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FDA banning e-cigarette sales to minors in US

10 August, 2016
Starting Monday, FDA Banning E-Cigarette Sales to Minors. medlineplus.gov. August 08, 2016. Agency also details other retail restrictions on access to vaping products.The sale of e-cigarettes to minors will be banned starting Monday, as part of the U.S. Food and Drug Administration’s long-awaited plan to extend the agency’s regulatory powers across all tobacco products.Read also: Many teens use the E-Cigarettes because they seem cool, new and fun in US
FDA banning e-cigarette sales to minors in US
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HealthDay news imageThe new rules halt the sale of e-cigarettes and any other tobacco product to anyone younger than 18.
The regulations also require photo IDs to buy e-cigarettes, and ban retailers from handing out free samples or selling them in all-ages vending machines.
The rules also cover other alternative forms of tobacco like cigars, hookah tobacco and pipe tobacco.
Electronic cigarettes are battery-operated devices designed to create an aerosol that delivers nicotine, flavor and other chemicals when inhaled by the user. Manufacturers have marketed the products as a way to help smokers quit cigarettes. But, opponents contend that the nicotine-laden e-cigarettes actually encourage people — especially vulnerable teens — to pick up the smoking habit.
"This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, which had gone largely unregulated," Mitch Zeller, director of the FDA Center for Tobacco Products, said during a media briefing when the oversight was announced in May.
The FDA action earned universal praise from medical associations, which have been concerned that e-cigarettes serve as a gateway drug to draw teenagers into a lifetime of smoking addiction.
"Youth use e-cigarettes more than any other tobacco product on the market today, serving as an entry point to more traditional tobacco products and placing kids at risk to the harms and addiction of nicotine and other tobacco products," Harold Wimmer, national president and CEO of the American Lung Association, said in May. "Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products."
E-cigarette manufacturers also will not be allowed to promote the devices as a healthy alternative to smoking, unless they provide strong scientific evidence that supports the claim, Zeller said.
Studies have shown that as many as 70 percent of current adult e-cigarette users also continue to smoke tobacco cigarettes, and may be using the devices to flout indoor clean air laws, Zeller said.
Until now, e-cigarettes and other alternative tobacco products have gone unregulated by the FDA, despite a 2009 law that granted the agency the authority to govern any tobacco sold in the United States.
Manufacturers of e-cigarettes also will be required to submit new and existing products to the FDA for review and evaluation, unless the product was sold prior to Feb. 15, 2007.
That grandfathering date means that 99 percent of all e-cigarette and "vaping" products now on the market will have to be submitted for FDA review, according to a statement by the Smoke-Free Alternatives Trade Association, an e-cigarette trade group.
The FDA anticipates that existing e-cigarette brands will have at least three more regulation-free years on the market — two years while manufacturers prepare their product application and another year for FDA review.
"The FDA is providing regulated entities with time to comply with these regulations," said FDA Commissioner Dr. Robert Califf.
E-cigarette trade associations condemned the new regulations.
The Smoke-Free Alternatives Trade Association stated in May: "Today’s final rule pulls the rug out from the 9 million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses. These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers," crippling a "multi-billion job-creating industry."
SOURCES: May 5, 2016, media briefing, U.S. Food and Drug Administration; statements, American Lung Association, American Academy of Pediatrics, American Vaping Association; Smoke-Free Alternatives Trade Association
HealthDay
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Read also: Why Teens Choose E-Cigarettes. medlineplus.gov. August 08, 2016. Kids who continue vaping cite 2 key reasons, study finds. Teenagers try e-cigarettes the first time for very teen-related reasons — they’re curious, friends use them, and there are lots of different flavors that taste good.
But the teens most likely to keep using e-cigarettes do so for very practical reasons, a new study suggests.
The low cost of the devices and the promise they can help teens quit smoking tobacco are the two strong predictors of continued use, said senior researcher Suchitra Krishnan-Sarin. She is a professor of psychiatry at Yale University School of Medicine in New Haven, Conn.
Teens who initially tried e-cigarettes because of their low cost had significantly stepped up their use of e-cigarettes by the time researchers checked in six months later.
