Vaping

Since the FDA Has Not Approved Any Vaping Products, All of Them Are Now 'Subject to Enforcement Action'

The agency's decisions so far reflect a bias against the flavored e-liquids that former smokers overwhelmingly prefer.

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When a court-set deadline for "premarket" review of nicotine vaping products came and went on Thursday, the Food and Drug Administration (FDA) had received millions of applications but had not approved any. As a result, the agency says, every vaping product sold in the United States—including myriad e-liquids, devices, and parts—is "marketed unlawfully" and "subject to enforcement action at the FDA's discretion."

Seven years after the FDA officially declared its intention to regulate e-cigarettes as "tobacco products," in other words, the entire industry remains in legal limbo, existing solely thanks to the agency's enforcement discretion and limited resources. The FDA laughably maintains that it is bringing "regulatory certainty" to a market it concedes has great potential to reduce smoking-related disease and death. In reality, the agency, despite its promises of regulatory flexibility, is perpetuating a situation in which companies that tried to play by the rules have no idea whether they will still be in business next week, next month, or next year.

As of September 9, 2020, the deadline set by U.S. District Judge Paul Grimm in response to a lawsuit by anti-vaping groups, the FDA had received 6.5 million applications from more than 500 manufacturers of "new tobacco products," the vast majority of them vaping liquids or devices. That was a far cry from the 25 annual applications the FDA originally expected—a projection that suggested nearly all vaping companies would be deterred by the effort and expense required to comply with the agency's daunting regulations. Grimm gave the agency an additional year to act on those applications.

While the FDA brags that it has acted on "about 93% of the total timely-submitted applications," that number is highly misleading. Three-quarters of those actions involved 4.5 million applications from a single manufacturer, JD Nova, that the FDA deemed incomplete in August because they did not include an "adequate Environmental Assessment" for each of the products, many of which had never actually been sold. In addition to seeking approval for hypothetical products, the company submitted a separate application for every flavor, strength, and size of its existing e-liquids, as required by the FDA.

As Filter's Alex Norcia noted at the time, the environmental assessment demanded by the FDA is "an onerous and complicated section that covers a product's environmental impact from the point of manufacture to disposal." Because JD Nova did not meet that requirement to the FDA's satisfaction, its applications were never formally filed. But later that month, the FDA issued its first "marketing denial orders" (MDOs), rejecting 55,000 applications for "flavored" vaping products from three companies because they "lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products."

The FDA noted that the rejected products included "flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal." Acting FDA Commissioner Janet Woodcock said "flavored tobacco products are very appealing to young people," so "assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed."

For tobacco harm reduction advocates, that rationale is alarming because it suggests a bias against e-liquids in flavors other than tobacco, which are enormously popular among smokers who switch to vaping. It also implies that the FDA's requirements for overcoming that bias may be impossible to satisfy, especially for small businesses that could not afford to spend hundreds of thousands or millions of dollars on new research.

"Based on existing scientific evidence and the agency's experience conducting premarket reviews," the FDA said, "the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable. Because this evidence was absent in these applications, the FDA is issuing MDOs."

Less than a week later, the FDA denied applications from three companies for about 800 other flavored products. It said it would "continue to review other premarket tobacco applications for non-tobacco flavored ENDS [electronic nicotine delivery systems] to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth." All told, the FDA says, it has issued "132 MDOs for more than 946,000 flavored ENDS products."

The FDA has yet to act on applications from major manufacturers such as Juul, which in 2018 preemptively stopped selling most of its flavors in response to the agency's concerns about underage vaping. "How the FDA could fail to make a decision on Juul products is beyond me," said Michelle Eakin, chair of the American Thoracic Society's Tobacco Action Committee, in a press release. "Juul has the largest share of the e-cigarette market and its products were a primary driver in the sky-rocketing rise in youth e-cigarette use. The FDA has delayed long enough. Until the agency addresses Juul, Puffbar and other companies that are driving the youth e-cigarette market, it is failing to do its job."

