The Past, Present, and Future of E-Cigs and the FDA
In recent months, everyone has speculated about how the Food and Drug Administration (FDA) will handle electronic cigarettes. Official regulations were expected to roll out in October of 2013, but so far, the world is still waiting as the FDA debates how to handle smoke-free e-cigarettes. This is not the first time the FDA has gotten involved with e-cigarettes and the organization already has a long drawn out history of demonizing the whole industry, despite thousands of smokers claiming e-cigs were life altering. Let’s take a look back at how the FDA has handled e-cigs from the very beginning.
It all started in 2007 when electronic cigarettes first began arriving in the United States. Shortly after that in August of 2008, GreenCig tried to register their products with the FDA and opened a can of worms that no one could possibly have imagined. One month later, the World Health Organization called for all e-cig companies to stop making health claims and to cease marketing the products as smoking cessation tools. They wanted scientific research before any claims could be published.
In November 2008, the FDA rejected GreenCig’s application because of lack of study data. That was really when the battle began. In 2009, the FDA started seizing shipments of e-cigarettes as they were entering the United States. They claimed they had grounds to take the products because they were labeled incorrectly. With plenty of support from a group of senators, the FDA continued to crackdown on e-cigs, seizing and blocking shipments.
It wasn’t long before the e-cigarette companies started to fight back. In April 2009, Smoking Everywhere sued the FDA for seizing their e-cig shipments. They claimed the shipments contained a cigarette product and no medical devices so the FDA had no grounds for retaining their products. The FDA fired out a lab report in return, condemning e-cigs.
Pretty soon, NJOY got involved and joined in the lawsuit against the FDA. As the legal battle heated up, the FDA sent out a press release full of negative claims about e-cigarettes. They focused on chemicals found in one cartridges out of thousands and claimed they studied samples and found carcinogens.
NJOY retaliated by publishing their own report, debunking the FDA’s lab reports. In their statement, they claimed a lack of standard protocols for lab testing and criticized the lack of comparisons with contents in other nicotine replacement products. They also pointed out that many of the carcinogens they claimed to find in the lab were below normally detectable quantities.
In early 2010, Federal District Judge Richard Leon ordered to FDA to stop blocking e-cig shipments. He instructed them to rely on tobacco regulation powers to deal with the situation instead. The FDA wasted no time in filing an appeal and they won a temporary state of injunction, allowing them to continue blocking shipments. By June of 2010, Smoking Everywhere had dropped out of the court case. The legal fees were taking a toll, not to mention that the company was no longer able to import products without the FDA seizing them at the port.
In September 2010, the FDA issued a letter to E-Cigarette Direct, Ruyan, Gamucci, E-Cig Technology, and Johnson Creek. In the letter, they warned that they had plans to regulate e-cigarettes and the companies were not in compliance. By the end of 2010, the court battle is over with the federal appeals court ruling in favor of NJOY. At that point, the FDA decided against taking the case to a Supreme Court judge.
Despite the judge’s orders to cease their shipment holds, many companies claimed the FDA was still seizing e-cig shipments in early 2011. Totally Wicked started a new lawsuit against the FDA for seizing shipments against federal ruling. That was enough to make the FDA back down and they finally stopped holding e-cig shipments in April of 2011.
Instead, the FDA decided to pursue e-cigarette regulation within the powers President Obama granted through the Tobacco Control Act. While some senators pushed the FDA to roll out regulations in 2011, there was no big change. In May 2012, the FDA announced an intent to have e-cig regulations prepared in a draft by summer. By the end of summer, there were no regulations but the FDA did release a new report on supposed adverse events related to e-cig use.
The battle continued and the FDA stalled, eventually promising to release regulations for e-cigs in October 2013. However, the long government shutdown stalled the process and as of this writing, there are still no known regulations.
As far as the future, it still looks a bit bleak for e-cigarette companies. Now that many big tobacco dealers are unveiling their own e-cigs, it is already putting strain on smaller businesses. If the FDA moves forward with strict regulations, it could potentially put smaller operations out of business nearly overnight.
What do you expect the FDA to do with e-cigarettes in 2014? Is regulation imminent?