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I had the privilege of serving at the US Food and Drug Administration (FDA) for 7 years and helping oversee the agency's 1994–1996 investigation of the tobacco industry. That effort enabled FDA to assert jurisdiction over cigarettes and smokeless tobacco products. From 1997 to 2000, FDA began to regulate these products and enforce certain youth access restrictions. In March 2000, after a lawsuit brought by the tobacco industry, the US Supreme Court overturned the FDA assertion of jurisdiction.
It was nearly a decade before FDA returned to the business of regulating tobacco products. On 22 June 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA)1 into law.
The FSPTCA passed with overwhelming bipartisan support in both houses of the US Congress. It gives FDA broad regulatory powers to control the manufacture, sale and distribution of tobacco products. The law itself, and FDA's approach to implementation, have important implications for global tobacco product regulatory initiatives under the relevant provisions of the Framework Convention on Tobacco Control. Now that just over 3 years have passed, it is time for an overall assessment of the implementation of the FSPTCA.
The law is built around a public health standard that represents a departure from the traditional ‘safety and efficacy’ standard in the Food, Drug and Cosmetic Act. This standard obligates FDA to regulate tobacco products in a manner that ‘is appropriate for the protection of the public health.2 Equally important, the public health decisions FDA makes must take into account key population-level behavioural considerations, including the impact of regulation on initiation, cessation and re-initiation of tobacco use.3
FDA faced the daunting task of building an entire regulatory program while simultaneously meeting various mandatory deadlines in the FSPTCA. The agency has done an admirable job of creating a new …