TPA to Testify During FDA “Listening Session” on Center for Tobacco Products

The Taxpayers Protection Alliance (TPA) Consumer Center was accepted to testify during a U.S. Food and Drug Administration’s (FDA) “Listening Session” on the agency’s Center for Tobacco Products (CTP) strategic plan to advance tobacco control efforts and improve the marketing process to bring new tobacco and vapor products to market.

TPA has long advocated for the adult use of less harmful alternatives to cigarettes, including e-cigarettes, heated tobacco and snus. TPA’s international team includes TPA Consumer Center Director Lindsey Stroud, Senior International Fellow Martin Cullip (United Kingdom), and  Research Fellow Skip Murray ( former vape shop owner) who has extensively researched tobacco harm reduction and worked with small manufacturers prior to TPA.  TPA’s Consumer Center is uniquely qualified to provide ample insight on reforms FDA could make to help accelerate the introduction and use of tobacco harm reduction products for the millions of adults who continue to smoke.

As noted in TPA’s written testimony, there are fundamental flaws at the FDA’s CTP that have stunted access to safer alternatives to cigarettes.  This is because of the flaws in the 2009 Family Smoking Prevention and Tobacco Control Act which gave FDA authority to regulate tobacco products – and subsequently all newly deemed tobacco products in 2014.

As such, e-cigarette manufacturers are required to go through an extensive, draconian, and often cost-prohibitive process in order to legally market their products in the U.S. The premarket tobacco product application process has failed to even capture one percent of an already-existing marketplace, as FDA has authorized only 23 marketing orders for e-cigarette products. Yet, between 2019 and 2022, the agency has issued more than 100 marketing orders for combustible cigarettes.

As noted in recent commentary by the CTP director, there is a misperception of nicotine and tobacco harm reduction among adults and even the medical community. This is severely impacting innovation and public health benefits. Ultimately, it is misinformed adults who smoke who suffer due to FDA’s inaction, as they are unaware of the continuum of risk that exists among tobacco products.

Even worse, the FDA’s CTP is completely funded by user fees from only six tobacco product categories, and 85 percent of its budget comes from combustible cigarette user fees. There is no incentive for FDA to authorize new products not subject to user fees, but it is also unfair that existing fees are being used for the enforcement actions for non-user fees products. It is also alarming that the FDA claims to want to advance public health and reduce the smoking burden when most of its funding rely on the lungs of those adults who smoke.

TPA is looking forward to providing oral testimony to the FDA and looks forward to working with agency to help develop sustainable pathways to accelerate tobacco harm reduction in America.