The FDA Hands Big Tobacco a Big Win

The FDA released it’s 500-page deeming document relating to “Tobacco Products” on May 5th. For right or wrong, e-cigarettes. e-liquids, mods, batteries and even drip tips will now all fall under these regulations. We’ve been waiting with bated breath for these since October of 2015. And they are every bit as bad as we’d feared.

Anything done in the name of safety is generally a good thing, but these regulations proposed by the FDA are so off base that we are left to wonder if there was any research done at all, or if this was simply blind fear and hysteria fueled by those with a vested interest in seeing this revolutionary industry fail. After review, here are some questions these regulations pose:

  • The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.” How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?
  • Did the FDA determine how many e-cigarette businesses will be affected by the rule?  If not, why?
  • Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products?
  • How can the FDA reasonably classify tanks, batteries, drip tips, mods and software as “tobacco products”?
  • How can the FDA reasonably classify any individual, business or process that assembles any two of these parts together as a “tobacco manufacturer”?

How does it get to this point? How can an agency charged with protecting the public health arbitrarily decree that 98% of products available are subject to crippling regulations based on seemingly no research at all? How has this been allowed to happen? Sadly, it doesn’t seem to be arbitrary at all. The entire situation smacks of collusion and backdoor deals. When one industry – an industry known to spread disinformation and lies and disease and death – benefits from the decimation of another, you have to ask yourself why. When people have genuinely changed their lives for the better with a new technology only to have that technology effectively relegated to Prohibition status based solely on popular perception, hysteria reigns while progress dies. Where money talks and the good of The People takes a backseat, something is desperately wrong.

A witch!

There certainly are a lot of parallels here.

Clearly, we find it hard to be objective on the subject. We have put our entire lives into this shop and this industry. Our employees count on it for their livelihoods. We are fortunate to be able to do what we love and make a modest living at it. However, much, much more than our own personal and monetary stake in this business,  we and millions of others have consciously made the choice to be healthier in our daily lives by quitting smoking, and have come to count on vaping as a way to continue to be smoke-free.

Because there haven’t been any exhaustive, definitive studies done by an official U.S. agency, we have to be very careful about making any claims about vaping being a smoking cessation tool. However, in ours and many others’ personal experiences, e-cigs are a viable smoking cessation tool. It is the ONLY one that got us to put down cigarettes for good. Not cold turkey, not the patch, the gum or the lozenges. Vaping did.

Of the six people here at Offbeat and Unique, five have successfully quit smoking by switching to vaping (Bethany never smoked to begin with) . Marc personally kicked a 20-year, pack a day habit 3 years ago, using e-cigs. It took him a while to actually try it, but once he did, he says he kicked himself for waiting so long. TJ was even further down the path after 25 years and a pack-and-a-half a day habit. Both beat the addiction by switching to vaping. There are similar stories with the rest of the crew. Granted, that is an example wrought from a tiny sampling of the overall population. But it’s not just the few of us at the shop who have made the switch to vapor from smoking. Millions of others in the U.S. and across the globe have done it as well. We have successfully quit smoking with the assistance of vaping. Every day, more and more people put down traditional tobacco with the help of vaping. What’s more, it has been proven to be – conservatively – 95% safer than smoking.

The UK's Royal College of Physicians sounds off in a big way

The UK’s Royal College of Physicians sounds off in a big way

That is monumental, as this year alone, nearly 500,000 people will die from smoking-related diseases in the US alone. Half a million people, dead from tobacco. Every year. And before they die, they will rack up trillions of dollars in healthcare expenses, raising healthcare costs for everyone. Extrapolated worldwide, tobacco is on course to kill one billion people this century. One billion lives, lost to tobacco.

16.8% of the US adult population smokes traditional cigarettes. That is roughly 40 million smokers. In a study conducted in 2014 and published by the CDC in October 2015, 3.7% of the U.S. population – or about 9 million people – were vapers. The cries of “E-cigs are a gateway to traditional cigarettes.” are an absolute farce. The 40 million smokers in the US alone didn’t all show up in the 9 years that vaping devices have been on the market.  In fact, the number of smokers in the US has been in a steady decline for the last 40 years, with a noticeably sharper downturn since 2009. Industry analysts pose that vapers are set to outnumber traditional smokers by 2025. That, we believe, is the real reason for the scrutiny and vilification of vapers and the vapor industry.

