The Vape News of 2016: Year in Review Part 2

The Vape News of 2016: Year in Review Part 2

In Part 1, we took a look at the biggest vape news during the first quarter of 2016, including positive news out of the UK in early January and the passing of the Cole/Bishop Amendment in the US during the Agricultural and Rural Development Appropriations bill hearing in mid-April. Now we’ll take a look at what came next for the vaping industry.

A Review of the Vaping Industry in 2016: Part 2

From federal regulations and state-level crackdowns to the world premiere of the first vaping documentary, the vaping industry had its highs and lows during the summer of 2016. One of the biggest highs was the world premiere of A Billion Lives, a documentary about vaping and government involvement in tobacco harm reduction around the world, and one of the biggest lows was the official release of the FDA’s Deeming Regulations for vapor products in early May.

Vape News from May 2016

FDA

Despite the positive news making headlines the month before, May 2016 was a very bleak month for the vaping industry in the US. On May 5th, the FDA announced the early release of its long-awaited Deeming Regulations for vapor products. The 499-page document sent the vaping industry into an uproar, with tobacco harm reduction expert Dr. Michael Siegel claiming the regulations to be “a disaster for public health”. It has been projected that 99% of the vaping industry could be shut down by 2018 due to the predicate date of February 15, 2007 remaining intact. As a result, all vape companies are required to submit the extensive and costly Pre-Market Tobacco Application (PMTA) for every product introduced to the market after the set predicate date, with the deadline for approval set to August 2018. Additionally, innovation in the industry has essentially been stifled as the regulations prohibit new vaping products from entering the market without an approved PMTA.

Related: A Guide to Understanding the FDA’s Vaping Regulations

A Billion Lives Documentary

On May 11, Just one day after the FDA’s Deeming Regulations were published in the US Federal Register, the long-awaited vaping documentary titled A Billion Lives made its world premiere at the Doc Edge Film Festival in New Zealand. The documentary was created by Director Aaron Biebert and Attention New Era Media, a film crew that traveled the world to reveal government failure in accepting what renowned researchers and tobacco harm reduction experts have been calling “a public health miracle.” At the time of the premiere, the sale of e-cigarette products containing nicotine or claiming to help people quit smoking were illegal within the country. Shortly after the film’s debut, the New Zealand Minister of Health issued a proposal to lift the ban on the sale of vapor products within the country to instead be used as an option for tobacco harm reduction.

Vape News from June 2016

Teen Vaping Study

In June, the “teen vaping leads to smoking” theory came back with a vengeance after a survey of about 300 high school students was conducted by a researcher with the University of Southern California’s Tobacco Center of Regulatory Science. The survey quickly drew criticism based on the fact that not only was the sample was much too small to conclude that all teens who experiment with vaping will take up smoking, but also because the steady decline is youth smoking rates completely contradicts the theory. Critics also pointed out that the lead author of the survey misrepresented the survey methods and its findings. This wasn’t the first (and probably won’t be the last) study to manipulate study methods and findings to support the vaping gateway theory. In fact, there have been so many that now there is even a guide entitled “How to not be duped by gateway effect claims”, written by tobacco harm reduction expert Clive Bates.

Vape News from July 2016

Utah Vaping Regulations

July 2016 brought on more state-level crackdowns on the vaping industry when the state of Utah implemented a complete ban on online orders for vapor products. The law was written and proposed by Paul Ray, a known anti-vaping rep who refers to the vaping industry as the “scumbag industry”. Ray has been accused of pulling a bait and switch tactic for adding hidden language within HB 415, which was never discussed or debated and didn’t clearly translate an all-out ban against ordering vapor products online. The Utah Smoke-Free Association has been working to change the law through legislation and has set up the UTFSA legal fund for vapors and vendors who would like to contribute.

