8/8

My original plan was to record a video today. A video about how I feel, and about where we go from here.

My thoughts, however, are way too erratic today. So it would have been a video far too disjointed and far too edited (and some of you thought the NX75 video was too edited!)

This is going to be a lengthy post with a lot of opinion and anger. Warning, there may be some adult language. I wouldn’t be surprised if I revisit it for additional content and edits.

Let’s start with A Billion Lives. First, I want to thank Aaron Biebert for this film. I also want to thank Molecule Labs, a company I’m quite proud to be associated with and who played a major role in making the premiere possible with their sponsorship of the after-party.

The movie was excellent. The movie was powerful. The movie was emotional. You’ll be both moved and pissed after watching it. Tears came to my eyes twice, and I gritted my teeth several more times than that. Although, as vapers, we all want to see it, none of us have to. This is not a movie for us, not a movie for vapers. This is a movie for Americans, for citizens, for politicians, for people around the world. It’s a movie that will show the general public the lunacy we’re dealing with. A movie showing the corruption we need to fight to keep our way of doing things alive. A movie showing the burdensome fight we have to live a healthier lifestyle. A movie that I truly believe can help our cause, but it needs to be seen, and seen by the correct audience.

Some of you may have heard that Senator Ron Johnson left before the movie was shown. In reality, Senator Johnson was in a pre-show private session which went too long preventing him from seeing the movie.   The good news is that Aaron has supplied him with a copy of the film.

A gentlemen contacted me last week about the movie. He was very excited to be attending, but more excited to be bringing his wife.

He explained to me…

She simply hates the fact that I use it but is terribly misinformed due to the bad media that has been around for who knows how long now.

I was very curious to see what she thought of the movie and if it changed her perception so I asked the gentleman to contact me after the movie.  This is what I received…

Sorry that I missed seeing you in my town of a Milwaukee. Unfortunately, my wife didn’t want to go to the after party.

Only time will tell if her mind has opened a little bit. I did promise I’d let you know. She at least followed the movie and can’t say if she really enjoyed it but I think it gave her a little more information.

She still isn’t sold on ecigs but at least I got that far. Her experience to learn was agitated by some disrespectful dillholes in front of us vaping in the theatre when they shouldn’t have been.

Her experience to learn was agitated” I think this says it all, or it at least says a lot. And it points to something I’ve been saying over and over again. I don’t care how you vape, as long as you do it safely and respectfully. Without the respectfully part, we will never win over the public, they will never understand our fight, they will never listen, they will always be against us, no matter how many studies and how much science tells us that vaping is safer than smoking.  Of course, there are those, no matter how respectful we are, we will never win over simply because it looks like smoking, but let’s not add fuel to their fire.

His words and his wife’s experience truly saddened me.

If you don’t care what the public thinks about us, if you don’t care how we’re perceived, and you’re just going to do whatever you want and however you want at the expense of others, then perhaps you too are part of the problem.

We’ll never know if that public perception got us into this mess in the first place, or had any effect at all, but I, for one, believe it has.

This brings us to 8/8.

Here we are. Is it the beginning of the end or just a new beginning? Is it “Prohibition” or a “Purge”? Regardless of how you perceive it, we must continue to fight until the end, whatever that end may be. Listen to the calls to action from whatever group you decide to follow. Stay away from the drama and the hate which helps no one.

What does 8/8 currently mean to you as a vaper and to the shops you may frequent? Here’s some information presented to several reviewers including myself by CASAA. Note that this should not be considered legal advice nor is it their final analysis of the deeming regulations.

  • **No Immediate Prohibition**

Given the rush to release before August 8th, 2016 (the “effective date”), there are tons of new products available and vapor retailers will be open for business and stocked with lots of new products. However, it should be emphasized that Monday, August 8th, 2016 starts the two year countdown to FDA prohibition of 99.9% of vapor products currently on the market unless the 2007 predicate date in the Tobacco Control Act is changed.

In other words, unless the 2007 predicate date is changed, 99.9% of vapor products available on the market today will be banned on August 8, 2018 due to the massive, likely seven­-figure cost associated with trying to keep just one product on the market.

  • **Online Sales**

Online sales are NOT affected by the deeming regulations other than the implied requirement that vendors use some sort of age verification system. Although the law states that sales to minors ­­online and brick and mortar ­­ are prohibited, it is not specific about how online sellers are supposed to verify the age of the buyer. Expect to see different verification systems and expect to pay slightly higher prices. (Some states already have in place some requirements regarding online sales and those laws still stand.)

  • **Sampling**

Consumers will still be able to sample e­liquids after August 8th. However, it is now required that retailers charge a reasonable fee for sampling. There has been no clear guidance as to what this fee needs to be other than “not free.” Many have discussed charging $1.00 for “X” number of puffs or samples. Given that many people rely on credit/debit cards for purchases, this may present issues for new customers who are interested in just sampling. In that regard, it is fair to say that the required fee for sampling is yet another barrier to smokers trying vapor products.

