January 2015

The ATS joined several other medical and public health organizations in a letter to the Health and Human Services Secretary Sylvia Burwell urging the department to retain the pre-market review requirement for all novel tobacco products. The legislation that gave the Food and Drug Administration authority to regulate all tobacco products – the Family Smoking Prevention and Tobacco Control Act – required that all new tobacco products not on the market prior to February 15, 2007 must go through an FDA pre-market review process. This process would require the tobacco product manufacturer to submit to FDA product information, testing and safety information.

Most of products in the emerging e-cigarette market were developed after the 2/15/2007 date. The e-cigarette industry is hoping to avoid any FDA pre-market requirements by seeking to "grandfather" e-cigarette products.

The letter urges the Secretary to reject requests to grandfather any tobacco products and notes that efforts to avoid pre-market review are really an attempt to avoid any type of FDA product regulation.