Democratic Leaders Urge FDA Action, Call For State Attorneys General To Classify E-Cigarettes Under The Master Settlement Agreement

[WASHINGTON, D.C.] –U.S. Senator Dick Durbin (D-IL), Representative Henry A. Waxman (D-CA), and Representative Frank Pallone, Jr. (D-NJ) sent letters to 29 State Attorneys General applauding their ongoing efforts to press the FDA to use its enforcement discretion to prevent e-cigarette manufacturers from targeting teens. The members also called on the Attorneys General to classify e-cigarettes as cigarettes under the Master Settlement Agreement (MSA) to prevent e-cigarette makers from marketing their products in ways that are appealing to youth.

The members wrote: “We have admiration for your efforts to protect children from the dangers of tobacco. We want to work with you to strengthen FDA’s resolve. At the same time, we hope you will consider taking this much-needed step in the ongoing battle against tobacco products. The MSA gives you a powerful tool to stop e-cigarette makers from targeting youth, and we urge you to consider using it.”

Earlier this year, Illinois Attorney General Lisa Madigan was one of 29 Attorneys General to submit comments to the FDA urging the agency to strengthen its proposed regulations of electronic cigarettes to better protect children and young adults from nicotine addiction. More information is available here.

The full text of the letter is available here.

December 19, 2014

Dear Attorney General:

            This week, three new studies were released that documented the soaring use of electronic cigarettes by America’s youth.  One study showed that for the first time, more teens used e-cigarettes than traditional cigarettes or any other tobacco products.^[1]  The two other studies indicate that more than one quarter of high school students in Connecticut and Hawaii have used e-cigarettes.^[2]  These findings are particularly concerning because e-cigarettes contain nicotine, a highly addictive drug, and because e-cigarette use may be a gateway to cigarette smoking, reversing the long-term decline in smoking over the past few decades.^[3]  

            The Food and Drug Administration (FDA) has issued a proposed rule that would bring e-cigarettes under its jurisdiction.^[4]  We applaud you and the 28 other Attorneys General who submitted comments to FDA setting forth your support for the proposal, as well as your belief that it should be strengthened in key ways, such as by prohibiting characterizing flavors in newly deemed tobacco products.^[5]  We share your views and those of the other co-signers and have urged FDA to use its enforcement discretion to make the final rule more protective of children.^[6]

            We hope you will continue to press FDA to act quickly and forcefully.  At the same time, we urge you to consider taking action at the state level.  Specifically, we believe you could take a significant step in the battle against tobacco use by classifying e-cigarettes as cigarettes under the Master Settlement Agreement (MSA) with the tobacco companies.  That is why we are writing to you and the 28 other attorneys general who signed the August 8, 2014, letter to FDA.  

            This action would have an immediate and much needed impact because it would stop the e-cigarette makers from marketing their products in ways that are appealing to kids.  Bringing e-cigarettes under the MSA would not remove them from the market or make them unavailable to adults who may see them as a safer alternative to conventional cigarettes.  But it would bar the manufacturers from targeting youth, using cartoons and youth-oriented sponsorships to promote their products, and advertising on outdoor billboards. 

Background

            New evidence continues to show an emerging epidemic of e-cigarette use by children.  According to the University of Michigan study, 9% of eighth graders reported using an e-cigarette in the past 30 days, but only 4% had used a traditional cigarette; 16% of tenth graders reported using an e-cigarette, while only 7% had used a traditional cigarette; and 17% of twelfth graders had reported using an e-cigarette, while just 14% reported using a traditional cigarette.^[7]  Two other studies released this week revealed that 25% of high school students in Connecticut and 29% of teens in Hawaii had used e-cigarettes.^[8]  The authors of one of these studies said e-cigarette use is growing exponentially among kids, doubling every year since 2009.^[9]  