Senator Johnson (R-Wis.) seeks answers from FDA

Senator Johnson (R-Wis.) seeks answers from FDA

And really, cigarettes don’t need a gateway when a tobacco industry is allowed to go unchecked for nearly 100 years. Once they finally were called to the carpet for violating the RICO Act, after (what amounted to) a nominal fine, a change in packaging and a slap on the wrist, it was pretty much back to business as usual.

On September 22, 1999, the U.S. Department of Justice filed a racketeering lawsuit against Philip Morris (now a division of Altria) and other major cigarette manufacturers. Almost 7 years later, on August 17, 2006 U.S. District Court Judge Gladys Kessler found that the Government had proven its case and that the tobacco company defendants had violated the Racketeer Influenced Corrupt Organizations Act (RICO). Specifically, Judge Kessler found that PM and other tobacco companies had:

Named in the suit:

The RICO Act was created to combat and prosecute organized crime. The Lucchese Crime Family, The Gambino Crime Family, Michael Conahan and Mark Ciavarella, The Chicago Outfit and many others have been prosecuted and/or jailed for violating it. The DOJ saw Big Tobacco as corrupt confederation, involved in the same types of activities that are typically the hallmarks of mobsters, drug kingpins and corrupt politicians.  These companies lied, concealed, denied key information about their products in a 50-year conspiracy, were found guilty under statutes used to put away the worst of the worst of society, yet are still in business to this day.

While compiling deeming regulations research, the FDA actually received studies provided by Big Tobacco, and seems to have used them as a basis for their regulations:

“the biggest of the big tobacco companies, RJ Reynolds, which also owns the fast-growing e-cig brand Vuse, is trying very hard to convince lawmakers to ban vaping.”


These regulations are so confounding, we can only assume a little bit of this is going on.

Read that again. RJ Reynolds is lobbying against refillable tanks and mods, in order to steer users towards the disposable, non-refillable, poor quality cigalikes that they manufacture. And it seems to have worked. Rather than investing the time and money to actually understand the vaping industry, the FDA seems to have taken its position directly from special interests hellbent on maintaining the status quo. Big Tobacco is an industry that has already been proven to be completely detrimental to the public health, yet has been allowed to flourish, largely – one would think –  due to the tax revenues they generate. Even worse, the FDA seems to be using a roadmap for regulation provided by these very same organizations.

Conversely, the vaping industry has been very up-front about potential health risks. Most manufacturers actively test liquids and strive for only the purest, safest ingredient sources, and then make that data available to the public. At Offbeat and Unique, we carry only authentic equipment, equipment that comes straight from the patent holders or their licensees. There are a few manufacturers who aren’t as diligent or scrupulous, for sure, but as a whole, this industry has been very proactive about quality and safety. As an industry, we’ve been leading by example with independent testing and a true desire to put out the best product possible almost from the start.

We want regulation; we want to know what is in our e-liquid. We want to keep vaping hardware, liquid and accessories safe to use and out of the hands of kids. Who could even argue that point? Reputable manufacturers, suppliers and shops have been taking it upon themselves  doing the right thing SINCE DAY ONE. Before it was a state (now national) law, most would not sell to anyone under 18 years of age. We actively encouraged liquid vendors to stop using questionable ingredients, pleaded with local shops to stop selling clones. And we are not alone in these goals. As an industry, we want this to continue to be a readily available, safer alternative to smoking.

We want to continue to allow a young, revolutionary industry to flourish. To continue to allow small businesses to drive the standard – so far, independent of government influence, we have set the standards for both quality and safety –  and to continue to give its consumers what they want: an array of equipment, nicotine strengths and flavors – much in the same way the newer trend of craft beer and infused liquors have been allowed to. The cream will rise to the top. It’s how standards are set and quality is improved.

What we do not want are ham-handed and overreaching regulations that appear to have been conceived out of ignorance and fear rather than the scientific facts and prudence that these products demand.

We do not want to be forced to financially support Big Tobacco by using their grandfathered, inferior products – essentially the only products that will be available if these regulations are put into effect as written – or worse: go back to using traditional tobacco.

It really is this bad. Our health, our freedom of choice and our very way of life are at stake. Please act now before we no longer have a choice.

Both HR 2058 and the Cole-Bishop amendment are vehicles for language that would change the predicate date in the Tobacco Control Act (

Both HR 2058 and the Cole-Bishop amendment are vehicles for language that would change the predicate date in the Tobacco Control Act. Click above to add your voice of support.

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