Vape News from August 2016

For the vaping industry in the US, August 8, 2016 because known as “D Day” as in the FDA’s Deeming Regulations officially took effect. This is the day the vaping industry officially came to a halt when it comes to innovation. Vaping products are now categorized and regulated as tobacco products and each new product must go through the extensive and costly Pre-Market Tobacco Application (PMTA) process to obtain FDA approval in order to enter the market after August 8, 2016. All other products that were on the market prior to this date but after the predicate date of February 15, 2007 must also go through the PMTA process and obtain FDA approval to remain on the market after August 8, 2018.

All 499 pages of the FDA’s Deeming Regulations, which are full of confusing language and several gray areas, were published in the US Federal Register. For more information, check out our guide to understanding FDA vaping regulations.

How Did 2016 End for the Vaping Industry?

In Part 3, we’ll take a look at the biggest news in the vaping industry during the last quarter of 2016, which includes outrageous tax hikes and more strict regulations proposed and/or implemented by local governments in the US.

The Vape News of 2016

The Vape News of 2016: Year in Review Part 1

The vaping industry was constantly making headlines in 2016. In fact, there was so much news surrounding the vaping industry last year that we had to break this review down into 3 parts. So, let’s take a look at part 1: vape news, research and regulations from January through April.

A Review of the Vaping Industry in 2016: Part 1

From positive news out of the UK to the “teen vaping leads to smoking” gateway theory that just won’t go away, there was much to talk about when it came to the vaping industry in 2016.

Vape News from January 2016

Vape News from January 2016

In early January 2016, the Consumer Advocates for Smoke-Free Alternatives Association (CASAA) released the results of the largest vaping survey to date. Conducted in November and December of 2015 with more than 20,000 participants, the results contradicted several ongoing anti-vaping claims. Not only did the results reveal the importance of vaping for smoking cessation among survey participants, but also the importance of flavors when it comes to adult vaping. Unfortunately, the survey results didn’t get as much attention as the “teen vaping leads to smoking” gateway theory, which dominated news headlines for the remainder of the month.

In the meantime, the UK started off the year by embracing vaping with the approval of the first vaping device to be prescribed for smoking cessation. Thanks to Public Health England’s Evidence-Based Review on electronic cigarettes published in August of 2015 and its conclusion that “vaping is 95% less harmful than smoking”, physicians in the UK can now prescribe the vaping device for smokers seeking assistance in quitting smoking.

Related: Public Health England’s Evidence-Based Review Recap

Vape News from February 2016

Vape News from February 2016

February 5th marked the first time a legal entity in the US made a clear distinction between vaping and smoking during a court hearing. The accused, Sean Thomas, was arrested for violating New York City’s Smoke Free Air Act after being caught vaping on a subway platform. Although the Smoke Free Air Act does prohibit vaping anywhere smoking is banned, Thomas was being charged under state law, which did not include vaping in the ban. This allowed Thomas to successfully challenge his citation in court. After the judge defined smoking as ““the burning of a lighted cigar, cigarette, pipe or any other matter or substance which contains tobacco”, he went on to rule that vaping “does not fit within the definition of ‘smoking’ under the law” and ruled in favor of the plaintiff.

Vape News from March 2016

Vape News from March 2016

On March 3, 2016, California lawmakers voted to raise the smoking/vaping age from 18 to 21 in an attempt to make it more difficult for minors to acquire tobacco and vaping products. This legislation came with some tough criticism as opponents pointed out that American citizens are officially recognized as adults as of their 18th birthday and if at that age they can commit a felony and go to prison, then they should have the choice of whether or not they want to buy a pack of cigarettes. To add more fuel to the debate just one week after the vote, Weill Cornell Medicine investigators published study findings which suggested that “imposing age restrictions on the purchasing of electronic nicotine devices may unintentionally increase teenage cigarette use”.

Vape News from April 2016

Vape News from April 2016

On April 4th, 2016, the United States Department of Transportation officially implemented a ban against vaping inflight. Among the reasons for the ban was the issue of increasing reports of exploding batteries in e-cigs, as well as concerns about the unknown risks of breathing vapor within confined spaces.