In addition, teens who tried e-cigarettes to quit smoking were more than 14 times more likely to keep using e-cigarettes than those who did not consider this a reason to try the devices, the findings showed.
However, e-cigarettes didn’t seem to help the kids quit. Four out of five teens who tried e-cigarettes to quit smoking were still puffing regular cigarettes six months later, the investigators found.
"Even though they said they were using e-cigarettes to quit smoking, it doesn’t appear to have necessarily helped them," Krishnan-Sarin said.
E-cigarettes don’t produce tobacco smoke, but they do contain nicotine. And researchers fear they’ll create a new generation of smokers, with kids hooked on nicotine turning to tobacco for a stronger fix, Krishnan-Sarin said.
"That is the huge public health debate," she said. "Are kids going to start with e-cigarettes and then move on to cigarettes? Is that going to be the start of nicotine addiction?"
For their study, Krishnan-Sarin and her colleagues surveyed 340 e-cigarette users in two middle schools and three high schools in 2013, asking them why they first tried e-cigarettes.
The most cited reasons for first trying e-cigarettes were curiosity (57 percent), good flavors (42 percent), use by friends (33 percent), healthier than cigarettes (26 percent), can be used anywhere (21 percent) and does not smell bad (21 percent).
Researchers revisited the teenagers six months later and asked if they were still using e-cigarettes, and if so, what were the reasons they’d kept vaping. The investigators compared the reasons for continued use against those given for first use.
Kids who cited the low cost of e-cigarettes or their potential help to quit smoking wound up vaping more days on average than those who cited other reasons, the study authors said.
Teens who cited low cost used e-cigarettes two out of every three days during the previous month, and those who wanted to quit smoking wound up vaping nearly that often, according to the study results.
Other reasons also predicted continued use of e-cigarettes: they don’t smell bad; they come in good flavors; friends use them; they can be used anywhere; they can be hidden from adults; and they are healthier than tobacco.
But for kids who kept using e-cigarettes, "the most robust predictors were the low cost and trying e-cigarettes to quit smoking," said lead researcher Krysten Bold, a postdoctoral fellow in psychiatry at Yale School of Medicine.
Krishnan-Sarin said these findings reveal several different means by which policymakers could make e-cigarettes less attractive to teenagers.
"For example, we found cost was an issue," she said. "Increasing the cost of e-cigarettes is something that could reduce use of e-cigarettes in this young age group." States could tax the devices, hiking their prices, she suggested.
Federal officials also could ban the use of flavors in e-cigarettes, as has already been done in traditional cigarettes except for menthol, said Dr. Norman Edelman, senior scientific advisor for the American Lung Association.
The U.S. Food and Drug Administration in May announced regulations that would ban sales of e-cigarettes to anyone younger than 18 and require strict regulation of the devices. Those regulations take effect Aug. 8.
The regulations also require photo IDs to buy e-cigarettes, and ban retailers from handing out free samples or selling them in all-ages vending machines.
"Despite recommendations from the American Lung Association and others, the final rule did not ban flavorings as they have in ordinary cigarettes," Edelman said. "We continue to believe all the measures that have been applied against ordinary cigarettes should be applied to e-cigarettes."
The study was published online Aug. 8 in the journal Pediatrics.
In response to the study, the e-cigarette industry group the American Vaping Association said this new research "adds to the growing body of evidence that youth smokers and those seeking to quit smoking are much more likely than nonsmokers to use vapor products beyond mere experimentation. The fact that 20 percent of those who reported using vaping to quit smoking succeeded should be looked at positively, as pharmaceutical nicotine replacement therapy products have been repeatedly shown to have pathetic success rates."
SOURCES: Suchitra Krishnan-Sarin, Ph.D., professor, psychiatry, Yale University School of Medicine, New Haven, Conn.; Krysten Bold, Ph.D., postdoctoral fellow in psychiatry, Yale University School of Medicine, New Haven, Conn.; Norman Edelman, M.D., senior scientific advisor, American Lung Association; Aug. 8, 2016, Pediatrics, online; news release, the American Vaping Association
HealthDay

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