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Showing posts sorted by relevance for query VAPING. Sort by date Show all posts

Monday, August 22, 2022

The F.D.A.’s Misguided War on Vaping

The government is putting stricter restrictions on vaping than on smoking. That’s bad for public health.



Clive Bates
Writes The Counterfactual by Clive Bates ·
Aug 8,2022


(Photo by Scott Olson/Getty Images)

While the boiling controversy over the use of e-cigarettes—popularly known as vaping—can seem like a quirky but noisy sideshow, in reality, millions of lives are at stake. E-cigarettes were first commercialized around 2006 and work by heating a nicotine liquid to create an inhalable mist, rather than by burning tobacco to create smoke. Though not completely safe, vaping is far less dangerous than smoking combustible cigarettes, the dominant product for nicotine use.

Despite this, the Food and Drug Administration has been cracking down on vaping—often claiming that vaping poses a health risk and is a threat to young people. This overly cautious approach is hindering a technology that will help eliminate the burden of disease, death, and suffering caused by smoking.

People smoke primarily to experience the effects of nicotine—for stimulation and pleasure; to reduce stress and anxiety; and to improve concentration, reaction time, and cognitive performance. For some people, these effects improve their quality of life. But on the dark side, nicotine use can lead to dependence.

Crucially, however, it is smoke, not nicotine, that causes the overwhelming burden of disease and death. Inhaling the toxic particles and gases from the burning tip of a cigarette exposes the body to thousands of chemicals, of which hundreds are known to be hazardous. The result is widespread death and disease, with cigarettes killing 480,000 Americans annually and leaving around 16 million suffering from a smoking-induced disease. Without the harmful effects of smoking, nicotine use starts to look more like moderate alcohol consumption—a modest substance use that fits within the normal risk appetites of modern society.

With vaping, we have a solution to two related problems. First, millions of American smokers have the option of switching from smoking to vaping, greatly improving their health prospects. Second, people in the future who want to use nicotine will be able to do so with considerably reduced consequences.

In a liberal society, we should not prohibit or aim to eliminate drug use or pretend that it can be risk-free, but we should try to limit the risks to the extent possible. Vaping is the best opportunity we have to do that for nicotine.

Critics of vaping typically rely on three main arguments.

First, we do not know the long-term consequences of e-cigarette use. This is true, as it is for any new product. We will have to wait another 50 years to know the full story. But what we do know today is that cigarettes are very dangerous. Additionally, all the available evidence suggests that vaping is much less harmful than smoking.

Second, vaping skeptics point to the outbreak of lung injuries in 2019 in the United States—which caused 2,800 hospitalizations and 68 deaths—as evidence that vaping is potentially extremely dangerous. But while this outbreak was initially attributed to e-cigarettes, it turned out to be caused by illegal and unregulated cannabis vaping products that included a dangerous cutting agent, Vitamin E Acetate, which is not added to nicotine liquids.

Third, opponents will claim that there is a “youth vaping epidemic,” pointing out that high school-age vaping reached 27.5% in 2019. While there has been a considerable uptick in youth e-cigarette use in recent years as the technology developed, the high 2019 numbers are an outlier. The headline number of the study measured any vaping in the past 30 days, and around two-thirds of users said they were making infrequent use of these products. Additionally, those vaping frequently were likely to have smoked previously, and it is possible that their vaping was a diversion from lifelong smoking. Furthermore, by 2021, the number of high-schoolers who had used a vape in the last 30 days had fallen to 11.3%, suggesting that claims of an “epidemic” were likely premature.

Together, these concerns have gained so much purchase among the general public that most Americans wrongly believe that vaping is just as harmful or more harmful than smoking. Even worse, the visceral politics around vaping, in particular the idea of the youth vaping epidemic, have driven the F.D.A. to apply overly burdensome and restrictive regulations on vaping products.

As a result, over one million vaping products have been denied access to the U.S. market, and the great diversity of flavors and device types have been cut down to a handful of uninspiring tobacco-flavored products. In stark contrast, no public health test applies to the 3,000 cigarette products that have been on the market for years throughout America. They were grandfathered in under the 2009 Tobacco Control Act.

In June, the F.D.A. announced that it had denied marketing applications made by Juul Lab Inc., one of the world’s biggest vaping companies with around three million adult users of its products. The F.D.A.’s case against Juul was very weak—it did not rely on youth vaping or any identified risk to health with the product but on some “inconsistent and conflicting data” in Juul’s 125,000-page application. These should have been addressed through discussions between the applicant and the regulator, but Juul argued in court that the F.D.A.’s “scientific” reasons were a feeble pretext for a politically-motivated attack. The F.D.A. withdrew from the legal proceedings and will review its approach internally.