April 19th brought some positive news to the vaping industry during the Agricultural and Rural Development Appropriations bill hearing when the House Appropriations Committee passed the Cole/Bishop Amendment by a 31-19 vote. The amendment would move the FDA’s set predicate date of February 15, 2007, to the effective date of the deeming regulations (August 8, 2016) to prevent the potential shutdown of 99% of the vaping industry. If passed, the amendment would grant products on the market prior to the August 8th date the ability to bypass the extremely costly PMTA process and remain on the market.

More positive news came on April 20th when a study on vaping and indoor air quality was presented at the 4th Workplace and Indoor Aerosols conference in Barcelona. The study’s findings suggested that the contents of exhaled e-cig vapor disappear within seconds after being tested in an enclosed room. This study, among others, contradicts the theory that secondhand vapor is just as harmful as secondhand smoke.

Perhaps the best news the vaping industry could have received (at least in the UK) arrived on April 28th when the UK’s Royal College of Physicians published the report, “Nicotine without smoke: Tobacco harm reduction”. The report concluded that vaping was likely to be beneficial to UK public health and e-cigarettes should be promoted widely for smoking cessation. The findings of the report fell right in line with Public Health England’s evidence-based review on e-cigs from 2015.

What Came Next for the Vaping Industry?

Now that we’ve you the rundown of the news surrounding the vaping industry during the first quarter of 2016, stay tuned for Part 2 as we take a look at the vape news from May through August of 2016.

White Cloud E-Liquids…and a Guy Who Loves Them!

About White Cloud E-Liquid Flavors

As a long time customer of White Cloud (long before I became a Customer Service Sentinel for the company) I have had the pleasure of using every product we have brought to market over the last 5 years. While my mainstays are the cartridges used with our Cirrus rechargeable e-cig line (first ClearDraw, then ClearDraw2 and now the ClearDraw Max) I have tried my fair share of disposables, cartridges, batteries, cases and flavors during my time here at WC.

Experimenting with E-Liquids and Nicotine Strengths

Regular Flavor E-liquid

When we here at White Cloud came out with our bottled e-liquids for purchase, I was chomping at the bit to give them a try – but, I had nothing to use them with as we were still awaiting the arrival of our e-liquid Mini Tanks (which are refillable tanks that screw onto your existing Cirrus batteries just like the pre-filled ClearDraw e-cig cartridges do). While I am well versed in our entire White Cloud product line, my knowledge of larger tank and mod systems (which are also suited for our e-liquids) was a bit lacking as I had never really used them regularly and only had a layman’s knowledge of what they were about.

Related: The Vaper’s Glossary

My curiosity (and, perhaps, a bit of my innate impatience) prompted me to go out and purchase a small tank system. With the glee of a kid let loose in a candy shop with a pocket full of change, I rushed home, glanced through the instruction booklet for the system I had just purchased (the print was very, very small so I was forced to squint very, very hard to read it) and loaded the tank up with my all-time favorite White Cloud flavor: Regular in the 5.4% NBV strength. With everything set up, I placed the mouthpiece to my lips and took a good, solid puff.

Nothing happened.

In my excited haste I had forgotten that, unlike White Cloud products, I needed to hold down a button on my new tank system when I took a puff. I shook my head (literally) and kicked myself a bit (figuratively) and tried again, this time button depressed as I puffed and pulled in a deep vapor cloud.

I spluttered and gagged.

My Regular, my 5.4% NBV, the very flavor and strength which kept me warm on the occasional chilly Florida winter days, the constant companion to my morning cup of coffee was…way too strong.

I tried a few more times, each attempt ending in the same result. When I got to work the next day, I picked up the 3.6% nicotine strength in the Regular flavor, one step below the 5.4% I usually use. While that was far more comfortable, it was still somewhat overpowering, which prompted me to start looking into why this may be. So I began experimenting with different nicotine strength levels, and I believe I may have hit on a good explanation, as well as a fantastic solution.

Choosing the Right Nicotine Strength for Open Tank Systems

Why Measure Nicotine as a Percentage in E-Liquids?

