Friday March 22, 2019

US Health Officials Restrict Sales of E-Cigarettes

The new guidelines, first proposed in November, are the latest government effort to reverse what health officials call an epidemic of underage vaping

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FILE - A woman smokes an electronic cigarette in London, Aug. 19, 2015. VOA

U.S. health regulators are moving ahead with a plan designed to keep e-cigarettes out of the hands of teenagers by restricting sales of most flavored products in convenience stores and online.

The new guidelines, first proposed in November, are the latest government effort to reverse what health officials call an epidemic of underage vaping.

E-cigarettes typically heat a flavored nicotine solution into an inhalable vapor. Federal law bans their sale to those under 18, but 1 in 5 high school students report using e-cigarettes, according to the latest survey published last year.

Under proposed guidelines released Wednesday by the Food and Drug Administration, e-cigarette makers would restrict sales of most flavored products to stores that verify the age of customers entering the store or include a separate, age-restricted area for vaping products. Companies would also be expected to use third-party identity-verification technology for online sales.

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Companies that don’t follow the requirements risk having their products pulled from the market, the FDA said. Pixabay

Companies that don’t follow the requirements risk having their products pulled from the market, the FDA said.

“The onus is now on the companies and the vaping industry to work with us to try and bring down these levels of youth use, which are simply intolerable,” FDA Commissioner Scott Gottlieb said in an interview. The restrictions won’t apply to three flavors that the FDA says appeal more to adults than teenagers: tobacco, menthol and mint.

The FDA will accept comments on the guidelines for 30 days before finalizing them later this year.

Anti-smoking activists have questioned whether the in-store restrictions will be enough to stop the unprecedented surge in teen vaping. The FDA has little authority over how stores display and sell vaping products. Instead, critics say the agency is essentially telling companies to self-police where and how their products are sold.

“FDA continues to nibble around the edges and that will not end the epidemic,” said Erika Sward, of the American Lung Association, which has called on the FDA to remove all flavored e-cigarettes from the market.

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Health experts say nicotine is harmful to developing brains, and some researchers worry that addicted teens will eventually switch from vaping to smoking. Pixabay

Health experts say nicotine is harmful to developing brains, and some researchers worry that addicted teens will eventually switch from vaping to smoking.

ALSO READ: Longer Exposure to PM2.5 Raises Risk of Diabetes: Study

Under regulations developed by the Obama administration, manufacturers were supposed to submit e-cigarettes for safety and health review by August 2018. But Gottlieb delayed the deadline until 2022, saying both the agency and industry needed more time to prepare. Under Wednesday’s update, the FDA will move the deadline to 2021.

Still, the American Lung Association and several other anti-smoking groups are suing the FDA to begin reviewing the safety and health effects of e-cigarettes immediately. (VOA)

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E-Cigarettes Twice As Effective In Helping Smokers Quit: Study

Ian Armitage was skeptical about e-cigarettes as a way to stop smoking, saying he tried vaping several years ago but gave it up.

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E-cigarettes, Smokers
A woman smokes an electronic cigarette in London, Aug. 19, 2015. VOA

A major new study provides the strongest evidence yet that vaping can help smokers quit cigarettes, with e-cigarettes proving nearly twice as effective as nicotine gums and patches.

The British research, published Wednesday in the New England Journal of Medicine, could influence what doctors tell their patients and shape the debate in the U.S., where the Food and Drug Administration has come under pressure to more tightly regulate the burgeoning industry amid a surge in teenage vaping.

“We know that patients are asking about e-cigarettes and many doctors haven’t been sure what to say,” said Dr. Nancy Rigotti, a tobacco treatment specialist at Harvard Medical School who was not involved in the study. “I think they now have more evidence to endorse e-cigarettes.”

At the same time, Rigotti and other experts cautioned that no vaping products have been approved in the U.S. to help smokers quit.

e-cigarette, smokers
Packages of flavored liquids for e-cigarettes are seen displayed at a smoke shop in New York City. VOA

 

Top cause of preventable death

Smoking is the No. 1 cause of preventable death worldwide, blamed for nearly 6 million deaths a year. Quitting is notoriously difficult, even with decades-old nicotine aids and newer prescription drugs. More than 55 percent of U.S. smokers try to quit each year, and only about 7 percent succeed, according to government figures.

Electronic cigarettes, which have been available in the U.S. since about 2007 and have grown into a $6.6 billion-a-year industry, are battery-powered devices that typically heat a flavored nicotine solution into an inhalable vapor.

Most experts agree the vapor is less harmful than cigarette smoke since it doesn’t contain most of the cancer-causing byproducts of burning tobacco. But there is virtually no research on the long-term effects of the chemicals in the vapor, some of which are toxic.

At the same time, there have been conflicting studies on whether e-cigarettes actually help smokers kick the habit. Last year, an influential panel of U.S. experts concluded there was only “limited evidence” of their effectiveness.