Despite this recent victory for Juul, the F.D.A.’s interventions have resulted in an anarchic market of a few authorized vaping products, thousands of products either under review or pending legal challenge, and an emerging black market for unregulated vape products.

If the F.D.A. is taking a tough stance on safer alternatives, what is it doing about cigarettes, the product that causes the most harm? In 2023, it plans to publish a plan to reduce nicotine levels in cigarettes to very low levels. The F.D.A. argues that this would make the products minimally addictive, help smokers quit, and prevent youth uptake.

The problem with this approach is that it amounts, in practice, to a prohibition of cigarettes in their traditional form. But most smokers won’t just quit as the F.D.A. hopes. Some will buy cigarettes on a black market while others will hand-roll their own or switch to cigars. And though it would be good if some smokers responded by switching from smoking to vaping, the F.D.A. seems to be working hard to make that option more difficult.

Ultimately, the most likely fate of this poorly constructed proposal is that it will be debated until it is no longer needed. Many consumers who wish to use nicotine will switch to products such as e-cigarettes that cause them much less harm but still allow them to experience mild psychoactive effects of nicotine.

This transition is already underway and likely to continue because it is highly beneficial to those directly involved, both consumers and suppliers. The question is the extent to which misguided, highly risk-averse regulators and prohibitionist activists slow the pace of change. Every day of delay will mean more avoidable death and disease.

Clive Bates is Director of Counterfactual Consulting a public and sustainability practice. He is a former civil servant and former Director of Action on Smoking and Health (UK), a leading anti-smoking non-profit.

[The author has no conflicts of interest with respect to the industries discussed in this article. He has filed an amici curiae brief in support of Juul’s motion for a stay pending substantive review on public health grounds after the FDA denied Juul’s applications to market its products in the United States.]

Saturday, December 21, 2019




'Vast majority' of vaping illnesses blamed on vitamin E
This Friday, Dec. 20, 2019 image shows the official message on one of 44 websites seized by the U.S. Drug Enforcement Administration for advertising the sale of illicit THC vaping cartridges to U.S. consumers, as part of Operation Vapor Lock. (AP Photo)
Health officials now blame vitamin E acetate for the "vast majority" of cases in the U.S. outbreak of vaping illnesses and they say doctors should monitor patients more closely after they go home from the hospital.

The Centers for Disease Control and Prevention announced the updated advice Friday.
And, in a related move Friday, authorities investigating how patients obtained possibly tainted vape products said they have shut down 44 websites advertising the sale of illicit vaping cartridges containing THC.
The new medical advice is based on a close look at about 3% of vaping illness patients who returned to the hospital after discharge and seven who died after hospital discharge.
The study suggests that vaping illnesses can get worse, even deadly, after patients leave the hospital and doctors should check on patients within two days of sending them home.
The two-day followup after hospital discharge is shorter than the previous recommendation of one to two weeks.
Compared to other vaping illness patients, those who went back to the hospital were more likely to have chronic conditions such as diabetes, heart disease or other breathing problems such as sleep apnea. Those who died after hospital discharge were more likely to be 50 or older.



'Vast majority' of vaping illnesses blamed on vitamin E
In this Tuesday, Nov. 12, 2019 file photo, Dr. Hassan Nemeh, surgical director of Thoracic Organ Transplant, shows areas of a patient's lungs during a news conference at Henry Ford Hospital in Detroit. A Henry Ford Health System medical team performed a double lung transplant for a patient whose lungs were irreparably damaged from vaping. On Friday, Dec. 20, 2019, the Centers for Disease Control and Prevention said vaping illnesses can get worse, even deadly, after patients leave the hospital and doctors should check on patients within two days of sending them home. (AP Photo/Paul Sancya)
The CDC also released new information that continues to point to a culprit: vitamin E acetate, a thickening agent that's been added to illicit THC vaping liquids. THC is the chemical in marijuana that makes users feel high.
A report published in the New England Journal of Medicine identified the substance in the lung fluid of 48 out of 51 vaping illness patients and did not find it in the lung fluid of healthy people. Vitamin E acetate also has been found in vaping product samples.
In the strongest language yet about what's caused the outbreak, Dr. Anne Schuchat of the CDC told reporters during a telephone briefing Friday that it is her "conclusion" that vitamin E acetate caused the illness in "the vast majority of patients."
The nation's outbreak of vaping-related lung injuries continues, but new cases are on the decline. More than 2,500 cases of vaping illness have been reported by all 50 states. There have been 54 deaths and more deaths are under investigation.
Interviews with patients and families led investigators to some of the websites that were shut down by the Food and Drug Administration and the Drug Enforcement Administration. The agencies did not announce any criminal charges.
The 44 website domains—with names including Stoners Marketplace and Anonymous Meds—now direct visitors to a message in red letters that says "This Site Has Been Seized."
Investigators have said they are not interested in taking action against individuals who use vaping products, and are focused instead on suppliers.
Some of the websites shut down were scam sites intended to collect money without ever mailing consumers any products, authorities said.

