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Trump Backs Off Flavored E-Cigarette Ban

Nov. 18, 2019 — U.S. President Donald Trump’s pledge in September to ban the sale of most flavored e-cigarettes to stem the rise in vaping among young people appears to be weakening.

Two months after he made the promise, Trump has yielded to pressure from lobbyists and political advisers and not taken any action on vaping, saying only that he wants to study the issue, The New York Times reported.

The proposed ban on flavored vaping products had wide support from health officials and others as an outbreak of severe vaping-related lung injuries has added to concerns about the teen vaping crisis.

On Nov. 11, Trump tweeted that he would be “meeting with representatives of the vaping industry, together with medical professionals and individual state representatives, to come up with an acceptable solution to the vaping and E-cigarette dilemma.”

However, one senior White House official said no such meeting had been scheduled, The Times reported.

In the absence of federal government action on vaping, several states have moved to ban flavored vaping products. That’s led to legal challenges from the industry and lobbying of lawmakers and the White House to prevent new rules that would affect adults’ use of e-cigarettes, The Times reported.

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NYC Sues Flavored Online E-Cigarette Sellers

Oct. 10, 2019 — Twenty-two online sellers of flavored e-cigarettes are being sued by New York City for allegedly targeting young people through social media.

The defendants created “a public nuisance” by selling e-cigarettes to people under 21 even though such sales have been illegal in the city since 2013, according to the lawsuit filed Tuesday, CNN reported.

“Preying on minors and hooking them on a potentially lethal, lifelong nicotine addiction is unconscionable,” Mayor Bill de Blasio said in a statement. “This lawsuit sends a message: we will do whatever it takes to protect our kids and the health of our city.”

Nationwide, state and local governments have taken action to limit children’s access to e-cigarettes, CNN reported.

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Bill Would Limit Nicotine in E-Cigarette Products

Oct. 8, 2019 — A bill to limit the amount of nicotine in e-cigarette products was introduced Monday by U.S. Rep. Raja Krishnamoorthi in a bid “to make them significantly less addictive and appealing to youth.”

The bill would restrict nicotine content to a maximum of 20 milligrams per milliliter, which matches regulations in the European Union, and would give the Food and Drug Administration the authority to reduce the cap if necessary, CNN reported.

Currently, there is no national limit in the U.S., and some brands have nicotine levels several times higher than 20 milligrams per milliliter.

Experts say high nicotine concentrations have contributed to what they say is a vaping epidemic among U.S. youth, CNN reported.

“Capping the concentration of nicotine in e-cigarettes is integral to ending the youth vaping epidemic by making these products less addictive, less appealing to youth, and less harmful to public health,” Krishnamoorthi said in a statement.

He’s leading a congressional investigation into youth vaping.

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Another Vaping Danger: E-Cigarette Explodes in Teen’s Face

By Dennis Thompson

HealthDay Reporter

THURSDAY, June 20, 2019 (HealthDay News) — A vape pen exploded in the face of 17-year-old Nevada boy, breaking his jaw and requiring multiple surgeries to repair the damage, according to a case report in the latest New England Journal of Medicine.

The 2018 incident highlights a little-known danger of e-cigarettes — the devices can unexpectedly blow up, causing burns and severe facial damage.

“He was [using] this vape pen, and it blew up in his face while he was [using] it,” said one of the doctors who treated him, Dr. Katie Russell, a pediatric surgeon at the University of Utah in Salt Lake City.

The e-cigarette blast was strong enough to break bones and blow out teeth.

“He broke his lower jaw, which takes a large amount of force,” Russell said. Doctors had to insert a two-inch plate on his lower jaw to stabilize the fracture.

“His jaw was wired shut for about six weeks,” she said. “He could only eat soft food for six weeks, until it healed, and then he had to come back and have another operation to get those wires removed.”

Although the boy has fully recovered from his injuries, he still has three or four teeth missing, because he’s lacked the insurance coverage to afford to have them replaced, Russell said.

“He’s still missing all those teeth, but he’s hoping to get them fixed this summer,” she added.

Between 2009 and 2016, there were 195 documented incidents of explosion and fire involving electronic cigarettes, according to the U.S. Fire Administration (USFA).

