Washington, D.C. May 5, 2016 – American Heart Association CEO Nancy Brown issued the following comments today on the Food and Drug Administration’s (FDA) release of the final tobacco deeming rule that gives the agency authority to regulate tobacco products, including e-cigarettes, hookah and cigars:

“At last, Americans can breathe a sigh of relief now that all tobacco products have the federal oversight they’ve needed for a very long time. The American Heart Association has strongly advocated for across-the-board FDA regulation, and we applaud the FDA for issuing the final deeming rule that will do just that.   

All tobacco products present risk. That’s why it was absolutely necessary for the FDA to assert its authority over these products. We commend the FDA for taking this significant step to protect the cardiovascular health of Americans and prevent children from starting down a dangerous and addictive path.

Keeping cigars, e-cigarettes and hookah out of the hands of young Americans should be a top priority for the agency now that the FDA’s jurisdiction has been extended. The Centers for Disease Control and Prevention (CDC) has found that e-cigarette use among U.S. teens has tripled in just one year. Similarly, hookah use has roughly doubled in middle and high school students, and cigar use remains high; every day more teenage boys start using tobacco with a cigar for the first time rather than a cigarette. Now, thanks to this new rule, more potential tobacco users will hopefully be steered clear from taking that first puff during adolescence. Research and tobacco surveillance shows that effective regulation of tobacco products helps reduce tobacco use in both youths and adults.

While the rule addresses the important issue of flavoring, we would have liked to see candy and fruit flavors banned outright for all tobacco products. According to a CDC-FDA study, seven out of 10 middle and high school students who currently use tobacco use a flavored product. While we are pleased that the FDA intends to issue a separate rule prohibiting characterizing flavors in cigars, we continue to encourage the FDA to extend the ban to e-cigarettes. Tough regulation is needed or tobacco companies will only continue to use cunning tactics and sweet flavors in an attempt to entice a new generation of kids to a lifetime of nicotine addiction.

The FDA also has stated it will consider additional access restrictions if necessary. In addition, the final rule raises concern about the increase in nicotine poisonings in children and begins to address the need for nicotine exposure warnings. We hope the agency moves forward with child-resistant packaging for liquid nicotine and other tobacco products quickly. We appreciate that the FDA is starting to examine the need for such packaging, but the time to act is now – before one more child is poisoned. Further, we press the FDA to build upon the requirements in the recently passed Child Nicotine Poisoning Prevention Act and require these products to bear a warning statement about the risks of nicotine exposure and the need to keep the products away from children.

The American Heart Association has fervently urged the FDA to crack down on the industry’s efforts to target children. We call on the FDA to go beyond its action today and take stronger steps to prevent manufacturers and retailers from using marketing and advertising techniques that appeal to kids and young adults. Similarly, we appreciate the enforcement provisions in the regulation and must be appropriately cautious and diligent to ensure that the period of time companies are given to submit their applications does not handicap effective enforcement and jeopardize public health.

The American Heart Association has been committed to the fight against tobacco for more than five decades. We are glad that the extended wait for this final rule is over and applaud the FDA for establishing a tighter grip on these products. These new regulations will go a long way in helping to protect Americans from cardiovascular disease, the number one killer in the United States, and move us closer to becoming a tobacco-free nation.”


Media ContactAbbey Dively (202) 785-7905 abbey.dively@heart.org