Federal health officials made clear Friday that tainted THC vaping cartridges are considered the primary cause of a vaping lung injury that has killed 54 people and hospitalized more than 2,000 across the United States.

UPI.COM
Federal health officials made clear Friday that tainted THC vaping cartridges are considered the primary cause of a vaping lung injury that has killed 54 people and hospitalized more than 2,000 across the United States.


SEE  https://plawiuk.blogspot.com/search?q=VAPING

Saturday, October 08, 2022

FDA WAR ON VAPING IS DISTRACTION FROM TOXIC TOBACCO

New survey suggests little progress against U.S. teen vaping

By MIKE STOBBE and MATTHEW PERRONE
October 6, 2022

n this Jan. 31, 2020 photo a woman holds a flavored disposable vape device in New York. A government study on adolescent vaping, released on Thursday, Oct. 6, 2022, finds more than 2.5 million U.S. kids were using some form of e-cigarette in 2022, suggesting there’s been little progress in keeping vaping devices out of the hands of teenagers. 
(AP Photo/Marshall Ritzel, File)


NEW YORK (AP) — The latest government study on teen vaping suggests there’s been little progress in keeping e-cigarettes out of the hands of kids.

The data seems to show more high school students vaping, with 14% saying they had done so recently, according to survey results released Thursday. In last year’s survey, about 11% said they had vaped recently.

But experts cautioned that a change in the survey makes it difficult to compare the two: This year, a much higher percentage of participants took the survey in schools, and vaping tends to be reported more in schools than in homes.

“It continues to be difficult to assess (vaping) trends since the pandemic,” said Alyssa Harlow, a University of Southern California researcher who studies youth e-cigarette use.

Despite its persistence, vaping appears to be less popular than it was: In 2019, 28% of high schoolers said they had recently vaped.

Educators say vaping is still a big problem.

Anecdotally, the 2021-22 school year was worse than it was before the pandemic, said Mike Rinaldi, principal of Westhill High School in Stamford, Connecticut. That school year was the first when most kids returned from remote learning following COVID-19 lockdowns, noted Rinaldi, who speculated that many kids may have taken up vaping as they dealt with mental health issues or stress related to the pandemic.

Kids vaping in school bathrooms and stairwells remains “a constant battle,” said Matt Forker, principal of the nearby Stamford High School.

Centers for Disease Control and Prevention researchers authored the new study, which is based on a Jan. 18 to May 31 online survey of about 28,000 U.S. middle and high school students.

The study asked about use of e-cigarettes and other vaping devices in the previous 30 days. In addition to the 14% of high school students who said they vaped recently, about 3% of middle schoolers said they had done so.

Of those who vaped, about 28% said they did it every day.

Nearly 85% of the youth who vaped used flavored products. Favored brands included Puff Bar and Vuse, followed by Hyde and Smok.

The Food and Drug Administration on Thursday took action against the makers of both Puff Bar and Hyde following months of urging from congressional lawmakers and parent groups.

The agency sent a warning letter to Puff Bar manufacturer EVO Brands, stating that the company never obtained U.S. permission to sell its products and that they are being marketed illegally. Only a handful of vaping companies have received FDA clearance for their products, which must demonstrate a health benefit for adult smokers.

The agency also said it ordered Hyde manufacturer Magellan Technology to remove its products from the market, after rejecting its application for FDA authorization.

The FDA has struggled to regulate the sprawling vaping landscape, which includes both established companies and smaller startups. Regulators have been pilloried by Congress and anti-vaping advocates for missing multiple deadlines to issue decisions on millions of vaping products submitted by companies.

In the last three years, federal and state laws and regulations have raised the purchase age for tobacco and vaping products, and banned nearly all teen-preferred flavors from small, cartridge-based e-cigarettes.

Some kids also may have been scared away by a 2019 outbreak of vaping-related illnesses and deaths — most of them tied to a filler in black market vaping liquids that contained THC, the chemical that makes marijuana users feel high.

Leaders of one advocacy group said they worry the battle to diminish youth vaping is not going well.

