The Real Threat of What Could Be Next…

September 21 2018

The vaping community and industry could be facing it’s most challenging threat yet. Today the FDA released a statement in regards to youth vaping and ease of access. Within FDA Commissioner Gottlieb’s statement, there were many topics and references that can potentially shut down thousands of vape shops around the nation. Now more than ever, the industry needs to band together and stand tall, otherwise, we’re doomed.

The main topic that is being discussed is youth use and ease of access. Vaping should only be available to adults, point blank. Media coverage has not been helpful for the industry, as many of the reports/headlines attack vaping – being seen as the ‘big bad wolf’ targeting children directly. When in reality, the majority of the vaping industry has taken several different steps in preventing access to youth, even before the FDA decided to get involved. Many companies started to use child-proof caps, added warnings to their labels saying ‘keep out of reach of children and pets’ and even went as far as making their shops ‘adult only’ locations requiring photo I.D.’s before any transactions occurred. In Gottlieb’s statement, he mentions ‘the most immediate tool to address youth use is enforcement’. As a result of the FDA’s concerns of youth access/use, they have issued warning letters to companies that sell/advertise misleading labels or kid-friendly designed items and even citing companies for illegally selling products to children. In the press release from the FDA, they mentioned ‘more than 1,300 warning letters and fines to retailers announced today were part of a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers, which was conducted from June through the end of August.’ This is definitely only the beginning of the FDA’s inspections and actions. Now more than ever, manufacturer’s and retailers need to be more vigilant and card everyone who walks into their stores. It’s important to keep minors from purchasing these products. Later in Gottlieb’s statement, he says: “I’ve been warning the e-cigarette [vaping] industry for more than a year that they needed to do much more to stem the youth trends. In my view, they treated these issues like a public relations challenge rather than seriously considering the legal obligations, the public health mandate, and the existential threat to these products. And the risks mounted. Well, I’m here to tell them this approach is over.” Their initial focus is currently on JUUL, Vuse, MarkTen, blu e-cigs, and Logic. These companies represent more than 97% of the current market for e-cigs according to the FDA. These 5 companies received letters today requesting that they bring the FDA, in no more than 60 days,  plans on how they intend to address the widespread use of their products by minors. Many of the companies have already made statements saying that they are looking forward to addressing this issue and working with the FDA to find a solution.”A Juul spokeswoman said the company will work proactively with the FDA in response to its request. “We welcome the FDA’s actions today, and we look forward to sharing our thoughts about how to prevent and reduce youth usage, an issue we’ve focused on for decades,” an Altria spokesman said.” according to the article on CNBC’s website.

“One factor we’re closely evaluating is the availability of characterizing flavors. We know that flavors play an important role in driving the youth appeal. And in view of the trends underways, we may take steps to curtail the marketing and selling of flavored products. We’re now actively evaluating how we’d implement such policy.” Gottlieb mentions in another section of his statement. This is what is the most concerning for the vaping industry – a flavor ban. Flavors are such an important part for adult vapers, but as Gottlieb says in his statement “The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.” If you recall, the FDA had a public docket open a few months ago asking for input on flavors and the importance they have for vapers. Many commented on their own personal stories and the use of flavors. Later Gottlieb mentioned that these comments are ‘anecdotes’ that can’t be used to help prove flavors are that important. The Vapor Technology Association(VTA) and Consumer Advocates for Smoke-Free Alternatives Association’s(CASAA) immediately responded and created a campaign to show the FDA that these were in fact not anecdotes. VTA’s facebook posted this on July 3rd, 2018, during their campaign: “FDA Commissioner Scott Gottlieb believes that any stories about quitting cigarettes are “anecdotes” but YOU ARE NOT AN ANECDOTE! Tell the FDA your personal testimonies on how you were able to quit cigarettes with the help of vapor products now.”  The campaign resulted in over 9,000 vapers responding. But from the sounds of his statement today, he’s not listening to vapers. The FDA’s tunnel vision about vaping is solely based around youth use/access.  Which isn’t a bad thing, but in order to keep the innovation and the industry thriving, you need to incorporate all the different aspects and create an informative and educated conclusion.

Last year the FDA introduced an initial comprehensive plan to create regulations and guidance for e-liquid manufacturers. Deadlines were pushed back to allow time for manufacturers to register their ingredients, labeling etc. while the FDA had time to create clear and transparent regulations for the industry. They had the intentions to make the process easier for manufacturers to understand, but Gottlieb goes on to say in his statement today, “Our public health mandate to prevent youth addiction has forced us to now revisit this element of our overall plan.” This means deadlines that were previously pushed back to give manufacturers time to register and apply for licenses etc., maybe sooner than expected. This could cause many businesses to be fined, or close if they can’t get their e-liquids registered and purchase the correct licensing in time. Gottlieb mentions in his statement “We’re actively considering whether we will enforce the premarket review provision earlier when it is apparent that these products are now subject to widespread youth use.”According to The American Vaping Association(AVA) facebook page, “Each PMTA could cost between $2 million and $10 million … This money might end up being wasted, as the agency has never approved a new tobacco product.” This means that the manufacturer will need to pay that amount per each flavor they create, with the possibility of not even getting approved. Many shops won’t or can’t afford to do this and that means the industry will crumble to only those run by multimillion dollar companies…aka BIG TOBACCO. The Vapor Technology Association released a statement following Gottlieb’s statement. “Decisions of this magnitude must be made on science, not emotion. That is FDA’s charge. Today’s actions have sent Big Tobacco stocks skyrocketing. Does FDA really want millions of Americans to return to smoking cigarettes?” added Tony Abboud, Executive Director of the Vapor Technology Association.

The FDA has taken the gloves off and the real battle is going to start sooner than we thought. It’s been rough for the vaping industry the past few years, but from the sounds of this statement from the FDA Commissioner Scott Gottlieb, M.D, things are about to get much harder. It’s more important than ever to stay vigilant and responsible. Manufacturer’s it’s important to re-evaluate your labels and advertising. Is there any element that can appeal to children? Do you have the appropriate warnings and statements? Are you carding everyone who enters your store or who is purchasing a vaping product? We urge all those in the industry to really evaluate where you stand and make the correct revisions to keep business responsible and legal. This is where we need to stand united and together because otherwise, we’ll be divided and conquered. Let’s make history….not become it.


If you would like to read the FDA’s press statement click here.

If you would like to read the Statement from FDA Commissioner Scott Gottlieb, M.D. click here.

If you would like to read the Vapor Technology’s Statement, click here.