The incidents resulted in 133 injuries — 38 severe enough to warrant hospitalization, the USFA says.

In October 2016, doctors at the University of Washington Medical Center in Seattle reported treating 15 patients with injuries from e-cigarette explosions over a nine-month span, according to a letter they published in the New England Journal of Medicine.

Injuries included flame burns, chemical burns and blast injuries to the face, hands, thighs or groin, the Seattle doctors said.

Dr. Hamad Husainy, a staff physician with Helen Keller Hospital in Florence, Ala., said, “It’s not so rare that we’re considering this a freak event that happens. This is a potential problem, and as these things become more and more popular, it’s probably going to become more prevalent.”

Continued

Husainy said his hospital saw two such cases in one week a couple of years ago, with e-cigarette explosions causing burns and breaking facial bones.

No one is exactly sure what causes e-cigarette explosions, according to the U.S. Food and Drug Administration.

“I can’t tell you why it exploded,” Russell said of the teen she treated. “He said he was just [using] it like regular and it just exploded.”

Some evidence suggests that the lithium-ion batteries that power the devices might be at fault, the FDA noted.

To help prevent e-cigarette explosions, the FDA recommends that users:

  • Buy vape devices with safety features such as vent holes and protection against overcharging.
  • Replace e-cig batteries if they get damaged or wet.
  • Keep loose batteries in a case to prevent contact with coins, keys or other metal objects in your pocket.
  • Always charge a vape device with the charger that came with it, never on one meant for phones or tablets.
  • Don’t charge a vape device overnight, or leave it charging unattended.

According to Gregory Conley, president of the American Vaping Association, “The vast majority of vaping devices on the market carry the same fire risk as other products that use lithium-ion batteries, such as cellphones and laptops.”

Conley said, “Adults looking to use these products to quit smoking should not be discouraged by rare events like this, especially since most or all of the incidents linked to the injuries present here involve advanced ‘mechanical mod’ devices that likely represent less than 1 percent of American vaping product sales today.”

Mechanical mod devices contain no safety features such as an automatic shutoff, Conley said. If a battery in a mechanical mod overdischarges and the device lacks enough air holes to allow it to vent, there is a risk of explosion, he explained.

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Sources

SOURCES: Katie Russell, M.D., pediatric surgeon, University of Utah, Salt Lake City; Hamad Husainy, D.O., staff physician, Helen Keller Hospital, Florence, Ala.;  June 20, 2019,New England Journal of Medicine

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Pagination

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Another Vaping Danger: E-Cigarette Explodes in Teen’s Face

THURSDAY, June 20, 2019 — A vape pen exploded in the face of 17-year-old Nevada boy, breaking his jaw and requiring multiple surgeries to repair the damage, according to a case report in the latest New England Journal of Medicine.

The 2018 incident highlights a little-known danger of e-cigarettes — the devices can unexpectedly blow up, causing burns and severe facial damage.

“He was [using] this vape pen, and it blew up in his face while he was [using] it,” said one of the doctors who treated him, Dr. Katie Russell, a pediatric surgeon at the University of Utah in Salt Lake City.

The e-cigarette blast was strong enough to break bones and blow out teeth.

“He broke his lower jaw, which takes a large amount of force,” Russell said. Doctors had to insert a two-inch plate on his lower jaw to stabilize the fracture.

“His jaw was wired shut for about six weeks,” she said. “He could only eat soft food for six weeks, until it healed, and then he had to come back and have another operation to get those wires removed.”

Although the boy has fully recovered from his injuries, he still has three or four teeth missing, because he’s lacked the insurance coverage to afford to have them replaced, Russell said.

“He’s still missing all those teeth, but he’s hoping to get them fixed this summer,” she added.

Between 2009 and 2016, there were 195 documented incidents of explosion and fire involving electronic cigarettes, according to the U.S. Fire Administration (USFA).

The incidents resulted in 133 injuries — 38 severe enough to warrant hospitalization, the USFA says.

In October 2016, doctors at the University of Washington Medical Center in Seattle reported treating 15 patients with injuries from e-cigarette explosions over a nine-month span, according to a letter they published in the New England Journal of Medicine.

