FDA Asserts Oversight Authority over Cigars, E-Cigarettes, Other Tobacco Products
Lung Association welcomes release of long-overdue public health protections, calls on Congress to support FDA’s commonsense steps
(May 5, 2016) - Chicago, IL
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Today, the Food and Drug Administration’s (FDA) Center for Tobacco Products issued its long-awaited final rule giving the agency regulatory authority over all tobacco products, including e-cigarettes, cigars, little cigars, hookah, pipe tobacco and other tobacco products. The regulation was released today by U.S. Department of Health and Human Services, and gives FDA authority over the sales, marketing and manufacturing of all tobacco products.
“Too many children and teens are using e-cigarettes, cigars and other tobacco products,” said Harold P. Wimmer, National President and CEO of the American Lung Association. “The American Lung Association welcomes this long-awaited step to protect public health. At last, the Food and Drug Administration will have basic authority to make science-based decisions that will protect our nation’s youth and the public health from all tobacco products, including e-cigarettes, cigars and hookah.”
The American Lung Association is pleased that the FDA followed our recommendation and is including all cigars in the rule. The proposed regulation sought public comment on two different options, one of which would have exempted certain cigars from the most basic of FDA oversight – including warning labels and federal prohibitions against selling tobacco products to minors.
FDA will now have authority over all e-cigarettes, the use of which is skyrocketing among children and teens. While FDA’s Center for Drug Evaluation and Research has always had the authority to review safety and efficacy of therapeutic claims, FDA’s Center for Tobacco Products can now halt e-cigarette manufacturers from making unproven health claims and marketing directed to kids. The rule sets the nationwide minimum age of sale 18 years of age and prohibits distribution of free samples of e-cigarettes and all other tobacco products.
“Youth use e-cigarettes more than any other tobacco product on the market today, serving as an entry point to more traditional tobacco products and placing kids at risk to the harms and addiction of nicotine and other tobacco products,” Wimmer said. “Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products.”
In April, the U.S. House of Representatives Committee on Appropriations included two policy riders on the funding bill for the Food and Drug Administration. The first rider would prohibit FDA from implementing this final deeming regulation unless the deeming regulation exempted certain cigars from basic FDA oversight. The second rider would grandfather in thousands of unregulated tobacco products currently on the market, including e-cigarettes, little cigars and hookah. Neither rider has the weight of law unless included in the final appropriations bill that is signed into law by the President.
“The Lung Association urges Congress to support public health protections and reject attempts to block or weaken FDA’s commonsense steps to protect the public health,” Wimmer said.
Congress passed the Tobacco Control Act in 2009, granting the Center for Tobacco Products immediate authority over cigarettes, smokeless and roll-your-own tobacco products. Congress also gave authority to the agency to assert jurisdiction over other tobacco products, which FDA is finally doing today. FDA initially announced its intent to assert jurisdiction over other tobacco products in 2010, and in April of 2011 announced its plan to include e-cigarettes as well. The proposed rule was released in April of 2014.
For media interested in speaking with an expert about lung health, tobacco use and tobacco policies, contact the American Lung Association at [email protected] or 312-801-7628.
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.