2022 Paul A. Volcker Career Achievement

Mitchell Zeller, J.D.

Directed federal efforts to regulate the marketing and accessibility of tobacco products that can cause death and disease, instituting policies that cut back on cigarette usage and saved lives.

The tobacco industry for decades used its political might, lawsuits and outright obfuscation of studies linking smoking to preventable death, as well as crippling lung, cancer and heart disease, to keep the federal government out of the cigarette-regulation business. 

Big Tobacco, however, met its match in Mitchell Zeller, who effectively used congressional authority given to the Food and Drug Administration to shepherd the first comprehensive effort to regulate the marketing and accessibility of tobacco products. 

“Mitchell Zeller is recognized globally as an expert and leader in tobacco control,” said Janet Woodcock, the FDA’s principal deputy commissioner. “During his tenure, we have seen a transitional shift in regulation of tobacco products, with new products under FDA’s jurisdiction, historic and precedent-setting actions, and lives and dollars saved due to effective and impactful public education.”  

After decades of obstacles, anti-smoking and public health lobbies prevailed on Congress in 2009 to pass a law giving the FDA authority to regulate the marketing of tobacco products. In 2013, the FDA brought Zeller back to the agency where he had served in the 1990s. 

Since the law passed, the adult smoking rate has dropped to less than 13% from 20.6%, representing 16 million fewer smokers. The youth smoking rate (ages 12-17) is down to 2.3% from about 17% in 2009. 

Even with the progress made, it is estimated 480,000 people in this country still die prematurely each year from tobacco use, primarily because of cigarettes.  

A strong believer in using scientific evidence to demonstrate the serious health consequences of smoking, the FDA under Zeller’s guidance extended its regulation to e-cigarettes, also known as vaping, pushing back against industry interests. It also announced its intent to issue rules to prohibit menthol in cigarettes and all flavors in cigars, which will avert hundreds of thousands of tobacco-related deaths in the coming decades.  

In addition, the FDA issued historic regulations that extended the agency’s authority over cigars, hookah tobacco and pipe tobacco, and finalized foundational rules related to submission and evaluation of applications for new tobacco products, to ensure they undergo appropriate regulatory review to determine if they meet the public health standards set by law. 

The agency also finalized a rule mandating cigarette health warnings with color images to promote greater public understanding of negative health consequences of smoking, and funded new research to better understand tobacco products, how they cause death and disease, and how to best reduce the harm from these products.  

Moreover, Zeller led the FDA’s effort to conduct more than one million retail inspections, and increased compliance and enforcement efforts to ensure that the tobacco industry follows the law and regulations designed to reduce the health burden of tobacco use. The agency also launched numerous public education campaigns to effectively reach youth and other at-risk audiences to prevent tobacco initiation and use and encourage cessation. 

Former FDA Commissioner Dr. Scott Gottlieb said Zeller achieved extraordinary results.  

“Here, you had a vast, wealthy, politically potent industry in place selling a product that was being used by millions of consumers, and you created a brand new regulatory program,” Gottlieb said. “Mitch was the modern architect of that. Most of the modern work was done under Mitch’s watch.” 

Zeller, who retired in April 2022, first joined the FDA in 1993 after working as a public interest attorney and serving as a staffer on a congressional subcommittee conducting health and safety oversight. During his first few years at the FDA, he supervised an investigation of the tobacco industry and the role of nicotine in the design and manufacture of cigarettes.  

In 1997, he became the FDA’s first director of its Office of Tobacco Programs, making good on President Bill Clinton’s pledge to clamp down on the cigarette industry and building the first nationwide enforcement program to reduce youth access to tobacco. Zeller was eventually promoted to associate commissioner. 

The program conducted nearly 200,000 inspections of tobacco retailers and collected over $1 million in penalties. But in March 2000, the U.S. Supreme Court stripped FDA of tobacco jurisdiction, ruling that without specific authorization from Congress, the agency acted outside its legal powers.  

Zeller then left the FDA, first going to an organization that focuses on youth tobacco prevention and then to a health policy consulting firm to work on tobacco cessation policy. 

In 2009, Congress passed and President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act. The law gave the FDA new authority with an emphasis on restricting promotion and sales to youth. It also prohibited tobacco companies from making reduced harm claims like “light,” “low” or “mild” without scientific proof.  

Zeller rejoined the FDA four years later, and while his predecessor helped launch the Center for Tobacco Products, “Mitch came when the rubber really had to hit the road in terms of implementation and making the team come together in an action-oriented way,” said Dr. Margaret Hamburg, a former FDA commissioner. 

Zeller said the FDA gave him the “opportunity to do something that no other country is doing, and that is use government authority to reduce the harm associated with tobacco, whether it’s preventing kids from starting, making existing products less harmful or getting adults to stop.” 

“It’s been the highest calling…and an opportunity to have a real impact,’” Zeller said. “While tobacco use remains the leading cause of preventable disease and death in the country, we are today experiencing a historically low rate of smoking in the U.S.”