Rassegna Stampa Scientifica Luglio 2022
The End of the Illusion That Smoking Is a Choice
Credit...Illustration by Shoshana Schultz/The New York Times; Photograph by Image Source via Getty
By Sarah Milov
Dr. Milov is an associate professor of history at the University of Virginia and the author of “The Cigarette: A Political History.”
The Food and Drug Administration recently proposed lowering the nicotine content in cigarettes to less addictive levels. If adopted, this regulation would finally test one of the tobacco industry’s favorite claims: that smoking is a choice. Portraying smoking as a willful, personal decision has long allowed tobacco companies to promote cigarettes even while acknowledging their deadly risks. But the paradigm of individual choice has also guided cigarette regulation, ironically strengthening the industry’s key talking point — until now.
Nicotine is the addictive element in a cigarette. By reducing nicotine levels in cigarettes, federal regulations will, for the first time, address the key driver of cigarette consumption, which claims 480,000 American lives each year. Nicotine’s effects are particularly acute in adolescence, which is when most smokers start.
Tobacco companies have long understood that physiological dependence on nicotine — or what executives preferred to call nicotine satisfaction — was central to their business. Since the 1960s, the tobacco industry has manipulated ammonia levels in cigarettes to enhance nicotine’s effects. As one cigarette company research director commented in 1954, “It’s fortunate for us that cigarettes are a habit they can’t break.”
Publicly, tobacco’s advocates have argued that smoking is a choice of free, responsible adults. As early as 1929, the United States Patent Office granted patents to engineers who had devised processes for denicotinizing tobacco. But as one 1935 American Tobacco Company pamphlet reassured its readers, “The makers of Lucky Strike cigarettes deliberately refrain” from these techniques because “such removal of nicotine produces an emasculated product, shorn of the very qualities which give a cigarette character and appeal.” Selling the cigarette has always involved selling both the illusion of choice and a product designed to preclude it.
Ironically, the argument for individual consent was even bolstered by the earliest federal regulations on cigarettes — some of which the industry quietly lauded. After the surgeon general released the landmark 1964 report on smoking and health, policymakers debated how they would heed its call for “appropriate remedial action” to respond to the deadly health threat posed by cigarettes. The Federal Trade Commission’s proposal for cigarette warning labels that explicitly linked cigarette smoking to cancer and death was pre-empted by the warning label proposed by a tobacco-friendly Congress: “Caution: Cigarette smoking may be hazardous to your health.” These labels, which have intensified in urgency with each revision since 1966, appear to put the responsibility for smoking squarely on the shoulders of the smoker. Having been duly warned, it is the smoker’s decision to smoke and bear the consequences.
While publicly the industry howled that a warning label was unfair, privately lawyers breathed a sigh of relief. The surgeon general’s report and the warning label could bolster the industry’s defense in the courtroom in any future product liability suits. Indeed, when a wave of product liability suits brought by dying smokers or their families hit the industry in the 1980s, industry lawyers could gloat that “no tobacco company has ever paid one penny in damages” to a plaintiff. The warning label shielded companies as much as it informed smokers.
To circumvent the power that the tobacco industry held in Congress and at courthouses, anti-tobacco activists in the 1970s and ’80s pioneered a different strategy. Laws and workplace rules aimed at reducing public smoking — such as the creation of nonsmoking sections and smoking sections, indoor bans and even outdoor bans — were enacted on behalf of nonsmokers. Whatever a smoker may have decided, nonsmokers never agreed to smoke secondhand. One antismoking bumper sticker from the late 1970s playfully satirized the assumption-of-risk paradigm: “Caution: Your smoking may be hazardous to my health.”
The nonsmokers’ rights movement catalyzed a sharp decline in smoking rates. But it left the paradigm of individual consent untouched — or even strengthened. For nonsmokers’ rights activists, the smoker can pursue his choice with full knowledge of the deadly consequences as long as his choices don’t affect others. “I would not mind a smoker killing himself privately,” one nonsmoker explained in support of public smoking restrictions in 1978. “I greatly object to his infecting my air.”
