Policy

When Carcinogens Are FDA-Approved, You Needn't Worry About Them

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Today the Food and Drug Administration announced that laboratory analysis of cartridges used in electronic cigarettes, which deliver nicotine in a propylene glycol vapor instead of tobacco smoke, "has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze." Six paragraphs down, we learn that the FDA tested only "a small sample of cartridges from two leading brands of electronic cigarettes" and that "these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed" (emphasis added). In a PDF file two clicks away, we learn that diethylene glycol showed up in just one out of 18 cartridges and that five cartridges contained tobacco-specific nitrosamines "at very low levels." The report does not say exactly how low, and it provides no evidence that these trace amounts pose a measurable health risk.

On his tobacco policy blog, Michael Siegel notes a salient fact overlooked by the FDA in its rush to hype the hazards of e-cigarettes: Smoking cessation products approved by the FDA as safe and effective also can contain "detectable levels of known carcinogens," a byproduct of deriving nicotine from tobacco. Yet the FDA is not trying to raise an alarm about the cancer risk allegedly posed by nicotine patches, gum, or inhalers. In fact, Siegel points out, the FDA used an FDA-approved nicotine inhaler as a comparison sample for its analysis of the nicotine levels in e-cigarette cartridges but for some reason decided not to test the inhaler for carcinogens. Siegel acknowledges that the diethylene glycol in one cartridge raises legitimate concerns about manufacturing standards, but he emphasizes that the FDA is once again perversely insisting that e-cigarettes be proven 100 percent safe even though they are substitutes for legal products, conventional cigarettes, that are indisputably far more dangerous (and that now have the FDA's imprimatur).

The rest of the FDA press release hits familiar themes. It warns that nicotine "is highly addictive"; worries that e-cigarettes "are readily available online and in shopping malls" and that they "could increase nicotine addiction and tobacco use in young people"; and complains that "these products do not contain any health warnings comparable to [those on] FDA-approved nicotine replacement products or conventional cigarettes." It also alleges that e-cigarettes "are marketed and sold to young people," by which it presumably means minors, although the only evidence it offers to support that claim is the fact that e-cigarettes are "available in different flavors, such as chocolate and mint." The statement closes by soliciting consumer complaints about "serious adverse events (side effects) or product quality problems with the use of e-cigarettes," possibly because the FDA does not have any yet and needs them to justify removing the product from the market. 

It seems clear that the FDA already has decided to ban e-cigarettes and is now seeking evidence to back up that decision. This approach, which replaces science and consumer protection with puritanism and bureaucratic pigheadedness, sacrifices the interests—and possibly the lives—of smokers who could dramatically reduce their disease risks by switching to e-cigarettes.

More on e-cigarettes here.