By: David Gabor
The FDA defines electronic cigarettes, also known as e-cigarettes, “e-cigs” or “vapes” (as in vapors), as “battery operated products designed to deliver nicotine, flavor and other chemicals. They turn nicotine, which is highly addictive, into a vapor that is inhaled by the user.” http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm.
Selling and advertising e-cigarettes, now more commonly known as “vaping,” presents an array of legal issues. It has grown into an industry estimated to be at annualized sales of $2 billion a year — and growing. David Gabor, a member of the advertising group at Weintraub Tobin, has represented several brands of e-cigarettes, and understands the issues it faces in terms of marketing and advertising such products.
It is the FDA’s position that the “safety and efficacy of e-cigarettes have not been fully studied” and there is currently “no way of knowing” if e-cigarettes are safe for their intended use, how much nicotine or other potentially harmful chemicals are being inhaled during use, or if there any benefits associated with using e-cigarettes. Id.
Most importantly, in raising what is known as the “gateway drug” argument, the FDA takes the position that it is “not known if e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes . . . .” It is this “gateway” argument that is now at the center of a new round of state and local-level legislation affecting the ability to market and advertise these products.
In 2010, the U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), issued what is now recognized as a landmark ruling that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes. This ruling was seen by some as a victory for the e-cigarette industry. Had the products been legislated as a drug, it would take years of approval and testing before they could be sold to the public, and the conditions of those sales would be similar to pharmaceutical drugs. Legislation under the rubric of “tobacco products” – even though certain e-cigarettes contain nicotine not derived from the tobacco leaf – allowed a looser standard of marketing and sale of the product. The result of this ruling was that shopping malls all over the country suddenly sprouted carts or kiosks selling an exotic array of e-cigarette products. More recently, there has been a noticeable increase in more traditional storefront operations selling “vapes.”
The FDA quickly made clear, however, that the Sottera ruling was not a free pass for the industry. Advertising of the product was still subject to both FDA and FTC regulation. For example, e-cigarettes cannot advertise themselves as “smoking cessation products.” Such claims would have to be vetted by the FDA under stringent pharmaceutical standards. The FTC could also raise claims under false advertising statutes, since the efficacy of such use is anecdotal, at best. At present, only one line of products, Nicorette-style chewing gum, is approved for such use. In late 2010, the FDA sent a number of warning letters to e-cigarette manufactures that the Agency viewed as having run afoul of these advertising and marketing rules. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm225224.htm
In response to the “gateway drug” argument and the generally unregulated state of affairs in marketing “vapes,” — including the rise of candy-flavored products that are viewed as attracting young “vapers” — states and cities are increasingly attempting to regulate the sale, advertising, and distribution of e-cigarettes.
As reported in the Los Angeles Times on December 5, 2013, the LA City Council took a position that it was concerned that the various flavored e-cigarettes and similar products were a gateway to other more serious addictions and that they were not going to “wait for the feds to do something.” Accordingly, in early December, 2013, the City of Los Angeles enacted a law to regulate the sales of e-cigarettes and other vaping devices. These new regulations put electronic smoking devices in the same regulatory “bucket” as tobacco products. This means that, at a local level, vapes will be subject to being banned from sales at street kiosks, ice cream trucks, and in self-service displays. Sale of the products will require a license (and no doubt license fees).
Generally, the e-cigarette industry takes the position that e-cigarettes are a “safer alternative” to traditional cigarettes because they satisfy the nicotine addiction without, arguably, containing carcinogenic tar and other negative tobacco-leaf related issues. The industry also criticizes studies that demonstrate increasing use of e-cigarettes among the high school population, arguing that the results were skewed because they include anyone who has tried the product even once.
Regardless, if your business is involved in the sale, manufacture, or advertising of e-cigarettes or other vapes, the interlocking web of quickly increasing federal and local regulation requires a roadmap. David Gabor, a member of the advertising and litigation group at Weintraub Tobin, has had many years of experience dealing with the advertising of such products. Contact him directly at [email protected] for advice on how to navigate through these regulations.