American Lung Association Deeply Troubled by FDA's Delay in Protecting Public Health from Newly-Deemed Tobacco Products

Statement of Harold P. Wimmer, National President and CEO of the American Lung Association, in response to today’s announcement by the U.S. Food and Drug Administration (FDA):.

“The American Lung Association is disappointed by FDA’s announcement today, which makes fundamental changes to how e-cigarettes, cigars and other newly-deemed products are regulated in the United States. There is no question that today’s announcement undermines key public health protections designed to protect the health of Americans and our nation’s children. 

“Of particular concern is the long and unreasonable delay for newly-regulated tobacco products to submit tobacco product applications for FDA review as required under FDA’s May 2015 deeming rule.The changes announced this morning would push these dates back to August 8, 2021, for newly-regulated combustible products, such as cigars and hookah, and August 8, 2022, for non-combustible tobacco products, such e-cigarettes. The changes would also allow all newly-regulated tobacco products on the market as of August 8, 2016, including all tobacco products with kid-friendly flavors, to stay on the market for years.

“FDA is right to recognize that the amount of nicotine in cigarettes must be evaluated. Reducing the addictiveness of these deadly products will make it easier for smokers to quit, which is why Congress gave FDA the authority to require such changes. However, the American Lung Association is concerned that the process outlined by the Commissioner today regarding nicotine levels will simply lead to delays.

“Also unacceptable is FDA’s announcement that it will seek public input on the role flavors – including menthol – play in attracting youth when the role of flavors in tobacco products are well known. In fact, in an earlier version of the deeming rule, FDA proposed to eliminate flavors from e-cigarettes, and last May then-Secretary of Health and Human Services Sylvia Burwell announced that FDA would propose a product standard to eliminate flavors from cigars. In 2011, FDA’s own Tobacco Product Scientific Advisory Committee released a detailed recommendation that menthol cigarettes be removed from the marketplace. In the final deeming rule, FDA also determined that there is no reason to exclude any cigars from FDA oversight.  The bottom line is that opening these issues for public debate when we have scientific evidence and consensus is a delay tactic that places health of our nation at risk.

“Today’s announcement means the tobacco industry will have at least four more years to continue to market candy-flavored tobacco products to children, and an unknown time to continue to sell menthol cigarettes.  The American Lung Association urges FDA to implement science-based public health standards that work toward ending our nation’s tobacco epidemic. Tobacco use is the leading cause of preventable death and disease, and the FDA must do more to protect the health of Americans and our children.” 

Learn more about e-cigarettes and lung health at Lung.org/ecigs. For media interested in speaking with an expert about e-cigarettes, tobacco use and lung health, contact the American Lung Association at [email protected] or 312-801-7628.

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About the American Lung Association
The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease, through research, education and advocacy. The work of the American Lung Association is focused on four strategic imperatives: to defeat lung cancer; to improve the air we breathe; to reduce the burden of lung disease on individuals and their families; and to eliminate tobacco use and tobacco-related diseases. For more information about the American Lung Association, a holder of the Better Business Bureau Wise Giving Guide Seal, or to support the work it does, call 1-800-LUNGUSA (1-800-586-4872) or visit:  Lung.org.