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FDA Denies Applications for Over 940,000 Vape Products, Leaving Fate of Juul Undecided

A federal judge gave the FDA until Sept. 9 to act on the million applications it was reviewing

The Food and Drug Administration (FDA) announced Thursday that it has issued marketing denial orders for over 940,000 vaping products.

Vape products have to submit a Premarket Tobacco Product Application, or PMTA, to the government. The FDA reviews and approves each application.

During its announcement, the agency cited concerns that the products could encourage nicotine usage in teens.

“Virtually all e-cigarette products contain nicotine, some in high levels — including Juul’s 5% pods, each of which contains as much nicotine as an entire pack of cigarettes. Nicotine also affects prenatal and adolescent brain development, making it dangerous for both teenagers and pregnant [women] to vape,” per NPR.

Those in the industry have known for years that the FDA was considering regulations. Anti-tobacco groups sued the FDA to force them to speed up their review. In 2019, a federal judge ordered manufacturers to submit their applications to the FDA. The agency had one year to review the application. During that time, the products were allowed to stay on the market.

Over 6.5 million products from 500 were included in the FDA’s review. The products varied, including anything from rechargeable vape pens to the liquids that fill them to disposable e-cigarettes. At least 4.5 million were rejected immediately because they did not include key information.

ABC News notes that the FDA “is still reviewing a smaller number of applications for other non-traditional tobacco products like hookahs, pipes and mini cigars. Those products weren’t covered by the original 2009 law that first gave the FDA authority to oversee some parts of the industry, including the review of new products.”

Actions have not been brought against popular brand Juul, which accounts for 40% of all e-cigarettes.

In a statement, a company spokesman for Juul Labs said “We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate … We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”

Last month, the FDA denied 55,000 flavored vape products from three companies, including Apple Crumble and Cinnamon Toast Cereal. The agency believes these flavors are designed to entice underaged users. The companies were ordered to withdraw their products from stores.

To stay on the market, companies needed to prove their products benefited public health. For many adults, vaping was a safer alternative to cigarettes and could aid those trying to reduce or quit smoking.

Currently, the vaping industry in America is valued at $4 billion. While the industry has existed for over a decade, Juul’s cartridges gained national popularity in 2018 due to their fruit flavors and high nicotine content. 

The FDA has not indicated when it will rule on Juul and other major manufacturers who were not included in their announcement.

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17 responses to “FDA Denies Applications for Over 940,000 Vape Products, Leaving Fate of Juul Undecided”

  1. Reptilian says:

    Agreed. The FDA is nothing more than big pharma’s minions. The fact that they’re applying these blatant double standards to vaping just proves how much safer they are than cigarettes. Cancer is their cash cow.

  2. Wolv256 says:

    “Think of the children” is what Democrats say when they masterbate.

  3. Wolv256 says:

    TLDR: 🍆

  4. Wolv256 says:

    Making fat chicks skinnier?

  5. Wolv256 says:

    Fuck the FDA. I do not consider them a legitimate organization. They are only the enforcement branch of a corrupt mafia. I do not care or respect their opinion or approval on things. I only wish them and everyone associated with them ill will and I will ignore and reject them at every turn. They are my enemy and I am theirs.

  6. Wolv256 says:

    No, the FDA should be nothing more than apologize for all their past corruption and tyranny, disband themselves as an organization, go fuck themselves, and repent for their actions.

  7. Element says:

    The Jungle was a novel. Upton Sinclair was a socialist and the reason he wrote the book was to advocate for socialism by decrying the conditions for workers. It was not supposed to be about the cleanliness of the food.

  8. Reptilian says:

    So what public health benefit do cigarettes have?

  9. KDiddy says:

    I’m with you on this. From my limited knowledge on the subject, which may be more than most, the FDA was formed around the time Upton Sinclair wrote “The Jungle” which was a book/report/document about the atrocious conditions at meat packing facilities. Varmints ran free, got into the meat, lived and bred in the packing facilities and would not only provide their own layer of toxic waste ending up in the food, but would also spoil the meat but eating into the stomachs of the cows while they were hanging, releasing the contents (digested grass, hopefully grass) all onto the insides of the carcass which would then be harvested, cut apart and shipped to markets in the areas. Plus, the cleanliness of the employees was in question. Some wouldn’t know how to properly butcher an animal, thus creating the same situation as the varmints. I think of Fight Club right now, what’s the cost of recall vs. the cost of settlement? The FDA was created to protect and enforce just as you say, the right for the consumer to know who, what, when, where, and why consumable products were manufactured and the risk they take consuming said products. Nutritional facts follow, complete with ingredients lists that inform the consumer of the product, outside of the advertisements, while maintaining the intellectual right of the recipe. It was a beautiful application of governmental regulation towards public health, until now where it’s a few COVID cases from being used as a means to force consumption or non-consumption of desirable consumables. Snake Oils salesmen keep your tongues back and food pyramid creators get your compass ready. Best thing we can do (maybe, I mean, just my opinion, man) as a species is truly look at peoples genetic makeups, regenerative failures, and craft diets unique to the individual(s). If that involves 2mcg of nicotine through a vapor device every 4 hours, so be it. We’re garbage disposals. We’re no better than a trash panda, In fact I’ve seen a dude on American Ninja Warrior that would eat from dumpsters. And he did better than most did on that episode and more to come. What’s the result of these efforts? Dictated and scientifically crafted diets made for you based on test results of your saliva? Or the right to have enough information about the food you are to consume to make your own informed choice. Know that no matter what you chose, your life span is likely to be altered by what you choose to consume. Cypher is a butch but you know what, it’s a personality type which won’t disappear and if you listen to it, you may be persuaded to keep eating the goop. All I see when I read nutritional facts, is blonde, brunette…. red head. I’ll stick to my Camel Filters (one whenever “I” choose now), you can take your throat hardening, drip permafying, back of throat gag bullshit while I’m trying to explain something to someone, and keep smoking it all day in whatever location you’re in, if that is what you like. I’m done pretending like my health was improved by vaping. Just me, just sayin. No judgments on anyone else. I really haven’t been able to swallow my snot for the past 9 months since I started vaping. Half a week away from the juice and my lungs are IRON baby!

