title: FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.
abstract: Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.
authors.affiliation: Tobacco Control Legal Consortium, a program of the Public Health Law Center, at the Mitchell Hamline School of Law, St. Paul, Minnesota, USA.
authors.forename: Desmond
authors.initials: D
authors.lastname: Jenson
authors.affiliation: Tobacco Control Legal Consortium, a program of the Public Health Law Center, at the Mitchell Hamline School of Law, St. Paul, Minnesota, USA.
authors.forename: Joelle
authors.initials: J
authors.lastname: Lester
authors.affiliation: College of Public Health & Moritz College of Law, The Ohio State University, Columbus, Ohio, USA.
authors.forename: Micah L
authors.initials: ML
authors.lastname: Berman
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D000067088:Direct-to-Consumer Advertising / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D011050:Policy Making; D015397:Program Evaluation; D012907:Smoking / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D000074606:Smoking Prevention; D019460:Tobacco Industry / Q000331:legislation & jurisprudence*; D062789:Tobacco Products / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
keywords: Advocacy; Public opinion; Public policy; Surveillance and monitoring; Tobacco industry