On April 25th, 2011 in a press release posted on the FDA’s website, the FDA finally acknowledged what the courts told them on multiple occasions; the electronic cigarette is not a medical device or new drug, but rather a tobacco product. In the press release they are clear that absent any therapeutic claims such as the ability to help smokers quit smoking, the e-cigarette is indeed a tobacco product. What is not clear is what regulations will be imposed.
Many e-cigarette advocates hail this news as a win for the electronic cigarette as well as for proponents of the reduced harm philosophy. And although we agree this was a necessary step towards the end goal, the question still remains of how exactly the FDA will treat the e-cigarette. Too many regulations with high market entry costs may stifle the market and give the advantage to traditional tobacco cigarettes. Not enough regulations could mean a negative perception of the technology in general.
What is important is not that the FDA realizes that it didn’t have a choice in the categorization of the smokeless cigarette, but rather what it does next. The courts had already decided the relative category of the product. What the courts didn’t say (and won’t) is what regulations will be in play.
We hope the FDA takes a thoroughly scientific approach to e-cigarette regulation. With politics and lobbying left behind, the e-cigarette should be able to compete fairly on the market with tobacco cigarettes…..which as we have mention before kills more people each year than AIDS, cocaine, heroin, alcohol, vehicular accidents, homicide and suicide combined. We also hope that the FDA does not squash an otherwise thriving small American industry. Yes, much of the components and e-liquid is made overseas (although our most popular e-liquid is made in the USA but the suppliers are small American businesses that utilize many other American companies in support of their business. And with such a new technology product, the continuation of development and product innovation will only be possible through fair and open market competition.
So we appreciate the FDA acknowledging what the courts have told them and are hopeful that their regulation is what is best for public health and the entire e-cigarette industry.