Electronic Cigarette Industry Regulatory Efforts and Views Clarified

Adversaries to electronic cigarettes misrepresent views and efforts of the industry to influence regulators.


Washington, DC -- (ReleaseWire) -- 02/08/2013 --An open comment period was held by the U.S. Food and Drug Administration through January 16th to accept input on innovative products and treatments for tobacco dependence. The comment period included a public hearing in December.

Electronic cigarette advocates and communities rallied to provide input on how regulation as either tobacco products or smoking cessation aids would negatively impact them personally. The argument is that regulated as tobacco products, the sale of electronic cigarettes would be subject to the same restrictions faced by conventional tobacco cigarettes. Regulated as smoking cessation aids, electronic cigarette companies would be required to prove their products successful as cessation aids before selling them to the public.

A number of electronic cigarette adversaries claim the industry wants to be able to make claims about the success of electronic cigarettes as cessation devices without going through the clinical trials necessary to prove it. This is a misrepresentation of the expectations the electronic cigarette industry has for regulation. This also, incorrectly, applies the statements and views of some private citizens and consumer groups to businesses and industry leaders.

In reality, responsible marketers of electronic cigarettes and industry leaders do not make cessation related claims. Indeed, the Sottera court ruling in 2010 determined that electronic cigarettes could not be regulated as drug delivery devices as long as cessation related claims are not made for the products. For this reason, electronic cigarette companies avoid making or supporting cessation-related statements.

The Smoke Free Alternatives Trade Association (SFATA) is not in support of regulation of electronic cigarettes as either tobacco products or smoking cessation products. The only common element between electronic cigarettes and tobacco is nicotine. Electronic cigarettes deliver a tobacco free vapor. Thus, SFATA believes that electronic cigarettes should be regulated separately from tobacco products. Although they deliver nicotine and resemble tobacco cigarettes, electronic cigarettes do not derive their vapor from tobacco leaves.

As to smoking cessation, electronic cigarettes do not exist for cessation and shouldn't be regulated (or banned) based on their success in this capacity. SFATA does believe that individual companies that desire to make smoking cessation claims should go through the FDA approval process as other companies have done for other smoking cessation products.

It is SFATA's belief that electronic cigarettes should be regulated under a niche category of their own. Only in doing so can electronic cigarettes be meaningfully regulated in a way that doesn't needlessly restrict or prohibit their sale by forcing them into an inappropriate regulatory framework.

The Smoke Free Alternatives Trade Association is dedicated to the advocacy, education, and reputation of the electronic cigarette industry. Through its membership, SFATA builds the networks necessary to support campaigning and research endeavors necessary to secure the future of the industry. SFATA's primary concern is the fair regulation of electronic cigarettes in a way that creates an even playing field for all companies in the market. For more information, visit SFATA.org.