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Are Electronic Cigarettes Safe | FDA Report Summary:
The report by the FDA cautioning use of the ecig, whether intentional or not, used and reported poor quality testing results failing to adequately support their claims of potential adverse health effects. This conclusion is supported by the study of the FDA's report by renowned expert Dr. Janci Chunn Lindsay, Ph.D in her Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes” See Report Analysis Below
Does this mean ecigs are safe? No it does not. But neither does it mean they are bad for your health. We know regular cigarettes contain approximately 600 additives that according to The Centers for Disease Control harm virtually every organ and cause cancer and cardiovascular/respiratory disease. And what about ecigs? 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
Report Analysis
The safety of Ecigs was questioned in a July 2009 FDA report. The report references the detection of DEG (diethylene glycol) in one sample tested. The problem with this reference is that no quantitative measure of DEG was 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 actually allows up 0.2% of diethylene glycol in polyethylene 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 knows about scientific testing knows that before a conclusion can be made, the results must be significant and repeatable. One cartridge from a number quantified only as "various" does not fit this criteria. In short, the report shows no evidence that the ecig has 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 NJOY’s cartridges because they were all below the limits of quantification (LOQ).
3.) All of the tobacco-associated impurities found in the NJOY 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.
The report by the FDA cautioning use of the ecig, whether intentional or not, used and reported poor quality testing results failing to adequately support their claims of potential adverse health effects. This conclusion is supported by the study of the FDA's report by renowned expert Dr. Janci Chunn Lindsay, Ph.D in her Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes” See Report Analysis Below
Does this mean ecigs are safe? No it does not. But neither does it mean they are bad for your health. We know regular cigarettes contain approximately 600 additives that according to The Centers for Disease Control harm virtually every organ and cause cancer and cardiovascular/respiratory disease. And what about ecigs? 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
Report Analysis
The safety of Ecigs was questioned in a July 2009 FDA report. The report references the detection of DEG (diethylene glycol) in one sample tested. The problem with this reference is that no quantitative measure of DEG was 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 actually allows up 0.2% of diethylene glycol in polyethylene 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 knows about scientific testing knows that before a conclusion can be made, the results must be significant and repeatable. One cartridge from a number quantified only as "various" does not fit this criteria. In short, the report shows no evidence that the ecig has 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 NJOY’s cartridges because they were all below the limits of quantification (LOQ).
3.) All of the tobacco-associated impurities found in the NJOY 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.