FDA, can’t we all just get along???

This week the Food and Drug Administration teamed up with the Federal Trade Commission (FDA & FTC respectively) to begin a full on assault against the vape industry. And for perhaps the first time in my 5+ years in this market, the FDA isn’t wrong! Let’s take a few minutes to break this down and figure out what it means for the immediate time, and for the future of vaping.

During the Obama administration, the primary lead for the FDA vs Vaping was Mitch Zeller, who was appointed as the director for the FDA’s Center for Tobacco Products. His disdain, bordering extreme hatred, for all things vaping was obvious to anyone observing this circus. He relished his power, authority, and appeared to believe himself the “right arm of justice”. Regardless of the FDA’s mission statement, there was little to no “science” or “health of the American people” that went into what would become the infamous Deeming Rule. Zeller would simply mount his podium, spew forth streams of illogical vendetta laced tirades, wait for his applause and disappear back behind the curtain. It was basically futile to offer any kind of defense using facts, applicable data, or common sense. The FDA wouldn’t acknowledge there was any other opinions, wouldn’t respond, wouldn’t even answer questions with regards to their own regulation. To say that Zeller was setting this industry up for failure was one of the biggest understatements in American political history. In the meantime countries like the UK were cautious with this new technology (as anyone should be), but they allowed emerging science to direct their regulatory framework. As the planet’s adult smoking rate began to plummet, nearly every society…except the US…embraced this change in humanity. They encouraged almost ANYTHING that would lead to lower traditional cigarette use, and vaping sure seems to have been THE primary contender. All the while Zeller ramped up his rhetoric and proved he was nothing more than a stooge for Big Tobacco.

Then came President Trump and with him a newly appointed head of the FDA, Scott Gottlieb. Gottlieb is not, and has not been, a politician, he’s a businessman. In fact he’s a businessman that prior to this appointment had even owned 60% shares in a large vape corporation. He doesn’t seem to care about politics, he appears to legitimately be concerned about the duties of his post, and he’s willing to let capitalism play out to the betterment of society. I realize I sound a bit like a Gottlieb fanboy, and while I’m not, I am hopeful with this new interface between my industry and the federal government we can come together on common middle ground. Had Zeller gotten his way, 99.7% of ALL vaping in the US would have been closed August 1st 2018. And yes that’s correct, not a typo. In just a few months, the only available vaping in the US would’ve been companies owned by big tobacco and sold only in major “big box retailers”. Zeller’s deeming rule also gutted the vape industry cutting it by 50% in less than 12 months. As with most things, the US is the world’s biggest customer of all things vaping, and Zeller’s actions still cause ripples being felt around the globe. One of Gottlieb’s first actions as director was to push the 2018 deadline, to 2022. He also spoke at length about how vaping appears to be making a significant dent in adult smoking rates, and the industry needed a little more time to sort out its own problems. In the same statement he also expressed his desire to attack traditional tobacco by lowering nicotine in cigarettes with the hope of removing it eventually. Since that time the FDA has had several “acts in furtherance” against big tobacco leading one to believe Gottlieb REALLY is trying to make a difference!

Which brings us to the purpose of this discussion. What is Gottlieb doing to vaping? Since his appointment, Mr. Gottlieb has continued to hammer the same points. He thinks that consenting adults should be free to live as they wish. But he realizes there is a difficult balance between “rights of adults” and “access to restricted products from minors”. In laymen’s terms, in order to give adults the plethora, prices, and efficacy they demand; those products inadvertently become more accessible to minors. This is not a new situation in the US; pornography, alcohol, and traditional tobacco (just to name a few) are all enjoyed in the US marketplace based on tenuous social contracts hammered out during the previous century. Vaping is no different, and we are currently in the midst of negotiating this brand new social contract dealing with a brand new product segment. Gottlieb has insinuated on multiple occasions that the vaping industry needs to go out of its way to “police its self” but if it refuses to do so, then the government will be required to step in. And there are two specific places Gottlieb has got a problem; marketing practices that could be interrupted as directed at minors, and flavors that might appeal to minors. For the latter, in April 2018 the FDA announced a public comment period to compile data with regards to flavors, how they are used in vaping, what their purpose is, and if they are effective in assisting adult smokers to quit smoking traditional tobacco. And that shall be a discussion for another time.

Marketing. Marketing. Marketing. Let’s discuss the FDA’s problem with marketing. In the final days of April 2018 the FDA with the FTC sent letters of reprimand to 13 vaping companies. The purpose of these letters were to warn the companies officially that their marketing practices are either over the line for seemingly enticing minors. Or that their marketing practices violate any number of international Intellectual Property (IP) laws, hence why the FTC is involved. And in my opinion, and that of most other common sense adults, the majority of these 13 companies are way WAY over the line! IP has become a hotly debated topic for humanity. The theft of another’s ideas can be more catastrophic then stealing the actual item. In many cases the offending company is simply trying to “ride the coat tails” of a more successful company. And in our specific scenario with vaping, several of the companies warned this week are guilty of BOTH. They have stolen the IP of other companies, ON products that are/were marketed to minors! If you inspect the photo at the top of this article you will see exactly what I am talking about. A vape company, NEwhere Inc. produced One Mad Hit Juice Box that is basically identical to Tree Top’s wholesome apple juice box designed for children’s lunch boxes. Other examples are e-juice bottles that resemble Whip Cream, Sour Patch Kids, and Sour Warheads; the last two being original products in the form of candy, and as we all know MOST candy is marketed to, and consumed by, children. Being a vape shop owner, I have been aware of these (and other similar products) in the market for some time, and I’m still speechless. I’ve never sold these types of products, nor would I ever, and from day one I have been concerned that there mere existence was a threat to the industry. But as with most things involving humans, it usually only takes one bad apple to spoil the barrel (no pun intended here).

Vaping needs to wake the f*%k up! We are past arguing about fairness, and comparing us to other age restricted industries. We are past telling people how it’s safe and they need to shut up and respect our rights. These have been some of the leading arguments to ANY government regulation. Well it’s obvious that those tactics are not working. Presently we are enjoying a reprieve from the FDA under Gottlieb, but let’s not forget the Deeming Rule being held over our heads. Let’s be honest about the 50% decline this industry witnessed over 18 months and the fact we are still in decay. There WILL BE REGULATIONS at a federal level. And we MIGHT HAVE AN OPPORTUNITY to help guide those regulations; if we can get our shit together and stop inflicting our own damage. This week the FDA and FTC, very politely, fired 13 shots across our collective bow. And if we don’t heed this message, I fear their next actions will be followed with, “I sank your battleship.”