May. 5 2016
WASHINGTON, DC – The Obama Administration today has taken a critical first step – but only a first step – to protect America’s kids from a new generation of tobacco products by issuing a long-overdue rule establishing FDA oversight of electronic cigarettes, cigars, hookah and other previously unregulated tobacco products.
On the positive side, this rule extends FDA oversight to all tobacco products, without exception, and rejects proposals to exempt so-called “premium cigars.” It applies common-sense public health protections to all tobacco products, including health warnings, a national prohibition on sales to minors and rules to prohibit manufacturers from making unproven health claims. The FDA also announced plans to extend the current federal ban on candy- and fruit-flavored cigarettes to include flavored cigars, although this will require additional rule-making and the FDA did not commit to a specific timetable.
However, the rule announced today falls short in protecting kids from e-cigarettes. It does nothing to restrict the irresponsible marketing of e-cigarettes or the use of sweet e-cigarette flavors such as gummy bear and cotton candy, despite the FDA’s own data showing that flavors play a major role in the skyrocketing youth use of e-cigarettes. While e-cigarette manufacturers will claim these rules impose an unfair burden on them, they allow all e-cigarettes to remain on the market for at least three years, no matter how great their appeal to kids, unless the Administration moves quickly to close these gaps.
The FDA’s own research, published in an October 2015 study in JAMA, found that most youth, ages 12-17, who had ever experimented with tobacco started with a flavored product, including 81 percent of youth who had ever used e-cigarettes. In addition, 85.3 percent of current youth e-cigarette users had used a flavored e-cigarette in the past month, and 81.5 percent of current youth e-cigarette users said they used e-cigarettes “because they come in flavors I like.”
A 2014 study found that e-cigarettes were available in more than 7,700 flavors, with hundreds more introduced every month. These include an assortment of candy and fruit flavors that clearly appeal to kids.
The FDA did announce plans to introduce a follow-up rule to prohibit use of most flavors in cigars. It must act quickly to do so. This is an important step because tobacco companies have peddled cheap, sweet-flavored little cigars to get around the 2009 federal ban on flavored cigarettes. However, as with cigarettes, this proposal would allow the continued sale of menthol-flavored products despite the FDA’s own conclusions that use of menthol leads to increased smoking initiation among youth and young adults and greater addiction. This proposal should be strengthened to prohibit e-cigarette flavors and end the use of menthol in all tobacco products.
The rule has other omissions: It does not restrict e-cigarette marketing, which often mimics tactics long used to market regular cigarettes to kids, nor does it take strong steps to prevent online sales of e-cigarettes and refill liquids to youth, despite studies showing many online vendors have inadequate age verification. The FDA must quickly develop follow-on regulations to address these challenges.
While the Administration should strengthen these new regulations, Congress must reject efforts to weaken them, including the two provisions recently approved as part of the House appropriations bill that funds the FDA. One provision would block the FDA from implementing this new rule unless it exempts certain cigars. The second provision would limit FDA review of e-cigarettes and cigars already on the market, including the many candy-flavored products that have flooded the market in recent years. These proposals would make it easier for tobacco companies to keep targeting our children.
Newly-Regulated Products Are Appealing to Kids
The final rule issued today is long overdue. It comes more than five years since the FDA first announced its intention to regulate all tobacco products and more than two years since the FDA issued its proposed rule on April 25, 2014. In the meantime, these unregulated tobacco products have become popular among youth:
Key Elements of New Rule
Today’s rule was issued under a landmark 2009 law, the Family Smoking Prevention and Tobacco Control Act. The law gave the FDA immediate regulatory authority over cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco and authorized the agency to extend its jurisdiction to all other tobacco products.
The new rule extends key provisions of the 2009 law to e-cigarettes and other newly regulated tobacco products. These provisions:
While the U.S. has made tremendous progress in reducing tobacco use, it still kills more than 480,000 Americans and costs the nation about $170 billion in health care bills. Effective FDA regulation of all tobacco products is necessary to accelerate progress and make the next generation tobacco-free.