Injuries included flame burns, chemical burns and blast injuries to the face, hands, thighs or groin, the Seattle doctors said.

Dr. Hamad Husainy, a staff physician with Helen Keller Hospital in Florence, Ala., said, “It’s not so rare that we’re considering this a freak event that happens. This is a potential problem, and as these things become more and more popular, it’s probably going to become more prevalent.”

Husainy said his hospital saw two such cases in one week a couple of years ago, with e-cigarette explosions causing burns and breaking facial bones.

No one is exactly sure what causes e-cigarette explosions, according to the U.S. Food and Drug Administration.

“I can’t tell you why it exploded,” Russell said of the teen she treated. “He said he was just [using] it like regular and it just exploded.”

Some evidence suggests that the lithium-ion batteries that power the devices might be at fault, the FDA noted.

To help prevent e-cigarette explosions, the FDA recommends that users:

  • Buy vape devices with safety features such as vent holes and protection against overcharging.
  • Replace e-cig batteries if they get damaged or wet.
  • Keep loose batteries in a case to prevent contact with coins, keys or other metal objects in your pocket.
  • Always charge a vape device with the charger that came with it, never on one meant for phones or tablets.
  • Don’t charge a vape device overnight, or leave it charging unattended.

According to Gregory Conley, president of the American Vaping Association, “The vast majority of vaping devices on the market carry the same fire risk as other products that use lithium-ion batteries, such as cellphones and laptops.”

Conley said, “Adults looking to use these products to quit smoking should not be discouraged by rare events like this, especially since most or all of the incidents linked to the injuries present here involve advanced ‘mechanical mod’ devices that likely represent less than 1 percent of American vaping product sales today.”

Mechanical mod devices contain no safety features such as an automatic shutoff, Conley said. If a battery in a mechanical mod overdischarges and the device lacks enough air holes to allow it to vent, there is a risk of explosion, he explained.

More information

The U.S. Food and Drug Administration has more about e-cigarette safety.

© 2019 HealthDay. All rights reserved.

Posted: June 2019

Drugs.com – Daily MedNews

FDA Gets Tough on Juul, Other E-Cigarette Makers

By Steven Reinberg

HealthDay Reporter

WEDNESDAY, Sept. 12, 2018 (HealthDay News) — Calling the use of electronic cigarettes a burgeoning epidemic among teens, the U.S Food and Drug Administration on Wednesday announced a crackdown on the sale of Juuls and other flavored e-cigarette devices to minors.

More than 1,200 warning letters and fines have been sent to retailers and five major e-cigarette manufacturers who illegally sold Juul devices, which look like computer flash drives, and other e-cigarette products to minors. The companies have 60 days to come up with plans to stop those sales or the FDA may consider a ban on the sale of all flavored e-cigarette products, the agency said.

“The disturbing and accelerating trajectory we’re seeing in youth and the resulting path to addiction must end,” FDA commissioner Dr. Scott Gottlieb said at a morning media briefing. “We’re seriously considering a policy change that would lead to the removal of these flavored products from the market.”

Manufacturers of the five top-selling national e-cigarette brands have received FDA warning letters, he said. All of these brands — JUUL, Vuse, MarkTen, blu e-cigs, and Logic — made up the majority of products sold illegally to minors, the agency said. The retailers targeted by the FDA include 7-Eleven stores, Circle K convenience shops and Shell gas stations.

In addition, the agency’s plan includes a series of actions to stop youth use of tobacco products, especially e-cigarettes. More than 2 million middle and high school students were regular users of e-cigarettes last year, according to the FDA.

“Our youth tobacco prevention plan focuses on three key strategies,” Gottlieb said. “First, preventing youth access to tobacco products. Second, curbing the marketing of tobacco products aimed at youth. And finally, educating teens about the dangers of using any tobacco-related products.”

Although Gottlieb believes that e-cigarettes can help some adults quit smoking traditional cigarettes, he is concerned that e-cigarettes pose health risks, including the possibility of releasing nicotine at higher levels than conventional cigarettes, and may lead to nicotine addiction in teens.

