TVECA on FDA’s Final Rule

MONTFOORT, the Netherlands, May 9, 2016 /PRNewswire/ --

It has been observed that America and England are nations divided by a common language.  When comparing the Food and Drug Administration's (FDA) proposed "deeming" rule regulating e-cigarettes with last week's publication of the Royal College of Physicians (RCP) report on the public health value of e-cigarettes, it appears this divide is alive and well.

The RCP, which has set standards for the responsible practice of medicine since 1518, recently issued a report on e-cigarettes which actually encourages their use.  The RCP concluded that e-cigarette and vapor devices actually promote the public health, leading to a decrease in death and serious disease.

The FDA, however, has adopted a different approach.  

"Rather than pursue a responsible regulatory structure for e-cigarette and vapor products, like the European Union (EU) has with its adoption of the Tobacco Products Directive (TPD), the FDA has taken the opposite path, issuing rules which will kill the e-cigarette category," said Ray Story, head of the Tobacco Vapor Electronic Cigarette Association (TVECA).

"This result is inexplicable, especially when a clear example exists of how to do it correctly," observed Mr. Story.

"I can't say I'm surprised.  Disappointed, but not surprised," said Mr. Story.  "We've had the proposed rule for months, and while we'd hoped that the FDA would not go down this path, it's apparent that facts and reason fell on deaf ears," he stated.

"Who is arguing that vapor is as harmful as combusted tobacco?" asked Mr. Story.  "Even Mitch Zeller, head of FDA's Center for Tobacco Products, has stated that `nicotine is not the problem'.  How do we get here from there?"

"The table is set," continued Mr. Story.  "This isn't new to us.  We've lead the charge in the past, and without our court victories over the FDA, the e-cigarette category wouldn't even exist today."

"In Europe, it's the same story," concluded Mr. Story.  "We fought the hard battles in the courts and in the European Parliament, and we have the scars, and victories, to prove it."  

Mr. Story ultimately struck a positive note.  "It's time that the industry consolidate behind a viable effort.  I'm confident that when everyone really understands what is at stake, the path will become clear."