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Burstyn barred from FDA workshop

The Tobacco Products Center of the Food and Drug Administration barred Drexel University's Igor Burstyn from speaking at the recent workshops on e-cigarette safety. Instead they gave the stage to a number of anti-harm reductionists eager to present data about trace levels of harmful substances, and to present them as grave threats.

Burstyn has not been an insider to the vaping world until recently. (He is now on the board of CASAA.) His field is environmental health science, and he specializes in understanding what levels of common substances rise to the level of danger. His landmark study last year gave a pass to e-cigarette vapor, including secondhand vapor.

Vaping opponents typically ignore concentration levels in their alarmist stories about carcinogens and other dangerous chemicals, and present them under headlines that mention only the substances, not their percentages. The FDA workshop was touted as an open fact-finding exercise, but was stacked with vaping opponents. Carl Phillips of CASAA believes that “they were intentionally avoiding Igor because he had the expertise and credibility to point out fundamental flaws in a solid majority of what was presented.”

Greg Conley, formerly with CASAA, and now head of the American Vaping Association, was given a chance to speak in the public discussion period of the workshop, and he gave the floor to Burstyn for 3 minutes of commentary. Here are excerpts from his comments, offered by Phillips: “We have rich experimental experience from other areas of environmental and workplace emission controls and hazard assessments that . . . are portable to the world of electronic cigarettes and tobacco products. And there’s really no reason to assume this precautionary posture that really amounts to willful ignorance.”

“The dose makes the poison,” Burstyn went on. “If we apply the standards that are admissible in workplaces to emissions from electronic cigarettes, . . . we see individual exposures that are way below a threshold. . . . Most of them are in trace quantities. They’re present, but they’re not going to hurt you.”

Conley gives some background on the issue in his published statement: “In 2009, . . . 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.”

Conley notes that public belief that vaping is less harmful than smoking has gone down by one quarter in the past 4 years, and that this “is not because of a lack of regulation, but because of false claims made by those seeking harsh regulation.”

He concludes, paraphrasing Clive Bates: “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.”