Over the past two days, the Food & Drug Administration has been holding a workshop on e-cigarette science. Sadly, little genuine discussion of harm reduction has taken place, and the workshop has instead functioned largely as a a platform for anti-harm reduction scientists to explain their position. Even worse, experts like Dr. Igor Burstyn (who authored the authoritative “Peering Through The Mist” analysis that found no hazard to bystanders exposed to e-cigarette vapor) were excluded from giving presentations.
Earlier this morning, the FDA took two hours of public comment from members of the audience. AVA President Gregory Conley started off the day and was followed by a great group of advocates, scientists, and business owners, including Dr. Riccardo Polosa, Dr. Igor Burstyn (now of CASAA), Scott Eley of AEMSA and Nicquid, Sean Gore of the Oklahoma Vapers Advocacy League, and others.
Audio of the workshop, including the public comment period, can be found here.
During the 3-minute public comment period, Conley delivered the following message:
AVA President Gregory Conley at the FDA
(December 11, 2014)
Good morning. My name is Gregory Conley and I am the President of the American Vaping Association, a nonprofit organization that advocates on behalf of small and medium-sized businesses in the vapor market. Thank you for having me today. Before I begin, I must say that as a longtime follower of the science on vapor products, I was disappointed in the level of scientific discourse displayed yesterday by numerous anti-harm reduction and anti-vaping presenters, as well as the inability of independent researchers who have published some of the most significant work on vapor products to give full presentations.
As an organization, we agree that continued research into vapor products is necessary. We encourage this research. However, as we saw in 2009 when the FDA misled the public on the hazards of the NRT-like levels of ‘nitrosamines’ found in e-cigarette cartridges — a study that continues to be used to this day to justify harsh actions against vapor products — such research becomes dangerous when it is spun to create the false perception of a material level of harm. The FDA’s misrepresentation was one of the first in the U.S., but it was not the last. Hype and conjecture surrounding e-cigarette toxicity has led us to a place where in 2013, 60% of the public thought vaping was less hazardous than smoking. This is down 25% from 2010, when 80% of the public accurately believed vaping was less hazardous. This lack of understanding is not because of a lack of regulation, but because of false claims made by those seeking harsh regulation.
Even worse, this research is hazardous from the onset when it is performed by researchers with no familiarity with the products or willingness to even speak to users to understand how the products work. Unlike with cigarette smoking, at the present time there is no generally acceptable standard for testing vaping products. So we find ourselves in a situation where researchers are presenting data on the toxicity of vapor that has been produced using unrealistic device settings that no vaper would actually use. When relying on evidence in such a new and fast developing field, the FDA should critically analyze each and every study and not just assume that passing “peer review” makes the study automatically valid.
Importantly, we encourage more research not because we fear that vaping may be more hazardous than smoking, but instead because we want to find out the relative risks of different classes of products. In the process we believe all players should keep in mind that the hazards of these products must be compared to cigarettes. This is what the primary stakeholders in this dialogue – smokers and vapers — deserve, but instead they are being discouraged by a small group that is using falsely-alarming language.
The greatest danger is that excessive regulatory reaction to minute risks will compromise the appeal of vaping to smokers and we end up with more smoking than we would have had without such regulation. Thank you very much for your time.
Ed. Note – Much appreciation to Clive Bates. The last two paragraphs were inspired by his writings. I used some of his language because I could not think of a possible way to improve upon Clive’s words.
