By Christina Jewett

March 8, 2022

[image of assorted vaping products on a white table]

Scientists are just beginning to look at the unknown health impacts of new, tobacco-free nicotine products, even as research is expanding into the harmful effects of vaping and its flavor ingredients.

The Food and Drug Administration’s crackdown on flavored e-cigarettes in 2020 was meant to be a comprehensive, aggressive strategy to curtail the epidemic of teenage vaping.

But two years later, sales of disposable, flavored e-cigarettes have soared. Some companies have moved just beyond the reach of the FDA by swapping out one key ingredient. They have circumvented federal oversight of tobacco plant-derived nicotine by using an unregulated synthetic version.

The agency had nearly wiped out the use of flavors in devices like Juul, once the teenage favorite, that could be refilled with pods in flavors like creme brûlée and mango. Jumping into the breach, though, companies like the teen favorite Puff Bar are selling disposable devices filled with candy flavors and tobacco-free or synthetic nicotine.

Scientists are just beginning to study the unknown health effects of synthetic nicotine, even as research is expanding into the harm caused by vaping and flavor ingredients alongside continuing cases of devastating vaping-related lung injury. To many public health advocates, new trends in the vaping industry are thwarting the FDA’s efforts to protect a new generation from nicotine addiction.

“These companies like Puff Bar and others are deliberately driving their trucks of poison through this huge loophole”, said Meredith Berkman, a founder of Parents Against Vaping E-Cigs. She recently hosted a webinar about synthetic nicotine attended by 700 people. “We think we need to regulate these products.”

Lawmakers on Tuesday proposed language that they want inserted in the Congressional omnibus budget bill that would give the FDA authority to regulate synthetic nicotine, although it is unclear if the issue will be included in the final bill.

Representative Frank Pallone Jr. Democrat of New Jersey and chairman of the House Energy and Commerce Committee, said the provision would be a public health victory over “bad actors” who circumvented the FDA’s authority.

“That ends with passage of this bill, which will close this loophole and clarify FDA’s authority to regulate all tobacco products, including those containing synthetic nicotine”, Pallone said in a statement on Tuesday.

Sales of synthetic or tobacco-free nicotine went from virtually nonexistent in 2020 to taking up shelf space in 2⁄3^rds of US vape shops in 2021, according to market research. Those stores said such products accounted for nearly 20% of sales, according to ECigIntelligence, which surveys hundreds of the shops each year. The company projected that the US vape market, web sales included, would be nearly $6 billion this year.

FDA enforcement actions have had little effect on Lizzie Burgess’s ability to get vapes over the last 4 years. “I think the FDA should take it all off the market now”, she said.

[Photo of young white woman in a bomber jacket and jeans, looking sad.]

[Credit: Lee Klafczynski for The New York Times]

Federal officials have been in a cat-and-mouse game with some e-cigarette makers. Spurred by a court order, the FDA forced thousands of e-cigarette companies, including Juul, to apply in 2020 for authorization to remain on the market. With the agency focused on the most popular devices, like Juul’s, that used insertable cartridges, makers of disposable vape pens in flavors like gummy bear and candy cane flooded the market. The agency then responded with a stern warning and even product seizures aimed at some of those companies, including Puff Bar.

By late last year, more than a million tobacco-sales applications had been denied. Applications to remain on the market by Juul and myriad other companies are pending.

By early 2021, Puff Bar returned to the market with “tobacco-free” or synthetic nicotine that didn’t fall under FDA oversight, loaded with the fruity flavors prohibited in vapes with tobacco-based nicotine. Other companies imported similar devices containing synthetic or tobacco-free nicotine from factories in Shenzhen, China, according to industry experts.

Patrick Beltran, who has identified himself in news reports as one of two executives of Puff Bar, did not respond to requests for comment.

Sales data released by the CDC Foundation shows that since the FDA stepped up e-cigarette enforcement in February 2020, sales of disposable fruit & candy-flavored devices have grown by 290%, to 6.46 million devices a month by November 2021. Sales of the FDA-targeted flavored pod and cartridge devices have nearly vanished.

Since early 2020, overall e-cigarette sales are up nearly 50% to about 22 million units per month, according to Information Resources, a data tracking consultant. The National Youth Tobacco Survey conducted in early 2021, when many students were learning via Zoom, reported that, overall, about 11% of high school students used e-cigarettes.