In more recent decades, age restrictions on smoking have reinforced the idea that smoking is the choice of fully consenting adults. After fighting such laws for decades, cigarette manufacturers supported 2019 legislation that raised the minimum purchase age from 18 to 21. Whereas the industry once feared that such laws would “gut our key young adult market,” in the words of a Philip Morris strategy document, it now embraces them as a way to preserve “adult choice.”
“We can’t defend continued smoking as a ‘free choice’ if the person was ‘addicted,’” a tobacco lobbyist observed more than four decades ago. And yet this is precisely what the industry has done — with the unintended blessing of even anti-tobacco lawmakers, whose rules have granted the validity of the cigarette’s engineering while making it ever more difficult, expensive and stigmatized to be a smoker.
The F.D.A.’s nicotine proposal is, at long last, an opportunity to test one of the industry’s core propositions. Only then will we truly see if smoking is a free adult choice rather than the consequence of addiction and skillful product design.
The fact is that most smokers want to quit. For all the industry’s insistence that cigarettes are an emblem of individuality, nearly 70 percent of adult smokers would prefer not to. More than half of the nation’s 31 million adult smokers attempt to quit each year, and only 7.5 percent succeed.
One study found that lowering nicotine levels could save an estimated 8.5 million lives in the next 80 years — lives of current smokers who will find it easier to quit, as well as lives of would-be smokers who never get hooked. It will save many millions more from tobacco-related heart and lung disease and from the unquantifiable grief that attends watching loved ones suffer prolonged and preventable illness. Such a stunning victory for public health is possible only with the kind of regulation that rightfully targets not individual smokers but the cigarette itself.
There's a new status symbol for Britain's teenagers – and it's toxic
Billed as a suitable alternative to tobacco and filling Britain’s high streets, can the nation’s youth resist the allure of e-cigarettes?
By Charlotte Lytton 14 July 2022 • 6:00am
‘If we’re just replacing one bad with another bad, are we really tackling the issue?’
You don’t have to look far in modern Britain to find a group of teenagers exhaling clouds of coloured, scented, flavoured vapour, insouciantly sucking on plastic tubes. Close by, you will probably find clusters of alarmed parents, worrying about their children’s new habit – vaping – but unsure what to do.
For while, in the UK, it is illegal for under-18s to buy e-cigarettes, the market is being flooded with unsafe, dessert-flavoured disposable devices aimed at children, according to Trading Standards in England and Wales, who say they are currently receiving hundreds of complaints per month. Last week, a YouGov survey for Action on Smoking and Health (ASH) found that a quarter of the products purchased did not meet the standards required to be sold on UK shelves.
And the trade seems unstoppable. Vaping has almost doubled among 11 to 17-year-olds to seven per cent, with use of disposable e-cigarettes rising in popularity sevenfold.
While the NHS recommends vaping as a suitable alternative to smoking tobacco cigarettes, what of those who balk at the idea of a ciggie, but have been lured in by the endless shops featuring brightly coloured nicotine pens for a couple of pounds a pop?
The average cigarette contains around 12mg of nicotine. Elf Bars – among the most commonly used in the UK – contain 20mg of nicotine per 2ml of liquid, equating to around 40-50 cigarettes’ worth in fewer than 600 puffs. The amount consumed by vapers is hard to calculate, as cartridges come in different sizes and many users begin inhaling at the outset of the day, and don’t stop.
UK restrictions on what is now a £15 billion industry limit vape cartridge capacity to no more than 2ml, and the volume and strength of nicotine-containing liquid to 10ml and 20mg/ml respectively. These guidelines are among the more relaxed globally: in Australia, vapes can only be purchased by over-18s with a prescription, while they are banned from sale in San Francisco (rules vary state-to-state across the US). In countries from Japan to Brazil, India to Hong Kong, it is illegal to sell e-cigarettes.
Stores full of brightly coloured vials of flavoured vape fluid are common on Britain’s high streets CREDIT: Loop Images Ltd / Alamy Stock Photo
A big part of the UK’s stance is formed by the Government’s encouragement of vaping as a means to wean people off cigarettes, not to encourage them to vape per se – and its pledge to make Britain smoke-free by 2030 (currently 14.5 per cent of over-16s smoke).
