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How Big Tobacco in the United States Seized Control of E-cigarettes Designed to Prevent Teen Smoking

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More than 2 million teens in the US say they use e-cigarettes, with a quarter of them saying they vape daily, a new national survey finds.

Earlier this month, the US Food and Drug Administration (FDA) announced it has delayed its decision on whether to ban Juul, the biggest-selling vaping device on the US market, and whose arrival triggered the global popularity of pod-based vape devices.

Although it has vetoed 950,000 lesser-known e-cigarette products, Juul and other top brands remain on sale as the agency takes more time to review the evidence.

For Lauren Etter, this is one more chapter in a long and often disastrous history.

Etter is an investigative reporter for Bloomberg News and the author of a new book, The Devil’s Playbook, which takes a deep dive into the story of Juul.

It is a tale of powerful personalities, staggering profits and losses, and it tells of how an agency charged with protecting public health was unable to intervene in time to prevent a new addiction crisis.

When Etter started reporting on Juul in 2019, the youth vaping epidemic was well under way. “I became very interested in Juul,” she says.

“I thought it was fascinating; how had a Silicon Valley company become involved with nicotine?”

Very early on, she realised you can’t tell the story of Juul without also writing about the history of the tobacco industry.

Persuading people from both sides to talk was a challenge, as there has always been a closed culture among tobacco executives and, by then, Juul was under scrutiny and facing numerous lawsuits.

“Ultimately, people who knew what was going on realised how interesting it was and wanted to share their story,” says Etter.

A big chunk of her book traces the history of Altria. Best known as the makers of Marlboro, this is the US company that split off from Philip Morris and went on to make a US$12.8 billion investment in Juul.

Etter exposes the tactics Big Tobacco has used to maintain its business while staying on the right side of regulators: quietly lobbying, noisily putting large sums into quit-smoking programmes and generously funding research.

As the market for tobacco slowly shrank, Altria had been struggling to innovate, producing smokeless devices that failed to catch on. On to the scene burst James Monsees and Adam Bowen, two Stanford University product-design students with a passion for social change. And in their sights was the cigarette.

The good guys

Smoking tobacco is incontrovertibly harmful.

If you light a cigarette, it produces more than 7000 chemicals, at least 69 of which are known to cause cancer. As the smoke is inhaled, a sticky chemical-laced layer of tar builds up inside of the lungs, damaging the lining and eventually exposing the user to the risk of developing cancer and emphysema. Despite knowing all this, many people are too addicted to give up the habit.

Monsees and Bowen asked themselves, what if there was a nicotine-delivery system that would give smokers the same experience and satisfaction without the same risk to health?

“There were one billion smokers in the world, yet the cigarette hadn’t been redesigned in more than a century,” says Etter.

As they set out to disrupt the market, like Big Tobacco before them, the two men were to discover that innovation in this space wasn’t easy.

Starting their company, then called Ploom, they struggled to get investment. Etter describes Bowen mixing tobacco in a big metal kitchen bowl and soaking it in a rainbow of flavours – peach, coffee, mint – sourced from speciality flavour companies, then getting employees to test the different strengths and flavours.

In 2009, they rolled out the Ploom Model One, which used butane to heat up aluminium pods filled with tobacco. According to Etter, there was a sense of excitement at the company back then. People felt they were the good guys, united against a common enemy, Big Tobacco.

“I do believe Adam and James had a true interest in harm reduction,” she says.

“They saw themselves as trying to put Big Tobacco out of business. They looked at this primitive product that had caused death and disease and wanted to create a technology that would reduce those harms.”

But at the same time, with a billion smokers in the world, there was a huge market of potential customers they could tap.”She reports that their first product wasn’t amazing. The nicotine hit was unsatisfactory and unpleasant, the device became too hot to hold and testers reported it was clunky to use. The second version swapped a lithium battery for butane, plus was sleeker and funkier, but still not a total winner.

By then, e-cigarettes from China were flooding on to the market. There was no legal age restriction on them, no clinical studies had been done to evaluate their safety and, unlike traditional smoked cigarettes, all kinds of flavours were allowed.

From the beginning, the FDA was blindsided by this sudden flurry of new devices. The agency tried to exert some sort of control, seizing a shipment of NJOY e-cigarettes being imported from China, declaring them unapproved drug-device products.

But the US owners of the NJOY brand, lawyers Mark and Craig Weiss, took the FDA to court and won.

A judge ruled that e-cigarettes couldn’t be regulated as drug devices unless they were being marketed purely for therapeutic cessation purposes, which effectively left the FDA toothless.

