Friday, July 24, 2009
The FDA Crusade Against E-Cigarettes
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 FDAs 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 The FDA report can be downloaded here.
For many years, I have investigated the cancer risks of cigarette smoking and smokeless tobacco use. As I wrote in a recent post, the FDA has never regulated nicotine effectively, and the agency had previously signaled its intention to ban e-cigarettes. So while the agencys new analysis of e-cigarettes comes as no surprise, it does undermine the assumption that the FDA bases it oversight activities purely on scientific principles.
The FDA analyzed 18 cartridges from two e-cigarette manufacturers, Smoking Everywhere and njoy (there are many other manufacturers). With respect to carcinogens, the agency looked at four tobacco-specific nitrosamines (TSNAs) with very long chemical names; Ill abbreviate the agents here as NNN, NNK, NAT and NAB.
I have some experience with TSNAs, since I participated in a project with a scientist at the Swedish National Food Administration to measure the levels of these agents in smokeless tobacco products. Our research showed that TSNAs are present in most American tobacco products at extremely low levels, about 0.1 to 12 parts per million by weight. At this level of TSNAs, someone who puts 1 gram (about 1/28th of an ounce) of smokeless tobacco in his mouth is exposed to, at most, about 10 one-millionths of a gram of TSNAs. There is abundant scientific evidence that exposure at this minuscule level is not associated with ANY cancer in smokeless tobacco users.
The FDA analyzed 14 products from Smoking Everywhere, but the agency only reported the TSNA levels for 7 of those products. Why did the FDA test only half of the companys products for carcinogens? And how did they choose those products? There are some clues in the report. First, the products that werent tested simply had blank boxes in the results chart. A footnote says, Open boxes indicate the sample was not available for testing. Another note in the methods section admitted that not all sample lots were available for analysis as they were consumed in other testing. In other words, the FDA didnt purchase enough of the products to conduct the testing in a systematic and scientific manner. Maybe its a budget problem. On the Smoking Everywhere website cartridges are $9.99 each.
The FDA tested 3 out of 4 njoy products for TSNAs.
What the FDA didnt test is even more important than what the agency tested. The report noted that the Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods. That inhaler is a pharmaceutical nicotine product that is regulated by the FDA, but the agency didnt test the product for TSNAs. This is a critical omission, because in 2006 a published research study revealed that pharmaceutical nicotine products contain TSNAs. In fact, its been known for almost 20 years that nicotine medications contain TSNAs.
Tobacco Truth
The FDA Crusade Against E-Cigarettes
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 FDAs 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 The FDA report can be downloaded here.
For many years, I have investigated the cancer risks of cigarette smoking and smokeless tobacco use. As I wrote in a recent post, the FDA has never regulated nicotine effectively, and the agency had previously signaled its intention to ban e-cigarettes. So while the agencys new analysis of e-cigarettes comes as no surprise, it does undermine the assumption that the FDA bases it oversight activities purely on scientific principles.
The FDA analyzed 18 cartridges from two e-cigarette manufacturers, Smoking Everywhere and njoy (there are many other manufacturers). With respect to carcinogens, the agency looked at four tobacco-specific nitrosamines (TSNAs) with very long chemical names; Ill abbreviate the agents here as NNN, NNK, NAT and NAB.
I have some experience with TSNAs, since I participated in a project with a scientist at the Swedish National Food Administration to measure the levels of these agents in smokeless tobacco products. Our research showed that TSNAs are present in most American tobacco products at extremely low levels, about 0.1 to 12 parts per million by weight. At this level of TSNAs, someone who puts 1 gram (about 1/28th of an ounce) of smokeless tobacco in his mouth is exposed to, at most, about 10 one-millionths of a gram of TSNAs. There is abundant scientific evidence that exposure at this minuscule level is not associated with ANY cancer in smokeless tobacco users.
The FDA analyzed 14 products from Smoking Everywhere, but the agency only reported the TSNA levels for 7 of those products. Why did the FDA test only half of the companys products for carcinogens? And how did they choose those products? There are some clues in the report. First, the products that werent tested simply had blank boxes in the results chart. A footnote says, Open boxes indicate the sample was not available for testing. Another note in the methods section admitted that not all sample lots were available for analysis as they were consumed in other testing. In other words, the FDA didnt purchase enough of the products to conduct the testing in a systematic and scientific manner. Maybe its a budget problem. On the Smoking Everywhere website cartridges are $9.99 each.
The FDA tested 3 out of 4 njoy products for TSNAs.
What the FDA didnt test is even more important than what the agency tested. The report noted that the Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods. That inhaler is a pharmaceutical nicotine product that is regulated by the FDA, but the agency didnt test the product for TSNAs. This is a critical omission, because in 2006 a published research study revealed that pharmaceutical nicotine products contain TSNAs. In fact, its been known for almost 20 years that nicotine medications contain TSNAs.
Tobacco Truth
