The Next 10 Years of Federal Tobacco Regulation: A Road Map to Protect Public Health and Advance Health Equity.

After a decade of fits and starts in regulating commercial tobacco products, the U.S. Food and Drug Administration (FDA) has built the infrastructure needed for robust tobacco product regulation. This article lays out a vision for the FDA in its second decade of tobacco product regulation. To realize the promise of the Family Smoking Prevention and Tobacco Control Act, the FDA must move quickly to adopt high-impact tobacco product regulation, define and operationalize the public health standard in a way that advances health equity, and bring all of its authority and resources to bear to reduce health disparities. In addition, the agency must engage more productively with states to reduce and eliminate tobacco use.

Finished with Menthol: An Evidence-Based Policy Option That Will Save Lives.

Smoking remains the leading cause of preventable disease and death in the United States, killing approximately 480,000 people each year. This crushing health burden falls disproportionately, and recent CDC data shows that large disparities in adult cigarette smoking remain. One factor in these disparities is the use of flavors. Menthol cigarettes and other flavored tobacco products are used at higher rates by vulnerable populations including youth and young adults, African Americans, women, Hispanics and Asian Americans. This is no accident; the tobacco industry has long targeted these same groups. Given FDA's failure to act to ban flavored tobacco products, states and municipalities are considering taking matters into their own hands to protect their communities from these dangerous products. The authors will explore state and local authority to restrict the sales of these products and review the evidence base indicating that removing flavored tobacco products - and menthol combustible products in particular - from the market would significantly reduce the toll of illness and death caused by these products.

FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

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.