The promotion and use of electronic nicotine delivery systems will be subject to higher regulation if H.R. 5010, currently pending in the U.S. House of Representatives, is enacted. On June 26, 2014, Representative Speier and four other co-sponsors introduced the Stop Selling and Marketing to Our Kids E-Cigarettes Act (the “SMOKE Act”). The SMOKE Act has been referred to the House Committee on Energy and Commerce.
The proposed law would subject e-cigarettes to several regulatory schemes which currently apply to traditional cigarettes and other tobacco products. If enacted, the SMOKE Act would prohibit certain forms of advertising, as well as limit nicotine dosage and generally restrict the access of e-cigarettes to youth.
Part of the motivation of Representative Speier for introducing the bill is the stated unknown risks of electronic nicotine delivery systems, and the effect their use could have on minors. “With flavors like gummy bear, cotton candy, and chocolate cake, and devoid of child-proof containers, our kids are literally gobbling these things up,” said Congresswoman Speier after she introduced the bill. “With advertising that uses sex and sex appeal, youth are drawn to these products in hopes they will make them more glamorous, sexy or appealing.”
The bill defines “electronic nicotine delivery system” as “any product, the use of which may resemble smoking, that provides an inhalable dose of nicotine by delivery of a vaporized solution, including any such product that is marked as an electronic cigarette, cigar, cigarillo, pipe, or hookah.” The definition includes “any component, part, or paraphernalia of such a product, including cartridges, cartomizers, e-liquid, smoke juice, tips, atomizers, batteries, and chargers, whether or not the component, part or paraphernalia is sold separately.” The bill defines “e-liquid” as “a solution that contains nicotine, flavorings, or other chemicals that is intended to be used to product an inhaled vapor from an electronic nicotine delivery system.”
If enacted, the bill would require the Secretary of Health and Human Services to complete a study, within one year, on any purported health benefits of flavorings in electronic nicotine systems and e-liquids and whether flavorings would appeal to children. After completion of the study, the bill calls for the Food and Drug Administration (“FDA”) to consider whether it should prohibit or restrict the use of flavorings in electronic nicotine delivery systems and e-liquids.
In addition, the bill requires that several tobacco product standards be promulgated under the Food, Drug and Cosmetic Act (the “FD&C Act”) within one year of its enactment. These standards include:
- requiring child proof packaging for electronic nicotine delivery systems and e-liquids;
- limiting the dosage for electronic nicotine delivery systems and e-liquids to an amount that is adequate for the majority of smokers who use electronic nicotine delivery systems as a substitute for smoking, but would allow access to a higher dosage through a prescription; and
- establishing the maximum concentration of nicotine in e-liquids, as well as labeling requirements for the concentration of nicotine that would be adequate for the majority of smokers using electronic nicotine delivery systems as a substitute for smoking, but would also allow access to a higher dosage through a prescription.
In its current form, the SMOKE Act would also:
- amend the FD&C Act to include the bill’s definitions of “electronic nicotine delivery system” and “e-liquid,” placing these devices under the same regulations as cigarettes and other tobacco products;
- extend the Federal Cigarette Labeling and Advertising Act to cover electronic nicotine delivery systems;
- task the Federal Trade Commission with prohibiting and enforcing against any marketing, advertising or promotion that would increase electronic cigarette usage by children; and
- vest state attorneys general with the power to bring civil actions and penalize violators.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco practice partner, at 804.697.1420 or by email.