FDA to Severely Restrict Sales of Many Vaping Products

Commissioner Scott Gottlieb caves to pressure campaign; makes it harder for adult smokers to quit.


https://www.vaporfi.com/?A=9329

WASHINGTON, D.C. — This morning, FDA Commissioner Scott Gottlieb is scheduled to make a speech regarding the future of tobacco and nicotine regulation in the United States.  According to leaks provided to the Washington Post and other outlets last week, Commissioner Gottlieb is expected to announce plans for the FDA Center for Tobacco Products to:

  • Restrict the sale of closed system e-cigarettes like JUUL and blu in flavors other than tobacco, mint, and menthol to vape shops (or other adult-only environments), while allowing flavored e-liquids to continue to be sold in all retail environments.
  • Issue guidelines for online sales of vaping products.
    • Begin the process of banning the sale of cigarettes and possibly e-cigarettes in menthol flavor.

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Gregory Conley, President of the American Vaping Association — a nonprofit that advocates for sensible regulatory policies towards vaping products with the aim of maximizing the number of adult smokers who switch to vaping — offered the following comments in the lead-up to Commissioner Gottlieb’s announcement:

On new restrictions on the sale of closed system vaping products:

“No youth should vape and there is room for more rigorous enforcement to ensure youth are not accessing these products. However, this move by Commissioner Gottlieb will only serve to make it harder for adult smokers to switch to a far less harmful alternative. Not every town has a vape shop, meaning that for many adults, it will be much easier to pick up a pack of Marlboros or Camels — or even an unrestricted cherry-flavored cigar — at a local convenience store than it will be to make the switch to a vaping product that can truly help smokers break their desire for cigarettes.
“While it is nice to see Commissioner Gottlieb recognize that flavored e-liquid products are not a significant issue with youth, the sad fact remains that he has done nothing in his tenure as FDA Commissioner to push for reasonable regulatory reforms on this sector of the industry. Without reform, the small- and medium-sized American businesses that produce these e-liquid products will be decimated by inordinately expensive application requirements that only large tobacco companies and perhaps JUUL are prepared to face. Simply put, the very same e-liquid products that Commissioner Gottlieb acknowledges are making a difference in the lives of adult smokers currently have no path to gain approval by the agency.
“Allowing convenience stores to continue selling mint and menthol pods is hardly a compromise worthy of applause. In the coming days or weeks, adult ex-smokers will find themselves unable to easily purchase products that have helped them become smoke-free. Tragically, some ex-smokers will likely end up relapsing back to cigarettes because of this reckless policy shift. Congratulations, Commissioner Gottlieb.”
On Internet sales:
“The vast majority of online sellers of vaping products use third-party age verification systems that appear to have withstood FDA compliance checks. Any retailer not using such a system should be put out of business, including sellers on third-party websites like eBay and Amazon.”
“Notably, the FDA has never released a list of Internet retailers that have refused to sell to minors in sting operations. Meanwhile, the FDA has documented tens of thousands of compliance checks on traditional retail stores. The FDA’s continual failure to release data on their Internet operations is worthy of questioning.”
On menthol e-cigarette bans:

“Commissioner Gottlieb has no rational justification for proposing this ban. While menthol in cigarettes has been documented as reducing the harsh taste of burning tobacco, the complete absence of tobacco leaf makes this argument nonsensical when applied to vaping products. If the FDA is going to ban menthol cigarettes, it should be working to ensure that satisfying alternatives are available for the adult smokers impacted by this ban, not prohibiting such products from remaining on the market.”

[Note: Like all early reporting on Commissioner Gottlieb’s forthcoming announcement, the menthol ban being extended to e-cigarettes has NOT been confirmed.]