In the new study, researchers tracked nearly 900 middle-age smokers who were randomly assigned to receive either e-cigarettes or nicotine replacement products, including patches, gums and lozenges. After one year, 18 percent of e-cigarette users were smoke-free, versus 9.9 percent of those using the other products.

“Anything which helps smokers to avoid heart disease and cancer and lung disease is a good thing, and e-cigarettes can do that,” said Peter Hajek, study co-author and an addiction specialist at Queen Mary University of London.

e-cigarette, cigarettes
Customers puff on e-cigarettes at the Henley Vaporium in New York City. VOA

More rigorous

The study was more rigorous than previous ones, which largely surveyed smokers about e-cigarette use. Participants in this experiment underwent chemical breath testing.

Smokers in the e-cigarette group received a $26 starter kit, while those in the nicotine-replacement group received a three-month supply of the product of their choice, costing about $159. Participants were responsible for buying follow-up supplies.

“If you have a method of helping people with smoking cessation that is both more effective and less costly, that should be of great interest to anyone providing health services,” said Kenneth Warner, a retired University of Michigan public health professor who was not involved in the study.

Several factors may have boosted the results: All the participants were recruited from a government smoking-cessation program and were presumably motivated to quit. They also received four weeks of anti-smoking counseling.

The researchers didn’t test e-cigarettes against new drugs such as Pfizer’s Chantix, which has shown higher rates of success than older nicotine-based treatments.

Funding for the study came from the British government, which has embraced e-cigarettes as a potential tool to combat smoking through state-run health services. Some of the authors have been paid consultants to makers of anti-smoking products.

e-cigarette, vaping
In this April 11, 2018, photo, an unidentified 15-year-old high school student uses a vaping device near the school’s campus in Cambridge, Mass. Health and education officials across the country are raising alarms over wide underage use of e-cigarettes and other vaping products. The devices heat liquid into an inhalable vapor that’s sold in sugary flavors like mango and mint — and often with the addictive drug nicotine. VOA

Long-term questions

U.S. health authorities have been more reluctant about backing the products, in part because of the long-term effects are unknown.

“We need more studies about their safety profile, and I don’t think anyone should be changing practice based on one study,” said Belinda Borrelli, a psychologist specializing in smoking cessation at Boston University.

The American Heart Association backed e-cigarettes in 2014 as a last resort to help smokers quit after trying counseling and approved products. The American Cancer Society took a similar position last year.

An editorial accompanying the study and co-written by Borrelli recommended e-cigarettes only after smokers have tried and failed to quit with FDA-approved products. Also, doctors should have a clear timeline for stopping e-cigarette use.

Borrelli noted that after one year, 80 percent of the e-cigarette users in the study were still using the devices. Nine percent of the participants in the other group were still using gums and other nicotine-replacement products.

E-cigarettes, Smokers
Talia Eisenberg, co-founder of the Henley Vaporium, uses her vaping device in New York, Feb. 20, 2014. VOA

No vaping company has announced plans to seek FDA approval of its products as a quit-smoking aid. Winning such an endorsement would require large studies that can take years and cost millions of dollars.

The FDA has largely taken a hands-off approach toward vaping. It has not scientifically reviewed any of the e-cigarettes on the market and has put off some key regulations until 2022. FDA Commissioner Scott Gottlieb has said he doesn’t want to over-regulate an emerging industry that could provide a safer option for adult smokers.

The delay has come under intense criticism amid an explosion in teenage vaping, driven chiefly by devices like Juul, which resembles a flash drive. Federal law prohibits sales to those under 18, but 1 in 5 high school students reported vaping last year, according to a government survey. It showed teenage use surged 78 percent from 2017 to 2018.

Tank vs. cartridge

Matthew Myers of the Campaign for Tobacco-Free Kids noted that the British study used so-called tank-based e-cigarettes, which allow users to customize their flavors and nicotine levels. Those devices have largely been overtaken in the U.S. by Juul and similar devices that have prefilled nicotine cartridges, or pods. Any benefit of e-cigarettes depends on the individual product and how it is used, he said.

“It is a fundamental mistake to think that all e-cigarettes are alike,” Myers said. “And in the absence of FDA regulation, a consumer has no way of knowing if the product they are using has the potential to help them or not.”

e-cigarette
E-cigarette additives impair lung function: Study.

Myers’ group is one of several anti-smoking organizations suing the FDA to immediately begin reviewing e-cigarettes.

Ian Armitage was skeptical about e-cigarettes as a way to stop smoking, saying he tried vaping several years ago but gave it up after experiencing twitching and shakes from nicotine withdrawal.

Also Read: Daily Cigarette Smoker Develop Greater Risks of Heart Attack, Says Study

`I tried it for a whole month, but it just wasn’t doing it for me,” said Armitage, an audio-visual technician in Washington. “I still wanted a cigarette afterward.”

Armitage, who has smoked for 15 years, said he also tried nicotine patches but found they irritated his skin. (VOA)