Blumenthal Statement after FDA Rejects Four New Tobacco Product Applications

Senator Reiterates Calls For FDA To Act Vigorously To Rein In Harmful Tobacco Products

(Washington, DC) – Today, U.S. Senator Richard Blumenthal (D-Conn.) issued the following statement after the U.S. Food and Drug Administration’s (FDA) used for the first time a new pathway to reject four new tobacco product applications. The substantial equivalence pathway provision of the Family Smoking Prevention and Tobacco Control Act of 2009 requires scientific pre-market review of all new tobacco products before they can enter the marketplace. In order to meet the requirements of one of the law’s provisions, an applicant product must be substantially equivalent to a valid predicate product already on the market.

“If this step is an indication that the FDA is finally bearing teeth, matching its bite to its bark, then they are to be commended. But the substantial equivalence test is only one part of a necessarily more aggressive strategy against the dangers of tobacco products. FDA can and must do more. FDA has a responsibility to protect the public health, and that means that existing tobacco products, including menthol cigarettes, for which there is scientific evidence of increased risk of addiction, should be removed from the marketplace. I hope the FDA will continue to act on its charge to protect the public health, and that it will assert jurisdiction over all tobacco products and not just review new product applications.”