Tag Archives: E-cigarettes

No Shortage of Controversies for New FDA Commissioner

Thomas M. Burton, The Wall Street Journal: January 29, 2020


New Food and Drug Administration commissioner Stephen M. Hahn rises at 4 a.m. each day for an hour of intensive strength and stamina training. On stressful days, he fits a second workout in during the late afternoon.

Dr. Hahn, 60, takes over an FDA under fire for failing to adequately respond to the health threat from growing use of e-cigarettes and vaping products. This spring, he and the agency will face applications from e-cigarette companies and have to decide what e-cigarette products can qualify to stay on the market.

[…]

Dr. Hahn also faces thorny decisions on stem-cell research and use of cannabidiol, or CBD, that will likely put him in the hot seat between rival advocacy groups.

The man taking on these challenges comes to the FDA with a sterling reputation in medicine and management, but with no previous government experience, unlike his predecessor Scott Gottlieb. That has some concerned about his ability to tackle the issues ahead.

“Always we have concerns when someone comes in who doesn’t know the FDA, which is a complex organization,” said Diana Zuckerman, president of the public-interest research group National Center for Health Research in Washington.  “I never think it’s a good idea.”

What’s more, Dr. Hahn may not have long to make his mark if Mr. Trump fails to win re-election Nov. 3. “It’s a hard thing to come in with so little time [in the president’s term] and so little government experience,” said a former FDA commissioner, Robert Califf, who served under President Obama. “It’s so difficult to change policy with so little time.”

Dr. Hahn didn’t immediately comment for this article.

[…]

Read the original story here.

Schools Seek Ways to Curb Vaping Among Students

Tawnell D. Hobbs, The Wall Street Journal: January 6, 2020


[…]

An estimated 5.4 million middle- and high-school students in the U.S. recently used e-cigarettes, a vaping device, according to a federal survey released in December. That is 20% of all students, far more than the 4.3% that used cigarettes.

The Centers for Disease Control and Prevention reported 2,561 cases of hospitalizations for lung injury involving e-cigarettes, and 55 deaths, as of Dec. 27. The majority of cases are linked to products containing THC, the psychoactive ingredient in marijuana.

School administrators say vaping is more challenging to tackle on campus than regular cigarettes. Vape devices are typically battery-powered and made to look like everyday items, such as pens, lipstick cases and USB drives.

They come in child-friendly flavors, from bubble gum to strawberry cheesecake, and have pleasant smells. Students can take quick whiffs undetected while sitting in class or walking down a hallway, with exhaled vapor dissolving quickly into the air or held in to be absorbed, unlike lingering smoke from lit cigarettes.

School resource officers in Chico, Calif., use 18-years-olds, under the nicotine purchasing age of 21, as decoys to bust businesses selling tobacco products used for vaping; officials said eight clerks have been cited. The officers also allow students to trade vape devices for coupons for pizza and smoothies, with no questions asked. In four weeks, about 50 vapes were turned in, said Sgt. Greg Rogers.

“We’re just trying something different,” Sgt. Rogers said. “We wanted it to not be punitive.”

Jupiter Community High School in Palm Beach County, Fla., in October banned students from using the restroom during class periods unless for emergencies and with an administrative escort. The rule has since been lifted.

“Parents were frustrated with the fact that their children weren’t just allowed to go to the restroom,” said June Eassa, a Palm Beach school assistant superintendent.

Plainwell Community Schools in Michigan is starting random nicotine testing of high-school students in extracurricular activities in January. Students testing positive are restricted in participating in their activity.

[…]

Juul Labs said that it has suspended broadcast, print and digital product advertising in the U.S. “We are focused on resetting the vapor category in the U.S. and earning the trust of society by working cooperatively with regulators, public health officials, and other stakeholders to combat underage use,” the company said.

According to Juul’s website, “one 5% strength JUUL pod is designed to replace one pack of cigarettes in nicotine strength,” and saves money.

Researchers are concerned that there doesn’t seem to be a standard of what should be a normal vape dose, leaving students to grossly overuse the product.

“There’s a certain understanding that you don’t smoke more than a pack a day,” said Diana Zuckerman, president of the National Center for Health Research. “With vaping, because it’s new and because all these products vary, there aren’t the sorts of standards that help people restrict what they’re doing.”