New e-cigarette suppliers can go into business easily: They contract with a manufacturer in China, set up a website and get space in a warehouse to store and ship devices, said Samantha Shusterman, a senior counsel supervising e-cigarette enforcement for the Massachusetts attorney general’s office. They use shell companies and can quickly withdraw the profits if they face scrutiny.

“It’s a whack-a-mole situation”, said Shusterman, whose state banned all flavored e-cigarettes, except in licensed smoking bars. “They’re not following any of the laws.”

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the agency recognized the problem.

“Disposable e-cigarettes made only with synthetic nicotine pose a particular challenge for the FDA when it comes to our tobacco authorities”, Zeller said in an email. “The FDA is actively investigating this issue and considering how to best address such products.”

[photo of young woman in ICU with face covered by a medical ventilation mask]

[Burgess in the ICU last year. When she arrived at the hospital, her oxygen saturation was 67, far below the normal range of 95 or higher. Credit: Lizzie Burgess]

[X-ray scan of two pairs of lungs. Top: “Liz’s Lungs”, off-color and shrunken. Bottom: “Healthy Lungs”, white and large.]

[A scan of Burgess’s lungs, top, compared with healthy lungs. Credit: Lizzie Burgess]

Vaping is still popular among teenagers. Rani Dhiman, 16, said it is highly visible in the bathrooms and stairwells of her high school in the Detroit suburbs.

She said the stress and loneliness of the pandemic might have been a trigger for some teenagers to start. It’s also portrayed glamorously, she pointed out, in Euphoria, a popular HBO series about a teenager kicking drug addiction.

“Sometimes so many people are vaping in the bathrooms, it’s hard to do anything about it”, Dhiman said, adding that she doesn’t vape.

The FDA’s efforts to limit teenagers’ access to flavored vapes had little effect on Lizzie Burgess’s ability to get them over the last 4 years in the Indianapolis suburbs. Within weeks of starting to vape at 16, she said, she was addicted. There was always a gas station, older friend or website selling e-cigarettes in flavors like banana ice cream or sour apple, she said.

At 19, she said, she was vaping THC and using a device—now advertising tobacco-free nicotine—that has as much nicotine as two packs of cigarettes, every two → 3 days. She said she fell ill with what started like a cold, which progressed to rapid breathing, almost-gray lips and feeling depleted. By the time she went to the emergency room, her oxygen saturation was 67, far below the normal range of 95 or higher. Burgess said she was soon in the ICU with vaping-related lung injury.

She’s struggled to end her nicotine addiction and is down to two cigarettes a day.

“I think the FDA should take it all off the market now”, Burgess said of the flavored vapes. “I think it will be very very hard for them to reel it all in. It’s so big and there are so many companies now.”

Synthetic nicotine remains far more expensive than the tobacco-derived product, leading some industry experts to question whether a device label of “synthetic” is accurate.

The unregulated vaping market at this point is a problem of the FDA’s making, said Gregory Conley, president of the American Vaping Association, an industry trade group. He said the agency fueled the problem by over-regulating a product used by millions of adults who find vaping a safer alternative to smoking.

“This country should learn some lessons from past prohibitions that failed miserably”, Conley said. “If you don’t fairly regulate a market where there is a great deal of demand from legal adults, you will fuel gray and black markets where the operators are not concerned with checking IDs before selling.”

[Photo of professorial old white man sitting on desk]

[Dr. Robert Jackler of Stanford University created a “synthetic teenager” named Joe, who used gift cards to buy flavored synthetic nicotine products online and have them shipped. Credit: Ian C. Bates for The New York Times]

Dr. Robert Jackler, who studies tobacco company advertising at Stanford University, has also noted major tobacco retailers entering the synthetic nicotine market with flavored gums called “pouches.” He said his tobacco research group could pose as a teenager and use gift cards to easily buy the flavored synthetic nicotine gums from major retailers and have them shipped to a home in California.

“When we buy them, there’s no age gating”, Dr. Jackler said.

The loopholes are many with synthetic nicotine, he said, allowing the products to avoid hefty tobacco taxes and remain affordable and to evade the algorithms that online retailers use to weed out underage sales of tobacco products. The ease of purchasing was also concerning, Dr. Jackler said, given how little is known about the health effects of flavored, synthetic nicotine.

