FDA to “to assert regulatory authority over e-cigarettes in the near future”

From: Associated Press

FDA tobacco chief says health community grappling with idea that some products are less risky

WILLIAMSBURG, Va. — Changes in the marketplace have forced the public health community to wrestle with the idea that some tobacco products may pose less of a health risk than others, the new head of the Food and Drug Administration’s tobacco control efforts told an industry group on Thursday.

Mitch Zeller, who took over as director of the FDA’s Center for Tobacco Products in March, also told attendees at the Tobacco Merchants Association annual meeting in Williamsburg that the agency is making progress on a backlog of more than 3,500 new product applications, how it plans to address menthol cigarettes and its plans to regulate other tobacco products like cigars and electronic cigarettes.

“You all sell a lawful product,” Zeller said. “Our job is to regulate the manufacture, sale and marketing of the tobacco products within our jurisdiction. And we try to do it efficiently, effectively and fairly.”

While the agency and the industry “may not always find common ground,” Zeller said it won’t be for lack of discussion.

The center was created following a 2009 law gave the FDA authority to regulate a number of aspects of tobacco marketing and manufacturing, though the agency cannot ban nicotine or cigarettes outright.

But the agency has taken its time assessing the scientific evidence for what would best improve public health, leaving the future of the industry and effects on both companies and consumers under a cloud of smoke.

There are two approaches to regulating tobacco use: one that says there’s no safe way to use tobacco and pushes for people to quit above all else. Others embrace the idea that lower-risk alternatives like smokeless tobacco and other nicotine delivery systems like gum or even electronic cigarettes can help improve overall health.

The public health and tobacco control communities have been left with “no choice but to grapple with the issues and the questions of harm reduction,” said Zeller, who helped spearhead efforts to regulate the tobacco industry in the 1990s and was most recently an executive pharmaceutical consulting firm that does work for GlaxoSmithKline, the leading seller of nicotine-replacement therapy products.

While a hypothetical pack-a-day smoker who switches to a smokeless product is going to reduce their risk, “it all comes down to how the products ultimately are used,” Zeller said.

The 2009 law, Zeller said, requires that the agency measure health effects at a population level, such as causing other people to start using a product, postpone quitting, or start using tobacco products again.

One such product that many have claimed has potential to reduce health risks are electronic cigarettes, battery-powered devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that users inhale.

E-cigarettes are gaining much of the attention as the industry pushes to diversify beyond the traditional cigarette business, which has become tougher in the face of tax hikes, smoking bans, health concerns and social stigma. Some e-cigarettes are made to look like a real cigarette with a tiny light on the tip that glows.

The market for e-cigarettes has grown from the thousands of users in 2006 to several million worldwide. Analysts estimate sales could double this year to $1 billion. Some go as far as saying consumption of e-cigs could surpass consumption of traditional cigarettes in the next decade. Tobacco company executives even noted that e-cigarettes drove total industry cigarette volumes down about 600 million cigarettes, or about 1 percent, during the first quarter, excluding Internet sales — a major avenue for e-cig purchases.

The FDA plans to assert regulatory authority over e-cigarettes in the near future. Public health officials say the safety of e-cigarettes and their effectiveness in helping people quit regular smokes haven’t been fully studied.








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