[…]

Read the original story here

Is Vaping Safer than Smoking Cigarettes?

Laura Gottschalk, PhD, John-Anthony Fraga, Jared Hirschfield, Diana Zuckerman, PhD, National Center for Health Research


Electronic cigarettes, or e-cigarettes, are being marketed as the “safe” new alternative to conventional cigarettes. By February 2020, reports of 68 deaths and more than 2,800 vaping-related hospitalizations due to lung illnesses have made it clear that vaping can be even more dangerous than smoking.1,2

The CDC has reported that Vitamin E acetate is a potential cause for the outbreak, but it might not be the only one.2 Many of the patients report vaping marijuana products or marijuana and nicotine products, but others only vaped nicotine products. Until these reports of hospitalized teens and adults are scrutinized in greater depth, we won’t know what types of vaping are most dangerous and under what circumstances.

E-cigarettes come in a variety of forms and include vape mods, Juuls, and vape pens. There are brand name products (Juul is the most widely used) and “home-made” versions.  Some contain high levels of nicotine, while others contain marijuana or just contain flavoring.  The focus of this article is on e-cigarettes because most of the research that exists has been done on them, but much of the information below is relevant to these other products as well.

The big questions are: Are they safe?  Will they reverse the decline in smoking—giving new life to an old habit—or can they help people quit smoking?  Here is what you need to know.

What are E-cigarettes?

E-cigarettes are battery-operated devices that were initially shaped like cigarettes, but now include vape mods, Juuls, and vape pens. Some look like flash drives or highlighter pens, making it easy for teens to hide them in plain sight.  The brand-name products contain nicotine, an addictive drug that is naturally found in tobacco and that stimulates, causes stress during withdrawal, and then feels relaxing as continued exposure follows withdrawal. It is the nicotine in cigarettes that makes smoking so addictive, and the same is true for most vaping and juuling. These electronic products allow nicotine to be inhaled, and they work by heating a liquid cartridge containing nicotine, flavors, and other chemicals into a vapor. Because e-cigarettes heat a liquid instead of tobacco, what is released is considered smokeless.3

Is Vaping Safer than Smoking Traditional Cigarettes?

The key difference between traditional cigarettes and e-cigarettes and related products is that the latter don’t contain tobacco. But, it isn’t just the tobacco in cigarettes that causes cancer and other serious diseases. Traditional cigarettes contain a laundry list of chemicals that are proven harmful, and e-cigarettes have some of these same chemicals.

While smoking can cause lung cancer, breast cancer, emphysema, heart disease, and other serious diseases, those diseases usually develop after decades of smoking. In contrast, in 2019 it became clear that vaping could cause seizures and serious lung damage after just a year, possibly less, based on CDC reports of patients hospitalized for lung damage caused by vaping.2,3 While there have been warnings about the possible risk of e-cigarettes for a decade, it was not expected that they could cause such severe damage in such a short period of time.

The COVID-19 pandemic has raised even more concerns about the safety of vaping. Youths aged 13-24 years old who have used e-cigarettes are more likely to be diagnosed with COVID-19, be tested for the virus, and to experience Covid-19 symptoms.4

Since 2009, FDA has pointed out that e-cigarettes contain “detectable levels of known carcinogens and toxic chemicals to which users could be exposed.” For example, in e-cigarette cartridges marketed as “tobacco-free,” the FDA detected a toxic compound found in antifreeze, tobacco-specific compounds that have been shown to cause cancer in humans, and other toxic tobacco-specific impurities.5 Another study looked at 42 of these liquid cartridges and determined that they contained formaldehyde, a chemical known to cause cancer in humans.6 Formaldehyde was found in several of the cartridges at levels much higher than the maximum EPA recommends for humans. In 2017, a study published in the Public Library of Science Journal showed that significant levels of benzene, a well-known carcinogen, were found in the vapor produced by several popular brands of e-cigarettes.7

The body’s reaction to many of the chemicals in traditional cigarette smoke causes long-lasting inflammation, which in turn leads to chronic diseases like bronchitis, emphysema, and heart disease.8 Since e-cigarettes also contain many of the same toxic chemicals, there is no reason to believe that they will significantly reduce the risks for these diseases.