“E-cigarette companies were free to hawk their wares in any flavour they wanted and to whoever they liked,” says Etter.

Desperate to hang on to its market share, Altria began unveiling more smokeless products, such as the Marlboro sticks designed to swirl around the mouth. Other brands trialled tiny teabags filled with tobacco that could be held in the cheek. Nothing worked with consumers. They preferred cigarettes.

In the meantime, Monsees and Bowen recruited a brilliant young chemist called Chenyue Xing, who had a background in inhalation-drug development.

Her job was to work on a nicotine formulation that had just the right kick in the throat without it being irritating and that delivered enough nicotine to create a buzz.

Xing spent a lot of time studying the chemical properties of tobacco, then began testing various formulations, first informally in the company’s San Francisco headquarters, and then in a lab.

That lab was in New Zealand. In early 2014, a team arrived at the world-class research facilities of the Christchurch Clinical Studies Trust. There, a group of male smokers tested e-cigarette nicotine blends and compared them with a traditional cigarette.

Quickly, it became clear the nicotine-salt formulations, with the fastest rate of nicotine uptake in the blood, were the star performers. By the time the team left Christchurch, they were zeroing in on what Etter calls “the secret sauce”.

It was a formula that packed a big nicotine punch and delivered a smooth, enjoyable experience – basically, the e-cigarette version of Marlboro. Once it was packaged in a stylish device, Juul had arrived. While the FDA still remained tangled in red tape, it was launched on to the market.

In The Devil’s Playbook, Etter identifies the point when Bowen and Monsees’ baby turned into a monster.

“It was the moment when the marketing came into play; sometimes I describe it as their original sin,” she says.

An initial plan for a quirky marketing strategy for Juul was rejected in favour of the “Vaporized” campaign, which was all glamour, good times and cool young models. There was a flashing billboard in New York’s Times Square, adverts in glossy magazines, lots of social media and, over the summer of 2015, parties where tens of thousands of free samples were handed out.

Had the company targeted existing smokers, most likely no one would have cared, aside from Big Tobacco. Juul’s mistake was appealing to a new market of young people who had never touched a cigarette before.

“Juul didn’t have the institutional knowledge the tobacco industry had from having been in the fire for so many years,” says Etter.

The first Juuls weren’t perfect. The little pods that snapped into the device could leak, causing nicotine to seep into the mouth, and engineers had to scramble to fix the problem. But with a 5 per cent nicotine concentration, this was by far the strongest e-cigarette on the market. Just one pod delivered an amount of nicotine equivalent to an entire pack of cigarettes. And it looked really cool.

Juul heist

Sales to teenagers soared and, by spring 2016, the Centers for Disease Control and Prevention announced that three million school students reported having used e-cigarettes.

Juul was having problems keeping up with demand. Yet no one knew how safe they were, what effect the vapour had on the lungs or what all those flavours contained. By the time the FDA managed to ban sales for people under 18, in August of that year, it was already too late. Kids were becoming nicotine addicts.

One of the pro-vape arguments is that, although people smoke for the nicotine, they die from the combustion and the tar. This is something Etter has wrestled with.”Nicotine can be a stimulant, it can make you brain more alert and it can be relaxing,” she says.

“There are studies that show it can exacerbate heart conditions and in pregnant women it can have adverse effects on the fetus, but overall it’s a fairly benign substance and people like to compare it with alcohol and caffeine.”

But nicotine is different. No 1, it’s extremely addictive. And No 2, there’s nothing good that can come from a child using nicotine. In fact, there are studies that show it can affect the development of the adolescent brain.

“So, I feel as though you need to have two conversations. You have to talk about nicotine use among adults and nicotine use among adolescents. And you have to ask if there are potential long-term implications of a lifetime of e-cigarette use that we don’t know about today.”

A 2015 review published by government agency Public Health England concluded that vaping was 95 per cent less harmful than tobacco. This statistic has continued to be bandied around, although subsequent research has undermined it.

One US study found that users of the common vape flavours menthol and mint are exposed to high levels of the carcinogen pulegone – synthetic pulegone is banned by the FDA as a food additive. And when cinnamon flavour is heated, it creates a unique aldehyde – cinnamaldehyde – that can damage the respiratory system. There are thousands of other flavours containing ingredients that are potentially toxic.

Plus, vapes contain humectants, such as propylene glycol and vegetable glycerine, which heat up to make the vapour. As they break down, these generate other more harmful components, including highly toxic formaldehyde, creating inflammation in the lungs.

