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Overcautious FDA has lost its way
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  1. Mark Gottlieb
  1. Correspondence to Mark Gottlieb, Public Health Advocacy Institute, Northeastern University School of Law, 360 Huntington Av #117CU, Boston, MA 02115, USA; mark{at}phaionline.org

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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.

When the Family Smoking Prevention and Tobacco Control Act (FSPTCA) was signed into law, some in the tobacco control movement expressed scepticism that a piece of legislation with compromises and provisions, reportedly included at the behest of Philip Morris, could result in meaningful regulatory action. After five disappointing years with little regulatory progress, those sceptics might very well feel even more convinced that the legislation itself is the problem.

Some features of the law are indeed troubling, such as the provisions preventing the US Food and Drug Administration (FDA) from ever banning cigarettes and requiring industry representatives to sit on the Tobacco Products Scientific Advisory Committee, however there is no reason to think that they have contributed meaningfully to the FDA's inaction. The solid regulatory framework itself, built around a public health standard, is extremely powerful and should result in potentially transformative actions, such as (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 …

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