On August 8, 2014, a group of Attorneys General from 29 states submitted comments in response to the Food and Drug Administration’s (“FDA”) Notice of Proposed Rule deeming certain tobacco products subject to the Food, Drug, and Cosmetic Act. In their letter, the group of Attorneys General stated that “[w]hile the Proposed Rule addresses some of our concerns, it fails to address matters of particular concern, such as characterizing flavors, the marketing of e-cigarettes, and the sale of tobacco products over the Internet.” As a result, the group of Attorneys General advocates, among other things, that the FDA should do the following:
- Prohibit characterizing flavors other than tobacco and menthol in electronic cigarettes;
- Impose on electronic cigarettes the same advertising, marketing and promotion restrictions that are currently in place for cigarettes and smokeless tobacco; and
- Restrict the advertising, promotion and sale of electronic cigarettes over the Internet
Ban on Characterizing Flavors
The Attorneys General acknowledged that cigarette consumption rates have been declining among youth and young adults; however, they argue that “youth are increasingly using other tobacco products.” As a result, the Attorneys General request in their letter that the FDA prohibit characterizing flavors – other than tobacco and menthol – in electronic cigarettes as well as other newly-deemed tobacco products. The Attorneys General offer “the protection of public health, particularly of youth” as their primary justification for the complete ban on characterizing flavors for all tobacco products. They also argue that such prohibition would provide consumers and manufacturers with clarity and certainty and would aid in enforcement because “enforcers would not have to make difficult determinations about whether a word, phrase, logo, or packaging connoted a flavor.”
The letter does not address the specific findings that the FDA must make in order to propose such a ban, or the fact that such a proposal must occur in a separate rulemaking – a fact that the FDA acknowledges in the proposed rule.
Advertising and Marketing Restrictions
According to the letter, electronic cigarettes have become increasingly popular in recent years, with increasing amounts of money being devoted to advertising: “Youth are increasingly bombarded with e-cigarette advertising in print, radio, and television.” The Attorneys General call for advertising and marketing restrictions that mirror those in place for cigarettes and little cigars. According to their letter, the electronic cigarette industry “has seized upon the lack of regulation to expose youth to advertising campaigns that would be prohibited for other tobacco products under current law and agreements.” Allowing such advertising to continue will likely increase youth electronic cigarette consumption rates according to the Attorneys General. Existing federal law prohibits advertising cigarettes and little cigars on any medium of electronic communications and the Attorneys General advocate for parallel restrictions on electronic cigarette companies.
The letter does not address whether the FDA actually has the authority to do this. The Tobacco Control Act contains no such express authority, as the Act’s advertising and marketing restrictions are limited to cigarettes and smokeless tobacco. Nor does the letter address the First Amendment implications of such a proposal.
The Attorneys General stated that the FDA’s proposed warning, “that e-cigarettes contain nicotine, which is addictive – will not prevent consumers from starting nicotine use or encourage them to quit.” Because electronic cigarette companies, as well as other tobacco companies, spend significant money on marketing, according to their letter, the Attorneys General call for more effective warnings on electronic cigarettes. Additionally, they also advocate that the warning labels should contain attention-grabbing color and cover 50 percent or more of the principal display area.
The letter likewise does not address the First Amendment implications of such a proposal. Nor does it address the utter lack of scientific evidence supporting more aggressive warnings.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco practice partner, at 804.697.1420 or by email.