Last year, a study from Stanford University showed that young people who vape are five to seven times more likely to be infected with Covid-19 than those who don’t. That study’s senior author, Bonnie Halpern-Felsher, is a developmental psychologist and the founder of the Tobacco Prevention Toolkit.

Addiction danger

During her many years in tobacco research, Halpern-Felsher says she has never seen such a quick surge in uptake with any other product. Everything about Juul appealed to young people.

“Their flavours, colours, their marketing, the fact that they’re small and easy to hide, but also their salt-based nicotine – it’s smoother, it gets absorbed more easily and it tastes good,” she says.

The term e-cigarette isn’t one that young people even use; they call it vaping, or Juuling, or maybe puffing. And Halpern-Felsher’s research has shown that many of them aren’t aware of the potential harms.

“I think teens are starting to get it now, but there are still some who say it’s harmless water vapour. And early on, when I published what were probably the first couple of papers out there on Juul, teens didn’t understand how much nicotine was in them, or know about the chemicals in the flavours, or appreciate how addictive they are.”

The lungs are an efficient route for a drug to reach the brain. Nicotine moves quickly from there to the bloodstream, then crosses the blood-brain barrier and binds to receptors in the brain that release neurotransmitters, including dopamine. We get a hit, then it wears off, so we crave another one.

Parental backlash

Young people are particularly vulnerable to nicotine addiction. Almost 90 per cent of daily smokers started smoking before the age of 18. But although cigarette use is more common among lower-income, lower-education groups, vaping has similar levels of popularity across all the demographics of wealth and gender.

“It’s what I call an equal-opportunity bad thing,” says Halpern-Felsher.

When she gives talks about vaping to parents, many are still unaware of the levels of nicotine the pods can contain, and there is always someone who doesn’t know what a Juul looks like. In her book, Etter tells the anecdote of one Silicon Valley parent who noticed that when his kids had friends over, they had devices plugged into power outlets that he assumed were flash drives.

Eventually, the adults caught on and Etter describes how parent-power became a key part of the Juul backlash in the US. “Parents were so upset, because they’d had no idea this was a thing,” she says.

“They had been concerned about cigarettes and drugs, and then this came out of nowhere. It hit the market and cascaded through middle schools and high schools.”

Groups such as Parents Against Vaping and the Campaign for Tobacco-Free Kids fought back against a style of marketing and a product that seemed directed at their teens.

In response to the increasing pressures, Juul did make some changes, with no more beautiful young models on social media and an increased focus on the stop-smoking angle of vaping. Plus, it removed some of the more appealing flavours from its bricks-and-mortar stores.

Still, the company’s problems continued. The city of San Francisco – Juul’s hometown – banned the sale of e-cigarettes. Then, young people with damaged airways started showing up in hospital emergency departments.

The condition was dubbed “Evali” (e-cigarettes or vaping use-associated lung injury). Some of those patients died, and even though the problem was mostly linked to vaping THC-laced cannabis products, the pressure on e-cigarette companies intensified.

By now, alarm bells were ringing loudly at the FDA and Juul was being run by a former Altria executive, KC Crosthwaite, who knew about being in survival mode.

He pulled all the fruit- and dessert-flavoured products from the US market, and when a study showed Juul mint pods were actually the most popular flavour with teens, they were removed, too, despite mint pods comprising 70 per cent of Juul’s business.

Last year, the FDA banned flavoured cartridges for products such as Juul. And thousands of lawsuits against the company started flying in, some filed on behalf of minors who had become addicted and others from adults claiming the product had contributed to lung injuries.

Once the fastest-growing start-up in Silicon Valley, Juul found things weren’t looking so rosy any more. Altria, which had paid US$12.8b in 2018 for a slice of the action, creating so-called “Juulianaires” in the process, saw the value of its investment dwindle, and in October last year, it announced its stake was worth just US$1.6b.

“It’s a fascinating arc of history connecting these two companies and I’m curious to see how it all plays out,” says Etter.

“I think Altria is going to be fine. Certainly, the investment in Juul was a total disaster. But it is able to continue to raise the price of its cigarettes to offset the decline in usage. There are still 38 million smokers in the US, so they still have a stable business model.”

But for Juul and other popular vape brands, everything continues to hang in the balance.

“Juul’s fate is really in the hands of the FDA right now, which is not a great position for a company to be in,” says Etter.

“But the FDA is in a difficult position, too. No matter what decision it reaches, there is going to be a lot of anger. And I have a hard time imagining the FDA putting an American company out of business.”

You were reading: How Big Tobacco in the United States Seized Control of E-cigarettes Designed to Prevent Teen Smoking

SourceNZ Herald

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