In fact, a preliminary study presented at the 2018 annual meeting of the American Chemical Society found that vaping could damage DNA.9 The study examined the saliva of 5 adults before and after a 15-minute vaping session. The saliva had an increase in potentially dangerous chemicals, such as formaldehyde and acrolein. Acrolein has been proven to be associated with DNA damage, for example, and DNA damage can eventually cause cancer.10

A study of mice funded by the National Institutes of Health found that e-cigarette smoke could cause mutations in DNA that could increase the risk of cancer. These specific mutations have been shown to potentially contribute to the development of lung and bladder cancer in mice exposed to electronic cigarette smoke. The researchers claim that these chemicals could also induce mutations leading to cancer in humans. It has not been reported how many of those harmed had used juul devices. While many of those harmed had vaped marijuana, many also used nicotine e-cigarettes,11 so the risks of “juuling” need to be carefully and immediately studied.

Because they are smokeless, many incorrectly assume that e-cigarettes are safer for non-smokers and the environment than traditional cigarettes. However, a study published in the International Journal of Hygiene and Environmental Health found that the use of e-cigarettes results in increased concentrations of volatile organic compounds (VOCs) and airborne particles, both of which are potentially harmful when inhaled.12 Although e-cigarette vapor may not result in the obvious smell and visible smoke of traditional cigarettes, it still has a negative impact on air quality, especially when vaping indoors.

There are no long-term studies to back up claims that the vapor from e-cigarettes is less harmful than conventional smoke. Cancer takes years to develop, and e-cigarettes were only very recently introduced to the United States. It is almost impossible to determine if a product increases a person’s risk of cancer or not until the product has been around for at least 15-20 years. Despite positive reviews from e-cigarette users who enjoy being able to smoke them where regular cigarettes are prohibited, very little is known about their safety and long-term health effects.

There is also danger from e-cigarettes exploding in the user’s mouth or face.  Last year, the British Medical Journal used data from several agencies to estimate that there were roughly 2,035 e-cigarette explosions and burn injuries in the U.S. just in a three-year period from 2015 to 2017. One of the authors of the study stated that the number was likely higher as such incidents were not well tracked. The report also said that e-cigarettes, commonly powered by a lithium-ion battery, could overheat to the point of catching fire or exploding, a phenomenon known as “thermal runway.”13

Can Vaping Help to Cut Down or Quit Smoking Regular Cigarettes?

If a company makes a claim that its product can be used to treat a disease or addiction, like nicotine addiction, it must provide studies to the FDA showing that its product is safe and effective for that use. On the basis of those studies, the FDA approves or doesn’t approve the product. So far, there are no large, high-quality studies looking at whether e-cigarettes can be used to cut down or quit smoking long-term. Most of the studies have been either very short term (6 months or less) or the participants were not randomly assigned to different methods to quit smoking, including e-cigarettes. Many of the studies are based on self-reported use of e-cigarettes. For example, a study done in four countries found that e-cigarette users were no more likely to quit than regular smokers even though 85% of them said they were using them to quit.14 Other year-long studies, conducted in the U.S., had similar findings.  A study published in a prestigious medical journal in 2014 found that although smokers may believe they are vaping e-cigarettes to help them quit,  6-12 months after being first interviewed, nearly all of them are still smoking regular cigarettes.15 Similarly, a year-long study published in 2018 compared smokers who used e-cigarettes to traditional cigarette smokers, and concluded that e-cigarette users were more likely to say they were trying to quit but no more likely to successfully kick the smoking habit, with 90% of e-cigarette users still smoking regular cigarettes at the end of the study.  Until there are results from well-conducted studies, the FDA has not approved e-cigarettes for use in quitting smoking.16