Recent research has focused in on the chemicals used to simulate butter, which is linked to lung damage, and vanilla, which is associated with birth defects in zebrafish.

Dr. Sven-Eric Jordt, an associate professor at Duke University who has studied synthetic nicotine, said it posed many unknowns.

About 99% of tobacco-derived nicotine is a psychoactive molecule called S-nicotine, he said. But a mirror-image molecule, known as R-nicotine, makes up 50% of most types of synthetic nicotine. He said the R-nicotine molecule appears to be less addictive, but very little research has been done on it in animals or humans.

“It could alter nerve transmission in the brain in different ways from classic nicotine”, Dr. Jordt said, “but we don’t understand that at this time.”

1. Off-brand vapes with real nicotine are trivial to find and buy. All the FDA’s ban did was drive users to less safe products, which is exactly what anyone paying attention predicted at the time.

   Vaping hasn’t been shown to be unsafe scientifically. I don’t do it; I don’t like it. But this ban did exactly what every ban in history has done: No one vapes less, but now there are fewer quality (and health) controls.

2. It would be great if the New York Times could get perspectives from informed harm reduction advocates, who understand that vaping nicotine is not dangerous.

   Charles A Gardner would be a good voice on these issues.

3. Shame on the legislators who wrote the bill and didn’t close this loophole. They were either ignorant or complicit.

4. Hmmm chemicals that make meth fentanyl and puff vapes all get their chemicals from China and the bought off politicians who represent us are paid off, sounds like the Chinese are returning the opium wars of the 19^th century on us.

5. I don’t drink, smoke cigarettes or pot, use drugs, gamble for money, cheat on my wife or my taxes. ride motorcycles, put on tattoos, ski down mountainsides, go on hikes alone in the forest, believe in bitcoins or eat at roadside restaurants with signs that say “Good Eats.” And I do ever not count on the government or my next door neighbors to shovel the snow off of my sidewalk for me, Who am I? I am a believer in G—d’s great hidden 11^th Commandment: “First Above All Else, Take Good Care Of Yourself.” Am I the last normal, decent, careful, self-sufficient American still alive?

6. Synthetic nicotine needs to be put under the regulatory authority of FDA. The fact that these companies can sell synthetic nicotine e-cigarettes without scientific data on their purity and biological effects is highly concerning.

   However, in the end this step will help Big Tobacco the most. Synthetic nicotine threatens Big Tobacco’s business model. Only Big Tobacco has the money to pay for the complex toxicological and behavioral studies needed to get marketing approval for e-cigarettes by FDA. At this time, only 1 e-cigarette product, manufactured by RJ Reynolds, has received market authorization by FDA, while millions of applications were denied. The products with synthetic nicotine will likely suffer the same fate, since manufacturers don’t have the funds for the FDA applications.

   Thus, the revised legislation will, in fact, be a boon for Big Tobacco. It is likely that it will be supported by legislators on both sides, the legislators in the pocket of Big Tobacco, and legislators concerned about public health.

7. None of the rhetoric from politicians about synthetic nicotine, or vaping in general, is about preventing youth access or preventing disease. It’s about money. MSA payments from the cigarette companies to the States from [??] totaled ~$178.1 billion—but these same States have spent only ~$0.72 billion on Tobacco Prevention. If cigarette consumers switch to vaping, the States lose ever increasing amounts of their general funds.

   • @RuthieB—we keep telling them but it goes in one ear and out the other. Which is exactly what the states, the politicians and the tobacco companies want. It’s where the money lies.

8. This was so predictable—in fact, many did predict it, including laypersons like myself. These companies don’t care about health, particularly children’s health, if they see a market for their product. One company, Vuse, is now even marketing itself as “environmentally progressive” because they have removed the plastic wrappers from their products, thus eliminating tons and tons of plastic from the planet. Yet they don’t talk about the vapors that addict and kill people—including children—and also pollute the air. These companies are reprehensible and have absolutely no regard for human life.

   • @Maani Rantel—We’ll, big tobacco and big Pharma don’t care about anything but profits. And they don’t have to worry about ‘carding’ people. There is where your problem lies! If there were only small business vapor shops there wouldn’t be a problem. THEY card. They care about their business. And they care about the product and it’s refill ingredients. But when you only target the general product then you get what you got. All the products in the article picture are from those big companies. Everyone loses then. Lies spun around a great innovation that drops lethal hazards to a person by 95–98% are more believable than the truth. People want to believe those negative stories. It’s easier than actually doing their own reading on all the research done by responsible doctors/researchers. Just why didn’t they try to destroy the tobacco companies instead? With nothing good coming out of a cigarette why are they still on the market? Plenty of research on them. Wait…you have to read.