Critics like Eakin think the FDA should ban all non-tobacco-flavored vaping products, despite the fact that former smokers overwhelmingly prefer them, because they also appeal to teenagers. Under the Family Smoking Prevention and Tobacco Control Act, the 2009 statute that the FDA used to assert authority over e-cigarettes (even though legislators did not contemplate that product category when they wrote the law), the agency is supposed to consider a product's impact on "the population as a whole," which includes underage vaping. But that collectivist calculus also includes reductions in smoking facilitated by vaping products. If banning flavored options makes these products less appealing to current and former smokers, that policy could perversely lead to more tobacco-related deaths than would otherwise occur.

"There is robust evidence that non-tobacco-flavored e-cigarettes help adults quit smoking," notes Competitive Enterprise Institute senior fellow Michelle Minton. "It seems their availability in non-tobacco flavors is, in fact, a major reason why e-cigarettes are at least twice as effective for smoking cessation as other nicotine replacement therapies."

Because of the standard set by the Tobacco Control Act, it is not enough for a manufacturer to show that its products are much less hazardous than combustible cigarettes. Nor is it enough to plausibly project that more vaping will mean less smoking (among teenagers as well as adults) and therefore fewer premature deaths. A manufacturer also has to persuade the FDA that the "public health" benefit from allowing its product to stay on the market outweighs the potential cost of vaping by teenagers who otherwise never would have used nicotine.

As a general matter, that should not be difficult, since the health hazards of nicotine itself are minimal compared to the hazards of cigarette smoking, the vast majority of teenagers who vape frequently are current or former smokers, and there is little evidence that vaping products are a "gateway" to smoking among teenagers. To the contrary, recent trends suggest the availability of these products has accelerated the downward trend in adolescent smoking, and there is reason to think that banning flavored e-liquids would have the opposite effect.

But if every manufacturer has to present "product-specific," "robust and reliable" evidence that the benefits of each variation it sells will outweigh the costs, that is a recipe for eliminating all but the biggest, wealthiest companies. Even a manufacturer that presents a "randomized controlled trial" or "longitudinal cohort study" indicating that flavored vaping products play an important role in reducing smoking has to contend with speculation about "the impact of potential or actual youth use."

Since 2015, Minton notes, the FDA "has approved new tobacco products from three companies, including flavored tobacco." Those products included "eight varieties of Swedish Match North America's snus, the heated tobacco product, IQOS, made by Philip Morris, and combustible cigarettes with reduced nicotine made by 22nd Century Group." In those cases, "the FDA was happy to accept more general evidence about the product category's appeal to adults and youth, as well as their general risks to public health." But when it comes to flavored vaping products, the FDA seems to be demanding more.

"America's tobacco and nicotine regulatory system is broken beyond repair," says Gregory Conley, president of the American Vaping Association, which supports vaping as a harm-reducing alternative to smoking. "It is absolutely absurd that the same agency that found time to ban over six million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares. Even worse, after spending five-plus years peddling false hope to businesses across America, the FDA now can't even be bothered to grant formal extensions to the remaining pending applicants. This decision brings even more uncertainty on the day FDA had previously pledged to provide the public with answers."

Norcia reports that some manufacturers, having concluded that satisfying the FDA is impossible, are shifting toward synthetic nicotine, which is not derived from tobacco and therefore is arguably not subject to the agency's jurisdiction under the Tobacco Control Act. Assuming that legal strategy is successful, there could be many vaping products that are not even notionally subject to FDA regulation. And if the FDA refuses to approve flavored products, vapers who prefer them will still find lots of black-market alternatives, which likewise will be completely unaffected by government-prescribed standards. Given the recent experience with lung injuries caused by black-market THC vapes, that is a situation a public health agency should be keen to avoid.

