Consumer Watchdog Reacts to FDA’s PMTA Process

For Immediate Release                      Contact: Courtney Mattison (202-525-7492)

September 10, 2021 

Washington, D.C. – The Taxpayers Protection Alliance (TPA) criticized the Food and Drug Administration for denying consumer access to tobacco harm reduction products. September 9, 2021 marked the deadline for the U.S. Food and Drug Administration (FDA) to determine the authorization – or denial – of millions of tobacco harm reduction products that were deemed as tobacco products in 2016. Per the regulations, the FDA was required to ascertain whether novel tobacco harm reduction products could be marketed in the United States for the protection of public health. Yesterday, the agency announced that it had issued more than 100 marketing denial orders to Electronic Nicotine Delivery Systems (ENDS) firms that manufacture e-liquid used in vaping devices. The FDA has also asked for a delay in determining the marketing order for larger vaping companies and is still in the process of examining the remaining applications. 

Lindsey Stroud, Director of TPA’s Consumer Center offered the following statement:

“TPA has long advocated for the adult use of e-cigarettes as a tool to help smokers switch to a less harmful alternative to combustible cigarettes. TPA is deeply saddened that a federal agency meant to protect public health would systematically eliminate such a product. We urge the agency to consider the risks associated with pulling these products from the market, including the economic losses and the possibility of a dangerous black market. 

“Since their introduction to the U.S. market, the FDA has lambasted the adult use of vapor products. In its decisions over the past week, the agency continues to needlessly  vilify less harmful alternative to combustible cigarettes. 

“The agency has systematically relied on alarmism found among tobacco control groups and the media instead of listening to science and the hundreds of small businesses that will be forced to shutter their doors. 

Public health agencies ought to stick to their mission statement and protect American public health, rather than picking winners and losers in the marketplace.” .

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Taxpayers Protection Alliance (TPA) is a non-profit, non-partisan organization dedicated to educating the public through the research, analysis and dissemination of information on the government’s effects on the economy.