Family Smoking Prevention and Tobacco Control Act 2009

United States, federal statute. The Family Smoking Prevention and Tobacco Control Act was signed on 22 June 2009 (Public Law 111-31), adding chapter IX to the Federal Food, Drug, and Cosmetic Act after the Supreme Court had ruled in 2000 that the FDA lacked tobacco authority. It created the Center for Tobacco Products, funded by industry user fees. Primary text: the FDA overview and the Congress.gov record of H.R.1256.

What it changed: cigarettes with characterising flavours other than menthol and tobacco were banned at once; new tobacco products need premarket authorisation; the agency may set product standards including reduced nicotine, require graphic warnings and restrict marketing to the young, but the Act forbids banning all cigarettes or reducing nicotine to zero. The 2016 'deeming rule' extended jurisdiction to e-cigarettes, cigars and hookah, which is the legal basis for authorising or denying vaping products. A proposed rule to ban menthol cigarettes, which are smoked disproportionately by Black Americans, was published in April 2022 and withdrawn in January 2025; a proposed nicotine cap was published the same month.

Why it matters for cancer: smoking still causes about one in three cancer deaths in the United States, and lung cancer incidence has fallen as smoking has, so product standards and youth-access rules are among the largest cancer prevention levers any regulator holds. The arguments run between public health groups, who see the FDA as too slow and too exposed to litigation, and the industry and vaping advocates, who see the premarket process as arbitrary. The 2019 federal Tobacco 21 law amended the same chapter.