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E-Cigarettes, Tobacco Vapor Devices to Come Under FDA Oversight


May 5, 2016 — 12:04 PM EDT


Industry worth $5.2 billion to falls under regulatory purview
Rising use among youth raises alarm, HHS's Burwell says

The U.S. Food and Drug Administration will for the first time oversee electronic cigarettes, an attempt to bring control to a multi-billion dollar industry that has grown rapidly in recent years.

The long-awaited regulations cover products including cigar and pipe tobacco, along with vape pens and refillable vaporizers, the FDA said Thursday in a statement. The rules prohibit sales to minors, ban free samples, require package warning labels, and call for makers of products released after 2007 to seek FDA permission to remain on store shelves.

The rules will impact big companies that also also make combustible cigarettes, such as Reynolds American Inc. and Altria Group Inc., as well as smaller players in the e-cigarette and vapor industry, which was worth about $5.2 billion in 2015. Congress gave the FDA authority to oversee tobacco products in 2009, but until now the agency had not finalized rules to regulate e-cigarettes and cigars.

Regulation was badly needed as growth of e-cigarettes and vapor products use among youth contrasts with declining rates of smoking traditional cigarettes, health officials said.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” Health and Human Services Secretary Sylvia Burwell said in a statement. “All of this is creating a new generation of Americans who are at risk of addiction.”
Time Line

While the regulations are a move in the right direction, additional action is needed from the FDA to reduce the lure of tobacco products to young people, the American Cancer Society Cancer Action Network said.

“The FDA should immediately take action to address flavorings attractive to youth in all products and the egregious industry marketing practices,” Chris Hansen, president of the group, said in a statement. “The tobacco industry has taken full advantage to exploit the lack of regulations on these issues.”

Companies will have 24 months to file pre-market applications for their products, according to the rule. The FDA then has a year to review the submission, during which the products can remain on shelves.

Manufacturers “were looking for that compromise,” said Kenneth Shea, a Bloomberg Intelligence analyst. “The critical question that no one really knows right now is, will the FDA conclude that these new products are unsafe or not?”

more http://www.bloomberg.com/news/articles/2016-05-05/e-cigarettes-tobacco-vapor-devices-to-come-under-fda-oversight