The White Cloud cig-a-like products I have been using for years deliver a certain amount of vapor and nicotine though a small opening; therefore, the vapor produced is relatively low compared to larger tank systems, which also operate at higher temperatures. As a very heavy smoker previously (over two packs a day for over 20 years), I craved a robust throat hit, as well as high nicotine content, and the 5.4% Regular flavor fit the bill quite nicely in that setting.

The tank system I was now using offered a very different delivery system. With a far, far wider aperture to pull vapor though creating vapor at higher temperatures than I was used to, combined with an awful lot more nicotine being distributed per puff, the 5.4% I was accustomed to puffing on was simply way too much of a good thing.

I started trying out different strength levels and found, much to my surprise, that the 1.6% nicotine strength suited me well, and the 0.8% nicotine strength suited me even better when used in my tank system. The additional vapor and heat produced from a lower nicotine strength level seemed to provide the throat hit and flavor I was used to when using a Cirrus battery with a cartridge.

After trying our e-liquids in refillable ‘pen’ systems, I found that the throat hit of 5.4% was a bit more robust than usual, but also found it to be quite comfortable; however, I did note that going a strength down (to 3.6%) seemed to do the trick nicely for me. In our new Mini Tanks, I found that using the 5.4% in Regular flavor provided the same experience I had grown accustomed to when using the ClearDraw family of cartridges.

Since that point, I have used the 5.4% in our Mini Tanks and the 0.8% in the larger tank system, and this has made for a very satisfying experience. I also found that I am really enjoying some flavors away from the Regular Tobacco Flavor – Cherry Black, Chocolate and The Orchard in ultra light strength are becoming new mainstay vape flavors for me when using my tank system.

I hope this experiment proves helpful to you. As a long time customer myself, I completely get how using something new (like e-liquids instead of pre-filled cartridges) might have a bit of a learning curve, so I am always willing to share my experiences. If you found this helpful, or have run similar experiments with different results, please let us know!

Guest blog by John Crumley, White Cloud Customer Service Sentinel.

FDA Vaping Regulations vs. Vaping Advocacy

The vaping industry has endured its fair share of controversies over the last few years. From bad science and scare-mongering news headlines to strict laws placing vaping under the same category as smoking, it’s no wonder why vapers have felt the need to step up and begin educating smokers and non-vapers; hence, the creation of vaping advocacy groups.

The Fight Against FDA Vaping Regulations

From massive vaping advocacy groups such as the Consumers Advocates for Smoke-Free Alternatives Association (CASAA) and the Smoke Free Alternatives Trade Association (SFATA) to state level advocacy groups such as the Tennessee Smoke Free Association, there are several groups working to promote vaping awareness while battling unfair regulations.

During our DeMISTified Webinar Series, we spoke with a couple of head members from these groups who provided some important insights into what vapers can do to join the fight against the FDA’s Deeming Regulations. Below you will find questions surrounding vaping advocacy with answers from the industry experts.

What more can we do beyond writing and calling Congress?

There are multiple ways to join the fight against the FDA’s Deeming Regulations. It’s important to note that the regulations will never completely disappear. They can, however, be altered.

“So I think that what everyone can do, who is concerned about this, is to write, call, or email their Congress members, especially in the House of Representatives right now, and let them know that this is going to lead many people back to smoking and that, for the interest of public health, we’re asking them to prevent the FDA from taking this action.” – Dr. Michael Siegel

To show your support for vaping advocacy in the fight against overly strict regulations, consider the following:

As Cynthia Cabrera said in our webinar series, “We need to educate, not intimidate, not threat, not insult,” when it comes to non-vapers.

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Click to tweet: “We need to educate, not intimidate, not threat, not insult.” @cyncab http://bit.ly/FDARegs #FDADeeming #ECigs #Vaping #VapeNation

Besides supporting advocacy groups, what should business owners be doing to help with advocacy efforts?