The numbers “may not reflect the much larger reality of youth e-cigarette use that we hear about on a daily basis from parents, teachers, pediatricians, and prevention specialists who are experiencing this urgent and ongoing adolescent public-health crisis,” the group, Parents Against Vaping E-Cigarettes, said in a statement.

The FDA tried to ban the leading e-cigarette maker Juul’s products earlier this summer, citing questions about its potential health risks. But it’s been forced to put that effort on hold following a court challenge.

In this year’s survey, about one-fifth of teens who vape reported recently using Juul, though it was no longer a favorite brand. That’s a big shift from 2019, when more than half of teens reported Juul as their usual brand.

Instead, many young people have migrated to e-cigarettes delivering laboratory-made nicotine — including Puff Bar — a loophole in FDA’s oversight that Congress closed this year. Despite gaining new authority over those products, the FDA missed a mid-July deadline to issue decisions on the vast majority of those products.

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Perrone reported from Washington, D.C.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Monday, January 27, 2020

GOOD NEWS

Most young people do not vape, and even fewer vape regularly

VAPING SCARE IS AN FDA FALSE FLAG

vaping
Credit: CC0 Public Domain
While youth vaping rates have increased in recent years, most middle and high school students don't vape or smoke and very few vape or smoke daily, finds a study led by researchers at NYU School of Global Public Health.
The study, published this month in the journal Nicotine & Tobacco Research, finds that over 80 percent of youth do not use any tobacco and over 86 percent don't vape—and among the minority who do vape, most are not regular users. In addition, the study reveals that most youth who are  are also current or former smokers.
"Our findings underscore the importance of examining the full context of how youth are using vaping and tobacco products," said Allison Glasser, an assistant research scientist at NYU School of Global Public Health and the study's lead author. "The key to protecting youth in the United States is determining the patterns of frequency of use and co-use of vaping and tobacco products, which will give public health decision makers the best possible information to protect the public's health."
While the FDA and CDC's National Youth Tobacco Survey has shown a concerning increase in youth vaping in recent years, little is known about the frequency with which youth use e-cigarettes—if it's an occasional occurrence or a daily habit—as well as whether they also use more harmful smoked tobacco products like cigarettes and inexpensive cigars or cigarillos.
In this study, the researchers analyzed the 2018 National Youth Tobacco Survey in which more than 20,000 middle and  were asked about their use of various tobacco and vaping products in the past 30 days. The analysis was conducted on the 2018 survey, the latest available full data set; the 2019 National Youth Tobacco Survey, which showed that youth vaping continued to grow from 2018 to 2019, has not yet been made available for public analysis.
A critical finding across all surveys from 2013 to 2019 is that smoking actually decreased much more rapidly to a record low during the very same years vaping increased. From 2015 to 2018, daily cigarette smoking among youth declined from 1.2 percent to 0.9 percent, while regular vaping (20 or more out of the past 30 days) increased from 1.7 percent to 3.6 percent.
"The faster drop in smoking suggests vaping is helping displace youth use of much more deadly smoking—a net harm reduction benefit to the population as a whole," said David Abrams, a professor of social and behavioral sciences at NYU School of Global Public Health and a study coauthor.
The researchers also found that while youth vaping increased from 2017 to 2018, the increase was driven by infrequent e-cigarette use rather than regular use: in 2018, while 13.8 percent of students had vaped in the 30 days, more than half of them vaped five days or fewer.
Critically, the majority of youth vapers also use or have used more deadly  (60 to 88.9 percent, depending on the frequency of vaping). While there has been fear that e-cigarettes are introducing nicotine to many  who otherwise would not have smoked, the data show otherwise—only a small proportion of tobacco-naïve youth report vaping.
"Examining tobacco and e-cigarette use patterns in youth is informative about the risk of continued use in adulthood. While in a perfect world young people would not be smoking or vaping, if the vast majority of youth who vape are already current or former smokers, vaping could offer them a safer alternative than cancer-causing cigarettes," said Ray Niaura, a professor of social and behavioral sciences at NYU School of Global Public Health and a study coauthor.
"This study provides us with a better understanding of youth vaping patterns, which is critical for creating effective public health policies around nicotine and tobacco. Reacting too quickly to reports of  vaping without considering the full context could do more harm than good," added Abrams. "We need to avoid prohibitionist regulations like banning e-cigarettes—while leaving much more deadly cigarettes and cigars in corner stores—and instead should consider strong enforcement of age 21 sales restrictions. Prohibition creates a black market for vaping products or inadvertently pushes individuals back to smoking ."
Three quarters of teens who vape report using nicotine, marijuana, or multiple substances

More information: Allison M Glasser et al, Youth Vaping and Tobacco Use in Context in the United States: Results from the 2018 National Youth Tobacco Survey, Nicotine & Tobacco Research (2020). DOI: 10.1093/ntr/ntaa010
Journal information: Nicotine & Tobacco Research 
Provided by New York University 



Thursday, August 25, 2022

New Survey Data Cast Further Doubt on the FDA's Opposition to Flavored E-Cigarettes

The "epidemic" of adolescent vaping seems to be fading fast, and vaping is replacing smoking among adults, a harm-reducing trend that regulators seem determined to discourage.