Nicotine is not a benign chemical, Gottlieb said. The developing adolescent brain is particularly vulnerable to nicotine addiction, he noted.

Continued

“The FDA will not tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products,” he said.

Gottlieb said that e-cigarette manufacturers have been given ample time to change their ways.

“I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem these youth trends,” he said.

“In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate and the existential threat to these products, and as they did, these risks have mounted,” Gottlieb said.

And some of the retailers that received warning letters are still advertising and selling these products, he said.

One manufacturer in the FDA’s crosshairs, Juul Labs, said in a statement, “JUUL Labs will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”

Fontem Ventures, makers of blu, issued a similar statement. “We fully support and advocate for both legislation prohibiting sales of vaping products to minors and the ongoing FDA enforcement action against retailers selling e-vapor and other tobacco products to minors,” the company said.

But the FDA said it is also investigating whether e-cigarette manufacturers have introduced new products after Aug. 8, 2016, without premarket authorization.

The agency said it continues to check retail stores that sell tobacco, to ensure they are in compliance with federal laws.

The steps announced Wednesday are just the initial elements of these new efforts, Gottlieb said.

Manufacturers say they’ve changed from the days of Joe Camel, he said.

“But look at what’s happening right now. On our watch, and on their watch. They must demonstrate that they’re truly committed to keeping these new products out of the hands of kids, and they must find a way to reverse this trend,” Gottlieb said.

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1 in 4 Teen E-Cigarette Users Has Tried ‘Dripping’

This method creates denser clouds of vapor, with unknown effects on health, researchers say

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By Dennis Thompson

HealthDay Reporter

MONDAY, Feb. 6, 2017 (HealthDay News) — One-quarter of U.S. teen e-cigarette users have experimented with “dripping” — a new vaping method that produces thicker clouds of vapor, researchers report.

Regular electronic cigarettes produce inhalable vapor by gradually drawing liquid into a heating coil through an automatic wick, explained lead researcher Suchitra Krishnan-Sarin.

“Dripping” involves placing drops of e-liquid directly onto the exposed heating coil of an e-cigarette or atomizer, and then immediately inhaling the cloud of vapor produced, said Krishnan-Sarin, a professor of psychiatry at Yale University School of Medicine in New Haven, Conn.

“They say it makes the flavors taste better and gives you a stronger hit,” Krishnan-Sarin said.

She said she learned about the practice while talking with teenagers, and decided to ask about it in a survey on e-cigarette use among high school students.

The survey revealed that 26 percent of student e-cigarette users at eight Connecticut high schools had tried dripping at least once.

“I didn’t know what to expect,” Krishnan-Sarin said. “We didn’t know what we would find, because we only had anecdotal evidence based on what kids were telling us.”

Experts are concerned that “dripping” could expose users to increased levels of toxins and carcinogens created when the liquid in e-cigarettes is vaporized at high temperatures.

Previous research has shown that “the levels of some chemicals like formaldehyde and other aldehydes, which are known carcinogens, are higher with direct dripping than with conventional e-cigarette use,” Krishnan-Sarin said.

Dr. Karen Wilson, chief of general pediatrics for Mount Sinai Health System in New York City, said the stronger nicotine hit produced by dripping also could do harm to the developing brains of teenage users.

“Adolescents should not be using nicotine at all,” Wilson said. “It changes the brain chemistry, and adolescents are uniquely susceptible to the addictive properties of nicotine.”

Out of 7,045 high school students surveyed, almost 1,100 had used e-cigarettes, the researchers found. One out of four e-cigarette users had tried dripping.

Reasons the students gave for dripping included producing thicker clouds of vapor (64 percent), which suggests these users may engage in smoke tricks or vape competitions, the study authors said.

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E-Cigarette Use May Be Rising Among Teens


E-Cigarette Use May Be Rising Among Teens

Nearly one-third of those surveyed in Hawaii have tried the devices

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By Maureen Salamon

HealthDay Reporter

MONDAY, Dec. 15, 2014 (HealthDay News) — Nearly a third of Hawaiian high school students have tried e-cigarettes, new research suggests.

This finding reflects a growing trend of American teens flocking to the nicotine inhalation devices, according to public health experts.