Business owners have a vested financial interest in a thriving vapor industry—an interest politicians in their areas also share. Creating jobs and stimulating the economy are as important to politicians as to entrepreneurs; thus, it’s important to educate politicians of the negative economic impact of overly burdensome regulations. Senator Ron Johnson is a great example of one of the many political leaders in support of vaping who are stepping up to protect the industry.

“Book meetings, don’t just send emails, book meetings. Meet with them face to face. Sit down, express your concerns, express what these regulations would do to your business, to your employees, and have them understand tobacco harm reduction.” – Dimitris Agrafiotis

How difficult is it to start a state level advocacy group like Smoke Free Tennessee and what steps does it take?

State level politics are no less important than the Federal level, and they are an important layer of advocacy that should not be ignored. Starting a state level advocacy group is not without its challenges, but it may be easier than you imagine.

“It’s extremely difficult for a small shop to reach directly into a national organization, so my goal was to form an association that the shops can turn to for help locally. The organization can turn to a federal group such as the VTA (because the Tennessee Smoke Free Association is a member of the VTA) when we need federal guidance and we can help each other in the state.” – Dimitris Agrafiotis

How does the FDA plan on enforcing these new regulations?

If you do not take steps to comply with the FDA’s Deeming Regulations, you will first receive a warning letter from the FDA, (here’s an example), then the No-Tobacco Sale Orders or Civil Money Penalties, and finally judicial actions will occur, including injunctions or even criminal prosecution.

The FDA has released extended compliance dates for some rules, such as the packaging requirements, and is taking into account that some changes will take longer than others.

“Essentially, they have abandoned their mission, which is to regulate tobacco products and they’re turning it into a single-handed focused crusade on vaping products.” – Dr. Michael Siegel

share on twitter

Click to tweet: Not going to comply with #FDADeeming? Find out what happens: http://bit.ly/FDARegs #ECigs #Vaping #VapeNation

Will any of the pending lawsuits put the regulations on hold?

Lawsuits challenging FDA Deeming Regulations have the potential to delay certain parts of the regulations; however, this process could take months, years, or even decades to obtain an end decision.

“Litigation only stops things if it’s an injunction. The cases, the two that have been filed so far, are not injunctions. So things are just gonna continue as planned.” – Cynthia Cabrera

What would it take to get an injunction?

We suggest you seek out an attorney for advice. Cynthia Cabrera goes into great detail in our webinar video below.

“Courts tend to side with the FDA, so already we’ve got that working against us.” – Cynthia Cabrera

Has the release of the federal regulations slowed the state level legislation?

No, in some cases it has increased the visibility to states. Let’s take a look at California, for example: they are leading the charge in not selling to minors by increasing tobacco purchasing age to 21, increasing delivery restrictions and photo identification rules, and are pushing towards banning vaping in public parks and beaches.

Then we have Utah, where online e-cig orders are banned; then New Jersey, where legislators are attempting to ban flavors. Other states have been looking into implementing or increasing taxation, such as Pennsylvania’s massive tax on vapor products

Vaping has been an issue that has long been put on the backburner, and the states are happy to jump on board.

“We’ve got challenges at the federal level, at the state level, sometimes at the local level and it’s just never ending. It’s absolutely exhausting. Yeah, we’ve got a lot of work to do.” – Cynthia Cabrera

What do you attribute to the different views of England and the U.S.?

Dr. Siegel does a great job explaining the differences between the two forms of public health in our webinar. Watch the video below for a snapshot overview.

“I think that one difference is that, what they have in England that we don’t have here is have public health groups that are embracing harm reduction.” – Dr. Michael Siegel

Related: Regulating Vapor Products: A Tale of Two Views

What will happen next?

Based on the direction of the FDA and news stories, we predict that we’ll start to see a push for flavor bans, requirements for ingredients to be listed on the products, and even more tax hikes on e-cigs. We have been waiting for this industry to become regulated for quite some time now. Unfortunately, the regulations failed to address some of the major concerns plaguing the vaping industry. For instance, the FDA deeming regulations did not address the risk of exploding e-cig batteries, nor did they specify a set temperature for e-liquids to prevent the release of carcinogens due to overheating.

