KHI News Service

Nation’s tobacco control chief to address Kansas public health conference

Mitch Zeller says new federal agency must take an evidence-based approach to regulating tobacco products

By Jim McLean | September 02, 2013

Mitchell Zeller, director of the Center for Tobacco Products at the Food and Drug Administration.

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The man who heads the federal government’s new tobacco control center will be in Kansas later this month to update public health officials on his agency’s efforts to curb cigarette smoking and keep other hazardous products off the market.

Mitch Zeller, head of the Center for Tobacco Products at the U.S. Food and Drug Administration, is scheduled to speak at 8:30 a.m. on Sept. 19 to members of the Kansas Public Health Association during their fall conference.

Zeller said he planned to talk about the “unprecedented opportunity” that his agency and health advocates have to reduce tobacco use, which federal officials say remains the nation’s leading cause of preventable death and disease.

“Over 440,000 people are dying prematurely each year and there has never been comprehensive regulation of these products,” Zeller said in an interview with KHI News Service.

Congress created the center in 2009. The Family Smoking Prevention and Control Act gave the FDA immediate regulatory authority over cigarettes, smokeless tobacco and roll-your-own tobacco. It also said the FDA could seek to regulate all other tobacco products, including cigars and electronic cigarettes. But opposition from the tobacco industry has slowed the agency. Legal challenges have already stalled attempts to regulate e-cigarettes and to require larger, more graphic warnings on cigarette packages.

Evidence-based approach

The four-year-old agency didn’t issue its first series of market-entry decisions until June, approving two new products and rejecting four. To reject a product, the agency must determine that it will increase health risks or that a tobacco company failed to demonstrate that it wouldn’t do so. The law forbids the agency from identifying rejected products. The two that it approved for sale were non-menthol cigarettes.

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E-cigarettes on the rise, but still unregulated

“As a regulatory agency, we can only go as far as the regulatory science will take us,” Zeller said. “So, we are making a major investment in better understanding how tobacco products work and better understanding the role of nicotine in the design and manufacture of tobacco products.”

That research led the FDA to conclude in a July report that menthol cigarettes posed a greater health risk, not because they’re more toxic than regular cigarettes but because they are less harsh, which causes people to smoke more of them and makes them a favorite among young smokers just picking up the habit.

“We know that kids who start smoking disproportionately use mentholated cigarettes,” Zeller said.

Even so, Zeller said the agency wants to do more research on whether menthol makes cigarettes more addictive and to gather public input before deciding whether to impose any new regulations.

Zeller said that meanwhile a $300 million education campaign aimed at young smokers is scheduled to launch before the end of the year and it will include “specific messaging aimed at the harms of menthol cigarettes.”

Reaching not preaching to kids

The effort to dissuade young people from experimenting with cigarettes and other tobacco products will avoid the kind of messages that kids are used to tuning out, Zeller said.

“Preaching to kids is a waste of money,” he said. “There is a way to reach teenagers and young people with meaningful messages and that’s what we’re aiming to do.”

Getting through to 12–17 year olds is critically important, he said, because they’re replacing most of the adult smokers who die each year.

“Kids remain the replacement customers for 75 percent of the adults who die or quit each year,” Zeller said, noting that 3,500 kids experiment with cigarettes every day and 1,000 become regular smokers. “And that’s why the FDA is making an investment in enforcement and education.”

On the enforcement side, the FDA has stepped up inspections of retailers to discourage the sale of tobacco products to minors. The agency contracts with state and local authorities to conduct the inspections. To date, Zeller said, more than 100,000 spot inspections have been done across the country leading to more than 10,000 warning letters. Fines are levied against retailers caught selling to minors after receiving a warning letter.

“There may be other ways for kids to get their hands on a pack of cigarettes, but if we’re doing our job as regulators they won’t be getting them over the counter at retail outlets,” Zeller said.

Linda DeCoursey, executive director of the Tobacco-Free Kansas Coalition.

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Kansas retailers responding

In Kansas, inspections by the Department of Revenue have reduced sales to minors, said Linda Decoursey, executive director of the Tobacco Free Kansas Coalition, a nonprofit advocacy group funded in part by the Kansas Health Foundation, which also provides funding to the Kansas Health Institute, the parent organization of KHI News Service.

“Our rate of sales to minors has dropped and it’s specifically due to the money we’re getting from FDA to pay for the inspections,” DeCoursey said.

DeCoursey said she was eager to hear Zeller talk about the FDA’s plans for regulating tobacco products, saying that the agency already has “made incredible strides.” At the same time, DeCoursey is among the anti-tobacco advocates who would like to see the agency pick up the pace when it comes to regulating produces such as cigars and e-cigarettes.

“I would definitely like for them to step up to the plate on e-cigarettes,” she said. “People are beginning to smoke them everywhere and we just don’t have enough research” on the potential consequences.

Zeller acknowledged the growing demand for guidance from the FDA on e-cigarettes, but he said agency rules and tobacco industry opposition to regulation dictated a deliberate approach.

“The FDA has been on record since 2011 saying it intends to create a regulatory framework for electronic cigarettes,” he said. “I can’t tell you when that’s going to happen but we are getting closer and closer to issuing a proposed rule that would begin that process.”

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