The overall rate of e-cigarette use in the new study is higher than found in mainland U.S. studies over the past several years. But e-cigarette use is “accelerating very rapidly” across the nation, according to Dr. Norman Edelman, senior consultant for scientific affairs at the American Lung Association.

An e-cigarette is a device that turns nicotine, flavorings and other chemicals into an inhalable vapor. Many e-cigarettes are designed to resemble tobacco cigarettes, according to the U.S. Food and Drug Administration.

The FDA is still reviewing evidence about the safety of e-cigarettes, but the agency has proposed banning sales of the devices to minors. According to the FDA’s website, the devices still haven’t been fully studied and it’s impossible to know their potential risks or even how much nicotine is being inhaled during use.

The new study surveyed more than 1,900 teens in Hawaii. The average age was between 14 and 15 years old. The teens were in ninth and 10th grades, and from both public and private schools, according to the study. The survey assessed e-cigarette and cigarette use, alcohol and marijuana use, and psychosocial risk factors for substance use.

The researchers also found that 12 percent reported using both e-cigarettes and tobacco cigarettes, while 17 percent had used e-cigarettes only and 3 percent used cigarettes only.

Study author Thomas Wills, interim director of the Cancer Prevention and Control Program at University of Hawaii Cancer Center, said his team was surprised by the research results in several ways.

“We had thought that persons who used e-cigarettes would look pretty much like smokers on the psychosocial variables we measured, like sensation seeking, impulsivity and peer smoking,” he said. “It turned out that the students who only used e-cigarettes had a lower risk profile than smokers and dual users — persons who use both cigarettes and e-cigarettes.”

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WHO’s Call for E-Cigarette Ban Criticized

By Peter Russell
WebMD Health News

Reviewed by Sheena Meredith, MD

Sept. 5, 2014 — A report commissioned by the World Health Organization (WHO) into e-cigarettes, which called for them to be banned in public places and workplaces, has been criticized as misleading by a group of U.K. tobacco and addiction specialists.

The WHO report says use of e-cigarettes could increase levels of toxins and nicotine in the air.

But experts writing in the journal Addiction say the evidence behind the WHO report is riddled with errors, misinterpretations, and misrepresentations.

Furthermore, they say, it could persuade policymakers to ignore the potential public health benefits of e-cigarettes.

The WHO did not respond to requests for comment in time for publication.

Health Benefits

Ann McNeill, PhD, the lead author of the article in Addiction, says in a statement: “We were surprised by the negativity of the commissioned review, and found it misleading and not an accurate reflection of available evidence.

“E-cigarettes are new and we certainly don’t yet have all the answers as to their long-term health impact, but what we do know is that they are much safer than cigarettes, which kill over 6 million people a year worldwide,” says McNeill, deputy director of the U.K. Centre for Tobacco & Alcohol Studies.

Saving Lives

Meanwhile, another group of health experts says that encouraging today’s smokers to switch to e-cigarettes could save tens of thousands of lives each year.

Writing in the British Journal of General Practice, Robert West, PhD, director of tobacco studies at University College London, says persuading a million smokers to switch to an e-cigarette could lead to 6,000 lives being saved each year “even in the event that e-cigarette use carries a significant risk of fatal diseases.”

He writes, “Given that smokers smoke primarily for the nicotine but die primarily from the tar, one might imagine that e-cigarettes would be welcomed as a means to prevent much of the death and suffering caused by cigarettes.”

‘Alarmist’

The article by McNeill and colleagues takes 9 key statements in the WHO-commissioned review and provides an alternative conclusion and a commentary. For instance:

  • The review implies that e-cigarette use among young people is a major problem and could be acting as a gateway to smoking. But in the U.K, use of e-cigarettes in nonsmoking youngsters is very low, and there is virtually no regular use in children who have never smoked or used tobacco, they write. (In the U.S., this is not true: E-cigarette use in kids and teens has doubled; a quarter of a million kids who had never smoked tried e-cigarettes last year, according to the CDC.)
  • The review fails to acknowledge that e-cigarettes are not just less harmful than tobacco cigarettes but that the concentrations of toxins are mostly a tiny fraction of what is found in cigarette smoke.
  • The review infers that bystanders can inhale significant levels of toxins from the vapor when the concentrations are too low to present a significant health risk.

