Compromise or Capitulation? US Food and Drug Administration Jurisdiction Over Tobacco Products

On June 12, 2009, the United States Congress passed the Family Smoking Prevention and Tobacco Control Act (S. 982), granting the US Food and Drug Administration (FDA) authority regulating tobacco products. The idea of FDA regulation of tobacco has broad [1], but not unanimous, support among medical and public health professionals. This law has many strengths (Table 1): it grants the FDA general authority over tobacco products, including the ability to reduce (but not eliminate) nicotine, requires improved warning labels on cigarette and other tobacco packages, and implements the rules limiting marketing of tobacco products to youth that the FDA issued in 1996. It also repeals pre-emption of state and local regulation of tobacco marketing and advertising, and grants states and localities broad rights to regulate or prohibit the sale, distribution, possession, exposure to, access to, or use of tobacco products. The new FDA law is a compromise between tobacco control organizations and the Philip Morris tobacco company that has its origins in the failed 1997 ‘‘global settlement’’ negotiated to settle litigation against the tobacco industry [2,3]. These organizations and their Congressional allies believed that the only way to win regulatory authority over tobacco products was to compromise with the tobacco industry. Some of the compromises, such as prohibiting the FDA from eliminating all nicotine from tobacco products, requiring a prescription for tobacco products, or banning them outright (Table 1) do not create overly burdensome regulatory hurdles or fundamental longterm advantages or legitimacy for the industry. Other provisions, however, do. Lessons from Past Compromises with the Tobacco Industry