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A federal appeals court this week sided with several companies whose applications to sell nicotine vaping products in a variety of flavors were rejected by the Food and Drug Administration (FDA). As Reason's Elizabeth Nolan Brown noted yesterday, the U.S. Court of Appeals for the 11th Circuit ruled that the FDA's decisions were "arbitrary and capricious" because the agency ignored marketing and age-verification plans aimed at preventing underage vaping. But as Judge Robin Rosenbaum noted in her dissent, the manufacturers' victory probably will be short-lived, because the FDA seems dead set against allowing the sale of vaping products in flavors other than tobacco.

That position is puzzling, since former smokers who have switched to vaping overwhelmingly prefer nontobacco flavors, and the FDA acknowledges that "electronic nicotine delivery systems" (ENDS) hold great promise as a harm-reducing alternative to cigarettes. But the FDA insists there is no solid evidence that flavor variety makes vaping more appealing to adult smokers, even as it worries that flavor variety makes vaping more appealing to teenagers. So when the FDA reconsiders these applications on remand from the 11th Circuit, it is almost certain to reject them again, notwithstanding the steps that the companies are taking to keep their products away from underage consumers

The FDA's opposition to flavor variety is driven by concern about an "epidemic" of adolescent vaping. But as new survey data from the government-sponsored Monitoring the Future (MTF) study confirm, the surge in electronic cigarette use by teenagers that alarmed the FDA in 2018 and 2019 is already receding, even though adults can still buy flavored ENDS that remain on the market because the FDA has not yet decided whether to allow them or has not taken enforcement action against them. Those data also indicate that adolescent smoking continued to decline as vaping became more popular. The picture is similar for young adults: As vaping continued to rise among 19-to-30-year-olds in 2021, cigarette smoking hit a record low.

These trends suggest that we are seeing precisely the sort of harm-reducing substitution that the FDA claims to want. The data certainly are not consistent with the idea that the availability of ENDS has resulted in more smoking. Yet Judge Rosenbaum, who seems to think the FDA's opposition to flavored ENDS is well-grounded, avers that "vaping has been shown to be a gateway to smoking combustible cigarettes." She cites no evidence to support that claim, which seems highly implausible in light of the continuing decline in smoking among teenagers and adults.

The annual MTF survey, which University of Michigan researchers conducts under contract with the National Institute on Drug Abuse, includes students in the eighth, 10th, and 12th grades. In 2021, it shows, the prevalence of past-month nicotine vaping fell sharply in all three grades.

That rate peaked at 10.5 percent in 2020 among eighth-graders before falling to 7.6 percent last year. Among 10th- and 12th-graders, it peaked at 19.9 percent and 25.5 percent, respectively, in 2019 and had fallen to 13.1 percent and 19.6 percent, respectively, by last year. Between 2019 and 2021, the prevalence of "daily" vaping (defined as use on 20 or more occasions in the previous 30 days) fell from 2 percent to 1.1 percent among eighth-graders, from 6.8 percent to 2.5 percent among 10th-graders, and from 11.6 percent to 5.4 percent among 12th-graders.

These findings are broadly consistent with results from the National Youth Tobacco Survey (NYTS), which is sponsored by the Centers for Disease Control and Prevention (CDC). That survey shows the prevalence of past-month e-cigarette use by high school students peaking at 27.5 percent in 2019 before falling to 11.3 percent in 2021. Even though adults still have access to ENDS in a variety of flavors, the "epidemic" decried by the FDA and the CDC seems to be fading fast.

Neither survey provides any evidence of the "gateway" that Rosenbaum perceives. On the contrary, the downward trend in adolescent smoking continued even when vaping was rising sharply. Among 12th-graders in the MTF survey, the prevalence of past-month cigarette smoking fell from 10.3 percent in 2011 to 2 percent in 2021. During the same period, the prevalence of "daily" cigarette smoking fell from 4.3 percent to 0.8 percent. In the NYTS, the prevalence of past-month cigarette smoking among high school students fell from 15.8 percent in 2011 to 1.9 percent last year.

