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

Though Efest has overrated this cell a bit it is a good performer, beating the 10A Samsung 48G and 15A Sanyo NCR20700B for total vaping time at low power levels, under 7A/20W. It appears to be a rewrap of the LG M50 cell.

The two cells I tested delivered 4900mAh and 4957mAh at 1.0A (0.2C) down to 2.5V. Neither cell met its 5000mAh rating. Every cell should easily beat the capacity spec as it’s just a minimum guaranteed value. It should not be the maximum you can expect if you’re lucky.

LG rates the M50 at 4849mAh minimum to 5014mAh typical though so this Efest still meets LG’s specs.

I am estimating this Efest’s ratings to be 7.3A and 4900mAh. 

Two cells were donated for the purposes of testing by Brad’s Vapor (https://www.bradsvapor.com). Thank you!

Ratings graphic: https://imgur.com/a/7vfDjU6

Test report: https://bit.ly/2uHWbWi

I want to work for the vaping community full time! If you feel what I do is worth a couple dollars a month and you would like early access to battery availability and testing news and a say in what I test then please consider becoming a patron and supporting my testing efforts: https://www.patreon.com/batterymooch

These tests only note the estimated ratings for these batteries at the time I tested them. Any battery that is not a genuine Samsung, Sony, LG, Panasonic, or Sanyo can change at any time! This is one of the hazards of using “rewrapped” batteries or batteries from other manufacturers so carefully research any battery you are considering using before purchasing.

Misusing or mishandling lithium-ion batteries can pose a SERIOUS RISK of personal injury or property damage. They are not meant to be used outside of a protected battery pack. Never exceed the battery’s continuous current rating and keep the plastic wrap and top insulating ring in perfect condition.

Any rating in my ratings tables can change at any time as different grade cells appear on the market, we get swamped with fakes, or new information becomes available to me. Please, never assume that the ratings in the tables are permanent and will never change! Always download the latest version before considering any cell purchase.

To see how other cells have tested check out this link: https://www.e-cigarette-forum.com/forum/blog-entry/list-of-battery-tests.7436/

This one made me angry. Aspire has a good reputation so my expectations were high. But for this cell they decided to roll us back a couple years and use a hugely exaggerated current rating without mentioning it is some sort of “pulse” rating. 

The wrap on this cell just says “35A”. We can only assume, since there is no (useless) “max” or pulse” designation, that it means this cell is rated to 35A even for a continuous discharge. Except that during a continuous discharge at that level the cell gets hot enough to boil water and one cell failed during its first discharge at 35A.

Some other concerns…

A paper insert included with the cell seems to indicate that they are claiming this cell has a continuous rating of 20A. A “Vaping Simulation” rating of 30A is also given by them on the insert. Where does the 35A rating on the wrap come from then?

What happens if this paper insert is lost or cells are taken out of their boxes for display in a shop? There would be no indication as to how exaggerated the 35A number on the wrap was.

The discharge graph for this cell on Aspire’s web site, now deleted but included below, showed temperatures about 20°C lower than I measured, a huge difference. I am unable to explain this. The temperatures on Aspire’s discharge graph don’t match those on their paper insert either.

The four cells I tested delivered 2944mAh, 2964mAh, 2989mAh, and 3077mAh at 0.6A (0.2C) down to 2.5V. Only one of the four met its 3000mAh rating. One other came close though. But every cell should easily beat the capacity spec as it’s just a minimum guaranteed value. It should not be the maximum you can expect.

These cells performed a bit worse than LG HG2’s but it’s probably not noticeable in a regulated mod. The shorter run time of this Aspire versus a 30Q or VTC6 might be noticeable though.

I am estimating this Aspire’s ratings at 20A and 2900mAh. It appears to be a China manufactured cell, probably from Long Deli New Energy Company, Ltd., which Aspire has used before.

Immediately after testing I fired off an email to Aspire basically yelling at them for all the things mentioned above. We spent a lot of time talking and I agreed to include a statement from them in this test report. I’m happy to say that they are willing to take the unsold stock of this battery and rewrap them all with more accurate ratings.

Four cells were donated for the purposes of testing by Aspire (http://www.aspirecig.com). Thank you!

Aspire’s statement: https://imgur.com/a/U1Yp5J3

Ratings graphic: https://imgur.com/a/jeyl0fo

Test report: https://bit.ly/2O0TU0t

These tests only note the estimated ratings for these batteries at the time I tested them. Any battery that is not a genuine Samsung, Sony, LG, Panasonic, or Sanyo can change at any time! This is one of the hazards of using “rewrapped” batteries or batteries from other manufacturers so carefully research any battery you are considering using before purchasing.

