By Ashley Hayes
WebMD Health News
Reviewed by Brunilda Nazario, MD
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The agency announced new rules Thursday that add those products to laws covering the sale of other tobacco items like cigarettes. It says the move is aimed at reducing the number of teens who use them.
A recent survey showed that e-cigarette use among high school students has risen from 1.5% in 2011 to 16% in 2015, the FDA says. Hookah use has also risen.
The rule changes take effect in 90 days. The key regulations:
- Set 18 as the age when users can legally buy products, including online purchases
- Require a photo ID as proof of age
- Don't allow products to be sold in vending machines (barring those in adult-only facilities)
- Don't allow free samples to be distributed
E-cigarettes and cigars will also carry health warning labels. Other parts of the rule changes may take years to put into effect.
The change 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, that had gone largely unregulated," says Mitch Zeller, director of the FDA's Center for Tobacco Products, in a statement.
In 2015, 3 million middle- and high-school students reported being "current" e-cigarette users.
"As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction," Health and Human Services Secretary Sylvia Burwell says in a statement.
In a news conference Thursday, Zeller compared the e-cig marketplace to "the Wild, Wild West."
He noted there have been reports of people burned and disfigured by e-cigarette battery explosions.
The products have a battery, a heating element, and a cartridge that holds nicotine and other liquids and flavorings. Users exhale vapor instead of smoke, in what's called "vaping."
Manufacturers claim e-cigarettes can help smokers quit, but opponents say they may also encourage people to pick up a habit and become nicotine addicts. A recent study also found that e-cigs didn't help cigarette smokers kick the habit.
Under the new rules, e-cigarette makers won't be allowed to promote them as healthier alternatives to smoking -- for example, having fewer toxins than cigarettes or posing a lower health risk -- unless they provide strong scientific evidence to back up the claim, Zeller said.
The American Academy of Pediatrics was among health and advocacy groups welcoming the move, but called it a "starting point." Health officials have expressed concern over flavored tobacco products and their appeal to younger users before.
"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 Benard Dreyer, MD, president of the organization. "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."
Dreyer said the FDA passed up "critical opportunities" by failing to ban flavored tobacco products and prevent "marketing tactics that target children."
Zeller said the agency plans to propose a separate rule banning flavors in e-cigarettes, small cigars, and other products that offer an alternative to tobacco.
Also, e-cigarette makers will be required to submit new and existing products (unless they were sold before February 2007) to the FDA for review and evaluation. The agency will look at ingredients, how the product is designed, its health risks, and its appeal to young people.
That will include 99% of e-cigs now on the market, according to a statement by the Smoke-Free Alternatives Trade Association. The FDA says those products will remain on the market for about 3 years -- 2 years to prepare their submission and a third year for FDA review.
E-cigarette trade groups spoke out against the new rules.
The Smoke-Free Alternatives Trade Association said in a statement: "Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging .... These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers."
HealthDay news service contributed to this article.
SOURCES: News release, FDA. HealthDay: "FDA Banning E-Cigarette Sales to Minors." Kalkhoran, S. The Lancet Respiratory Medicine, February, 2016. News release, Smoke-Free Alternatives Trade Association.
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