Supporting FDA in Marketing Denial Orders

April 29, 2024

The Food and Drug Administration (FDA) has been issuing marketing denial orders  (MDOs) for certain flavored e-cigarette products in accordance with Family Smoking and Prevention and Tobacco Control Act (TCA). Under the law, manufacturers must submit a Premarket Tobacco Application (PMTA) to the agency disclosing a product’s ingredients, along with scientific studies on its impact. FDA then makes a determination as to whether allowing the product on the market is appropriate for the protection of public health, weighing such factors as the risks and benefits to the population as a whole, whether people who currently use any tobacco product would be more or less likely to stop using such products, and whether people who currently do not use any tobacco products would be more or less likely to begin if the new product were available.  

In response to FDA issuing MDOs against some flavored products, e-cigarette manufacturers have sued to keep their products on the market. Beginning in October of 2021 up until a PDF iconrecent filing at the US Supreme Court, ACS CAN has joined other tobacco control groups in participating as amicus in numerous cases
supporting FDA across the nation. For example, Triton Distributors brought a lawsuit against FDA in an attempt to keep its flavored e-cigarette products Jimmy the Juice Man, Strawberry Astronaut, and Chew Clouds Sour Grape, in stores. Our briefs provide the courts with scientific data on the epidemic of e-cigarettes by children, including that e-cigarettes are the most popular tobacco product among youth, with more than two million young people reporting current e-cigarette use in 2021.  The briefs also provide background on how the tobacco industry has long understood that almost all new tobacco users begin their addiction as children, and that flavored products are essential to successfully market the products to young people. In 2021, over 80% of youth e-cigarette users used a flavored product. By contrast, there is little evidence that flavors have any role in helping cigarette smokers quit. Thus, flavored e-cigarette products should not be permitted to remain on the market during the litigation.