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  1. Once you accept a government mandate, you gotta accept them all. Either that or start shooting the bastards.

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        2. That’s why I support the Texas Heartbeat bill.

    2. The bastards order us shot proportionate to the number of cowards voting for the initiation of force. Right now that’s a 32-to-1 leverage factor. But before 1972 it was mathematically infinite. In fact, before infiltrators wrecked the 2018 LP platform and put the commie anarchist on the 2020 ticket, law-changing LP spoiler votes were increasing by 80% per year.

  2. This was always going to end up this way. A bureaucrat who approves something new is at risk of being blamed for any bad consequence. If ten thousand lives are saved by vaping, it can’t be proved; the deaths did not happen, so who can point to any one life saved. If one person gets sick or dies from vaping, that bureaucrat’s career is over.
    This is how it goes.

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    1. +1 John Nestor

    2. This is the true meaning of “if it saves just one life”

  3. Wahhh we wants our drugs smh

  4. This makes me want to start vaping.

  5. Karen is gonna Karen.
    Progressives really are the worst human beings.

  6. Juul moved its HQ from SF to DC last year in order to make sure they were first in line to suck the regulators’ dicks and it appears to be paying off for them. I don’t know why anybody is shocked that the FDA would favor those with the deepest pockets over a mom and pop vape shop. That’s how it’s always worked, folks…

    1. RTFA. It’s not paying off for Juul or any manufacturer.

      1. Not yet perhaps, but why would they hold off on a decision for Juul and other big manufacturers if its just going to be to same decision they made for the millions of applications from smaller companies? If they wanted to ban them all they could have done exactly that, the only reason to delay is they want to let the big boys keep playing while eliminating the competition

  7. Back in 2014 when FDA first proposed its Deeming Rule, I correctly predicted (at FDA public hearings, in written Docket comments, in press releases and in many action alerts) that FDA’s proposed regulation would ban the sale of >99.9% of nicotine vapor products currently on the US market, and would create a new multi billion dollar vapor manufacture monopoly/oligopoly controlled by the world’s largest cigarette companies (which aggressively lobbied the FDA along with Big Pharma and anti tobacco extremists to impose this disastrous regulation).

    But its nice to see an objective article by Sullum, who was obsessed with demonizing Trump for the past five years.

    1. I’ve read your testimony. Pretty alarmist.

      Sullum isn’t objective at all. He’s pushing the false narrative of harm reduction, without evidence that inhaling chemicals by heating chemicals is less harmful than inhaling chemicals by heating plant matter.

      It’s ironic that he’s pro pot, when he claims to care about harm.

      1. More than a dozen years of scientific studies and surveillance data have consistently found that vaping nicotine is about 99% less harmful than smoking cigarettes, and recent surveys have found that 10 million Americans (and another 10 million people abroad) have quit smoking by switching to vaping.

        But since the FDA’s Director of Tobacco Products Mitch Zeller is the former GlaxoSmithKline lobbyist who negotiated the 2004 FSPTCA (sponsored by Waxman and Kennedy) and lobbied for its Congressional enactment with Philip Morris lobbyists and Johnson & Johnson created/financed Campaign for Tobacco Free Kids, nobody should be surprised that FDA (and CDC, US SG and other DHHS agencies ) has lied about the very low risks of vaping since 2009 (when the FDA illegally banned all nicotine vapor products, which was struck down by federal court in 2011).

        1. And even that 99% figure is arbitrary, because has anybody found any harm from vaping? It’s a small error bar that includes 0, just because no sample size will ever insure certainty of 0.

        2. Thousands of people have had lung damage from vaping. It’s been all over the news.

          I don’t need phony studies with self-selected participants to know that inhaling heated chemicals isn’t healthy. Just open the newspaper.