  10. Mattical1980 says:

    Better yet, people should worry about their own children. It’s like we are seeing the social inverse. People seem to care more about what other people’s kids are doing, while completely ignoring what their own children do. My guess, it’s way easier to criticize other children then properly raise your own. We are a country of lazy critics.

  11. Mattical1980 says:

    Maybe this is a unpopular opinion, but the FDAs job should do nothing more then inspecting foods and drugs to make sure they contain what is advertised by the manufacturer, and give a list of warnings of what said chemicals have been known to do. The FDA should not be morality police, picking and choosing what products are “allowed” to be sold in the U.S. If “My body, my choice” is a principle, then it has to be applied universally, like principles should be. The slippery slope for this started with the second-hand smoke studies from the early 90s. From how I see it, there is a direct line from second-hand smoke-to-vaccine mandates. Second hand smoke made the public feel like they had a say in what other people can do with their bodies in the context of legal substances.

  12. EchosandWhisper says:

    Juul is owned by Altria, one of the biggest tobacco companies in the world right now. I don’t even see why the vape market is being hit so hard when they have both angles cornered. Altria even absorbed Philip Morris if I recall.

  13. EchosandWhisper says:

    I remember when Obama banned clove cigarettes and all other flavoured cigarettes. When I was growing up and I had friends who smoked (underage) not a one smoked anything other that Marlb’s or Camel’s. I never once saw anyone underage with the higher priced flavoured cigarettes. Bummed me out since Djarum Blacks were 100% my jam at the time.

    What I find more insulting is that it insinuates that adults can’t enjoy anything kids might like. The “think of the children” argument is pretty obnoxious and I’m tired of worrying about them when their parents suck.

  14. StMyles2 says:

    🤷🏻‍♂️ Give me tobacco.

  15. Odin_Supreme says:

    Any regulation by the government or agency will do nothing to stop teens from getting their hands on vapor products. It will only effect the law abiding users, trying to stay off cigarettes. There was a month where we had teenagers come and work with us at my job (I’m a city employee). There was one kid, he was a gangster kid, about 16 or 17, with three dots tattooed on his face. I vape regularly. I’m a hobbyist vaper, so I have box mods, different tanks and I build my own, exotic coils. He always had a disposable vape with him. I asked him where he gets them from, since we live in a small village in central New Mexico. There’s a guy who comes to one of our parks ( I used to see him do this regularly when I worked in the parks department) and would sell stuff out of his trunk, like weed. Apparently this teenager buys his disposables from this guy out of his trunk, who told him selling these disposables is more profitable than selling cocaine. All this is doing, is creating a new black market, where there wasn’t one. If you remember the panic of “EVALI” where people were getting severe lung damage from “vaping”, these injuries were not from nicotine vapor products. They were from black market THC cartomizers, tainted with vitamin e acetate, which was causing lipoid pneumonia.

  16. exactly34 says:

    This kind of action is extremely irresponsible from the FDA. There are products that very much benefit public health(getting adults away from smoking), and they are treating it like it is the same as cigarettes. Vaping can be an incredible tool to an addicted person. Also, liberty please? Teenagers used to smoke cigarettes. If they vape now, I still see it as a huge positive.

  17. Bellmorte81 says:

    Big tabacco is the only co with a history of targeting minors. I know many vapes shops, Vapor users, and have met many vape juice makers and they’ve all been in agreement about it being for adults. The vape shops are very strict about minors in shops. And I’m pretty sure there were reports about minors getting them from gas stations, family dollars and Walmart. So as we keep taking away from adults and ignore the big companies that are responsible for it. As our old governor from ri was ridiculed for saying “what adult likes chocolate milk”, I’d have to ask how many don’t. How may pot brownies, gummies and treats do you need as evidence that adults like sweet things as well. It’s more nanny state b.s. That feels they need to do what they feel is best for you while ignoring the real health threats because thier profiting from those

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