernization of the predicate date that is included in the House version of the budget.

Please TAKE ACTION and visit the Stop The Vape Ban site now. Let your Members of Congress know TODAY how important this issue is to you by tweeting them or sending an e-mail!

Click to Email Click to Email

Thank you for your continued support!

Posted 02.02.18 IN – Lafayette – Stop an indoor vaping ban!

Posted 1.30.18 Thank you for the Alert @beerdog123 on IG WA – Stop vaping taxes!

Posted 1.22.18 UT – Stop an outrageous tax on vaping!

Posted 1/19/18 AK – Keep Vaping OUT of Smoking Laws! (SB 63)

Posted 1.12.18 VapeWarriors and Vape Shop Owners: Download your Stop The Vape Ban Posters here

Posted 1/4/18

IQOS: Tobacco seeks to simulate the winning vape industry with it’s own alternative. Although better than traditional cigs, it’s still smoking whatever BIG Tobacco wants you to inhale. Vape e-liquid contains no deadly tar. Tobacco does. Plus, the trust of what you are inhaling is on Big Tobacco’s hands to do their worst. Such as the 900+ chemicals included with the tobacco in cigarettes. Now in a vaping device such as used for MMJ, BIG Tobacco can attempt to create the illusion of a healthier alternative. We can only hope this format of IQOS does not fool some into continuing the deadly tobacco habit. In worse case, reverting vapers back to Big Tobacco dollars. Truly a genius move by RJ Reynolds and all in Big Tobacco. VapeWarriors are a smarter bunch, yet need to heed the warning to family and friends. IQOS is still smoking BIG TOBACCO unknown fillers not VAPING a clean e-liquid.

IQOS
IQOS

 

The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is a non-profit 501(c)(4) organization with an all-volunteer board and a grassroots membership of more than two hundred thousand individuals from all walks of life, and we are growing daily. We are a consumer organization, not a trade association. We are dedicated to ensuring the availability of reduced harm alternatives to smoking and to providing smokers and non-smokers alike with honest information about those alternatives so that they can make informed choices.

The timeline includes links to articles, patents, court decisions, and many other resources to give a comprehensive history of this revolutionary alternative to combustible tobacco.

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VTA Webinar: Proper Vapor Marketing

VTA Webinar: Proper Vapor Marketing

VTAWeb1
Unacceptable Marketing will be just that, come August 10th, 2018

Dear VapeWarrior/VapeSlinger,

We’re sorry you weren’t able to attend our webinar. It was very well received and we are going to do a follow up to address MORE of the questions that were asked.

Many of you have asked to watch the recording and can do so using the link below. Also, if you want to download the documents, visit www.SaveVapor.org/Guidance.

Also, please make sure that you are signed up for our mailing list so that you can stay up to date on future webinars. You can sign up either at www.vaportechnology.org or www.SaveVapor.org.

Thank you for your interest!

Tony Abboud
Executive Director
Vapor Technology Association

Watch Recording

Please send your questions, comments and feedback to: abboud@vaportechnology.org.

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VapeSling LLC is a Nevada, USA based company. All our employees are proud members of The Consumer Advocates for Smoke-free Alternatives Association (CASAA), The Vaping Militia and the National Vapers Club (NVC); three organizations that further encourage ex-smokers to continue smoke-free lifestyles through scientific research on electronic cigarettes, education about vaping and vaping products, as well as help protect vaper rights through activism on the local, state, and federal levels. We also donate to .orgs such as NBS, and we hope you will too.

We created a VapersArmy on InstaGram that spread the word of justice for vapers. We furthermore, post every single CTA that exists currently on our dedicated web page –> Calls To Action – Vapor Products. We update this the daily in addition to update news posts under latest news. All vapers have access. No one has an excuse to not fight for Vaper Rights. Before this author goes on a rant about sheeple, we will move on.

On several occasions, VapeSling staff members have taken action on issues directly affecting our vaping community such as contacting several of our local Nevada politicians as well as the President himself. We encountered most favorable responses from Senator of Nevada, Dean Heller and recently Representative of Nevada Joe Heck . If you are a local to Nevada, please contact them to express your vaping concerns and relay any call to action from vaping advocate groups, clubs and associations. Furthermore, thank and support Joe Heck and Dean Heller by voting for their renewed services on election day.

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The FDA is Coming – Vapor Business

SFATAWebinar

The FDA is Coming – Vapor Business

The FDA is Coming – Vapor Business Watch the SFATA Recorded Video Webinar here

Please skip to the 9 minute marker, while waiting for attendees

SFATAWebinar
SFATA The FDA is Coming
The Webinar provides Comprehensive guidance for retail and manufacturing compliance regarding FDA regulations and inspections. Extremely important information for all in the Vapor industry. Also an interesting watch for vapers and what to expect at your Vape Stores/online sales.

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