20 Years Later: Returning to FDA to Regulate Tobacco

By: Mitch Zeller, J.D.

Since its emergence in colonial times, tobacco has been one of America’s most lucrative industries – and one of its least regulated. But four years after the Family Smoking Prevention and Tobacco Control Act became law and gave FDA the authority to start regulating tobacco, we can say that FDA isn’t only making policy, we’re making history.

Mitch Zeller, J.D., Director of FDA's Center for Tobacco Products

Mitch Zeller

This summer, FDA’s first decisions on substantial equivalence marked the very first time any tobacco maker was told they could either sell, or not sell, a tobacco product because of its potential public health implications. It was a historic moment for all of us at CTP and the entire FDA family, but it had particular resonance for me, personally.

Twenty years ago, I joined the staff of then-FDA Commissioner Dr. David Kessler, and was soon given the assignment to examine the practices of the tobacco industry – an industry not regulated by FDA. That transforming experience led to my serving as associate commissioner and director of FDA’s first Office of Tobacco Programs. I oversaw FDA’s investigation of the tobacco industry from 1994 to 1996, and helped craft FDA’s 1996 inaugural tobacco regulation. In 2000, the Supreme Court overturned the agency’s assertion of jurisdiction over tobacco.

As we all know, in 2009 Congress provided FDA with explicit authority to regulate tobacco through the Family Smoking Prevention and Tobacco Control Act. By then I had left FDA to work within the public health community on behalf of tobacco control, but standing in the White House Rose Garden when President Obama signed the new law, I immediately knew that FDA would be on the leading edge of protecting Americans from the dangers of tobacco use. That’s why I didn’t hesitate for a moment when Commissioner Hamburg asked me earlier this year to take the helm as the director for the Center of Tobacco Products.

Much of what’s made my experience at CTP so gratifying is that I’ve had the opportunity to build on the strong foundation left to me by CTP’s first director, Dr. Lawrence Deyton. From that foundation, we will continue to move forward, using all the tools available to us in the Tobacco Control Act to transform tobacco for a healthier tomorrow. This is particularly important – especially since each year, more than 300,000 kids under 18 become regular smokers. But we can, and must, change that.

It’s true that tobacco use remains the leading cause of preventable death and disease in the U.S., resulting in more than 443,000 deaths every single year. But FDA’s ability to enact science-based regulation has true potential to reduce the huge death and disease toll from tobacco use.

I am thrilled to be back at FDA, working with such talented and dedicated colleagues who have joined forces to help reduce tobacco-related disease and death for all Americans.

Mitchell Zeller, J.D., is FDA’s Director, Center for Tobacco Products  

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