US: FDA Names New Head of Tobacco Governance Group

Source from:  Winston-Salem (NC) Journal  02/25/2013

The Food and Drug Administration has replaced the head of its tobacco governance group with a former associate commissioner with ties to an anti-smoking advocacy group and a pharmaceutical company.

Mitch Zeller becomes director of the Center for Tobacco Products on March 4, replacing Dr. Lawrence Deyton, who is stepping down to become a professor of medicine and health policy at George Washington University.

The FDA began regulating tobacco products and marketing in June 2009, but it cannot ban nicotine or tobacco. FDA panels advise it on scientific issues, with the agency usually following the FDA's recommendations.

Zeller served as associate commissioner and director of the FDA's Office of Tobacco Programs from 1993 until 2000.

FDA Commissioner Margaret Hamburg said in an internal memo obtained by The Associated Press that under Zeller's leadership, the center's "work will continue to vigorously build FDA's role in tobacco product regulation and efforts to improve public health."

One of the center's chief tasks is creating regulations for smokeless tobacco products, such as moist snuff. It also is charged with evaluating applications for new "modified-risk" tobacco products, such as R.J. Reynolds Tobacco Co.'s Camel dissolvable orbs, film strips and sticks, Zonnic nicotine-replacement therapy product, and potentially electronic cigarettes.

A company that wants to market a lower-risk tobacco product in the United States must offer scientific proof to the FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole. An AP review in December uncovered that the agency had not ruled on thousands of tobacco product applications, a majority of which have lingered for more than a year.

What could make Zeller's appointment controversial is he currently serves as an executive with Pinney Associates, a pharmaceutical consulting firm that does work for GlaxoSmithKline, the top seller of nicotine-replacement therapy products.

He also worked as an executive with the American Legacy Foundation, an anti-smoking group established as part of the Master Settlement Agreement between states and the tobacco industry.

In a 2012 interview with AP, Zeller said that while cigarettes are "absolutely a legal product to sell to adults, to market to adults," the tobacco industry engineered them to "create and sustain addiction."

"The reason why it is the leading preventable cause of death and disease is because people smoke for the nicotine but they die from the tar, and the product is deliberately designed to make that happen," Zeller said.

In February 2011, R.J. Reynolds Tobacco Co. and Lorillard Inc. sued the FDA and U.S. Department of Health and Human Services, charging the Tobacco Products Scientific Advisory committee has members with "conflicts of interest and fixed views." The manufacturers want the court to stop the FDA "from receiving or relying on recommendations," particularly about menthol and smokeless products.

The menthol issue is pivotal to both manufacturers. Lorillard is the maker of Newport, the best-selling menthol cigarette in the United States. Reynolds has gained market share with its Camel and Pall Mall menthol styles.

An unbiased review of smokeless tobacco products is pivotal, the tobacco manufacturers say, because makers of nicotine-replacement therapy and other smoking-cessation products, such as pharmaceutical companies, "are in direct competition with tobacco-product manufacturers for the purchasing choices of adult smokers."

In October 2010, the consumer health care division of GlaxoSmithKline requested that the FDA take Reynolds' dissolvable tobacco products out of test markets. GlaxoSmithKline sells nicotine-replacement therapy products Nicorette and NicoDerm. In August, U.S. District Court Judge Richard Leon denied the FDA's attempt to have the manufacturers' lawsuit dismissed.

Reynolds filed a petition in December that asks the FDA to adjust one of four warning labels for smokeless products from "WARNING: This product is not a safe alternative to cigarettes," to "WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."

Zeller said in the AP interview that FDA needs to "come up with a comprehensive nicotine regulatory policy aimed at shifting tobacco users down the continuum from the most harmful to the least harmful."

Matt Myers, president of the Campaign for Tobacco-Free Kids, applauded Zeller's appointment, saying he is "deeply familiar with the harmful practices of the tobacco industry and the need for the FDA to act aggressively to curtail those practices in order to reduce the death and disease caused by tobacco use."

Bryan Hatchell, a Reynolds spokesman, said the company remains "committed to our work with the FDA as we believe an open line of communication is the best way to establish an effective, science-based regulatory framework for the tobacco industry."

Brad Rodu, a professor of medicine at the University of Louisville and a smokeless-tobacco advocate, said he is concerned that Zeller's work with GlaxoSmithKline could create a regulatory bias against manufacturers' smokeless products.

He urged the FDA to take an open-minded approach to smokeless innovations, "especially when smokers have increasing access to vastly safer alternatives." Enditem