On JUUL’s ‘voluntary’ plan to restrict sales of their flavored pods:
“Saying we are disappointed in JUUL’s decision to fold on flavors would imply that we actually thought they had a backbone and would fight for their adult customers.”
“With massive private investments and big prospects for international expansion, JUUL should not have an issue surviving this hit to their revenue. That does not mean this was a smart move though. Waving the white flag of surrender in their home market in a desperate attempt to win over their enemies will only serve to set a terrible precedent that will come back to haunt them as they bring JUUL to new countries.”
These comments are preliminary and may be changed if the content of Commissioner Gottlieb’s announcement differs from the agency’s leaks to the media.

 photo 14680600_10153766777976249_8873161743145297457_n.jpgAbout the American Vaping Association The American Vaping Association is a 501(c)(4) nonprofit organization that advocates for fair and sensible regulation of vapor products, otherwise known as electronic cigarettes, with the goal of maximizing the number of adult smokers who use these products to quit smoking. The AVA was founded by Gregory Conley, a consumer and industry advocate with a long track record of advocating for vapor products dating back to 2010.

We are dedicated to educating the public and government officials about public health benefits offered by vapor products, which are battery-powered devices that heat a liquid nicotine or nicotine-free solution and create an inhalable vapor.  The AVA is not a trade group and does not speak for any particular businesses, including our industry sponsors.

You can learn more about AVA and vaping by visiting the AVA website. You can also find us on FacebookTwitter, and Instagram.  You can also reach out to Greg Conely at Contact: Gregory Conley
Tel: 609-947-8059
Email: gconley@vaping.org


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VTA RESPONDS TO FDA ANNOUNCEMENT


https://www.vaporfi.com/nextmind-ct1-vape-pod-starter-kit.html?A=9329

Today, the Food & Drug Administration announced numerous actions related to tobacco control and the vapor industry.  Vapor Technology Association has met with the FDA and worked relentlessly on vaper’s behalf to advocate for our industry. Our members have already announced proactive steps far in advance of today’s actions to curb youth access. Most importantly, VTA has been your voice in Washington advocating for the fair and common-sense regulation of these products.

Today’s announcement makes one thing abundantly clear: The FDA has heard our message. 

First, flavored ENDS products must be treated differently than dangerous combustible cigarettes. We applaud Commissioner Gottlieb’s recognition that combustible cigarettes and flavored cigars must be treated differently than live-saving ENDS products. ENDS products – specifically flavors – are fundamental to improving public health through transitioning adult smokers to less harmful alternatives.

Second, from the first time that VTA met with the Commissioner they spoke of the importance of vape shops.  Today, we are pleased to see FDA’s recognition of the hard work from vape shops around the country in being responsible stewards and representatives of our industry.  The VTA are currently represents vape shops in nearly 30 states, and today’s announcement vindicates the hard work our retailers do every single day to ensure proper distribution and strong enforcement of age verification to keep these products out of the hands of minors.

Third, FDA indicated its intent to continue to crack down on the improper marketing of ENDS products, rather than simply ban flavors in ENDS.  This was the single most important message we left with the Commissioner, and his actions to date and again today demonstrates that he is dedicated to eliminating those improper marketing practices as we are.

As FDA finalizes a framework around certain aspects of today’s action – including third party online verification – we’ll continue to keep you informed of developments related to today’s announcement.   We will also provide a deeper dive into the announcement later.
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Here is the summary of the major points in FDA’s announcement:

  1. Flavored ENDS products that are not sold in an age-restricted, in-person location.
    • Have all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) sold in age-restricted, in-person locations. All ENDS products, including e-liquids, cartridge-based systems and cigalikes, in flavors except tobacco, mint and menthol, would be included. For instance, the proposed policy would apply to flavors such as cherry, vanilla, crème, tropical, melon and others.
    • To advance this goal, the FDA is revisiting the compliance policy on PMTA authorization for such flavored products sold in physical locations where people under the age of 18 are permitted.
    • The FDA is not revisiting the compliance policy with respect to ENDS products sold exclusively in age-restricted locations – for instance, a stand-alone tobacco retailer (such as a vape shop) that adequately prevents persons under the age of 18 from entering the store at any time; or, a section of an establishment that adequately prevents entry of persons under the age of 18 and the flavored ENDS products are not visible or accessible to persons under the age of 18 at any time.
    • At this time, ENDS products with tobacco, mint or menthol flavors, as well as any non-flavored ENDS products, sold in any location, would not be included in any policy revisions. This distinction among flavors seeks to maintain access for adult users of these products, including adults who live in rural areas and may not have access to an age-restricted location, while evidence of their impacts continues to develop. It also recognizes that combustible cigarettes are currently available in menthol in retail locations that are not age-restricted. This approach is informed by the potential public health benefit for adult cigarette smokers who may use these ENDS products as part of a transition away from smoking.
    • The FDA, however, will not ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids. We will continue to use all available surveillance resources to monitor the rates and use patterns among youth and adults for these products, and we will reconsider our policies with respect to these products, if appropriate.
  2. Flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) that are sold online.
    • In addition, we will seek to curtail the sale of applicable flavored ENDS products that are sold online without heightened age verification processes.
    • The FDA will be working to identify these heightened measures for age verification and other restrictions to prevent youth access via online sales. These best practices would be available soon, so sites can quickly adopt them.
    • Because no tobacco products should be sold to kids (including non-flavored ENDS products or those with tobacco, mint and menthol flavors), the FDA will continue to enforce the law whenever we see online sales of these products to minors and will closely monitor online sales of mint and menthol ENDS products.
  3. Flavored cigars.
    • Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars. This data also indicates that eliminating flavors from cigars would likely help prevent cigar initiation by young people.
    • Given these public health concerns, I believe flavored cigars should no longer be subject to the extended compliance date for premarket authorization — regardless of the location in which the products are sold.
    • The FDA’s proposal to revisit the compliance policy for flavored cigars that are new tobacco products does not apply to the entire product category, as some products were considered “grandfathered.” Accordingly, the FDA intends to propose a product standard that would ban flavors in all cigars.
    • In July, the comment period for our ANPRM on flavors in tobacco products closed. The FDA has expedited review and analysis of these comments, and we intend to proceed with developing a proposed regulation. As included in the most recent Unified Agenda, the FDA intends to prioritize the issuance of this proposed rule.
  4. ENDS products that are marketed to kids.
    • The FDA will pursue the removal from the market of those ENDS products that are marketed to children and/or appealing to youth. This could include using popular children’s cartoon or animated characters, or names of products favored by kids like brands of candy or soda.
  5. Menthol in combustible tobacco products.
    • Informed by the comments from our ANPRM, the FDA will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.
    • The FDA started this process several years ago with an ANPRM. That ANPRM issued alongside the FDA’s preliminary scientific evaluation, which suggested menthol use is likely associated with increased smoking initiation by youth and young adults.
    • Now, armed with the additional years of data, comments from the public – and with the perspective of our Comprehensive Plan and its implementation – the FDA will accelerate the proposed rulemaking process to ensure that our policies on flavored tobacco products protect public health across the continuum of risk.


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Trump’s Nominee to Lead the FDA Got Paid Millions by the Health Care Industry

Dr. Scott Gottlieb, President Donald Trump’s nominee to head the Food and Drug Administration (FDA), is a widely respected physician and prominent conservative health care thinker. He also has some serious financial ties to the industry he’s tasked with overseeing if ultimately confirmed by the Senate.

The nominee, Dr. Scott Gottlieb, has spent the bulk of his career working in the drug and health care industry, which experts say raises the potential for myriad conflicts of interest. If confirmed to head the F.D.A., he would wield considerable power over companies and investment firms that have paid him millions of dollars over the years.

Gottlieb has received millions of dollars in compensation from some 20-odd biopharma and health firms, according to financial disclosure documents reported by the Wall Street Journal.

Gottlieb says he plans to recuse himself from any FDA decisions involving those firms. That would include drug giants such as GlaxoSmithKline (GSK, -1.21%) and Bristol-Myers Squibb (BMY, +0.04%) — two companies that have an approximate combined $185 billion market cap between them alone.

But the nominee’s involvement in the business of health care is far more involved. For instance, he served as a venture partner at New Enterprise Associates and poured cash into several health care startups while involved with outfits like T.R. Winston & Co.