Teenagers, Children, and Vaping

According to survey data collected between 2014 and 2017, 9% of middle and high schoolers reported that they were current vaping users. Vaping was most common among Native Hawaiian and Pacific Islanders (18%), as well as American Indian and Alaskan Native teens (13%). About 10% of White and Hispanic teens vaped, and vaping was least common among Black (5%) and Asian teens (4%).17 The percentage of teens who reported vaping doubled between 2017 and 2019.18 In 2019, about 28% of highschoolers and 11% of middle schoolers reported e-cigarette use. Most teens who vaped reported that they used flavored products.19 Two 2020 surveys found that the percentage of students vaping decreased early in the year. A CDC study analyzing data from the National Youth Tobacco Survey, a study of over 14,000 students, found that about 20% of 9th-12th grade students and 5% of 6th-8th grade students reported that they used e-cigarettes in the last 30 days.20 A different survey conducted by researchers from the University of Michigan, funded by the National Institute on Drug Abuse, studied over 8,000 students in only the 10th and 12th grades, and found that 22% reported vaping in the last 30 days.21 Although these numbers are still high, and comparable to the statistics in 2018,17 they are notably lower than 2019. E-cigarette use may have dropped due to growing awareness of the dangers of these products, including media coverage of young men hospitalized with serious lung damage.21,22 The drop may also be due to raising the legal age for the purchase of tobacco products and the ban on flavored products.21,23

It is important to note that these surveys conducted about e-cigarette use in 2020 were collected between January and March of 2020, and the surveys were stopped due to the COVID-19 pandemic.  

An online survey conducted in May 2020 measured how e-cigarette use changed during the pandemic, during a time where many people are staying at home.24 The survey included almost 1,500 participants under 21 (the legal age to purchase tobacco products) who reported e-cigarette use. Over half of the underage e-cigarette users who responded to the survey reported that they had changed their e-cigarette use during the pandemic. About 20% of the sample had quit using e-cigarettes altogether, about 17% reduced their use slightly or by half, and another 9% actually increased their nicotine use. 

The researchers followed up by asking those participants who reduced their e-cigarette use for the reasons why they lowered it. About 14% reported that the primary reason for reducing was because they were at home and their parents would know, 18% said the primary reason was because they can no longer get the tobacco products, 23% said it was because they know e-cigarette use harms the lungs, and another 37% said that their reasons were a combination of those 3 reasons. Of those who increased their use during the pandemic, about 25% reported that it was due to boredom, 15% because they were stressed, 7% because they needed a distraction, and about 50% said that their reasons were a combination of those 3 reasons. 

Future research is needed to measure whether e-cigarette use has changed even more as the pandemic has continued, as well as to measure the overall percent of youth still using e-cigarettes. 

E-cigarette and juul use by young people is worrisome for several reasons:

  1.     The younger people are when they begin smoking, the more likely it is they will develop the habit: nearly 9 out of 10 smokers started before they were 18.25
  2.     Nicotine and other chemicals found in e-cigarettes, juuls, etc. might harm brain development in younger people.26
  3.     Vaping may introduce many more young people to smoking who might otherwise never have tried it, and once they are addicted to nicotine, some may decide to get their “fix” from regular cigarettes. Whether vaping or juuling is a “gateway” to regular cigarettes or not, young people who use them risk becoming addicted to nicotine and exposing their lungs to harmful chemicals.
  4.   While smoking can cause permanent lung damage over the years, vaping can cause inflammation resulting in hospitalization and permanent damage after just a few weeks or months.27,28

The sharp rise in vaping among youth highlights the need to stop manufacturers from targeting teenagers with candy-like flavors and advertising campaigns. Although the FDA banned flavors for reusable vape devices, flavored disposable e-cigarettes are still being sold.20 However, in July 2020, FDA issued warnings to 10 companies selling flavored disposable e-cigarettes, notifying them to remove their products from the market because they do not have the authorizations required to sell them.29 

Even children who are too young to smoke have been harmed by e-cigarettes and related products. The liquid is highly concentrated, so absorbing it through the skin or swallowing it is far more likely to require an emergency room visit than eating or swallowing regular cigarettes. In 2012, less than 50 kids under the age of six were reported to poison control hotlines per month because of e-cigarettes. In 2015, that number had skyrocketed to about 200 children a month, almost half of which were under the age of two!30

Many e-cigarettes look like USB devices, and some are made to look like other products, in order to disguise their use. The Director of Communications at the FDA’s Center for Tobacco Products has written this guide to help parents identify these hidden e-cigarettes. The FDA has also helped create this pamphlet for parents and teens to discuss the risks of vaping, and it provides resources for saying “no” and for quitting.

For more information about juuls, check out our article here.

