FDA Rules a Win for Big Tobacco

Coverage and Analysis by Kyle A. Lohmeier

On May 5, the federal Food and Drug Administration finalized the rules that grant the bureaucracy the right to regulate electronic cigarettes. The new regulations prohibit the selling of electronic cigarette products to persons younger than 18 years old, requires sales be accompanied by an ID verification of the purchaser’s age, and prohibits the distribution of free samples.

We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell in a press release. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

The rule also requires that all e-cigarette products now under FDA regulation, which would be any e-cigarette or related product put on the market after February 15, 2007, be submitted to the FDA’s testing process to assure they meet public health standards as determined by law. Those products can continue to be sold for up to two years while their manufacturers submit their new tobacco product applications; the FDA will allow them to sell those products for up to one more year while the administration reviews the application.

Furthermore, the FDA requires manufacturers, importers and/or retailers of all e-cig products to register their manufacturing establishments and provide product listings to the FDA as well as report all the ingredients of their products, including harmful and potentially harmful constituents. The FDA also now requires premarket review and authorization of all new tobacco products and will require health warnings be placed on all products and advertisements. Also, as with cigarettes, e-cigarette manufacturers won’t be able to brand products as “light,” “low,” or “mild” unless given specific authorization to do so by the FDA.

This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products in a press release. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

While the FDA has their focus on public safety and tobacco addiction prevention, some in the e-cigarette industry hear the death knell of their businesses in the new rules.

It’s going to kill vaping as a whole. The only things that will be out are the ‘cig-a-like’ devices,” said Rick Hatcher, General Manager of Mo’ Vapor, a vape shop kiosk at the Polaris Fashion Place Mall in Polaris, Ohio, referring to smaller, mostly disposable e-cigarettes that look much like a traditional cigarette. “Those are the only things that are going to be left out, because most of those are owned big tobacco, and big tobacco can afford to keep them out.”

Most vape shops are built around a large variety of products, not just the cig-a-like devices often sold side-by-side with cigarettes at gas stations and other retailers, and having a steady stream of new products to offer is what keeps these stores, often recently opened in a strip mall with long-standing vacant units, in business, according to Hatcher.

Something new comes out almost every two months. Stuff comes out so quickly in the vaping industry,” Hatcher said. “A lot of it you can do on line, but most people support their local brick and mortar shops, I’m a small little kiosk inside a mall, if I have the option to order something on line or go to the local shop, I’d go to the local shop. They’re my friends and we support each other. It’s a community.”


As with anything the federal government and its assorted bureaucracies ever do, it would be asinine to assume the FDA’s new regulations of the electronic cigarette industry have anything at all to do with public safety. Of course the FDA couches their commentary on the new regulations in language dripping with a nanny-state desire to protect all the dear little children from themselves, and I’m sure an awful lot of people accept their assertions at face value.

It would, however, be silly to believe for even a moment the FDA doesn’t expect the majority of e-cigarette makers to either go out of business altogether, or go out of business in the United States, anyway. Even a cursory glance at some of the forms and documents that will have to be completed for each and every e-cigarette device on the market will make one go cross-eyed at the endless miles of legalese in tiny print on multi-page forms. While some of the “largest” e-cig firms not called “R.J. Reynolds” and “Phillip Morris” may be able to survive, the trickle-down effect of the slowing of the new-product pipeline will certainly drive many small retailers, particularly mom-and-pop shops not affiliated with a manufacturer, out of business. This will, as Mr. Hatcher in the above article predicted, kill the vaping industry as a whole and leave only the products produced by big tobacco left on the market. Coincidentally, it’s those same companies that can afford lobbyists as well as the legal teams needed to meet the FDA regulations on new tobacco products.

And, in the end, will anyone actually be any safer as a result of all this? Will anyone even benefit at all? Are “For Lease” signs in strip-mall unit windows good for an economy that’s already struggling through the worst post-recession recovery in the history of post-recession recoveries? Obviously not.

And do homo sapiens sapiens living in one of the most technologically advanced nations on earth here in the 21st century, with the vast majority of human knowledge available on a smartphone, actually need a giant, expensive, intrusive and oppressive government bureaucracy to tell them that inhaling combusted chemicals into their lungs might pose a health hazard? No, not really.

Speaking of inhaling things, the disingenuousness of the FDA’s new rules becomes utterly transparent when one considers the fact that “vaping” has helped a lot of people kick the habit of routinely inhaling combusted plant material and associated tars and resins into their lungs – a practice science has long since demonstrated to be sincerely unhealthful. And, instead of relying on the color of a box for a clue as to the concentration of nicotine in a cigarette, e-cig users can dial in their own nicotine concentration based on the liquids they use. Most e-liquid makers offer nicotine-free versions of their flavors, allowing users to eventually wean themselves off of nicotine altogether if they so choose.

Now, thanks to the FDA, the clock is ticking on how long Americans will be able to decide for themselves what vaping products to use or not, and once the timer expires, their options will become dramatically limited. Which, not at all ironically, is all government can ever produce: fewer choices and less freedom. If Bernie Sanders thinks there are too many brands of underarm deodorant available, he’d be appalled at the staggering array of choices confronting him inside a well-stocked vape shop. Well, for now, anyway. Give it roughly three years and there won’t be any such shops to worry about, the “For Lease” sign will be back in the window.

And, gazing into my crystal ball here, I am predicting that three years from now, when the regulations have driven most e-cig businesses into bankruptcy, we’ll see the actual intended effect of the FDA’s actions. A decrease in across-the-board nicotine use? No, those numbers will remain roughly the same. The numbers that got bigger, however, will be found on the quarterly reports of Phillip Morris and R.J. Reynolds. The oligarchs will have been made safe by the corporatist government that serves to protect them from competition and innovation.

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