By Thomas Kiklas, Co-Founder, TVECA
Recently, the Tobacco Vapor Electronic Cigarette Association (TVECA) was asked to participate at VapeWorld in Chicago. During a roundtable question and answer period there was great confusion as to why e-cigarettes are and will continue to be regulated as a tobacco product. This is a pervasive question.
When I speak to individual c-store owners or managers they also inquire also as to why a product that simply delivers a vapor, not smoke, is being regulated as a tobacco product.
To understand why, you must understand what brought the industry to this point. The electronic cigarette is by no means a new product. Cigarettes have been on the U.S. market for hundreds of years and patents for “smokeless cigarettes” go back to the 1960s.
The e-cig industry has simply refined a product that was in great need of advancement and gave that product a new social utility in a world that is using microcircuitry to advance and refine many aging technologies.
A tobacco cigarette delivers nicotine to the lungs through pulmonary action-as does an electronic cigarette. The nicotine in an electronic cigarette is derived from leaf and stem of the tobacco plant, as is a tobacco cigarette.
In 2005, this variant of a tobacco cigarette was developed and brought to the U.S. market. In 2008, the U.S. Food and Drug Administration (FDA) visited a kiosk in Washington D.C. that was offering TVECA Founder Ray Story’s electronic cigarette brand Smoking Everywhere (SE). After examining the product, the FDA said, “SE’s product met the definition of both a drug and device under the Federal Food, Drug and Cosmetic Act.
This determination spurred the FDA to seize SE’s shipment and subsequent shipments. It was the FDA’s position that an electronic cigarette was a drug/device combination.
Many experts believe that nicotine is a “pharmacological agent,” and having drug-like effects. SE disagreed with this determination that nicotine is a drug and brought suit against the FDA in Smoking Everywhere vs. FDA. To be absolutely clear, there was no option to not be regulated and no option to be a simple consumer product.
Fighting the FDA
SE successfully argued in the litigation against FDA that nicotine is not a drug and is not therapeutic as it does not treat or cure any disease nor does it alter the function of mind or body. Is nicotine addictive? Yes. Should it be available to minors? No. It is the position of the TVECA now and successfully argued in the landmark case that as the nicotine used in the electronic cigarette is “derived from stem or leaf of tobacco” the electronic cigarette is indeed a tobacco product.
In December 2010, the Washington D.C. Appellate Court reaffirmed that the e-cig was a tobacco product in Sottera vs. FDA and stated that “unless a product derived from tobacco is marketed for therapeutic purposes, the FDA may regulate it only under the provisions of the Tobacco Control Act.”
Without the successful litigation brought by the TVECA, there would NOT be an electronic cigarette industry in the U.S. The TVECA successfully brought similar litigation in the Netherlands where the e-cig was a medicinal product and now freely available to its citizens as a tobacco product. Finally the electronic cigarette would be a medicinal product in the E.U. requiring a prescription without the lobbying efforts of the TVECA and impassioned others.
We hope this provides the industry and retailers with an understanding of the years of arguing and very extensive and expensive litigating for the electronic cigarette the TVECA has done and is still doing to keep the electronic cigarette freely available to consumers as any path other than as a tobacco product would remove the electronic cigarette from the markets.