In 2010 the U.S. Court of Appeals in the District of Columbia rejected the federal Food and Drug Administration attempt to control and block import of e cigarettes as drug delivery devices. The Circuit Court instead determined that the FDA could only regulate e-cigarettes as tobacco products, which is still incredibly inaccurate, but less of a slippery slope than determining that nicotine which is on no Class A prohibited drugs list in the U.S. is a regulated drug.
The FDA has been spoiling for an appeal to this decision every since it was handed down. Progress was made in thwarting the FDA’s plans this week by the CEO and founder of the e-cig company NJOY, Mr Roy Anise.
Anise, along with his board of directors launched what they termed as an epic battle not unlike that of the Biblical David against Goliath in taking on the federal agency, by committing over 2 million dollars in company assets towards preventing the FDA from pursuing their Appeal of the 2010 Decision. The agency announced on February 6th that they were abandoning plans to continue their quest for the reversal of the Appeals Court decision. This means, bottom line that e-cigs will continue to be regulated like tobacco by the FDA and that for now, at least, no further effort to class them as drug delivery devices will be pursued. To celebrate, Anise lit up his own e-cig in the FDA’s Tobacco Control Center—all to make a point.
While ultimately recognition that e-cigarettes which contain no tobacco are not “tobacco products” is the goal for the industry, keeping their products out of classification as drugs is a major victory in the short term. While this also means that no health benefits can be claimed and e-cigs cannot be marketed as “smoking cessation devices” in the United States (in spite of some anecdotal evidence to the contrary) any effort that results in e-cigs not being limited to being made available by prescription is to be celebrated.