For vaping enthusiasts in the United States, 2016 could be a challenging year. Since their introduction into the marketplace, electronic cigarettes have grown in popularity at a pace that few could have envisioned less than a decade ago. Many millions of users have successfully switched from dangerous tobacco-based smoking products to electronic nicotine delivery systems. Many others have used electronic cigarettes as a smoking cessation tool that has enabled them to quit using nicotine altogether.
Of course, whenever an industry grows this quickly, it naturally attracts the attention of people in high places. Almost as if on cue, here comes President Obama’s Food and Drug Administration. And if you haven’t heard anything about the latest FDA news with regulating electronic cigarettes, you might want to sit down. This might come as a bit of a shock.
The Obama FDA has issued a proposed rule that would extend the agency’s regulatory authority over tobacco products, and include electronic cigarettes under the definition of “tobacco.” Naturally, anyone who has any experience with electronic cigarettes could be excused for laughing at that notion, since e-cigs are most definitely not tobacco. As US News and World Report noted in 2014,
“The FDA is pushing a new set of rules that would classify e-cigarettes, which are non-combustible products that use no tobacco, as tobacco products.”
In that report, the author also concluded that any FDA rule that purported to regulate electronic cigarettes as tobacco would have the effect of stifling a multi-billion dollar industry made up of thousands of smaller, often family-owned enterprises. And who would end up controlling that market as those small enterprises shuttered their doors? You guessed it: the major tobacco companies. The reason for that is simple: complying with FDA tobacco regulations is a costly endeavor that only the largest, most well-financed companies can manage. Big tobacco can afford to play by those rules. These small e-cig manufacturers and shops simply cannot.
So, what exactly is the FDA looking at by way of regulatory action? Well, their new rule would enable them to exercise their tobacco regulatory powers in relation to these electronic nicotine delivery devices. On the agency’s own website, it asserts that the rule would cover “additional products that meet the legal definition of a tobacco product, such as e-cigarettes.” That, of course, might cause some to wonder whether anyone in the FDA has read the agency’s own website, which defines tobacco products as:
“…any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.”
And no, you are not wrong if you too noticed that the agency’s own definition currently includes only products that are actually tobacco-related. Apparently, they are willing to overlook the absurdity of pretending that electronic cigarettes are tobacco products, just as long as it furthers their agenda.
The process of such a classification would involve electronic cigarettes being “deemed” to be tobacco (for government purposes, the act of deeming something to be something that it is not is often the equivalent of a child’s game of make-believe) so that they would then be subject to the same type of FDA regulatory authority. When the rule was initially proposed back in 2014, the then-Secretary of Health and Human Services, Kathleen Sebelius, actually remarked that this attempt to regulate electronic cigarettes was “the latest step in our efforts to make the next generation tobacco-free.” Obviously, she enjoys a nice game of make-believe as well.
The new rules would require that e-cig manufacturers register with the FDA, report their ingredients, obtain FDA approval before marketing, and demonstrate that their products can meet any claims that they make about health benefits. The rule would also require age restrictions for purchase (something that many state and local jurisdictions are already doing on their own), add health warnings, and prevent the devices from being sold in vending machines.
As devastating as this news could be for the industry, the fact that it could have been avoided is even more disheartening for some. During the Omnibus Bill effort in December, 2015, Republicans in the House had attempted to throw a lifeline to the vaping industry by adding a bill rider that would have exempted the electronic cigarette industry from FDA meddling. The Democrats managed to block the exemption, and Minority Leader Nancy Pelosi boasted that “the GOP policy rider exempting e-cigarettes and other tobacco products – including flavored products designed specifically to attract young smokers – from FDA’s pre-market review requirement, was not included in the Omnibus.”
Apparently the Democrats in Congress are also pretending that electronic cigarettes are just “other tobacco products.”
Meanwhile, back in the real world, mom and pop vape shops and electronic cigarette manufacturers are gearing up for the fight of their lives. For many, it is a fight to remain in business and pursue their own American dream without fear of overreaching governmental interference. One battle appears to have been lost, but the industry’s war is just beginning.