Furthermore, Gottlieb was a senior adviser to rare disease drug maker Vertex Pharmaceuticals and helped found the cancer biotech upstart Cell Biotherapy. His payments from the industry have mostly been for consulting and speaking fees, including more than $87,000 from GlaxoSmithKline since 2016 and $1.85 million from T.R. Winston.

Those associations may not ultimately sway Gottlieb’s decisions as FDA commissioners. Previous heads of the agency have also had relationships with the biopharma sector, including Obama FDA chief Dr. Robert Califf, and it’s rare for commissioner to get personally involved in individual company-related decisions.


https://www.vapordna.com/?Click=697159

 

Dr. Gottlieb’s nomination comes at a momentous time for the agency, which Mr. Trump has promised to significantly remake. The next commissioner will be charged with putting into practice a far-reaching law, passed in December, aimed at bringing drugs to market more quickly. Congress also must reauthorize a set of bills this year that determine how much the drug and medical device industry will pay in user fees, which fund more than half of the agency’s budget to review new drugs.

FDA comes down hard on vaping

FDA limits flavors

AMERICA’S Food and Drug Administration (FDA) plans to ban sales of most flavored e-cigarettes in stores and gas stations nationwide under a plan to stop underage vaping, it has been revealed.

The FDA is expected to announce details of the new measures next week, according to a senior agency official as reported in America’s Washington Post.

The new law change, which is expected to have a “significant impact” on the vaping industry, has already been criticized by industry experts and public health groups who are concerned ex smokers who have successfully quit cigarettes thanks to vaping flavors, could return to their old habits if the products are harder to get hold of.

New measures will also include setting up age-verification measures for online sales to stop minors buying flavored pods.

Those opposing the flavor ban include American Vaping Association‘s Gregory Conley who recently told a panel discussion on e-cigarettes hosted by US news website Axios that enforcing bans on both flavors and sales could do huge damage to America’s public’s health, since vaping has helped over 4.5 million ex smokers quit tobacco for good.

He explained: “I vape Tropical Twist, so it has some pineapple to it, so mostly I use fruits – the vast majority of adult vapers are using non tobacco flavors and it’s the non tobacco flavors that so many of ex smokers say: ‘That’s the reason why I was able to quit because once I’d had mango, once I’d had watermelon, a tobacco cigarette didn’t taste so good after a week or two.’

“No doubt flavors are a reason why people are drawn to the product but it’s not the only reason why youth use the product. When the government ask them: ‘Why have you vaped?’, the number one and number two reasons are that: ‘It’s less harmful than smoking’ and ‘because it’s less harmful to those around me’.

“So ignoring the hurt – the grave damage – that this would do to adult smokers if there was a flavor ban tomorrow, if youth are using these products for nicotine, many will continue to use these products if there are flavors or not.”

He added: “The number one issue – if you don’t have flavors you do not have adults switching to these products….Tobacco flavors are awful. You do not have harm reduction with these products. You can just get rid of the entire category if you are not going to have flavors available.”

The FDA, meanwhile, has claimed the new initiative has been spurred by new preliminary government data that shows e-cigarette use rose 77 percent among high schoolers and nearly 50 per cent among middle schoolers in 2018.

It also comes after the FDA conducted investigations into underage vaping sales in stores across America earlier this year and issued over 1,300 warning letters and fines to retailers who illegally sold e-cigarettes to minors.

Retailers who were caught include national convenience stores and gas stations like 7-Eleven, Circle K, Shell and Mobil, according to an FDA database.

This flawed data is spuriously misleading. It’s simple arithmetic!!: The seemingly alarming increase is only because the base for the % increase is relatively small. E.g., let’s make the the computation small for illustration: Say the number of teenage vapers was 10 in 2017 and increased by 8 in 2018…that’s a whopping 80% increase…but the number of new vapers is only 8. I’m willing to bet a dollar and a doughnut that despite the high % increase, the actual number of new teenage vapers was less than the number of new teenage smokers.