“If we’re just replacing one bad with another bad, are we really tackling the issue?” asks dentist Anna Middleton. She has seen a rise in young patients coming into her Chelsea clinic presenting with bleeding gums – brought on by the nicotine in e-cigarettes, which “is a vasoconstrictor, and therefore affects blood supply. It’s a recipe for gum disease, because the bad bacteria is just thriving in that toxic environment.” Those risks aren’t communicated to would-be vapers, she adds.
A 2018 report from the National Academies of Science, Engineering and Medicine also found that e-cigarettes “contain and emit numerous potentially toxic substances,” and exacerbated asthma and wheezing among adolescent users.
The Medicines and Healthcare products Regulatory Agency says it seeks to create “an environment that protects children from starting to use these products”. Yet ASH’s research found that almost half of under-18s surveyed bought their e-cigarettes from shops whose purveyors were clearly unbothered by their customers being underage. Though the cost is comparatively small – from £1.99 for a 600-puff Elf Bar, compared with around £12 for a packet of cigarettes – the industry is predicted to grow 30 per cent year-on-year.
One “very concerned” parent of an 18-year-old says her daughter’s friends “order vape juice online with no problem” – and that while they consider cigarette smokers “disgusting”, they “don’t feel vaping is the same”. Others report that they believe vaping can be a gateway to cigarettes themselves.
Josh, an A-level student from Nottingham, had never smoked before being handed an Elf Bar at school last year, aged 17. E-cigarettes then began popping up in social settings so often, he was soon using them frequently – within a few months becoming so used to the nicotine hit, he switched to tobacco cigarettes. “I had no intention of more than one try for fun,” he says. But “with more and more people using them, I felt I needed to own one”; he didn’t want to seem “uncool or boring”.
Vaping is now something of a status symbol for teenagers, adds Josh. “Middle class teens and students opt for Elf Bars, Geek Bars or other smaller disposable vapes.” At festivals, they are often handed out for free by vape companies.
Vaping has almost doubled among 11 to 17-year-olds to seven per cent, with use of disposable e-cigarettes rising in popularity sevenfold CREDIT: Phoenixns
Image is a huge part of the appeal, says Dr Sandro Demaio, CEO of VicHealth in Australia. “The packaging looks like make-up or products that are very alluring to young people.” While Australia’s e-cigarette laws are far more stringent than the UK’s, he is calling for tighter restrictions on an industry “targeting teenagers, tweens and very young people” who are “breathing highly toxic, highly addictive products deep into their lungs as their bodies, minds and identities are still developing”.
He adds: “We urgently need to do all we can to protect young people to ensure that we don’t end up with another entire generation addicted, for life, to nicotine.”
Dr Demaio says that in the past week, he has met children as young as 10 addicted to vaping – and that a black market for illegal vapes is thriving on the likes of TikTok.
“The glamorous promotion of vaping on social media is completely inappropriate and social media platforms should take responsibility,” agrees Deborah Arnott, chief executive of ASH. The Khan review that produced the 2030 no-smoking benchmark also suggested that £15 million should be invested in enforcement, but “online platforms like TikTok don’t need to wait, they must act now”, Arnott says.
Skirmishes between companies and consumers continue, with little action. In the US, one family sued Juul, another e-cigarette brand, after their 15-year-old became addicted, resulting in seizures. And last month, the company received a ban on sales from the Food and Drug Administration – which was then revoked last week.
Part of the issue for governments considering further restrictions is how useful the devices are as a proxy for tobacco cigarette smokers. “Smoking is still the leading cause of premature death [worldwide],” Arnott points out. “That’s what’s killing people; not vaping.”
The challenge remains the new cohort. “I do believe that vaping products are used as the new cigarette ,” Josh says, adding that it is “now a large part of youth culture and identity in the UK”. There is data to show relative safety, compared with tobacco cigarettes – but nothing that goes beyond around the 15-year mark.
