Accusations that the FDA was being influenced by big tobacco began to circulate with the first FDA statement questioning the safety of electronic cigarettes. The statement was based on an extremely small non-scientific test and claims made were that various problems “might” be encountered by users of e-cigarettes.
For forty years the public has been informed about the dangers of smoking tobacco. That is when the first warnings were placed on cigarette packs yet our current pack warnings are among the weakest in the world. Only last year was the FDA sufficiently concerned about tobacco to move to regulate the products. In a magnanimous statement, big tobacco said they welcomed regulation and oversight by the FDA. Of course they did. It was a smart move by a company that could influence the regulations and make it more difficult for competing products to reach the public.
After various expressions of concern, the FDA banned importation of e-cigarette supplies from China. The ban was imposed in 2009 affecting the world’s biggest exporter of e-cig supplies. When announcing the ban, the FDA claimed concern that underage users would be tempted by flavored e-liquids and become addicted to nicotine. No proof or studies were offered as evidence for this concern.
In a decision handed down by a Federal Judge on January 15, 2010, the FDA was ordered to lift the import ban that affected electronic cigarettes. The FDA was criticized for aggressive efforts focused on turning a recreational product into one designated as a device or drug that could then be regulated out of existence.
Pointing to the newly established tobacco division created within the FDA to regulate tobacco, the judge stated that the same regulations could be applied to electronic cigarettes and supplies.
Responding to the court decision brought a charge from the FDA about “health issues” surrounding e-cigarettes. It appears the youth argument didn’t sway the court so a new “reason” was presented. Tobacco companies stand firmly behind the FDA efforts to eliminate electronic cigarettes. What could be better than to have a government agency strike down your competition?
One great outcome for tobacco companies would be allowing the FDA to set separate standards and restrictions for e-cigarettes. This would significantly increase the cost of buying e-cigs and refill supplies. Currently, tobacco products can’t compete in price with alternative electronic products.
Pharmaceutical companies, big tobacco and the FDA have a relationship that calls for further scrutiny after this court decision. Tobacco provides billions of dollars to government coffers from taxes at federal and state levels. The regulations attempted by the FDA seem clearly designed to protect the market share of big tobacco. Would tobacco companies be in favor of electronic cigarettes if they have been involved in offering such a product as an alternative to their tobacco? In the confusion caused by the defeat suffered in the tobacco trials of the late 90s, it’s likely big tobacco did not realize the competition electronic cigarettes would present.
The unusual steps taken by the FDA have created their own controversy about the focus of this government agency. The FDA has never proposed banning tobacco products to protect the health of the public. Traditionally, the FDA issues statements and warnings and takes action only after conducting full scientific testing. In the case of the FDA vs electronic cigarette manufacturers, the FDA has ignored testing to develop standards and instead has focused on finding reasons to ban a product that is arguably safer than the product it may eventually replace.
Mary Kay Rivers is an acclaimed expert on all aspects of e-cigarettes. Her publications about the history of electronic cigarettes and about the best electronic cigarette have become well-known.



