FDA’s New Rule for E-Cigarettes,… | Campaign for Tobacco-Free Kids
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FDA’s New Rule for E-Cigarettes, Cigars Takes Effect Today; Congress Must Reject Proposals to Weaken Agency’s Oversight

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
August 08, 2016


WASHINGTON, DC – The Food and Drug Administration’s long-overdue rule to protect kids and public health from electronic cigarettes, cigars, hookah and other previously unregulated tobacco products takes effect today. This rule is necessary to address the skyrocketing use of e-cigarettes among youth and prevent kids from using any tobacco product.

As the FDA takes this important step, it is critical that Congress reject efforts to weaken the FDA’s rule, including the two provisions that were included in the House appropriations bill that funds the FDA. One provision exempts so-called “large and premium cigars,” but defines such cigars so broadly that it could also exempt some cheap, machine-made, flavored cigars that are widely used by kids. The second provision limits FDA oversight of e-cigarettes and cigars already on the market, including products with kid-friendly flavors such as gummy bear, cotton candy and fruit punch that have flooded the market in recent years.

Make no mistake: The provisions in the House appropriations bill benefit tobacco manufacturers at the expense of our nation’s children. They ensure that the industry will continue to target kids with candy- and fruit-flavored e-cigarettes and cigars and help the industry addict yet another generation of children. Fortunately, these provisions are not in the Senate appropriations bill that funds the FDA. They must not be allowed to become law.

In fact, the FDA’s rule must be strengthened rather than weakened. The FDA should quickly issue additional regulations prohibiting the use of all flavors in tobacco products, including candy, fruit and menthol flavors. E-cigarettes and cigars are sold in an array of sweet, kid-friendly flavors, and the FDA’s own research shows these flavors play a key role in the popularity of these products among kids. The FDA proposed removing such flavored products from the market in the rule it submitted to the White House Office of Management and Budget for review, but OMB deleted this provision from the final rule issued on May 5, as revealed by recently released government documents. This inexplicable action must be reversed.

There is a clear need for the FDA’s new rule. Government surveys have shown that youth use of e-cigarettes has skyrocketed and now far exceeds youth use of regular cigarettes. The CDC’s 2015 Youth Risk Behavior Survey found that 24.1 percent of high school students were current (past-month) users of e-cigarettes, compared to 10.8 percent who smoked cigarettes. This survey also showed that high school boys now smoke cigars at a higher rate than cigarettes – 14 percent for cigars and 11.8 percent for cigarettes.

The United States has made enormous progress in reducing smoking, but tobacco use remains the nation’s No. 1 cause of preventable death, killing nearly half a million Americans and costing the nation about $170 billion in health care bills each year. The FDA’s new rule is critical to preventing a new generation of tobacco products from threatening this progress.

Key Elements of New Rule

The FDA rule being implemented today was issued under a landmark 2009 law, the Family Smoking Prevention and Tobacco Control Act. The law gave the FDA immediate 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, cigars and other newly-regulated tobacco products.

Provisions taking effect today for these newly-regulated products:

  • Prohibit sales to children under 18, require retailers to verify age for over-the-counter sales and provide for federal enforcement and penalties against retailers who sell to minors.
  • Prohibit free samples.
  • Restrict vending machine sales to adult-only facilities.
  • Prohibit manufacturers from claiming a tobacco product is less harmful without first providing the FDA with scientific evidence supporting the claim and demonstrating that it will benefit public health as a whole.
  • Prohibit the introduction of new or changed products without prior FDA review and scientific evidence demonstrating that allowing a product is “appropriate for the protection of public health” (this provision applies to all products introduced since February 15, 2007, but manufacturers will have up to two years to submit applications to the FDA for products already on the market).
  • Authorize the FDA to set standards governing the content of tobacco products.

Provisions to be implemented at later dates will:

  • Require all tobacco products containing nicotine to carry an addiction warning label and cigars to carry one of five other rotating warnings as well.
  • Require disclosure of ingredients and documents related to health, and authorize FDA to request additional documents related to research and marketing.