FDA veteran to spearhead tobacco regulatory efforts; current director to step down in March

By Associated Press,
RICHMOND, Va. — A Food and Drug Administration veteran who helped spearhead efforts to regulate the tobacco industry in the 1990s is taking over the agency’s Center for Tobacco Products.

Mitch Zeller will become the center’s director on March 4, FDA Commissioner Margaret Hamburg said in an internal memo sent late Thursday and confirmed by The Associated Press.

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. Its first chief, Dr. Lawrence Deyton, plans to step down and become a professor of medicine and health policy at George Washington University, Hamburg said.

Under Zeller’s leadership, Hamburg said the center’s “work will continue to vigorously build FDA’s role in tobacco product regulation and efforts to improve public health.”

Zeller, who served as associate commissioner and director of agency’s Office of Tobacco Programs from 1993 until 2000, is currently an executive with Pinney Associates, a Maryland-based pharmaceutical consulting firm that does work for GlaxoSmithKline, the leading seller of nicotine-replacement therapy products.

He previously served as an executive with the American Legacy Foundation, the Washington, D.C.-based anti-smoking organization established as part of the settlement between states and the tobacco industry.

“For the longest time there was no regulation, it was the wild, wild west in the marketplace,” Zeller said in an interview with the AP last year discussing the documentary “Addiction Incorporated,” which profiled a Richmond, Va.-based Philip Morris USA whistleblower’s efforts that eventually led to the heads of the major cigarette companies to testify in front of Congress in 1994 about the addictive nature of cigarette smoke. “We can’t say that regulation alone is going to reduce all the death and disease from tobacco, but I look at it as a vital element of a comprehensive national tobacco control program.”

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,” he said. “I don’t believe we have the science now, but (the FDA) could one day be in a position to use these newfound tools to do something about the addictiveness of cigarettes.”

While the regulatory framework was passed in 2009, 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 2009 law lays out the possibility for both, prescribing a scientific approach to improve public health. But the challenge and opportunity is for the agency 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,” Zeller said, who also co-chairs the National Cancer Institute’s Tobacco Harm Reduction Network.

“This is a game-changer,” said former FDA Commissioner David Kessler, who championed the anti-tobacco public health movement in the 1990s. “He really has committed his career to understanding tobacco at all levels. … This is a guy that knows how to get things done.”

The FDA’s measured approach hasn’t stopped it from making changes prescribed by the law: limiting marketing, especially to children; banning flavored cigarettes except for menthol; removing labels such as “light,” ‘’mild” and “low-tar” from cigarette packs; and increased the size of warning labels on smokeless tobacco.

It has also begun to look at the ingredients in cigarettes as well as the health impacts of menthol cigarettes and dissolvable tobacco products. The agency also has said it plans to expand its regulatory authority to include cigars and electronic cigarettes.

Still, attempts to regulate the industry haven’t come without battles. Several tobacco makers are challenging various marketing restrictions and proposed graphic cigarette warning labels, and a review by the AP 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.

The nation’s largest cigarette maker, Marlboro manufacturer Altria Group Inc., said, “We believe that, under Dr. Deyton’s leadership, the Center for Tobacco Products has been focused on establishing a science- and evidence-based approach to regulating tobacco products, and we will continue to engage with the Agency to further this regulatory focus on science and evidence.”


Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum

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