Supporting FDA in Marketing Denial Orders

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.  

IIn 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, ACS CAN has joined other tobacco control groups in participating as amicus in numerous cases, culminating in an amicus filing in September in a critical case that will dictate whether many of these products can stay on the market and lure children into a lifetime of nicotine addiction.  At issue are flavors like Jimmy the Juiceman Peachy Strawberry and Pink Lemonade.  Read our statement.  ACS CAN had also urged the high court to accept the case in a separate amicus brief. Our briefs consistently provide the courts with scientific data on the epidemic of e-cigarette use by children, including that e-cigarettes are the most popular tobacco product among youth, and that more than two million young people reporting e-cigarette use in 2023.  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 2023, almost 90% 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.