CASAA Call to Action: I have always maintained that the FDA is a corrupted bureaucracy. Systemic in nature and unlikely to ever change. Understanding the FDA in 2014 and defining our current expectations with respect to Vaping regulations is enhanced by a detailed examination of their actions in 2009. The following July 22, 2009 FDA press release forms the basis of our analysis and is filled with lies, half truths, and junk science. A few exstracts for your reading pleasure:
“They are also available in different flavors, such as chocolate and mint, which may appeal to young people.”
“Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people….”
“The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.”
It’s impossible for me to quantify the negative impact this specious Press Release had on smokers who were considering Vaping and wanted to quit cigarette smoking. I know three smokers who decided that based on this single Press Release it was to dangerous to try Vaping. How many lives did the FDA shorten with this Press Release? Is it fair to label the FDA “Killers”? Even today, politicians and many members of the Public Health community continue to use these 2009 flawed studies and completely ignore current studies.
The July 22, 2009 FDA Press Release
Fortunately for all of us, their were a few enlightened individuals who refuted the statements and junk science of the FDA. Brad Rodu is a Professor of Medicine at the University of Louisville. He holds an endowed chair in tobacco harm reduction research, and is a member of the James Graham Brown Cancer Center at U of L. His Blog post of July 24, 2009 focuses on and says:
“On July 22, 2009, the FDA released the results of laboratory tests of e-cigarettes, which were conducted by the Division of Pharmaceutical Analysis at the FDA’s Center for Drug Evaluation and Research. In a press release, the FDA said: “These tests indicate that these products contained detectable levels of known carcinogens…”
A few additional extracts from Brad’s post:
“Unfortunately, the agency did not report TSNA levels. Instead, it reported that TSNAs were either “Detected” or “Not Detected,” which is entirely inadequate. For hundreds of years, one of the basic tenets of medicine has been “the dose makes the poison.” Mere detection of a contaminant is meaningless; the critical question is: At what concentration is it present?
As I noted earlier, many tobacco products have TSNA levels in the single-digit parts per million range, a level at which there is no scientific evidence that TSNAs are harmful. According to the report, the FDA used an analytic method published in 2008. The report notes that “the published method is quite sensitive for the TSNAs…” and it goes on to explain that the level of detection is 40 parts per TRILLION. The implications of this are astounding. Apparently, the FDA tested e-cigarette samples using a method that detects TSNAs at about 1 million times lower concentrations than are even possibly related to human health.”
In lay terms, the FDA manipulated their junk science to fit their deplorable agenda, which in this case has nothing to do with “Public Health”. Given this look back at the 2009 actions of the FDA, we can expect the FDA to continue these disgusting actions until an appropriate court case/legal action stops them.