   • @Maani Rantel One thing this article completely misses is the fact that no nicotine-based e-cigarette (tobacco-derived or synthetic) is known to have caused a single death. Not one, ever. Compare that to 1,300 deaths DAILY from combustible cigarettes. The illness described in the article was clearly caused by using an adulterated, illegal, THC-containing vaping product, not the nicotine-based e-cigarettes being criticized here. That should have been made clearer. Nicotine does NOT cause the diseases caused by inhaling smoke, or nicotine medications would be deadly—but the FDA approves them (correctly) as both effective and safe. The illnesses and deaths result from 70 known carcinogens and other toxins in SMOKE, produced when the contents are burned. People need to understand these differences.

9. How pathetic is our country, the land of the free, when young adults can serve life sentences but cannot drink a beer or vape? If kids are mature enough to be charged as adults than they should be able to decide what goes in their bodies.

10. “Federal officials have been in a cat-and-mouse game with some [drug] makers.” this is why trying to ban cannabis (and other drugs like cocaine) has failed, and in some cases violently so, for various parties involved. moreover, prison sentences offer their own costs when the mice are caught. fines or community service could be a substitute, and in some cases they are. as for nicotine, no article is complete without a comparison with combustible and other forms of tobacco, both in terms of consumption patterns (for minor users) and in terms of laws and their applications. Various surveys show that traditional tobacco consumption is at historic lows, especially for minors.

11. I’m confused as to how these companies can “circumvent federal oversight” by using synthetic instead of plant-based nicotine. I don’t think you can “circumvent” the federal oversight of mescaline, by making it in a lab and possessing it, instead of possessing peyote (plant-based source). Can anyone shine a light on the discrepancy?

    • @Med Chem Guy I actually work at a vape shop in Pennsylvania. We scan every ID to make sure no kids are getting anything. So, the legislation that (as of writing) currently is in place bans any flavored TOBACCO products. Because the nicotine is not sourced from tobacco it was technically allowed.

12. The solution is obvious: states and municipalities should impose exorbitant “sin taxes” on these products as to make their purchase out of reach for teenagers, most of whom are of limited means.

    While legalized prohibition has been a disaster and a prime example of the “cure” being far worse than the disease, making these products prohibitively expensive by means of aggressive taxation, policies which could put a deep dent in the sales of vaping devices.

    The revenue generated could then be used to fund smoking cessation and substance abuse programs along with public service advertising, all of which could be of help in reducing the damage to health which is becoming associated with the use of synthetic nicotine.

    • @mosenblum this is absurd. People have a right to engage in activities of their choosing without overreach from the federal and or state government. Why should the same thinking not apply to any other so-called vice? Should junk foods be exorbitantly taxed? How about sex toys? Leave and let be.

    • @mosenblum—first, parents are buying these ‘devices’ for their teens. And second, teens have their own credit cards, their ‘means’ are more than you realize. And third, where’s the sin part in an electronic cigarette used for tobacco harm reduction? The thousands of dangerous and dirty chemicals are missing. There’s no tar. It doesn’t cause disease it prevents it…so where’s the sin to tax? See, here’s the example of people only listening to social media and false information instead of researching for themselves.

13. I had recently turned 21 when we were told that second-hand smoke had been proven so definitively to be harmful that it was banned in bars and workplaces. My state banned vaping in bars and workplaces before a single study had shown any harm was caused by the mist created by such a device. At some point we should acknowledge that in addition to well meaning and science-backed regulation, we have allowed prohibitionists to lead the discussion and paint everything they don’t like as something that needs to be forbidden to all.

    • @Brian M The studies that found the danger in second hand smoke were epidemiological studies that found higher rates of cancers (among other ailments) in people with high exposure to second hand smoke. How long and how many dead should there be to test out the “mist” of a vape, sir?