As most pro-vaping tobacco control experts predicted, the FDA is already experiencing issues in keeping up with enforcing the regulations. As a result of their website crashing while vape companies were attempting to register their products by the December 31, 2016 deadline, the FDA has extended the registration deadline to June 30, 2017 for all vaping companies who were already manufacturing their products prior to August 8, 2016, when the regulations officially took effect.

Additionally, some other changes to the regulations have already been made, including the withdrawal of a direct final rule outlining when the FDA would be entitled to deny PMTAs. According to the FDA, a revision of the rule was made “due to some significant adverse comments received”; thus, it is quite possible we may see some other changes to the regulations within the next few years.

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FDA Vaping Regulations: Importing and Exporting

When it comes to the FDA’s regulation of vaping products, there have been concerns with how the rules affect the importing and exporting of products in and out of the US. With the history of the FDA’s involvement in the vaping industry dating back to when the organization had no legal authority over vaping products, it’s no wonder why vape shop owners and e-cig retailers are concerned.

How Do Vaping Regulations Affect Shipping?

Back in 2009, before having any authority over vaping products, the FDA began seizing e-cig shipments based on the claim that they had grounds to seize products for incorrect labeling. This infringement launched a massive lawsuit against the FDA from two major e-cig companies. In a court hearing, the judge ruled in favor of the vape companies and the FDA was told to cease seizing shipments; however, some e-cig companies claimed the FDA continued to seize e-cig shipments against the judge ruling, which resulted in another lawsuit. The second lawsuit was dropped when the FDA finally ceased seizing e-cig shipments and announced its intention to pursue authority over vaping products.

So how do the FDA’s rules affect the shipping of vaping products today? That’s a good question. We received a few questions about this during our DeMISTified webinar series. You can find these questions below with answers from industry experts.

Will e-liquids containing nicotine be allowed to be shipped via "delivery sales" via USPS, UPS, FEDEX, etc.?

Yes, as long as there is a warning label on the outside of the package starting May 10, 2018; however, state regulations may have different requirements, such as age-verification and signature at the time of delivery as seen in California. Another example of state laws affecting the shipping of e-cig products comes out of Utah. As of July 2016, the shipping of vape products into Utah is no longer permitted due to legislation that banned online e-cig sales. Other state laws are imposing tax hikes on vapor products, so be sure to keep up with proposed legislation in your state with CASAA’s Calls to Action by State and do what you can to oppose unfair regulations.

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Click to tweet: Starting May 10, 2018, a warning label must be on the outside of the packaging to ship #ecigs. http://bit.ly/FDARegs #FDADeeming #Vaping

If we're a US-based manufacturer selling a product line for export, would the product line that is being exported be subject to the regulations?

Yes, manufacturers based in the US can export their vapor products overseas; however, they are required to follow the same processes as FDA-regulated products in the US. The FDA does require vape companies to maintain detailed records of the products you are exporting and must meet the following qualifications:

1) Meets with the foreign purchaser’s specifications.

2) Does not conflict with the laws of the foreign country.

3) Is labeled on the outside of the shipping package that is intended for export.

4) Is not sold or offered for sale in the United States.

The exporter can also keep documentation, such as letters from the foreign government or notarized certifications from a US official, stating that the product does not have any issues being imported into the foreign country.

Can items still be imported from overseas?

Yes, vapor products can still be imported from overseas as long as they have the correct nicotine warning label on the packaging. According to the FDA, “Importers who import finished tobacco products for sale or distribution in the U.S. are considered tobacco product manufacturers” and must follow the deeming rules before distribution to consumers. Some of these requirements include:

  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Submitting an application for premarket review and receiving authorization from FDA before marketing new tobacco products;
  • Complying with health warning requirements on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by FDA.

The FDA’s website also states that, “importers who own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a newly regulated tobacco product need to register the establishment and submit product listing to FDA by December 31, 2016.”. Visit the FDA website for more information on how to comply with the FDA regulations as a manufacturer.

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