The FDA Center for Tobacco Products (CTP) is responsible for regulating the manufacture, marketing, and distribution of tobacco products to protect public health. This regulation includes developing standards on nicotine levels or levels of other harmful ingredients, identifying requirements for products to be marketed as having a modified risk, and establishing good manufacturing practices for tobacco products. The Tobacco Control Act (TCA) requires that all new tobacco products (those marketed or modified as of February 15, 2000) must undergo a pre-market review and receive marketing authorization from the FDA before they can be introduced into the market. The mission of the CTP is to reduce the number of deaths and illnesses caused by tobacco. To this end, the TCA immediately banned cigarettes with all characteristic flavors, except for the tobacco flavor or menthol.
In addition, all new products that are considered tobacco products must undergo a thorough scientific review before they can receive marketing authorization. Despite the clear legal mandate, the FDA and its compliance partner, the DOJ, have for years allowed new unauthorized tobacco products to be introduced to the market without scientific review or FDA enforcement. Now, with the addition of the FDA's tobacco product regulation as a new component of the national tobacco control strategy, the public health community has the opportunity to wage a renewed and expanded war against tobacco use.