There is reason to think that ENDS, far from interfering with the decline in adolescent smoking, hastened that downward trend, which accelerated as vaping took off. The replacement of smoking by vaping is indisputably an improvement in terms of "public health," which the FDA claims to be promoting. But the agency instead portrays it as a grave danger to the youth of America. When it comes to teenagers, the FDA refuses even to consider the positive impact of such substitution.

A 2019 analysis of NYTS data found that frequent e-cigarette use was concentrated among teenagers who were current or former smokers. So far the recent decline in adolescent vaping has not led to an uptick in smoking, which makes sense if casual users, rather than teenagers who vape instead of smoking, account for most of the drop. But the FDA should be wary of any policy that makes cigarettes easier to obtain than ENDS or makes ENDS less appealing to people who otherwise would be smoking. Over the long term, the upshot could be more rather than fewer smoking-related deaths.

Logically, that analysis should include teenagers as well as adults. But the FDA insists that the health benefits of substituting ENDS for cigarettes don't count when vapers are younger than 21. So let's consider what the MTF data tell us about the potential cost of refusing to let adults buy the vaping products they demonstrably want.

"Cigarette smoking among young adults has been declining steadily since
2004 and reached new historic lows in 2021," an MTF report notes. "Cigarette use in the past 30 days decreased by more than half in the past decade," from 21.2 percent in 2011 to 9 percent in 2021.

In recent years, that downward trend in smoking by 19-to-30-year-olds has been accompanied by an upward trend in vaping. "Since it was first measured in 2017,
nicotine vaping in the past 30 days has nearly tripled among young adults to 16.1% in 2021," the report says. "Nicotine vaping in the past 12 months was reported by 21.8%, just below the all-time high of 23.6% in 2019."

Between 2017 and 2021, as the prevalence of past-month vaping in this age group rose by 160 percent, the prevalence of past-month cigarette smoking fell by 39 percent. Those trends are not consistent with Rosenbaum's theory that more vaping means more smoking. But they are consistent with the theory that many young adults are choosing to vape instead of smoke.

The FDA ostensibly would like to see more of that. The whole premise of approving the sale of ENDS as "appropriate for the protection of the public health"—the standard the FDA is supposed to apply under the Family Smoking Prevention and Tobacco Control Act—is that it will help reduce tobacco-related morbidity and mortality by offering smokers a much less hazardous way to consume nicotine. Yet the FDA claims to be unpersuaded that flavor variety plays an important role for smokers who have made that potentially lifesaving switch or might be interested in doing so.

The FDA contradictorily insists that flavor variety is important to teenagers. It thinks at least some of them will eschew vaping if tobacco is the only flavor they can find. The possibility that some teenagers therefore will smoke instead does not enter into the FDA's calculations at all. And it dismisses the danger that the same thing will happen among adults, saying ENDS manufacturers have not produced enough evidence to that effect.

Contrary to its legal duty, the FDA has not carefully weighed the costs and benefits of its supposedly youth-protecting policy. Instead, it refuses to admit there are any costs to consider.


Tuesday, January 16, 2024

A surgeon general report once cleared the air about smoking. Is it time for one on vaping?


MIKE STOBBE
 Mon, January 15, 2024 


Vaping Health Effects
 - A health warning is seen on the packaging of a disposable vaping pod device in Washington
on Monday, June 26, 2023. Sixty years ago, the U.S. surgeon general released a report that settled
a longstanding public debate about the dangers of cigarettes and led to huge changes in smoking
in America. Some public health experts say a similar report could help clear the air about vaping.
(AP Photo/Andrew Harnik, File)

NEW YORK (AP) — Sixty years ago, the U.S. surgeon general released a report that settled a longstanding public debate about the dangers of cigarettes and led to huge changes in smoking in America.

Today, some public health experts say a similar report could help clear the air about vaping.

Many U.S. adults believe nicotine vaping is as harmful as — or more dangerous than — cigarette smoking. That’s wrong. The U.S. Food and Drug Administration and most scientists agree that, based on available evidence, electronic cigarettes are far less dangerous than traditional cigarettes.

But that doesn’t mean e-cigarettes are harmless either. And public health experts disagree about exactly how harmful, or helpful, the devices are. Clarifying information is urgently needed, said Lawrence Gostin, a public health law expert at Georgetown University.

“There have been so many confusing messages about vaping,” Gostin said. “A surgeon general’s report could clear that all up.”

One major obstacle: E-cigarettes haven’t been around long enough for scientists to see if vapers develop problems like lung cancer and heart disease.