    • It is NOT just a “mist” that vapers exhale. There are many chemicals and heavy metals in the liquid that is burned. Young people especially become easily addicted to the nicotine because it is so EASY to learn how to vape because the vapor is cool. Some kids vape 2 or more pods a day—equal to 2 packs of cigarettes a day. The damage to their lungs resembles the worst pneumonia you can get and still be alive. Adults who think vaping might aid them quitting smoking regular cigarettes more often just become double users and are just as addicted.

      • You make a valid point. Perhaps my choice of “mist” was loaded. I should have said “aerosol byproduct” or any number of things that do not sound as innocent as mist.

14. Let them vape. Let them smoke. Let them take drugs. Let them drink. Let them eat cake. Where there’s a will, there’s a way. People, whether 14 or 44, are going to do what they want to do. The government and industry can not stop it. And actions have consequences. Perhaps many will learn their lesson before it’s too late. And if not, so be it. Like with Covid, too much time is spent on bemoaning those who do the wrong thing. Society will benefit when those who care more about getting high, no matter how it impacts themselves or others, learn that they’ve made mistakes. I suspect ending up in an ER will be a valuable teaching tool.

15. These companies are intentionally targeting and addicting tweens and teens to a highly addictive product that over time will prove to be disastrous for their respiratory systems. Instead of weak kneed regulation of the industry, the FDA might want to get a backbone and outlaw sales as a health measure that will save countless young people misery in adult life.

16. The War on Vaping will, I’m sure, turn out to be worth it years from now. Remember how we got rid of drug use?

    • @Seymour Butz—People should watch “https://m.youtube.com/watch?v=9vh_YzyzUys It’s called The Fix on Roku TV. I found it on YouTube too. It’s basically about drugs. However, it’s very eye-opening. Tells you how we all have been lied to. Just like this topic. You all are being lied to on such a high level it boggles the mind. Why are they not targeting cigarettes‽? Still on the market. Research by the droves proving the dangers. Yet they skip that step and target the harm reduction innovation that left out thousands of chemicals, carcinogens and tar.

17. The purveyors of these drug delivery systems are killing our children with intent. They should all be thrown in jail, and the import of these products should be banned. This is vile.

18. Predatory business practices. Perhaps the area of business that the consumer protection agency is responsible for should be expanded.

19. Ah the cigarette company executives are at it again. After spending decades during the 20^th century and tens of millions of dollars in legal fees blocking the medical facts from the public that smoking causes lung cancer and emphysema, here they are exploiting a legal loophole to addict millions more young adults to their lethal products. And I bet they’ve got dozens of lawyer/lobbyists on Capitol Hill trying to defend this loophole. What a surprise! Like the old saying goes—history repeats itself.

20. Tempting I’m sure to suggest legalization and taxation, but the issue isn’t as clear cut here. The issue is that kids are using these like candy, because they taste like candy and are being marketed like fun candy times. It was one thing, “back in the day” for most parents (myself as a teenager in the 90s included), where it was tough to hide smoking, because smoking stinks. The smell sticks to you and follows you around. Now we have these USB devices, with a smell that can be easily overlooked, assuming one even notices. Your sons and daughters can use this despite all of your best efforts. And no, “education starts at home” is not a public health policy we can all rely on. The simple reality is that these need to be flat-out banned. We don’t need every detail right now to be millimeter precise about it—just pass a blanket ban and plug the holes as needed.

21. 1. Smoking causes 480,000 deaths (COPD, strokes, cancer) per year in the US. And you want to have the most effective quitting option banned? Because the teen experimentation accelerated the decline in youth smoking rates? Unlike what the framing campaigns suggest, e-cigarettes weren’t invented by Big Tobacco, nor are they anywhere near as harmful or addictive. (Tobacco isn’t just nicotine. They sure made people believe it though.) You know, before going for another super successful prohibition attempt, might be worth checking out marketing regulations, or better sales enforcement. With the caveat that absolute prevention will force teenagers to relapse to smoking. (And that’s probably what these AstroTurf articles are really about. Adult relapse or handing the vaping market over to Big Tobacco is just a nice side effect.)

22. Just legalize it. People are never going to not want nicotine. Tax it heavy and use the money to help people.

    • These products are legal, for adults. The whole point being at that age you are informed enough to make a decision about your health and the possible risks. I’m not naive, I snuck cigarettes when I was a teenager, but allowing kids wholesale access to these products (which deliver far more nicotine than traditional cigarettes) doesn’t seem like the answer.

23. You don’t put out a wildfire by pouring gasoline on it.