Washington, D.C. – The U.S. Food and Drug Administration (FDA) issued draft guidance this morning outlining steps it will take to address the public health crisis that has resulted from surging rates of youth use of tobacco products, a trend being largely driven by access to and use of flavored e-cigarettes. While the draft guidance does include some restrictions on the sale of flavored e-cigarettes, a major contributing factor to the popularity of the products among youth, it falls far short of the agency’s statutory obligations under the Family Smoking Prevention and Tobacco Control Act of 2009.
The following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN):
“While we appreciate Commissioner Gottlieb and the administration’s recent efforts to shine a light on the public health epidemic that is resulting from youth use of tobacco products, the guidance released by FDA today falls far short of adequately addressing this crisis. Only a full prohibition on all flavored tobacco products will help prevent new, young consumers from initiating use.
“It is disappointing that FDA continues to stop short of fulfilling its full statutory obligations, instead relying on industry self-improvement to address the very problem the industry has created. In short, the plan unveiled today will not do nearly enough to improve the health of our nation by keeping kids off tobacco products.
“No tobacco product defined as “new” by the Tobacco Control Act should be on the market without a premarket review order from the FDA. Yet, the vast majority of e-cigarettes that are driving the explosion of tobacco use among youth have not undergone a premarket review. It’s for this reason ACS CAN and our public health partners have filed suit in federal court to compel FDA to exercise its statutory mandate and regulatory authority over all tobacco products.
“We once again are calling on FDA to implement proposals that will reverse the alarming trend of youth use of e-cigarettes and other tobacco products by prohibiting all flavors and exercising its full authority over all tobacco products. FDA must also stop relying on the tobacco industry to self-improve when their very products and actions are designed to addict a new generation of consumers to their deadly and addictive products.”
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