FDA scrambling to catch up with e-cigarette market, assess safety

Some researchers are asking volunteer “vapers” to tell them how many puffs they are taking on e-cigarettes while others will search Facebook posts for any information they can find on how users are modifying their devices to deliver more nicotine.

by John Tyburski

Copyright © Daily Digest News, KPR Media, LLC. All rights reserved.

First published at Daily Digest News on July 11, 2014

Groups of researchers are receiving funding to determine how much people are using electronic or e-cigarettes, how they are altering their devices, and how effective online marketing is at getting children to buy the e-cigarettes and the vapors used in them.

The new research is part of a total of 48 funded projects totaling $270 million the U.S. Food and Drug Administration (FDA) is putting toward urgent investigations into the possible risks associated with e-cigarettes. The most important problem the FDA is facing in assessing e-cigarette risks is how fast the market for e-cigarettes has grown in recent years and how fast it is growing now.

“They want data and they want it yesterday,” said Dr Suchitra Krishnan-Sarin of Yale University to Reuters. Krishnan-Sarin is leading four FDA-funded e-cigarette projects.

Most biomedical research projects funded by federal agencies last five years, and this puts completion of most research aims in the e-cigarette-related projects at 2018 at the earliest. Meanwhile, makers of e-cigarettes and related products are selling in an essentially unregulated market as the pace of scientific research allows a regulatory vacuum to persist. However, the FDA will not regulate a product without evidence that regulation is necessary. While e-cigarettes deliver nicotine through the inhalation of a nicotine-laced vapor, this is where the similarity with traditional tobacco-based cigarettes ends.

“There shouldn’t be regulations akin to those for cigarettes without evidence of similar health impact, especially since the preliminary evidence is positive for the industry,” attorney Bryan Haynes told Reuters. His Richmond, Virginia-based firm, Troutman Sanders, represents e-cigarette manufacturers.

The world’s largest tobacco companies are backing most of the e-cigarette industry. The expected sales revenue around the world for 2014 with e-cigarettes is projected at $2 billion. Currently in the U.S., over 14 million adults and almost two million children under 18 have used e-cigarettes. According to the most recent data available, usage doubled among high-school-age children from 2011 to 2012.

According to one agency spokeswoman, the FDA “will always make regulatory decisions based on the best available science.”