Analysis Of FDA Report On E-Cigarette
The FDA published the now infamous report vilifying e cigarettes but apparently did not expect the backlash it would cause. Their report attempted to portray the ecig as containing toxic substances possibly having adverse health effects for the user. In response to the FDA report, manufacturers of e-cig products commissioned a study of the report to validate its credibility. The study was performed by Dr. Janci Chunn Lindsay, Ph.D. Let's look at Dr. Lindsay's credentials....
Dr. Lindsay is the Senior Analyst at the Toxicology And Mechanistic Biology Division of the firm Exponent Engineering and Scientific Consulting. Her education includes training in pulmonary physiology research and also evaluation of the contribution of airborne toxins to disease states such as COPD (chronic obstructive pulmonary disease) asthma, pulmonary fibrosis and bronchitis. Her research focuses on particulate exposure. So how did she reach her conclusions...
Dr. Lindsay examined the methods used by the FDA for their analysis of the e-cigarette. Dr. Lindsay's analysis found 4 major discrepancies in the FDA's conclusions.
1.) The FDA's report did use standard testing procedure or study design when recording the number of tested samples within or across the testing samples. The FDA also failed to present valid statistical analysis of any quantifiable results they observed.
2.) Of the products tested by the FDA, TSNAs and tobacco-associated impurities were not quantifiably assayed because they were under the LOQ or limits of quantification.
3.) The impurities noted in the tested samples were detectable but at a level considerably lower than those found in the Nicotrol inhaler which is a medically prescribed device and approved by the FDA for smoking cessation.
4.) The data in the FDA's analysis does not support their conclusion that ecig users are exposed to tobacco-associated impurities or TSNAs in the atomized product produced while using an electric cigarette.
Ok, so what does all of this mean? In a nutshell, the FDA's report cannot be considered valid as none of the standard protocol required for scientific testing was observed. But why would the FDA present a poor quality study and try to pass it off as scientific research? There are many opinions on this ranging from the FDA being pressured by big tobacco to discredit e-cigs to the FDA attempting to gain control over the e-cig market. Currently, all we know for sure is that the FDA's report is seriously flawed and further, more accurate testing of the e-cig needs to be done before any conclusions can be made.