The Food and Drug Administration Kicks the Habit- The FDA's New Role in Regulation of Tobacco Products- Smoking is one of the leading causes of death in the United States.1 On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act ("the Act").2 One of the major purposes of this legislation was to reduce tobacco use by children and adolescents.3 After signing the Act, President Obama declared victory in the "decades-long effort to protect our children."4 In order to accomplish this goal, the Act expressly granted the Food and Drug Administration (the "FDA") the ability to regulate tobacco products for the first time. The Act creates a new Chapter IX in the Federal Food, Drug and Cosmetics Act ("FDCA") that grants the FDA oversight over the sale, distribution, manufacturing, advertising and marketing of tobacco.
Historically, tobacco products have been legal, widely available in the United States, and not subject to extensive federal safety regulation.5 In 1996, the FDA attempted to assert jurisdiction over the regulation of cigarettes and smokeless tobacco absent an express grant of authority by Congress.6 The FDA declared that nicotine is a "drug" within the meaning of the FDCA," and that cigarettes and smokeless tobacco are "combination products" that deliver the addictive drug to the body.8 Tobacco manufacturers challenged the FDA's assertion of jurisdiction. As such, on March 21, 2000, the Supreme Court held that Congress had not given the FDA the authority to regulate tobacco products because such authority was inconsistent with Congressional intent expressed in the FDCA's overall regulatory scheme.9
Under the new Act, however, the FDA will regulate tobacco products based on a public health standard rather than the safety and effectiveness standards that the FDA uses to regulate pharmaceutical products and medical devices.10 Thus, any tobacco product regulations promulgated by the FDA must be appropriate for the protection of public health, taking into consideration the risks and benefits to the entire population.11 This legal update addresses the implications of this new law on tobacco manufacturers and retailers.
Congress bases this new legislation on grounds that under Article I, Section 8 of the Constitution, Congress has the authority to regulate interstate commerce: the sale, distribution, marketing, advertising and use of tobacco products substantially affect interstate commerce because these activities occur nationwide.12 Among its provisions, the Act requires registration with the FDA and biannual facility inspections of all tobacco product manufacturers.13 More explicit health warnings in bold type will replace current health warning labels, with new labels occupying at least 50% of the front and back of the product package for cigarettes and 30% for smokeless tobacco.14 To manufacture any new tobacco product, unless it is a minor product modification, the maker must submit a marketing application to the FDA for approval.15 In order to market a tobacco product with a reduced-risk or a reduced-exposure claim (e.g., "light" or "mild"), the manufacturer must seek FDA approval, agree to conduct post-market surveillance, and provide scientific evidence to substantiate the claim.16
The Act authorizes the FDA to establish tobacco product standards "as appropriate for the protection of public health," such as reducing nicotine yields, reducing nicotine levels below the point where it causes addiction, and eliminating harmful constituents of tobacco.17 The FDA cannot, however, ban all tobacco products or require that the nicotine yields of a tobacco product be reduced to zero.18 The Act requires the FDA to develop new regulations for the testing, reporting, and public disclosure of tobacco product ingrethents and smoke constituents.10 It also creates the Tobacco Products Scientific Advisory Committee ("the Committee") to provide advice, information, and recommendations to FDA. …