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FDA Issues Much Tougher Rules For E-Cigarettes, Tobacco Products

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The U.S. Food and Drug Administration will, for the first time, extend its authority on electronic cigarettes, overseeing the multibillion industry that has seen rapid growth in recent years.

The regulations covering cigar, pipe tobacco, hookah, vape pens and refillable vaporizers, to name a few, were announced on May 5. They also restrict the sale of these products to minors nationwide, ban free samples, require warning labels on the package and urge makers of products released post-2007 to seek the agency’s permission to stay on store shelves.

Health officials harped on the need for regulation as the e-cigarette and vapor product use rose among the youth as smoking traditional cigarettes declined.

“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,” said Health and Human Services' Secretary Sylvia Burwell, who dubbed the move a crucial step in fighting for a “tobacco-free generation.”

The rule is seen to impact both major players — those making combustible cigarette products like Reynolds American and Altria Group — as well as smaller companies in the e-cigarette landscape. These were worth about $5.2 billion last year.

In an email to Bloomberg, Reynolds spokesperson David Howard said that smokers should get accurate information on products “potentially less risky than cigarettes,” and that they seek to discuss with the FDA how best to structure review and product approval.

While Congress handed oversight of tobacco products to FDA in 2009, the agency only recently finalized its rules governing e-cigarettes. In 2014, the FDA assured it will form rules to cover e-cigarettes, where they would have to pass a certain review to stay on the market.

According to FDA Commissioner Robert Califf, as he sat as the agency head this year, the regulations were already forthcoming.

Given tougher regulations, companies cannot sell to persons under age 18, whether in person or online; need to verify age through photo ID; cannot sell in vending machines except for adult-only facilities; and cannot distribute free samples.

Companies selling newly regulated products — or those that were on the market after Feb. 15, 2007 — also have 24 months to file pre-market applications for their products, with FDA having a year to review the submission. During this time, the products can remain on shelves.

Mitch Zeller, FDA’s Center for Tobacco Products director, said the final rule addresses largely unregulated products being used at “alarming” rates.

“[O]ur approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA,” Zeller explained.

E-cigarette use among high schoolers climbed 900 percent from 2010 to 2015, according to a CDC survey. In 2015, 3 million in middle and high school used e-cigarettes, with high school boys smoking cigars at around the same rate as cigarettes.

According to a joint study by the FDA and the National Institutes of Health, almost 80 percent of current youth tobacco smokers reported trying flavored tobacco in the last 30 days, citing the range of flavors as a persuasive factor.

Photo: Lindsay Fox | Flickr

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