Another Looming Threat to E-Cigarettes

Even if the FDA does not ban flavors, its regulations will soon drive most vaping businesses and products from the market.


President Donald Trump reportedly has reconsidered a plan to ban flavored e-cigarettes, a reversal that was widely portrayed as a triumph of politics over public health. Yet that criticism more aptly describes the proposed ban, which would have sacrificed the interests, and potentially the lives, of current and former smokers in the name of curtailing underage vaping.

There were political arguments on both sides of this debate. Advocates of the flavor ban argued that it would appeal to suburban women concerned about the recent rise in e-cigarette use by teenagers, while opponents warned that it would alienate vapers who were otherwise inclined to support the president, endangering his re-election.

The opponents, bolstered by rallies and polling data suggesting that vapers were highly motivated and apt to vote (or refrain from voting) based on this issue, seem to have prevailed. But they not only had the stronger political argument; they also had the stronger public health argument.

Millions of Americans have quit smoking by switching to vaping, a far less hazardous source of nicotine. Consumer surveys and sales data show they overwhelmingly prefer the products targeted by the proposed ban.

That policy, which was expressly designed to make vaping products less appealing, would have driven some former smokers back to their old habits while deterring current smokers from making a switch that could save their lives. Even The New York Times saw the folly of this approach, warning that it "would almost certainly force people who already use these products, including roughly 11 million adults, to choose between traditional cigarettes (which remain widely available, despite being deadlier than e-cigarettes) and black-market vaping products."

For the time being, the vaping industry, including thousands of mom-and-pop shops across the country, seems to have dodged a bullet. But it still faces the looming threat of federal regulations that are expected to drive most businesses and products from the market.

Under a 2016 rule, manufacturers, which include vape shops that mix their own e-liquids, have to persuade the Food and Drug Administration (FDA) that allowing sales of their products is "appropriate for the protection of public health." Although it's still not clear exactly what that means, vaping businesses must submit a "premarket tobacco application" (PMTA) for each of their products by May 12—less than six months from now.

A PMTA is required for every product variation. The FDA puts the "average cost" at $132,000 for e-liquids and $467,000 for devices, although it says some applications could cost more than $2 million.

Either way, those costs are likely to deter all but the largest vaping companies. The FDA itself predicts that "54 percent of delivery systems and somewhere between 50 and 87.5 percent of e-liquids" will "exit the market" before the application deadline.

If a business manages to file adequate applications in time, it will be allowed to keep those products on the market for up to a year while the FDA decides whether to approve them. But even at this late date, the requirements for approval remain opaque, as a lawsuit filed last month by a coalition of small vaping companies points out.

The FDA, for instance, demands "sufficient information regarding the potential abuse liability" of each product and suggests it would be satisfied with "a double-blind, placebo-controlled, within-subject study comparing several doses of a new product to a comparator product with a known abuse liability." It's not clear whether anything short of that prohibitively expensive option would suffice. And while manufacturers are supposed to list "harmful or potentially harmful constituents," the FDA still has not fully specified what those are.

"Our next focus will be on ensuring that the Trump administration recognizes the need to reform the FDA's regulatory system for these products," says Gregory Conley, president of the American Vaping Association, an advocacy group that supports vaping as a harm-reducing alternative to smoking. "If President Trump wants to win in 2020, mere inaction on this issue is not enough."

© Copyright 2019 by Creators Syndicate Inc.

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  1. Can’t ban it?

    Regulate it to death!

    The safety-regulatory complex is another wing of the deep state, btw. A bureaucracy comprising unaccountable self-important little tyrants. Eisenhower called out the military industrial complex, but that was merely one wing, with which he was very familiar.

    Government employment should have term limits.

  2. It’s hard to argue too much about making sure these products are adequately tested even if the testing is expensive.

    Didn’t we just go thru a panic where hundreds got sick and dozens died because of inadequately tested products?

    My son Vapes, and I vastly prefer that to cigarettes, but I don’t want him vaping something that someone is mixing up in the back room.

    There is a big difference between cupcakes sold at a bake sale going in your stomach, and backroom Vapes going into your lungs.

    1. Really? Does it depend on how big your stomach is?

    2. Then tell your son not to buy his vapes from Joe on the street corner. The FDA already regulates the stuff sold in stores

    3. Sure, let’s require testing of every consumer product, with the most extensive (and expensive) protocols possible. And I assume we mean government testing, since no arrangement of private entities could possibly satisfy the nanny needs of ignorant sheeple.

    4. Instead of going after the backroom shit that is making people sick, the geniuses at the CDC and FDA ignored the science and did everything they could to link the disease to commercially available nicotine ecigs because it suits their agenda. As long as your son is not vaping THC, he should be fine-I’ve been vaping for 10+ years now and can run 5 miles. Something I could never even attempt when I used to smoke.

      1. So you didn’t use the e-cig as a quitting tool but a replacement. Just out of curiosity, why didn’t you just quit? If smoking was making you unable to run, why choose to stay addicted to nicotine?

        1. Why not? Have you not heard the phrase, people smoke for the nicotine but die from the tar?

    5. Makes sense, until you realize that perfumes aren’t required to be tested for toxicity. Under the FFDCA, cosmetics ingredients are legal unless specifically banned. And when you consider that vaping is essentially (heh) the same as sniffing perfume, why the special rules for vape liquids?

  3. 100 or more people in the US die every day from the inept use of perfectly legal cars and trucks. Why is the FDA so much more “helpful” than NHTSA? Over 80% of drivers self-report having above average skills, so it’s obviously the products to blame.

  4. Has Reason expanded the Holy Trinity of Assex, Mexicans and Pot to a foursome by including Vaping?

  5. Fuck the FDA, the government needs to close down these meddlesome, unaccountable government oversight organizations. I don’t need Big Brother looking out for me.

  6. Vaping is a dog whistle for white supremacy. Do not be fooled. From the spittoon and a banjo to a cloudy monsoon made of mango!

  7. I like how the ADA is essentially saying that we don’t have long term knowledge of what vaping does, therefore it should be 100% illegal forever. Especially since if not for vaping, I’d still be smoking cigarettes which are specifically a product that we do know the long term effects: cancer and death.

    I also like how they point to how people simply replace cigarettes with vaping products, and that’s a bad thing. No mention of how the exact same thing happens with patches and nicotine gums.

    It’s selective outrage, and curious definitions of what is a ‘cessation’ product vs. a ‘replacement’ product. Lunacy.

    1. The AHA and most other health groups get lots of money from Big Pharma whose smoking cessation products are threatened by vaping-of course they aren’t going to bite the hand that feeds them.

      1. Big Pharma needs to buy some vape companies, making early vape producers rich. Appropriately paid for taking the risk.

      2. This is also a silly argument. Vaping products like Juul are responsible for a surge in teen addiction to tobacco. Big Pharma’s tobacco addiction products have a larger potential market now that Big Tobacco has found a new way to addict kids to their drug.

  8. I’m wondering if vaping provides similar tax revenues to the states as tobacco. If not, I suspect the governments would prefer to have citizens pay taxes for tobacco products. And also die younger, since Social Security could do better with fewer participants.

    1. It does not, and yes that’s probably a reason why States in particular aren’t fans of vaping. They planned on the cash from the settlement to be neverending, and budgeted as such.

      1. That’s a silly argument. States could more easily raise taxes on vaping than make vaping illegal. The Feds could easily include tobacco vaping products in the same tax category as other tobacco products. (Such a bill was introduced last month.)

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