“There’s a remarkable lack of evidence,” said Dr. Kelly Henning, who leads the public health program at Bloomberg Philanthropies.

SMOKING AND VAPING

Cigarette smoking has long been described as the leading cause of preventable death in the United States. The Centers for Disease Control and Prevention puts the annual toll at 480,000 lives. That count should start to fall around 2030, according to a study published last year by the American Journal of Preventive Medicine, thanks in part to a decline in smoking rates that began in the 1960s.

Back then, ashtrays were everywhere and more than 42% of U.S. adults smoked.

On Jan. 11, 1964, U.S. Surgeon General Luther Terry released an authoritative report that said smoking causes illness and death — and the government should do something about it. The report is considered a watershed moment: In the decades that followed, warning labels were put on cigarette packs, cigarette commercials were banned, governments raised tobacco taxes and new restrictions were placed on where people could light up.

By 2022, the adult smoking rate was 11%.

Some experts believe e-cigarettes deserve some of the credit. The devices were billed as a way to help smokers quit, and the FDA has authorized a handful of e-cigarettes as less-harmful alternatives for adult smokers.

Vaping’s popularity exploded in the 2010s, among both adults but and teens. In 2014, e-cigarettes surpassed combustible cigarettes as the tobacco product that youth used the most. By 2019, 28% of high schoolers were vaping.

U.S. health officials sounded alarms, fearing that kids hooked on nicotine would rediscover cigarettes. That hasn’t happened. Last year, the high school smoking rate was less than 2% — far lower than the 35% rate seen about 25 years ago.

“That’s a great public health triumph. It’s an almost unbelievable one,” said Kenneth Warner, who studies tobacco-control policies at the University of Michigan.

“If it weren’t for e-cigarettes, I think we would be hearing the public health community shouting at the top of their lungs about the success of getting kids not to smoke,” he said.

VAPING’S BENEFITS AND HARMS

Cigarettes have been called the deadliest consumer product ever invented. Their smoke contains thousands of chemicals, at least 69 of which can cause cancer.

The vapor from e-cigarettes has been estimated to contain far fewer chemicals, and fewer carcinogens. Some toxic substances are present in both, but show up in much lower concentrations in e-cigarette vapor than in cigarette smoke.

Studies have shown that smokers who completely switch to vaping have better lung function and see other health improvements.

“I would much rather see someone vaping than smoking a Marlboro. There is no question in my mind that vaping is safer,” said Donald Shopland, who was a clerk for the committee that generated the 1964 report and is co-author of a forthcoming book on it.

But what about the dangers to people who have never smoked?

There have been 100 to 200 studies looking at vaping, and they are a mixed bag, said Dr. Neal Benowitz, of the University of California, San Francisco, a leading academic voice on nicotine and tobacco addiction. The studies used varying techniques, and many were limited in their ability to separate the effects of vaping from former cigarettes smoking, he said.

“If you look at the research, it’s all over the map,” Warner said.

Studies have detected bronchitis symptoms and aggravation of asthma in young people who vape. Research also indicates vaping also can affect the cells that line the blood vessels and heart, leading to looks for a link to heart disease. Perhaps the most cited concern is nicotine, the stimulant that makes cigarettes and vapes addictive.

Animal studies suggest nicotine exposure in adolescents can affect development of the area of the brain responsible for attention, learning and impulse control. Some research in people suggests a link between vaping and ADHD symptoms, depression and feelings of stress. But experts say that the research is very limited and more work needs to be done.

Meanwhile, there’s not even a clear scientific consensus that vaping is an effective way to quit smoking, with different studies coming up with different conclusions.

CLEARING THE AIR

Last month, the World Health Organization raised alarms about the rapidly growing global markets for electronic cigarettes, noting they come in thousands of flavors that attract young people.

In 2016, U.S. Surgeon General Dr. Vivek Murthy said efforts were needed to prevent and reduce e-cigarette use by children and young adults, saying nicotine in any form is unsafe for kids.

About four months before the report’s release, the FDA began taking steps to regulate e-cigarettes, believing they would benefit smokers.

The agency has authorized several e-cigarettes, but it has refused more than 1 million product marketing applications. Critics say the FDA has been unfair and inconsistent in regulation of products.

Meanwhile, the number of different e-cigarette devices sold in the U.S. has boomed, due largely to disposables imported from China that come in fruit and candy flavors. But vaping by youths has recently been falling: Last year, 10% of high school students surveyed said they had used e-cigarettes in the previous month, down from 14% the year before.

Why the decline? “It’s hard to say what’s working,” said Steven Kelder, a University of Texas researcher.

