Electronic Cigarette Safety | FDA Report
The report by the FDA cautioning use of the e-cig, whether intentional or not, used and reported poor quality test results failing to adequately support their claims of potential adverse health effects. This conclusion is supported by a study of the FDA's report by Dr. Janci Chunn Lindsay, Ph.D in her Technical Review and Analysis of FDA Report: “Evaluation Of The e-cigarette” See Report Analysis Below
Does this mean the e-cig is safe? No it does not. But neither does it mean they are bad for your health. We know regular cigarettes contain approximately 3000 additives that according to The Centers for Disease Control harm virtually every organ and cause cancer and cardiovascular/respiratory disease. And what about the e cigarette? They contain water, propylene glycol, nicotine and a scent or flavor. None of which have been shown to cause any adverse health effects to humans. See Report Analysis Below
The safety of the E cig was questioned in report published by the FDA. The report references the detection of DEG (diethylene glycol) in one sample of e-liquid (of several) they had tested. The problem is that no quantitative measure of DEG is noted. The report only states that DEG was Detected. Why is this important? Because if the level of DEG detected was considered toxic by the FDA, they would have a responsibility to state the amount. The U.S. Code of Federal Regulations allows up 0.2% of diethylene glycol when used as a food additive.
Another problem with the FDA report is they tested "various cartridges" from 2 brands of electronic cigarettes and only one cartridge had detectable levels of DEG. Again, there is no mention of the number of cartridges tested. Was it 10, 100, 1000? Anyone who is familiar with scientific testing knows that before a conclusion can be made, the results must be significant and repeatable. One cartridge from a number quantified by the FDA as "various" does not fit this criteria. In short, the report shows no evidence that the e cig causes adverse health effects.
Dr. Janci Chunn Lindsay, Ph.D. analyzed the procedures used by the FDA for their report. Dr. Lindsay is the Senior Scientist of the Toxicology & Mechanistic Biology Division at Exponent Engineering and Scientific Consulting. She has an extensive background in pulmonary medicine research and has evaluated toxicant contributions to lung disease such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and pulmonary fibrosis associated with chemical, drug, or particulate exposure.
Her report contained several key points:
1.) The (FDA) report failed to present standard protocols for proper study design with regards to the testing of the referenced control device, documenting the number of samples tested either within or across tests, or presenting statistical analysis when quantifiable results were obtained.
2.) In the lots tested by the FDA, none of the key chemicals of concern in this study such as TSNAs and tobacco-associated impurities were able to be quantifiable measured in the liquid of cartridges because they were all below the limits of quantification (LOQ).
3.) All of the tobacco-associated impurities found in the products were “present but at less than the level of the Nicotrol® inhaler" (The Nicotrol Inhaler is a prescription medical device approved by the FDA for use in smoking cessation.)
4.)There is no indication in the published scientific literature that cotinine or ß-nicotyrine are carcinogenic or have toxicity ratings of concern. These were the only tobacco-associated impurities found in trace levels in the vapor phase of (some of) NJOY’s products.
5.) Data presented in the report does not adequately support the opinion that users of ecigs would be exposed to TSNAs and tobacco-specific impurities in the vapor phase during normal device use; and if exposed, that those levels would be a health concern as compared to other FDA-approved products.