          1. You mean from the black market THC vapes? Cool, now let’s make black market nicotine vapes common place.

    2. All Trump did was act as a moderate stalking horse camouflaging the berserk Christian National Socialist and ku-kluxers that are all that’s left in the Gee-Oh-Pee-In-A-Dixie-Cup Party. Once the mask fell, revealing the girl-bullying machinations of Greene Teeth, Lyin’ Ted and Graham Cracker, women across America blamed The Don for helping the thugs tie them to posts and pack their feet in faggots and kindling. Tear-streaked Trumplerjugend fanboys drip like snowflakes at any criticism of their Christ-like Fuhrer because it’s an old tradition.

  8. PS:
    Fuck Joe Biden

    1. Wow! Talk about latent homosexual tendencies and Freudian slips…

  9. Had a friend who made this stuff. There was quite a cottage industry brewing 10 years ago.

    This is, simply, regulatory capture. Period. Philip Morris and the like trying to make small guys who make a product that 1. draws away their customers and, B. fills up a market they can now fill with “approved” tobacco flavored vape juice.

    Big business first, fuck the little guys. They can’t afford lawyers and lobbyists.

    1. The little guy got smoked by big tobacco.

      1. They are the butt of the joke.

    2. And if the feds ever legalize Mary Jane, expect the exact same thing, and expect it to happen quicker. No Doubt Phillip Morrie et. al. have plans already drawn up and waiting.

    3. RTFA. Nothing was approved, big or small.

      1. Wrong. FDA approved PMs IQOS tobacco heating system. What does that tell you?

      2. Its not about what was approved, its about what was (and wasn’t) denied.

  10. “Synthetic nicotine” will make no difference. The FDA claims authority over devices that “could” be used for vaping nicotine.
    Not to mention currently the the cost is about 5 times that of tobacco based nicotine. Makes you wonder if they will regulate/ban eggplants and tomatoes.

    1. Sure, but materials costs are an insignificant portion of the total manufacturing cost of products like this.

    2. As soon as Dutch geneticists spliced truffles that produce psilocybin, the coercive thugs backed away. What this country needs is a good five-cent mescalin-producing barrel, prickly pear or Saguaro cactus.

  11. Got what you wanted Jacob all within normal parameters. Fuck you. And fuck Joe Biden also.

    1. How cute! A sockpuppet Siamese twin combining Ed Hominem and Ed Baculum. I’ll just mute one of them…

  12. I remember when cigarettes first hit $10 a pack, some stores advertised vaping kits for the same price, $10.00. I never smoked, so I had no reason to get one, but I was almost tempted to buy one anyway, because I knew that the cheap and easy availability of these things wouldn’t last. And it didn’t.

  13. Does the “tobacco products” ban also apply against THC or CBD vapes?

  14. How are applicants to generate evidence regarding the other leg of the comparison, i.e. danger to youths? Would they need to do clinical trials on minors showing their products to be safe when used on them? Where are they going to get an IRB to allow that study? Actually you could probably get an independent IRB to do so, but it seems they’d already have to assume the conclusion, i.e. that nicotine is harmless to children, which is probably true.

    1. Probably need to get some evidence from an animal model that nicotine might be therapeutic in some condition affecting children, and then propose a trial on children with that condition, and then abandon it after phase 1, which will generate your safety data.

    2. Do it on poor people in some third world country. No IRB needed.

  15. Sullum points to the truth of the matter. If Ayn Rand is right about altruism being anti-life, it would follow for the fascist and communistic halves of the Kleptocracy to ban vaping precisely because the method fails to deposit Polonium 210 and free radicals in people’s lungs. Look at how rabidly they lunge to ban every relatively safe alternative to the nicotine, alcohol, airplane glue and paint thinner which “both” parties regard as preferable for children and other living things.

  16. Good article, I only take issue with one statement “even though legislators did not contemplate that product category when they wrote the law” – Jacon Sullum, if you scrutinize the Congressional Record of 2008-2009, you will find in the debates, e cigarettes were contemplated or spoken of by various federal legislators

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