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FDA to regulate e-cigarettes, set minimum purchase age at 18 :

May 5, 2016

Federal authorities soon will begin regulating e-cigarettes, cigars and other tobacco products under a new rule released Thursday.

The Food and Drug Administration’s (FDA’s) rule follows years of advocacy by the Academy and other health groups aiming to protect children from addiction to nicotine and the harms of tobacco.

“The rule is a welcomed starting point, but it is only a framework upon which to build meaningful regulation to end the tobacco epidemic in the United States once and for all,” said AAP President Benard P. Dreyer, M.D., FAAP. “Today’s action marks an historic step forward in helping to alleviate the threat of lifelong nicotine addiction for our youth, and should serve as a foundation for further progress when it comes to keeping children safe from dangerous tobacco products.”

Under the 499-page rule that takes effect in 90 days, the FDA will regulate cigars and electronic nicotine delivery systems (ENDS) such as e-cigarettes, e-hookahs and vape pens. Anyone purchasing such products in person or online must be at least 18 years old and be able to show valid identification. In addition, the products cannot be given out as free samples or sold in vending machines accessible to minors.

Approximately 16% of high school students used e-cigarettes last year, up from 1.5% in 2011, according to research from the FDA and Centers for Disease Control and Prevention. In addition, nearly 70% of adolescents were exposed to e-cigarettes through ads in 2014.

“Today’s announcement is an important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” Health and Human Services Secretary Sylvia Burwell said in a news release.

Manufacturers of newer tobacco products like e-cigarettes will have up to two years to apply for FDA approval. For these two years and for an additional year during FDA review, manufacturers can continue to sell their products. Like makers of cigarettes, they will have to report their ingredients, and their packages eventually will be required to carry health warnings.

However, the FDA has yet to decide whether to allow flavored e-cigarettes. The new rule also does not immediately address flavored cigars, marketing, child-resistant packaging and warning labels on children being exposed to liquid nicotine.

“More work must be done now as e-cigarettes become more and more common in households and communities across the country,” Dr. Dreyer said. “FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape or to prevent marketing tactics that target children.”

While the FDA didn’t immediately act on child-resistant packaging, the AAP-backed Child Nicotine Poisoning Prevention Act that requires such packaging on liquid nicotine containers nationwide goes into effect this summer.

As the Academy continues its advocacy efforts, it also urges pediatricians to follow recommendations from its 2015 policy statement Electronic Nicotine Delivery Systems. The policy calls for screening adolescents for use and educating families about the dangers of using ENDS as well as being exposed to secondhand vapors. ENDS also should not be viewed as a way to curb tobacco dependence.

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