  • **Wire, Wick, Materials, Etc.**

The basic materials used to build your own coils should still be available. The general rule of thumb is that as long as the product was manufactured, marketed, and sold prior to August 8th, 2016 and has not been altered, it can continue being sold and there is no requirement to file a PMTA before August 8th, 2018. You’ll likely see your local shops approaching various issues differently, such as whether or not to break down multipack replacement coils for resale. Some shops, especially if they have a record of this activity before August 8th (for example, a PLU code set up in their POS system which documents sales of individual coils before August 8th), may feel that they are not manufacturing a new product and will continue this practice. Other shops will choose to avoid potential problems by not selling individual coils from multipacks, especially if they are concerned about additional rules they may need to follow as “manufacturers.”

  • **Rebuilding in Shops**

If retailers have a well documented catalogue of every type of coil they are building and can prove that each one was manufactured, marketed, and sold prior to 8/8/2016 and can demonstrate that these coils are made the same way, consistently after 8/8/2016, then it is possible that the shop may decide to continue to offer coils built in­house. However, installing these coils on a customer’s device adds another variable that may need to be accounted for.

For example, if a retailer has documented installing a coil on several atomizers prior to 8/8, in theory, they should be able to continue installing coils on those same atomizers after 8/8. But, if a customer comes in with a device they’ve never seen before and asks to have a coil installed, staff may, effectively, be manufacturing a new tobacco product. Because of the wide range of variables here, many shops will simply decide to stop rebuilding for customers to avoid the potential problems. We expect that many shops will decide to instead instruct customers on how to rebuild.

  • **House E­liquid**

Similar to the issues surrounding rebuilding coils, there is an expectation that the FDA will require shops (in this case “manufacturers”) to prove that their products were being manufactured, marketed, and sold by 8/8/2016 and can demonstrate that these liquids are made the same way, consistently after 8/8/2016. Of course, with e­liquid manufacturing there is the added layer of operating a sanitary manufacturing facility. The level of detail and precision that the FDA will require of e­liquid manufacturers may be beyond the capabilities of many in­house e­liquid makers, but this does not foreclose the possibility of single­ shop manufacturers being able to continue to operate after 8/8/2016 However, mixing custom liquid on demand, adding flavor shots, or introducing new nicotine levels is definitely prohibited.

  • **Assembling Products for Customers**

Retail staff can instruct and even demonstrate how a device is assembled or a tank is filled or how eliquid is dripped. They cannot assemble products for customers. That would qualify them as a manufacturer. To that point, repairing or adjusting a customer’s device is also considered manufacturing. The range of possibilities alone makes it virtually impossible to file the appropriate number of PMTAs to continue offering this service.

  • **Tobacco Definition**

Changing the definition of “tobacco product” under the federal Tobacco Control Act does not automatically change or “update” the definition used in state or other federal laws. Legislatures will need to update their laws independently. This means that things like taxes, indoor use bans, and other restrictions do not automatically apply at the state or federal level on August 8th, 2016. To that point, consumers and businesses should be on high alert going into 2017 for such laws to be introduced.

I truly believe innovation will continue. It is our access to this innovation that is now in question.

People are frightened.  People are scared.  I’m one of them.  Our way of doing things is threatened.  In many cases our very livelihood is in jeopardy.  We are looking to blame and lashing out, and in many cases in the wrong direction.

But we need to fight. We need to fight as a unified and organized group… as individual vapers, as shop owners, as manufacturers, and as advocacy organizations.  All as one unified voice.  We are far more powerful standing together.

Something I’ve read recently has affected me. It was the Jeremy Dollars post about his meeting with US Representative Sanford Bishop. The Senator basically told us what we need to do.

Get organized!

I’m not the expert in advocacy and never claimed to be, but let me give you some of my opinions.

Retailers, manufacturers, and other members of the industry need our own version of the NRA… a single, unified group with our best interests in mind.  Everyone pays them and then they in turn lobby for us.  What does that mean?  We have to “pay to play”.  You know what? That fucking sucks. But it’s also how things work. We can complain and bitch about it all day long and that too will get us nowhere.

“That fucking sucks”  Yep.  Let’s hope this changes, let’s hope we can change it, let’s hope A Billion Lives can change it, let’s continue to fight to change it, but right now, it’s what we got.

Jeremy writes:

We need to stop the bickering and stop bashing one another and realize that if we want to have freedom to do what we do best, we have to learn to play the political game. Vendors should be donating some proceeds to the appropriate groups that in turn, put those funds into political action committees on both the federal and state level because essentially, we are paying our representatives to push our agenda to the congress, senate and all other entities that apply. I’m not a politician, I don’t claim to know much about this, but I do know that the groups that have vested interest in putting us out of business, are paying to do so. The politicians want to be re-elected to maintain their spots. We need to make that happen for the ones that can help us. We have to get organized on all levels. It may be too late, but maybe not.

Something else I don’t care about is where the help comes from. I’d personally like to see people who are experienced with all of this rather than going it the first time. If those people happen to be ex big tobacco employees, then so be it. At least they’ve been in the game and bring experience to the table.

Whether that unified group is the VTA or SFATA, or AVA, or some other pre-existing group or a new group yet to come, I personally don’t give a shit as long as we’re united under a single, powerful voice and presence that can get things done.   But united we must be and need to be yesterday.