The authors criticize those behind the WHO-commissioned report for using alarmist language to describe findings and to present opinion as though it were evidence.

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E-Cigarette Vapor Contains Potentially Harmful Particles: Review

WEDNESDAY May 7, 2014, 2014 — E-cigarettes may not be as harmless as they initially seemed. New research suggests that e-cigarette vapor produces tiny particles that users suck deep into their lungs, potentially causing or worsening respiratory diseases.

The particles are of comparable size to those contained in cigarette smoke, and as many as 40 percent of them reach the deepest part of the lungs when inhaled, said Jonathan Thornburg, lead investigator and a senior research engineer at RTI International, a North Carolina research institute.

That means if the particles turn out to be harmful, they’ll be causing damage throughout the lungs.

“These small particles have a high surface area-to-volume ratio,” Thornburg said. “When they deposit in your lungs, it makes it easy for whatever chemicals are in them to dissolve into your lung tissue.” Those chemicals potentially could cause or worsen respiratory problems such as asthma or bronchitis.

In its review of emissions from two types of e-cigarettes, Thornburg’s team did not find any toxic substances in the vapor produced by the devices.

“Everything we found was what the [U.S. Food and Drug Administration] and others generally regard as safe,” he said, noting that the cancer-causing agents produced by burning tobacco are not present in e-cigarettes.

But another new study raises the possibility that the liquids used to produce e-cigarette vapors could contain carcinogens or harmful ingredients, The New York Times reports.

The study found formaldehyde, a known carcinogen, in overheated vapor produced by high-power e-cigarette devices known as tank systems, the newspaper reported. These systems are larger devices than typical e-cigarettes, and are designed to vaporize liquid nicotine quickly to give users a bigger nicotine kick.

These studies provide even more impetus for the FDA’s recent proposal to begin regulating e-cigarettes as tobacco products, said Dr. Norman Edelman, senior medical advisor for the American Lung Association.

“We certainly don’t believe e-cigarettes are a safe alternative,” Edelman said. “The question is whether it’s a safer alternative, and we believe those results aren’t in yet. This is a tobacco product and should be regulated by the FDA as all tobacco products should.”

Thornburg and his colleagues tested the vapor from e-cigarettes using a new smoking machine built to replicate the physical experience of a 14-year-old boy using one of the devices.

They first tested an e-cigarette liquid designed to create a tobacco flavor. That liquid produced particles about 184 nanometers in size. A second liquid — this one with a fruit punch flavor — produced particles about 270 nanometers in size. Those are within the same range as the particles in cigarette smoke, according to Thornburg.

The researchers also found that 47 percent of the inhaled emissions deposited in the lungs, with nearly all of these particles reaching the deepest part of the lungs.

The remaining 53 percent of the emissions, when exhaled, create a potential source of secondhand exposure to people nearby, the study authors said.

The main ingredients found in the e-cigarette liquids are glycerin and glycol ethers, which are used as the liquid carrier into which all of the nicotine, flavorings and preservatives easily dissolve, Thornburg said. Those substances are not considered harmful.

Other ingredients included nicotine, the preservatives BHA and BHT, and chemicals that create the taste of caramelized sugar and the scent of citrus.

“It’s unknown whether these chemicals are harmful if you inhale them,” Thornburg said. “A lot of the chemicals are considered safe, but that’s from an ingestion perspective, not inhalation,” he noted.

According to Thomas Kiklas, CFO of the Tobacco Vapor Electronic Cigarette Association, “All constituents [of e-cigarettes] have been in the U.S. food supply for generations and all are approved by the EPA/FDA for human inhalation and use dermally.”

Kiklas contends, “The e-cig has and is being used by millions of Americans. There have been billions and billions of uses without a single incidence of harm.”

Thornburg said nicotine researchers need to come together and agree on a set of standards for researching e-cigarettes, given that there are so many different liquids and devices available.