And…to cite as a reason and allude that regular stores can’t do an adequate job checking ID for vape products “because vape stores are better at checking ID from customers”…but apparently adequate enough for checking ID for indisputably deadly tobacco products to Alcohol  is so laughable it totally insults my intelligence!

Count me as one of those who was able kick my 2-pack a day habit with fruity flavored tropical juices.  Say’s David Giudice of Vaping Advocacy Network.

 

JUUL pulled all flavored vapor products from the market today in an ill advised attempt to squelch Scott Gottliebs imaginary “Epidemic”

This is the single greatest attack on American health I have ever witnessed.

Smoking will kill 480,000 people this year alone.
In 9 years of mass vaping by people worldwide ZERO deaths

We are seeing the lowest levels of Adult and Teen smoking EVER!

Yes, teenagers are vaping.
No , they shouldn’t
But teenagers historically do things they shouldn’t.

Taking away vaping flavors from adults will never stop teenagers from scheming ways to do things they shouldn’t

Why would Scott Gottlieb and the U.S. Food and Drug Administration take away what is working at stopping the single deadliest addiction in America, in an attempt to prevent teens from using a product that is provably AT LEAST 95% safer than smoking?

The answer is that the FDA is not interested in healthy citizens.

This is despicable

Smoking kills people
Making quitting harder means less people quit

Which means more people will die because of this action which came from FDA pressure

The FDA loves dead smokers more than healthy vapers

 

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Tesla Punk 220W TC Vape MOD

Tesla has mastered the art of the unique and powerful mod, and their latest take on the Steam Punk Revolution includes this boldly powerful, artistically-crafted mod that features a design scheme like nothing else.

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The Tesla Punk 220W Vape MOD produces a max of 220 watts via variable power, and executes all functioning impeccably thanks to the ingenious chipset it contains.
The Punk 220 is a dual battery mod that has the ability to fire at a phenomenal length of voltage capacity, and it is very much 510 compatible so you can attach just about any tank you’d like. This device’s temperature control mode works with Titanium, Nickel, and Stainless Steel wires, enabling the most precise functioning possible.
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Specs & Features

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  • Requires 2 x High Drain 18650 Batteries (Sold Separate)
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SnowWolf VFeng BF 120W Squonk Vape Starter Kit

SnowWolf VFeng BF 120W Squonk Vape Starter Kit

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The latest innovation from the phenomenal Snow Wolf VFeng series from Sigelei, this option allows for excellent functioning when squonking. This mod features the same futuristic styling of the other mods in the Vfeng line, and it offers sleek lines, contrasting colors, and a superior construction of high-quality zinc alloy.

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When powering this innovative mod, you have the option to use a single 21700, 20700, or 18650 battery (not included). This mod fires at a maximum of 120 watts, and it features a range of different protection features. A 1.3 inch HD color screen allows for easy access to all of your details and settings, with the easiest operation and clearly displayed stats.

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  • 1 x Snow Wolf VFeng Squonk 120W TC Mod
  • 1 x SnowWolf BF RDA
  • 2 x Pre-Build Wires
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  • 1 x Snow Wolf 21700 40A 3750mAh Battery
  • 1 x Micro USB Cable
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Snow Wolf VFeng Squonk 120 MOD Specs & Features

  • Snow Wolf Chipset
  • Wattage Range: 10W-130W
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  • Main Material: Zinc Alloy
  • Temperature Range: 100C – 300C / 212F – 572F
  • TCR Functionality
  • Temperature Coefficient of Resistivity
  • 3-Button Control Face
  • 1.3″ TFT Colored Display
  • Dual Squonk Bottles
  • Micro USB Charge and Update Port
  • Requires 1 x 18650, 20700 OR 21700 High Amp Battery
  • 1 x Snow Wolf 21700 Battery Included
  • 20mm Stainless Steel 510
  • Reverse Polarity / Short / Low Resistance / Low Battery / Overheat Protection