Misusing or mishandling lithium-ion batteries can pose a SERIOUS RISK of personal injury or property damage. They are not meant to be used outside of a protected battery pack. Never exceed the battery’s continuous current rating and keep the plastic wrap and top insulating ring in perfect condition.

Any rating in my ratings tables can change at any time as different grade cells appear on the market, we get swamped with fakes, or new information becomes available to me. Please, never assume that the ratings in the tables are permanent and will never change! Always download the latest version before considering any cell purchase.

Hundreds of thousands of fake comment submissions have ground FDA’s regulatory process over the proposed regulation of flavors in vaping products to a halt.

As RegWatch first reported, a minimum of 250,000 bot submitted fake form-letters that are anti-flavors and anti-vaping in nature overwhelmed servers at Regulations.gov putting the entire public consultation process at risk. FDA could decide to throw out all submissions, including legitimate testimonials, provided by tens of thousands of vapers.

The vaping industry is fighting back. The Vapor Technology Association, a leading industry trade group, is running a coordinated public comment campaign to help vapers make an impactful “declaration” to the FDA on why flavors are essential to vaping.

In this extended edition of RegWatch, hear from VTA’s executive director Tony Abboud and learn what the strategy is going forward, to save flavors.

Only on RegWatch by RegulatorWatch.com

Produced by: Brent Stafford

Released: July 17, 2018

This is the VT4, not the VTC4. While both are similarly rated the VT4 didn’t perform as well.

The two cells I tested delivered 2130mAh and 2156mAh at 0.4A (0.2C) down to 2.5V. This cell’s rated capacity is 2000mAh and its nominal capacity rating is 2100mAh. I try to use the rated capacity as that is the guaranteed minimum but I think most of them will deliver 2100mAh (at low current levels).

The two cells ran a little hot at 22A in my testing for that to be their continuous rating. I am estimating this Sony’s ratings to be 20A and 2100mAh.

While these are not bad performing cells at all the VTC4 performs better at 10A and much better at 20A. Considering the high internal resistance I measured for the VT4’s they could be lower grade cells as Sony does not overrate.

Two cells were donated for the purposes of testing by 18650BatteryStore (http://www.18650batterystore). Thank you!

Ratings graphic: https://imgur.com/a/ooWbW3x

Test report: https://bit.ly/2moUgl7

I want to work for the vaping community full time! If you feel what I do is worth a couple dollars a month and you would like early access to battery availability and testing news and a say in what I test then please consider becoming a patron and supporting my testing efforts: https://www.patreon.com/batterymooch

These tests only note the estimated ratings for these batteries at the time I tested them. Any battery that is not a genuine Samsung, Sony, LG, Panasonic, or Sanyo can change at any time! This is one of the hazards of using “rewrapped” batteries or batteries from other manufacturers so carefully research any battery you are considering using before purchasing.

Misusing or mishandling lithium-ion batteries can pose a SERIOUS RISK of personal injury or property damage. They are not meant to be used outside of a protected battery pack. Never exceed the battery’s continuous current rating and keep the plastic wrap and top insulating ring in perfect condition.

Any rating in my ratings tables can change at any time as different grade cells appear on the market, we get swamped with fakes, or new information becomes available to me. Please, never assume that the ratings in the tables are permanent and will never change! Always download the latest version before considering any cell purchase.

To see how other cells have tested check out this link: https://www.e-cigarette-forum.com/forum/blog-entry/list-of-battery-tests.7436/

A quick recap: It appears that Vapcell is now wrapping a lower current rated cell, estimated in the 20A-25A range.

What I am doing now: I have received four cells I ordered from Liion Wholesale and four more I ordered from Illumn are on the way. I have also received two from Eciggity (arranged by Vapcell) and four more are being sent by Economy Ecigs Distro, the ones who sent me the first set of lower rated cells.

No cells are being sent directly from Vapcell. No cell will be accepted without the clear outer heat shrink added when they were initially wrapped. I am confident that none of the cells I am testing have been “cherry picked” but, if true, it is easily confirmed by comparing their performance to the others. If any company ever tries crap like that there will be hell to pay.

I am making this retesting a priority.

I will be doing physical examinations and AC and DC internal resistance, capacity, and discharge testing of these fourteen cells to try to figure out what the hell is going on.

This is going to take a lot of work so my response time to the questions I get every day will get longer. Please, be patient.