“Each combination could create a unique exposure that could impact the user as well as bystanders,” he said. “With so many different potential combinations, we really need standardized methods for conducting the research with the devices we use and some liquids we use, so all of the research will be comparable.”

More information

For more information on e-cigarettes, visit the U.S. Food and Drug Administration.

Posted: May 2014

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Drugs.com – Daily MedNews

FDA to Propose E-Cigarette Regulations

THURSDAY April 24, 2014, 2014 — The U.S. Food and Drug Administration is proposing long-awaited regulations governing the fast-growing electronic cigarette industry.

The new rules, to be made public Thursday, are expected to regulate e-cigarettes as tobacco products, placing them under the same requirements as cigarettes. That would likely include a ban on the sale to minors.

“That would be a little less stringent than if they were regulated as medicinal products used in smoking cessation,” said Dr. Hilary Tindle, assistant professor of medicine and director of the tobacco treatment service at the University of Pittsburgh Medical Center.

The FDA said the public, the electronic cigarette industry and others will have 75 days to comment on the proposed regulations. Then the agency will review those comments before issuing a final rule. There’s no timetable for the final rule, which will probably end up facing a court challenge, the Associated Press reported.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said: “When finalized [the proposal] would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misperceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA,” the AP reported.

E-cigarettes are battery-operated devices that turn nicotine, flavorings and other chemicals into a vapor that can be inhaled. Most are designed to look like a tobacco cigarette, but some look like pens, USB drives or other everyday objects.

The devices are advertised on TV and the Internet, and come in sweet flavors like green apple, watermelon and bubble gum.

The new proposed regulations also are expected to rein in a number of tobacco products that up to now have had no federal oversight.

“It would give FDA authority over all unregulated tobacco products,” said Erika Sward, the American Lung Association’s assistant vice president for national advocacy. “That would be e-cigarettes, but it also would be cigars, little cigars, hookah-type tobacco and any other products that aren’t currently under the FDA’s authority now.”

Such regulations would close a huge loophole that allows children to freely purchase e-cigarettes and little cigars in many parts of the country, according to proponents of stricter regulations.

E-cigarette use more than doubled among middle and high school students from 2011 to 2012, with more than 1.78 million students nationwide inhaling nicotine-laced vapor from the devices, the U.S. Centers for Disease Control and Prevention reported last year.

“What’s concerning is that high rate of rise,” Tindle said. “Who knows where it will be next year, or the year after that? Everyone agrees that’s not a good thing. The least amount of regulation has to close that hole, so children can’t get access to them as easily.”

The drive for regulation is also being fueled by a dramatic increase in the number of calls to poison centers involving nicotine poisonings from e-cigarettes, according to federal health officials.

Calls related to poisoning from the liquid nicotine in the devices rose from about one a month in 2010 to 215 in February this year, the CDC reported in April.

Electronic cigarettes may be safer than conventional tobacco cigarettes, in that people don’t have to inhale harmful smoke. But without regulation, it’s impossible to know what people are inhaling when they use an e-cigarette, Tindle said.

“There are so many manufacturers right now making e-cigarettes, and there have been multiple reports of contaminants in the vapor and in the e-liquids,” she said. “People don’t necessarily know what they are getting in their bodies, based on the label.”

The new regulations would end the “Wild West” nature of the e-cigarette market, Sward said.

“Once these companies come under FDA authority, it would require them to register with the FDA to disclose their products and ingredients. That’s really important in understanding how these new products impact public health,” she said.

Given the lack of federal action so far, some states and cities have started pursuing e-cigarette regulations of their own. New York City added e-cigarettes to the city’s overall ban on smoking in December, treating them the same as tobacco products.

Some argue that e-cigarettes can help people quit smoking, but evidence supporting that claim has been mixed. Recent studies published in The Lancet and JAMA Internal Medicine have reported that e-cigarettes either don’t help people quit or are about as effective as a nicotine patch.

If the FDA decides to regulate e-cigarettes as tobacco products, some companies may decide to proceed with clinical trials that would allow them to market the devices as safe and effective smoking-cessation devices, Tindle said.

More information

For more on e-cigarettes, visit the U.S. National Institute on Drug Abuse.

Posted: April 2014

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Drugs.com – Daily MedNews