Snow Wolf BF RDA Specs & Features

  • Diameter: 27mm
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  • Quad Terminals
  • 3mm x 1mm Each Terminal
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  • Juice Well: 7mm
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  • 18mm Wide Bore Delrin Drip Tip
  • Bottom Feed 510 Pin Pre-Installed

Snow Wolf 21700 40A 3750mAh Battery Specs

  • Battery Capacity: 3750mAh
  • Amp Capacity: 40 Amps
  • 3.7 Volts

WARNING: This is an advanced Item. Please use at your own risk and always use proper precautions and handling as these are very sensitive to charging characteristics and may explode or burn if not properly handled. Please note that there is an inherent risk with the use of any and all rechargeable batteries in any circumstance. DirectVapor is not responsible for any damage, injury, or defect caused by the improper use and/or mishandling of Li-ion (Lithium-ion), LiPo (Lithium-ion Polymer) and any rechargeable batteries and chargers. Images are for illustration purposes only. Actual color, finish and packaging may vary.

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Wismec Active 80W Vape Starter Kit w/ Bluetooth Speaker

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The Wismec Active Kit is designed for vapers who enjoy a very active lifestyle. One of the most impressive features of this kit is the fact that it doubles as a Bluetooth speaker. Plus, the entire kit is encased in a waterproof shell to protect it from possible water damage.

An internal 2100mAh battery allows the Active to deliver 80 watts of power, but that’s not all. You can explore various temperature control settings. Plus, it’s extremely durable, making it perfect for vapers who are always on the go. In fact, it’s designed to be shockproof so that you don’t have to worry about the occasional drop.

The tank can hold a max of 4.5mL of e-liquid when you use the bulbous glass piece. The WS04 MTL 1.3ohm coil head is optimized for salt-based and free-based e-liquids, allowing for incredible cloud or flavor production. With firmware capable of being upgraded and everything else in between, the Wismec Active Kit is simply revolutionary.

What’s Included:

  • 1 x Wismec ACTIVE 80w BOX MOD
  • 1 x Wismec Armor NS Plus Tank
  • 1 x Hook
  • 1 x 0.2ohm WS01 Triple Coil
  • 1 x 1.3ohm WS04 MTL Coil
  • 1 x QC Micro USB Cable
  • 1 x Bag of Spare Parts
  • 2 x User Instruction Manual

Wismec Active MOD Features & Specs:

  • Dimensions: 94.5mm x 55.6mm x 26.6mm
  • Integrated 2100mAh Rechargeable Battery
  • Wattage Output Range: 1W-80W
  • Voltage Output Range: .5V-9.0V
  • Resistance Range – Temperature Control: .05ohm-1.5ohm
  • Resistance Range – Variable Wattage: .05ohm-3.5ohm
  • Temperature Range: 100-315°C/200-600°F
  • Supports the Following Heating Elements: Ni200, Titanium, and Stainless-Steel
  • Modes: Temperature Control, Voltage. BYPASS, TCR, and Music
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  • .91″ OLED Screen
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Wismec Amor NS Tank Features & Specs:

  • 27mm Diameter
  • Capacity Range: 2mL Standard – 4.5mL Expanded
  • Superior Stainless-Steel Construction and Pyrex Glass Reinforcement with 510-Connection
  • Wismec WS Coil Line
  • .2ohm WS01 Triple Coil – Rated for 40W-80W
  • 1.3ohm WS04 MTL Coil – Rated for 8W-14W
  • Method for Filling: Sliding Top-Fill
  • Dual Slotted Bottom Airflow

WARNING: This is an advanced Item. Please use at your own risk and always use proper precautions and handling as these are very sensitive to charging characteristics and may explode or burn if not properly handled. Please note that there is an inherent risk with the use of any and all rechargeable batteries in any circumstance. VaporFi is not responsible for any damage, injury, or defect caused by the improper use and/or mishandling of Li-ion (Lithium-ion), LiPo (Lithium-ion Polymer) and any rechargeable batteries and chargers. Images are for illustration purposes only. Actual color, finish and packaging may vary.

 

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