So this is a request for unity… no, this is a plea for unity.

I’m a reviewer, I’m a vaper and now I have a liquid line. My two favorite tanks at the time I write this are the Kabuki and the Kayfun. One replaceable, one rebuildable BOTH refillable.  I use and review different product each and every day.

Those who think I want the open systems to go away need to get a grip.  Those of you who think I want direct lung to go away in favor of mouth to lung, need to get that same grip.  Just because I choose one for myself does not mean I’m against the other.

Variety and choice is part of what has made vaping so successful when all other methods have failed so miserably.

Now we’re hearing a lot about closed systems. Due to some far out conspiracy? I don’t think so. Instead, I think in part due to smart business people who read the following in the FDA regulations:

Page 69:

FDA will consider, the ways in which the new product is likely to be used. For example, PMTAs for these products should contain information on whether the product is likely to be used alone or together with other legally marketed tobacco products (such as available delivery systems), as well as the type and range of other products with which it is likely to be used. For example, where a manufacturer seeks authorization of a new e-liquid to be used with ENDS, the manufacturer may need to provide evidence and analysis of the product’s likely impact when used in the range of delivery systems available. Similarly, a manufacturer seeking authorization of a stand-alone apparatus component–such as a heating coil or cartridge–may need to provide evidence and analysis of the product’s likely impact when used together with the range of other components and liquids available. In the case of e-liquids, FDA expects that it may be possible for manufacturers to satisfy the statute by demonstrating that marketing of the liquid is appropriate for the protection of public health as it may be used in any of the legally available delivery systems. While FDA recognizes that there may remain some degree of uncertainty in any such analysis, FDA expects that the range of delivery system specifications authorized by FDA will provide a sufficiently specific spectrum of possibilities, such that a meaningful public health impact analysis can be done. In the case of ENDS hardware/apparatus components, FDA expects that it may be difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are 70 considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components. In the case of these complete delivery systems–systems for which the application covers all potential parts, including customizable options as applicable, and where labeling, instructions for use and/or other measures are used to help ensure use as intended–FDA expects that the range of possible outcomes may be narrow enough for the manufacturer to demonstrate, and for FDA to assess, public health impact.

Page 80:

In the case of ENDS hardware/apparatus components, FDA expects that it may be difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components. In the case of these complete delivery systems–systems for which the application covers all potential parts, including customizable options as applicable, and where labeling, instructions for use and/or other measures are used to help ensure use as intended–FDA expects that the range of possible outcomes may be narrow enough for the manufacturer to demonstrate, and for FDA to assess, public health impact.

Page 164:

However, as noted elsewhere in this document, for ENDS hardware or delivery system components or parts, such as batteries, FDA expects that it may be difficult for manufacturers to obtain premarket authorization for such products, given the great extent of possible variations in combinations of hardware components, if all considered and sold separately. Thus, with respect to such apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components.

There are more references.

So those of you blaming the closed systems on anything other than the wording you see above… perhaps you should read it again, because some insightful manufacturers certainly have.

I’ve been thinking a lot about the closed systems and what they mean. In the Digirette review, I said that I both love them and hate them.

I hate them because they’re a threat to our way of vaping, ESPECIALLY if they’re the only choice we’re given. It’s variety that has driven this industry so hard and so fast and has been able to convert so many smokers. That variety needs to continue. The fight for that variety needs to continue.  The fight for open systems needs to continue.

So if I hate them, why do I also love them? Because they are another tool we can use to rid the world of cigarettes once and for all.

And it is due to the love/hate relationship that I recognize a need for them.

I always think about my mother and wife when it comes to vaping. Not enthusiasts, not hobbyists, just two individuals who don’t want to smoke anymore… and want to do it as painlessly as possible. My wife is far better with her equipment than my mother. I often joke that my mother changes her coil 4-6 times per year when I see her. I’ll try her vape and be disgusted by a very old coil. Why is this? Could it be forgetfulness? Laziness? A desire to save money on coils? Perhaps she just didn’t have them around and was waiting to get to the store or for her delivery in the mail. The closed system solves this by offering (ok, forcing) a fresh coil with every pod change. The model makes sense for many smokers who also get a fresh filter with every cigarette, so I get it.

But even here we need choice.  Choice in liquids, and choice in flavors.

There’s a reason the Keurig model works. Ease of use, variety, and availability.

So if after all of the fighting, and lobbying, and lawsuits are said and done, if this is the hand we’re dealt, if this is the curve ball we’re thrown, then we still need to hit it out of the fucking park. There are still 40 million smokers out there in the US that need our help.  I, for one, still want to be involved with helping these people and freeing them from their tobacco cigarette addiction and guiding them to the life saving potential that vaping promises, no matter what tools I’m given to do so.

I leave you with this.  Stay calm, stay positive, stay focused, stay informed, continue to fight, continue to convert smokers, support the change of the predicate date, write letters, make phone calls, get organized, get involved, avoid the drama,  and stay united.

Because this isn’t over until the fat lady sings, and in the words of Will Smith, “I Ain’t Heard No Fat Lady”… at least not yet.

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Author: pbusardo