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Morning Briefing

Summaries of health policy coverage from major news organizations

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Friday, May 6 2016

Full Issue

FDA Brings E-Cigarettes Under Federal Authority With Sweeping New Rules

The regulations ban the sale of e-cigarettes to anyone under the age of 18 and require manufacturers to submit their products for approval from the agency. Critics say many of the shops can't afford that process, and others worry that the new rules will push consumers back toward traditional cigarettes.

After years of debate about the health risks of electronic cigarettes, the federal government on Thursday made it final: They need to be regulated and kept out of the hands of children. The Food and Drug Administration issued sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them. The long-awaited regulations, 499 pages of them, shifted the terms of the public debate over e-cigarettes, putting the federal government’s heft behind a more restrictive approach to the devices. (Tavernise, 5/5)

In an action e-cigarette makers had been dreading, the Food and Drug Administration said it was assuming regulatory authority over e-cigarettes. Though the product-approval process will be phased in during three years, that will be little solace to the fledgling but fast-growing $3.5 billion industry that has, until Aug. 8 when the rules take effect, largely been unregulated and dominated by small manufacturers and vape shops. (Mickle, 5/5)

"Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical," Health and Human Services Secretary Sylvia Burwell said. "We cannot let the enormous progress we've made toward a tobacco-free generation be undermined by products that impact our health and economy in this way." (5/5)

The number of young people using e-cigarettes now exceeds the number who smoke traditional cigarettes, according to the Centers for Disease Control and Prevention. About 5.3 percent of middle school students reported in 2015 that they had used e-cigarettes in the previous 30 days. For high schoolers, the figure has risen to 16 percent. In 2015, 3 million middle- and high-school students reported using e-cigarettes, according to the FDA and the CDC. (McGinley and Dennis, 5/5)

The popularity of "vaping" has grown in recent years. The FDA says about 16 percent of high school students used e-cigarettes in 2015. Some have welcomed the devices as an alternative to traditional cigarettes, whose dangers are well-known, and as an aid to help smokers quit. (Kodjak, 5/5)

Opponents said the FDA's product-review rules could harm the e-cigarette industry. Although the FDA contends that the cost of its approval process is less than $1 million per item, other estimates place the cost above $1 million. Either way, critics said the price would be too onerous for many of the small businesses that manufacture e-cigarettes, the vaping liquids and other related items. "This gigantic price tag is affordable to Big Tobacco companies but small- and medium-sized businesses will be crushed," said Gregory Conley, president of the American Vaping Assn. (Peltz and White, 5/5)

The implications for the growing electronic cigarette, or "vape," industry could be big. Industry insiders claim the new rules could force many shops, which often also manufacture e-cigarette products, and manufacturers to go out of business. In addition to requiring approval of products, the FDA's new mandates also prohibit sales to minors. At one 'vape' shop in New York City, the Henley Vaporium, owner Peter Denholtz said he was concerned about the new rules. "They're 499 pages." he said. "It's going to take a while before we really understand what they mean." (Safo and Sharpe, 5/5)

The White House called the Food and Drug Administration move on Thursday to ban the sale of e-cigarettes and cigars to anyone under age 18 and impose other regulations a "common sense proposal" that helps the public health and safety of Americans. (Mason, 5/5)

U.S. health officials ... said they will look at potential future regulations on flavors used in the products as more data becomes available. Mitch Zeller, head of the Food and Drug Administration's center for tobacco products, said the agency would review data on how many addicted smokers and tobacco users have actually been able to quit using e-cigarettes with flavors before making decisions on any flavor regulations. (Gershberg and Berkrot, 5/5)

Kaiser Health News: FAQ: How The FDA’s New Tobacco Rule Affects Consumers

Here are some questions and answers about how the Food and Drug Administration’s new rule will affect consumers. (Galewitz, 5/6)

Meanwhile, KQED examines how the new California tobacco laws play off the regulations —

Last night, California’s governor signed into law a package of sweeping tobacco regulations. This morning, the federal Food and Drug Administration (FDA) handed down its own landmark regulations on e-cigarettes. (Aliferis, 5/5)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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