“We have no long-term data on health implications and the concentration of nicotine varies,” the mother of the 18-year-old says. “They think no health problems will pop up in their future.”
Gillian Golden, CEO of the Independent Vape Trade Association, comments: “It is illegal to sell vape products to anyone under 18, so young people should not be able to access them.
“E-cigarettes are meant for adult smokers who are looking to quit, or looking for a far safer alternative to cigarettes. The IBVTA would like to see more funding for enforcement and stiffer penalties for those who break the law.”
F.D.A. Orders Juul to Stop Selling E-Cigarettes
The agency ruled against the company’s application to stay on the market, a decisive blow to a once-popular vaping brand that appealed to teenagers.
In its heyday, Juul occupied 75 percent of the market share and employed 4,000 people. Credit...Jeenah Moon for The New York Times
By Matt Richtel and Andrew Jacobs
June 23, 2022, 10:36 a.m. ET
The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the U.S. market, a profoundly damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis.
The order affects all of Juul’s products on the U.S. market, the overwhelming source of the company’s sales. Juul’s sleek vaping cartridges and sweet-flavored pods helped usher in an era of alternative nicotine products among adults as well, and invited intense scrutiny from antismoking groups and regulators who feared they would do more harm to young people than good to former smokers.
“Today’s action is further progress on the F.D.A.’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Dr. Robert M. Califf, the agency commissioner, said in a statement. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
The move by the F.D.A. is part of a wide-ranging effort to remake the rules for smoking and vaping products and to reduce illnesses and deaths caused by inhalable products containing highly addictive nicotine.
On Tuesday, the agency announced plans to slash nicotine levels in traditional cigarettes as a way to discourage use of the most deadly of legal consumer products. In April, the F.D.A. said it would move toward a ban on menthol-flavored cigarettes.
The action against Juul in particular is part of a newer regulatory mission for the agency, which must determine which electronic cigarettes currently for sale, or proposed for sale, will be allowed onto U.S. shelves permanently now that the F.D.A. has authority over e-cigarettes.
But it could take years before these proposals take effect — if they can withstand fierce resistance from the powerful tobacco lobby, antiregulatory groups and the vaping industry.
Juul is expected to appeal the F.D.A.’s decision.
Public health groups hailed the ruling.
“The F.D.A.’s decision to remove all Juul products from the marketplace is both most welcomed and long overdue,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. “Juul’s campaign to target and hook kids on tobacco has gone on for far too long.”
A statement from the American Vapor Manufacturing Association, an industry trade group, hinted at the fight ahead.
“Measured in lives lost and potential destroyed, F.D.A.’s staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history,” Amanda Wheeler, the association’s president, said in a statement.
Read More on Smoking and Vaping
- Nicotine Levels: Aiming to reduce the toll of smoking, the Food and Drug Administration is planning to require tobacco companies to slash the amount of nicotine in cigarettes.
- Menthol Ban: The F.D.A. has also proposed a plan to ban sales of menthol cigarettes, a measure experts say may save hundreds of thousands of lives, especially among Black smokers.
- ‘Smoking Is Back’: Cigarettes, still the No. 1 cause of preventable death in the United States, are making a comeback with a younger crowd.
- Vaping Loophole: A crackdown on flavored e-cigarettes was meant to curtail teenage vaping, but sales are rising due to synthetic nicotine.
- The Rise of Juul: A Times documentary traced the e-cigarette maker on its path from fledgling start-up to Silicon Valley juggernaut and, eventually, public health villain.
The agency’s ruling capped a nearly two-year review of data that Juul had submitted to try to win authorization to continue selling its tobacco- and menthol-flavored products in the United States. The application required the company to prove the safety of its devices and whether they were appropriate for the protection of public health.
Juul, in particular, had been the target of regulators, schools and policymakers for years, starting in 2018, when the F.D.A. began an investigation into Juul’s marketing efforts. Before that time, Juul had advertised its product using attractive young models and flavors like cool cucumber and creme brulee that critics said attracted underage users.
