Letter to Sylvia M. Burwell, Secretary of the Department of Health and Human Services - FDA E-Cigarette Regulation

Letter

We write to urge you to act quickly to finalize the proposed deeming rule to assert jurisdiction over all unregulated tobacco products, including e-cigarettes and cigars, without any exceptions. This regulation is critical in order for the Food and Drug Administration (FDA) to exercise federal oversight and reduce the adverse health consequences of these unregulated products, particularly to our nation's children.

More than six years ago, Congress passed the Family Smoking Prevention and Tobacco Control Act. This historic legislation gave the FDA immediate authority to exercise oversight of cigarettes and smokeless tobacco, but required FDA to promulgate regulations to assert similar authority over all tobacco products. We are concerned that the longer we delay oversight of unregulated tobacco products--e-cigarettes and cigars, and pipe tobacco products--the more harm these products will cause to the health of our nation. For far too long, the tobacco industry has exploited loopholes and continued to market its products to children.

We applaud the agency for including important provisions--like prohibiting e-cigarette sales to minors as well as restricting vending machine sales and prohibiting free samples to further prevent sales and use by minors--in the draft regulation proposed last year. In addition, the proposed rule makes important strides for consumer protection by requiring manufacturers to list product ingredients, and to ensure that labeling is not false or misleading. Lastly, we support FDA's position that pre-market approval is required for products that were not on the market as of February 15, 2007, as set forth by the Family Smoking Prevention and Tobacco Control Act. We agree with FDA's position that this grandfather date is set by statute, and we urge the agency to reject any requests to modify the grandfather date for deemed products.

While we commend FDA for proposing these important steps, we believe that the agency must take further steps to strengthen provisions related to e-cigarettes by regulating the use of flavorings and preventing companies from marketing e-cigarette products to children. According to recently released data from the 2014 National Youth Tobacco Survey, the use of e-cigarettes amongst middle school and high school students tripled between 2013 and 2014.[1] This extraordinary increase in e-cigarette use amongst our nation's children in just one year suggests that e-cigarettes bear the potential to outpace and reverse recent progress made in reducing youth tobacco use.

Unfortunately, the proposed rule, while acknowledging that flavorings can be "especially attractive to youth," declines to address this significant public health risk. A recent report documented an astonishing 7,764 unique e-cigarette flavor names available online in January 2014, under 466 different brands. Of the 7,764 flavors, only a small number relate to tobacco--the vast majority are candy-flavored in nature, such as chocolate raspberry, cherry cheesecake, cotton candy, vanilla, grape, apple, coffee, and bubble gum.[2] The Family Smoking Prevention and Tobacco Control Act prohibits flavorings from being used in traditional cigarettes, and we believe that the same prohibition should extend to e-cigarettes and other flavored tobacco products.

Additionally, we believe that the FDA should consider applying the same marketing regulations to e-cigarettes that exist for traditional cigarettes. A 2012 Surgeon General Report, Preventing Tobacco Use Among Youth and Young Adults, made clear that "there is strong, consistent evidence that advertising and promotion influence the factors that lead directly to tobacco use by adolescents."[3] E-cigarette companies are using the very same techniques that were once used to market cigarettes to children,[4] and as suggested by CDC's latest statistics, such strategies remain successful in hooking the next generation of our youth on tobacco products.

Finally, we ask for your leadership in ensuring that the final deeming regulation does not exempt any tobacco products. Specifically we urge that the final rule adopt the option in the proposed rule, Option 1, which would bring all cigars under FDA authority. There is no safe cigar and FDA's oversight is needed to meet the goals of the Tobacco Control Act.

Tobacco remains deadly -- it is still the number one cause of preventable death in the United States. We urge you to take swift action to strengthen and finalize the deeming rule.

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