How are these products regulated?

The FDA was given the power to regulate the manufacturing, labeling, distribution and marketing of all tobacco products in 2009 when President Obama signed into law the Family Smoking Prevention and Tobacco Control Act and in 2010 a court ruled that the FDA could regulate e-cigarettes as tobacco products.31

E-Cigarette Ad

It wasn’t until 2016 that the FDA finalized a rule to regulate e-cigarettes, which would ban the sale of e-cigarettes to anyone under the age of 18 and would require all e-cigarettes that hit shelves after February 15, 2007 to go through a “premarket review,” the process that the FDA uses to determine whether potentially risky products are safe.25 Companies were to be given from 18 months to two years to comply with this rule and prepare their applications. However, in 2017, the Trump administration appointed a new FDA Commissioner, Dr. Scott Gottlieb, who defended the safety of e-cigarettes and delayed implementing the rules until 2022.9 Nevertheless, as the epidemic of e-cigarette use among youth became obvious, in 2018, Commissioner Gottlieb threatened to crack down on the advertising of e-cigarettes to children under 18.32 Critics have questioned whether sales and ads can be effectively restricted. Moreover, Commissioner Gottlieb resigned in 2019, and it is unclear how the agency will respond to the growing evidence that vaping can cause serious harm. However, in 2019, a federal court ruled that the FDA must implement regulations in May 2020 instead of waiting until 2022.

In September, President Trump responded to the health crisis by proposing a ban on flavored e-cigarettes. Two months later, the administration has not taken any action as Trump states that he is worried children will seek out unsafe alternatives if flavors are banned. In the meantime, individual states have always had the power to pass laws restricting the sale and use of e-cigarettes. Current laws pertaining to e-cigarettes are available on the Public Health Law Center website.

The Bottom Line

E-cigarettes, juuls, and other similar products have not been around long enough to determine the harm they cause in the long run. Unfortunately, many people, including teenagers, are under the impression that e-cigarettes are safe or that they are effective in helping people quit smoking regular cigarettes. Studies by the FDA show that e-cigarettes contain some of the same toxic chemicals as regular cigarettes, even though they don’t have tobacco. There is evidence that some of these toxic chemicals can cause DNA damage that can cause cancer. More important, the reports of teens and adults who died or were hospitalized due to vaping are proof that vaping can be extremely dangerous even after just a few weeks, months, or years.

The big three tobacco companies—Lorillard, Reynolds American, and Altria Group—all have their own e-cigarette brands, so it’s not surprising that e-cigarettes are being marketed and advertised much the way regular cigarettes used to be. Here are the 7 Ways E-Cigarette Companies Are Copying Big Tobacco’s Playbook.

Although there are clearly serious dangers from vaping, more research is needed to confirm the impact of vaping on DNA damage, especially in children. Meanwhile, claims that e-cigarettes are an effective strategy to quit smoking are not supported by the evidence thus far. In addition, more toxicological studies and epidemiological studies are needed to understand the hundreds of reports of permanent lung damage and deaths from vaping.  It is essential to find out whether some types of vaping are more dangerous than others in the short-term and the long-term.  To understand the risks for everyone who vapes, research is needed to compare the risks of specific brands of e-cigarettes with tobacco products, as well as to neither smoking nor vaping.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

The National Center for Health Research is a nonprofit, nonpartisan research, education and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.

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  29. U.S. Food and Drug Administration. FDA Notifies Companies, Including Puff Bar, to Remove Flavored Disposable E-Cigarettes and Youth-Appealing E-Liquids from Market for Not Having Required Authorization. Updated July 2020. https://www.fda.gov/news-events/press-announcements/fda-notifies-companies-including-puff-bar-remove-flavored-disposable-e-cigarettes-and-youth 
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  31. Food and Drug Administration. Regulation of E-Cigarettes and Other Tobacco Products. FDA News & Events. April 25, 2011.
  32. Saltzman J, Freyer F. The FDA issues a warning: Teen vaping is ‘an epidemic.’ Boston Globe. September 13 2018. https://www.bostonglobe.com/metro/2018/09/12/fda-cracks-down-vaping-orders-makers-address-sales-minors/JaiqQYzZAl4CINLufnkKlL/story.html