By April 2018, the F.D.A. announced a crackdown on the sale of such products, including Juul’s, to people under the age of 21.
Use among young people had soared. In 2017, 19 percent of 12th graders, 16 percent of 10th graders and 8 percent of eighth graders reported vaping nicotine in the past year, according to Monitoring the Future, an annual survey done for the National Institute on Drug Abuse.
For its part, Juul routinely denied that it targeted young people, but it was pursued in lawsuits and by state attorneys general, with some cases resulting in millions of dollars in damages against the company. In one settlement in 2021, Juul agreed to pay $40 million to North Carolina, which represented various parties in the state who asserted the company had helped lure underage users to vaping. More than a dozen other states have lawsuits and investigations that are still pending.
Dr. Scott Gottlieb, the former F.D.A. commissioner, explained his approval of the move against Juul on Wednesday, which was first reported in The Wall Street Journal.
The news is somewhat less weighty for the industry now than it would have been in Juul’s heyday, given the company’s plummeting market share. Once the dominant player with 75 percent of the market, Juul now has a considerably smaller share of the market.
But the news delivers a significant blow to Altria, formerly known as Philip Morris and the maker of Marlboro, which in December 2018 bought 35 percent of Juul for $12.8 billion. Because of smaller market share and regulatory headwinds, Altria said, the value of that stake fell to $1.7 billion by the end of 2021.
At its peak, Juul had more than 4,000 employees. It now has slightly over 1,000, mostly in the United States, but with some in Canada, Britain and other countries. Its revenue has fallen to $1.3 billion in 2021, down from $2 billion in 2019, with about 95 percent in U.S. sales.
Nicotine itself is not the cause of lung cancer and other deadly ills from smoking, but the drug is exceedingly addictive, making it difficult for smokers to quit despite the health risks. The adolescent brain is particularly susceptible to nicotine, which can affect memory, concentration, learning and self-control.
Already, the e-cigarette companies have said they will challenge the decision in court.
E-cigarettes have been sold on the U.S. market for more than a decade without formal F.D.A. authorization, because they did not fall under the agency’s regulatory purview for several years.
In 2019, the F.D.A. issued a warning letter to Juul, saying that the company violated federal regulations because it had not received approval to promote and sell its products as a healthier option to smoking.
The agency has been reviewing all types of vaping products, some in development, for more than a year, and companies awaiting a decision have been allowed to keep selling some products.
The F.D.A. recently said it had so far rejected more than a million applications whose products it considered more of a health risk than a benefit. In October, it authorized R.J. Reynolds to continue marketing Vuse. This was the first time the agency granted approval to a vaping product made by a big cigarette company.
In its review of devices that it compared with traditional cigarettes, the agency said that the devices contained a “significant reduction” in harmful chemicals, although some were still present. The review said the toxins and potential cancer-causing chemicals were far lower in the blood and urine of people using the Vuse device compared with those of smokers.
Still, California law required R.J. Reynolds to warn Vuse buyers about exposure to glycidol, which is “known to the state to cause cancer” based on studies of mice and rats.
In March, the agency authorized several tobacco-flavored products from Logic Technology Development, saying the company was able to show that its products were likely to help adults make the transition from traditional cigarettes while posing a low risk of attracting young, new users.
But the agency disappointed some prominent lawmakers and advocacy groups when it announced recently that it would not be able to finish reviewing all of the e-cigarette marketing applications until June 2023, a year after a court-imposed deadline.
Some tobacco-control experts said the decision to ban Juul from the U.S. market was misguided and ultimately counterproductive.
Clifford Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health, said that the F.D.A. appeared to punish Juul for its past activity marketing to teenagers, and that many experts had come to see Juul and other e-cigarettes as valuable tools for helping adult smokers quit conventional cigarettes.
“They are so-called off ramps that can provide smokers an alternative to combustibles, which are responsible for virtually every death related to tobacco,” he said. “But now that off ramp is being narrowed and sort of paved over, which is putting millions of adult lives at risk.”
Christina Jewett and Sheila Kaplan contributed reporting.