Well folks, the FDA is at it again, using subtle propaganda techniques to paint an unflattering picture of electronic cigarettes. Dr. Ii-Lun Chen, MD, an FDA employee has a Letter published in the most recent issue of the SRNT's medical journal, tobacco and Nicotine Research, titled "FDA Summary of Adverse Events on Electronic Cigarettes." Sign In
Section 909 of the tobacco Act specifies that tobacco companies should report any adverse events (AE) concerning their products to the FDA. The Act doesn't specify how these reports should be submitted. For many years, medical providers and the general public have used the FDA's Adverse Event Reporting System (AERS) to report problems with drugs and medical devices. But the FDA's page on reporting Adverse Events makes no mention of tobacco products: Adverse Event Reporting System (AERS)
Dr. Chen's article states:
Anyone who didn't know the whole story would think, "Wow! Electronic Cigarettes are more dangerous than any other type of tobacco product." But what is not mentioned is that the FDA did not take over regulation of tobacco products until 2009. So any report on tobacco products that came in between the late 1980s and the present would have been an off-label use of the system, so-to-speak. But even more important that until this article was published, the FDA has not asked the public to submit AE reports on tobacco products such as combustible cigarettes, cigars, or smokeless tobacco.
During a July 2009 press conference, the FDA invited the public to use their AERS surveillance system to report problems with e-cigarettes. So it would make sense that there would be more reports on e-cigarettes than on other tobacco products. In fact, if the FDA had not specifically asked for AE reports to be submitted on e-cigarettes, the odds are good that there would have been no more than a handful of such reports.
Leaving out pertinent information is a propaganda technique known as "Card Stacking."
The article concludes:
Notice how the FDA is setting up an expectation that the AE reports will be used to implement "quality control" measures, by implying that there are huge problems in this area. Let's see now, 47 AE reports in three years. Is that a vast amount?
According to John Polito:
Here's the score:
Edited to correct Chantix Serious AEs: The 1005 serious events that I previously listed were only for the 3Q of 2010. The total to date is over 10,000.
NOTE: I am not claiming that there are no e-cigarette quality control issues. If anything, battery safety is a more serious problem than harmless trace amounts of chemicals in the liquid that are not even present in the vapor. And vendors do need to take care to ensure that nicotine content matches what's on the label. But I do believe that these issues pale in comparison to the safety record of products such as Chantix.
Also I find it very questionable why the FDA would keep recommending that we stop using e-cigarettes and switch to the "safe and effective" products like Chantix.
Section 909 of the tobacco Act specifies that tobacco companies should report any adverse events (AE) concerning their products to the FDA. The Act doesn't specify how these reports should be submitted. For many years, medical providers and the general public have used the FDA's Adverse Event Reporting System (AERS) to report problems with drugs and medical devices. But the FDA's page on reporting Adverse Events makes no mention of tobacco products: Adverse Event Reporting System (AERS)
Dr. Chen's article states:
Anyone who didn't know the whole story would think, "Wow! Electronic Cigarettes are more dangerous than any other type of tobacco product." But what is not mentioned is that the FDA did not take over regulation of tobacco products until 2009. So any report on tobacco products that came in between the late 1980s and the present would have been an off-label use of the system, so-to-speak. But even more important that until this article was published, the FDA has not asked the public to submit AE reports on tobacco products such as combustible cigarettes, cigars, or smokeless tobacco.
During a July 2009 press conference, the FDA invited the public to use their AERS surveillance system to report problems with e-cigarettes. So it would make sense that there would be more reports on e-cigarettes than on other tobacco products. In fact, if the FDA had not specifically asked for AE reports to be submitted on e-cigarettes, the odds are good that there would have been no more than a handful of such reports.
Leaving out pertinent information is a propaganda technique known as "Card Stacking."
The article concludes:
Notice how the FDA is setting up an expectation that the AE reports will be used to implement "quality control" measures, by implying that there are huge problems in this area. Let's see now, 47 AE reports in three years. Is that a vast amount?
According to John Polito:
Here's the score:
| Chantix | E-Cigarettes |
| 35,000 + AE reports | 47 AE reports |
| 10,000 + Serious | 8 Serious |
| 272 Deaths | 0 Deaths |
Edited to correct Chantix Serious AEs: The 1005 serious events that I previously listed were only for the 3Q of 2010. The total to date is over 10,000.
NOTE: I am not claiming that there are no e-cigarette quality control issues. If anything, battery safety is a more serious problem than harmless trace amounts of chemicals in the liquid that are not even present in the vapor. And vendors do need to take care to ensure that nicotine content matches what's on the label. But I do believe that these issues pale in comparison to the safety record of products such as Chantix.
Also I find it very questionable why the FDA would keep recommending that we stop using e-cigarettes and switch to the "safe and effective" products like Chantix.
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