He mentioned a 2019 outbreak of hospitalizations and deaths among people who were vaping products with THC, the chemical that gives marijuana its high.

The illnesses were traced to a thickening agent used in black market vape cartridges, a substance not used in commercial nicotine e-cigarettes. But it may be a reason many Americans think of e-cigarettes as unsafe, Kelder said.

Sherri Mayfield, a 47-year-old postal worker, remembers the 2019 outbreak and reports of rapid illnesses and deaths in youths. Vaping “absolutely” needs to be studied more, Mayfield said last week while on a cigarette break in New York with some co-workers.

“Cigarettes aren't safe” but at least it can take them decades to destroy your health, she said.

The surgeon general's office said in a statement that the 1964 report “catalyzed a 60-year movement to address the harmful effects of smoking" and suggested similar action was needed to address youth vaping.

Murthy's website, however, currently lists neither vaping nor smoking as a priority issue.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Thursday, September 09, 2021

THE WAR ON VAPING
FDA delays decision on e-cigarettes from vaping giant Juul

Thu., September 9, 2021,


WASHINGTON (AP) — Federal health officials on Thursday delayed a high-stakes decision on whether to permit bestselling vaping brand Juul to stay on the market, while banning the sale of thousands of other electronic cigarettes.

The Food and Drug Administration said it rejected applications for nearly 950,000 e-cigarettes and related products, mainly due to their potential appeal to underage teens. Some of the products are currently being sold while many others were only proposed by manufacturers. But the agency didn't rule on Juul, the most popular brand with adult smokers and many teens.

Parents, politicians and anti-tobacco advocates have pressured the FDA for years to ban Juul's high-nicotine devices, which many blame for the recent spike in underage vaping. But the agency said it would need more time to rule on that company's products.

“There’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes,” the agency said in a statement. The agency noted 80% of teens and children who vape use flavored products.

Thursday’s action is part of a sweeping review by the FDA to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays. The agency has yet to authorize any vaping product as a less harmful option for smokers.

The FDA faced a court deadline Thursday to issue decisions on marketing applications from Juul and hundreds of other companies. The date was set by a federal judge after anti-tobacco groups successfully sued the FDA to speed up its review.

To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use the products are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.

FDA regulators previously said they would prioritize Juul and a handful of other key players, but none were included in the agency's announcement.

The delay was immediately panned by anti-vaping groups.

“This is an outrageous move by FDA,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “Millions of families whose kids’ lives have been upended by the youth vaping epidemic created by Juul have waited long enough for action.”

The FDA didn't indicate when it might rule on Juul and other major manufacturers. Matthew Myers, president of the Campaign for Tobacco-Free Kids, said his group will go back to court if the FDA doesn’t clarify its timeline for the remaining decisions.

E-cigarettes first appeared in the U.S. more than a decade ago with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution into a vapor that’s inhaled.

But there has been little rigorous study of whether the e-cigarettes truly help smokers quit. And efforts by the FDA to begin vetting vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.

Today, the vaping market includes hundreds of companies selling an array of devices and nicotine solutions in various flavors and strengths. But the vast majority of the market is controlled by a few companies including Juul Labs Inc. — which is partially owned by tobacco giant Altria — and Vuse, part of cigarette maker R.J. Reynolds.

Juul accounts for nearly half of the $4 billion U.S. market but sales have fallen sharply from when the company controlled more than 75%. In 2019, the company was pressured into halting all advertising and pulling all of its flavors except for menthol and tobacco.

The FDA received applications for more than 6 million vaping products. The agency said Thursday it has taken action on 93% of those applications, including for 4.5 million products that were immediately rejected because they were missing key information.

It 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. Also awaiting review: larger vaping devices with refillable tanks that are mainly popular with adults and sell at specialty vape shops.

The vaping issue took on new urgency in 2018 when Juul’s high-nicotine, fruity-flavored cartridges became a nationwide craze among middle and high school students, leading the FDA to declare an “epidemic” of underage vaping. Last year, the FDA limited flavors in those small vaping devices to just tobacco and menthol, and teen vaping dropped. But the question of whether e-cigarettes should be sold at all remained.

Most experts agree the chemicals contained in e-cigarette vapor are less harmful than tobacco smoke, which contains thousands of cancer-causing chemicals.

“E-cigs and other reduced harm products present a fantastic opportunity to replace cigarettes with far less dangerous products,” said Jonathan Foulds, an addiction and public health specialist at Penn State University. “But I’m concerned this may be the start of an overly aggressive regulation for e-cigarettes — especially compared to how we treat regular cigarettes.”


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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Matthew Perrone, The Associated Press