In an editorial published in the May, 2014 issue of the journal, Tobacco Control, PHAI’s Executive Director, Mark Gottlieb, calls the FDA’s approach to implementation of the Family Smoking Prevention and Tobacco Control Act, “Overcautious,” and urges the agency and the White House to take a much more aggressive approach to saving lives.
The summary of the editorial, entitled “Overcautious FDA has Lost its Way,” states:
Five years after the passage of the Family Smoking Prevention and Tobacco Control Act, little progress has been made in the effort to regulate the US tobacco industry and advance the public health goals of tobacco control. Legal challenges by the tobacco industry, and evidence of political interference from the White House have resulted in the US Food and Drug Administration’s (FDA) overcautious approach toward advancing a meaningful regulatory agenda. While the White House bears final responsibility, it is incumbent upon the FDA and its Center for Tobacco Products to become more aggressive and seize the extraordinary opportunity to save lives that the Family Smoking Prevention and Tobacco Control Act has created.
Despite the capabilities of the FDA’s Center for Tobacco Products and its director, Mitchell Zeller, who directed the FDA’s tobacco efforts in the 1990s under commissioner David Kessler, progress in meaningfully regulating tobacco products is moving at a glacial pace. Predictably, the tobacco industry is utilizing its full legal arsenal to challenge and delay FDA’s efforts. It is becoming apparent that the White House is also responsible for the FDA’s inaction through delays caused by its Office of Management and Budget.
Gottlieb believes that the agency should be: (1) eliminating menthol; (2) regulating nicotine levels to reduce dramatically abuse liability and toxic exposure; (3) implementing arresting and effective graphic warnings; (4) facilitating an increase of the national minimum tobacco sales age to 21; and (5) responsibly controlling new tobacco products’ entry into the market. This is simply not happening.
Gottlieb suggests that because litigation by the tobacco industry to challenge regulatory action is inevitable, the best strategy is for the FDA to use the best available evidence now and rollout the regulatory agenda as fast as the law will allow. Delay only serves to benefit the industry and, consequently, increase the morbidity and mortality that the industry’s products cause in the United States.
Another suggestion by Gottlieb is for FDA to consider how Sharon Eubanks, lead attorney for the U.S. Department of Justice, handled similar legal and political challenges when litigating the racketeering case, U.S. v. Philip Morris.
The editorial concludes by noting that, “[t]here exists no better public health opportunity of any kind than this one, now in the hands of the FDA. They should run with it, not from it.”