As soon as I have more information I will post it.

Please do not send me pictures asking me what version of this cell you have. Compare your cells to the pictures I have posted. If you are not sure, assume they are rated 20A. 

Photos: https://imgur.com/a/GXjagS1

This and another recent incident, to be posted about soon, have pushed me far enough. I’m not happy about the abuse I am taking from every angle just because these companies are using exaggerated ratings, inconsistent performing cells (they often don’t even know about), switching cells, or using lower grade Samsung, Sony, etc., cells whenever they want.

New ratings methods for China manufactured cells are being created. If companies want to use these cells, fine. But the ratings will reflect the actual inconsistency of their performance. I imagine lots of people will be pissed off with the new ratings but this is the hand we have been dealt by these companies. More info about this in a week or two.

Dammit…

A PBusardo Review – The Vaporesso Polar Kit (Again) + New Contest!

In this video we take another look at the Vaporesso Polar.

Did they fix the issues? Well… kinda. Take a look. This time it get’s the “Full Busardo”.

The Links:

Vaporesso
Vapor DNA

The Video:

*NOTE: Any use of these videos in part or in their entirety without Phil Busardo’s expressed written consent is strictly prohibited.

The Photos:

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The Test Sheet:
ReviewForm - Vaporesso Polar

As war stories go, no one tells it better than the man at the center of the battle to legalize vaping in Canada: Shaun Casey. As the president of the Canadian Vaping Association, he’s played a pivotal role in guiding the industry through the minefield of what is now newly minted regulation. While at the same time, fighting fiercely for vaper rights and the long-term viability of Canada’s vaping industry.

In this special in-depth edition of RegWatch, we sit down with Casey at Canada’s Vape Expo in Toronto to talk wins, losses and what’s next in the fight to save vaping.

Only on RegWatch by RegulatorWatch.com

Produced by: Brent Stafford
Released: July 11, 2018

A PBusardo Review – The Aspire Spryte AIO + Last Contest Winner!

In this video we take a look at the Aspire Spryte AIO, a wildly satisfying little device. We also find out who one the last “Not A” Contest and add a Spryte to the prize pack!

The Links:

Aspire
Vapor DNA
Vandy Vape
VapeFly
GeekVape
Smok Tech

The Video:

*NOTE: Any use of these videos in part or in their entirety without Phil Busardo’s expressed written consent is strictly prohibited.

The Photos:

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While this cell has a useless large 35A “max” current rating on the wrap it has an accurate continuous current rating. Its capacity rating is slightly exaggerated though.

I am thrilled that the continuous discharge rating (CDR) is mentioned on the wrap but I hate seeing the use of a “max” current rating. I hope Golisi removes the max rating soon.

The four cells I tested delivered 2577mAh, 2580mAh, 2586mAh, and 2600mAh at 0.5A down to 2.5V. Only of the four met its 2600mAh rating and barely at that.

These cells performed pretty well. While the Sony VTC5A outperforms it for the first half of a 25A discharge this cell matches the VTC5A for the rest.

I am estimating this Golisi’s ratings at 25A and 2550mAh.

Golisi wanted our community to know that they have product liability insurance for their batteries. I don’t know the specifics of what benefits this offers to vapers or vendors. Contact Golisi for more information.

Four cells were donated for the purposes of testing by Golisi (http://www.golisi.com). Thank you!

Ratings graphic: https://imgur.com/a/BZnDVkl

Test report: https://bit.ly/2u5iCVk

I want to work for the vaping community full time! If you feel what I do is worth a couple dollars a month and you would like early access to battery availability and testing news and a say in what I test then please consider becoming a patron and supporting my testing efforts: https://www.patreon.com/batterymooch

These tests only note the estimated ratings for these batteries at the time I tested them. Any battery that is not a genuine Samsung, Sony, LG, Panasonic, or Sanyo can change at any time! This is one of the hazards of using “rewrapped” batteries or batteries from other manufacturers so carefully research any battery you are considering using before purchasing.

Misusing or mishandling lithium-ion batteries can pose a SERIOUS RISK of personal injury or property damage. They are not meant to be used outside of a protected battery pack. Never exceed the battery’s continuous current rating and keep the plastic wrap and top insulating ring in perfect condition.

Any rating in my ratings tables can change at any time as different grade cells appear on the market, we get swamped with fakes, or new information becomes available to me. Please, never assume that the ratings in the tables are permanent and will never change! Always download the latest version before considering any cell purchase.