            One of the primary causes of the rising use of e-cigarettes by children is the lack of effective regulation.  E-cigarettes are subject to none of the restrictions on advertising and marketing that apply to conventional cigarettes.  E-cigarette makers are advertising their products on TV and radio.  They are using cartoon imagery, sports sponsorships, and candy flavors.  Their print advertisements feature celebrities and sex appeal.  In fact, as we wrote FDA Commissioner Margaret Hamburg in August, “E-cigarette companies are employing the same tactics used by big tobacco decades ago: showcasing glamorous celebrities, creating cool cartoons, and pushing their brands through sexy television and print advertisements.”^[10]

We support FDA’s proposal to deem e-cigarettes to be tobacco products under the Family Smoking Prevention and Tobacco Control Act.^[11]  We share your view that the proposal should be strengthened before it is finalized to more effectively curb the youth targeting by e-cigarette makers.^[12]  But the FDA process has been a lengthy one and it could be months before FDA finalizes the proposed rule.  That is why we are writing to urge you to consider using your authority under the MSA to take immediate action against the efforts of e-cigarette companies to target children.

E-Cigarettes and the Master Settlement Agreement

            We believe e-cigarettes meet all the criteria for the definition of cigarette (and tobacco product) in the Master Settlement Agreement.  Indeed, the MSA contemplated that novel products -- like e-cigarettes -- would later meet the definition of cigarette.  Inclusion of these products in the definition of cigarette is consistent with the MSA’s overarching goal of protecting America’s youth from the harms of tobacco use.

            The MSA defines “tobacco products” as “cigarettes and smokeless tobacco products.”^[13]  In turn, “cigarettes” are defined as follows: 

any product that contains nicotine, is intended to be burned or heated under ordinary conditions of use, and consists of or contains (1) any roll of tobacco wrapped in paper or in any substance not containing tobacco; or (2) tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette; or (3) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in clause (1) of this definition.^[14]

            We believe e-cigarettes meet this definition.  They “contain nicotine.”  They are “heated under ordinary conditions of use.”  They “contain … tobacco, in any form” because their key ingredient is nicotine, which is produced from tobacco leaves.  In fact, at least one of the leading e-cigarette brands bears a label which lists “tobacco-derived nicotine” as the first ingredient.^[15]  E-cigarettes are also “likely to be offered to, or purchased by, consumers as a cigarette.”  Often, the whole e-cigarette experience is designed to resemble cigarette use through sales of e-cigarettes in packs (like traditional cigarettes), the vapor inhalation process replicating a traditional smoking experience, and the glow of the e-cigarette tip mimicking what happens when users take a drag of a combustible cigarette.^[16] 

            Classifying e-cigarettes as cigarettes under the MSA would have immediate benefits.  A principal goal of the MSA is “reducing underage tobacco use by discouraging such use and by preventing [y]outh access to [t]obacco [p]roducts.”^[17]  Tobacco companies subject to the MSA are prohibited from taking any action “directly or indirectly, to target [y]outh … in the advertising, promotion or marketing of [t]obacco [p]roducts, or take any action the primary purpose of which is to initiate, maintain or increase the incidence of [y]outh smoking.”^[18]  The MSA bans the use of cartoon images to advertise or promote tobacco products; prohibits brand-name sponsorship of youth-oriented events; restricts outdoor advertising of tobacco products; outlaws gifts without proof of age; and prohibits payments to promote tobacco products in movies and other forms of media.^[19] 

            We understand that there is a debate within the public health community about the value of e-cigarettes as an alternative to conventional cigarettes for adult smokers.  But no one should be in favor of the use of these products by children.  By taking action to apply the MSA to e-cigarettes, you could make a giant stride in protecting kids from a lifelong addiction to nicotine.

Conclusion

            Members of Congress first raised the idea of action under the MSA in a letter to the Attorneys General of their states earlier this year.^[20]  We believe the new studies add urgency to the need for action and so are writing you today.

            We have admiration for your efforts to protect children from the dangers of tobacco.  We want to work with you to strengthen FDA’s resolve.  At the same time, we hope you will consider taking this much-needed step in the ongoing battle against tobacco products.  The MSA gives you a powerful tool to stop e-cigarette makers from targeting youth, and we urge you to consider using it. 

Sincerely,

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