FDA’s Motive For Releasing Vapor Product Reports Raises Questions

Carl V. Phillips | Contributor

The FDA maintains a database of problem reports for products they regulate, which includes health effects and flaws in the product itself. Its primary purpose is to collect medical reports that might reveal previously undetected harmful side effects from pharmaceuticals and medical devices. But a harmful side effect of having this system is that problems with products the FDA regulates as tobacco – including e-cigarettes – are also reportable. The agency just decided to make this year’s submissions public.

Unsurprisingly, the list is short. Few consumers or medics are going to report the well-known health effects of nicotine and tobacco products as adverse events, let alone involve the FDA in a complaint that there was a manufacturing problem. Physicians are not going to bother to report that cigarettes appear to have given someone emphesema. Many will, however, report what they believe is an adverse effect of vaping, either because they wish to denigrate vaping or out of legitimate concern that they may have found an unreported side effect. As a result, 67 of the 107 reports from 2017 are about e-cigarettes.

The majority of these (42) were problems with the product (e.g., consumer complaints about a defect) with no reported health effects. However eleven of these are tagged with “child safety hazard” (it is not possible to know exactly what this means) and seven are about overheating or explosion incidents that apparently caused no health effects. Of the 25 reports of adverse health effects, most outcomes are consistent with someone getting a mild overdose of nicotine, while some seem quite unlikely to be related. Seven reported burn or explosion injuries.

The reported information is a very terse summary, so it is not possible to know exactly what happened. In particular, it is often not possible to know if there is any reason to believe that vaping caused the problem. In many cases it seems safe to assume it did not. One entry suggests e-cigarettes caused diabetes – for someone other than the user no less (presumably a child in a household with a vaper). Whoever is seeing the physician who reported this should probably find another doctor, lest their next disease be blamed on witchcraft.

Amusement value aside, vaping advocates should be aware that dishonest or seriously ignorant critics might soon be using entries from this list in their “arguments.” The FDA explicitly states that these reports are raw data, possibly inaccurate or incomplete, that they have not analyzed, and in particular they have not concluded that the product actually caused the outcome. Nevertheless, it is easy to imagine claims in legislative hearings along the lines of, “FDA’s own reports show that e-cigarettes cause…” followed by a list of twenty outcomes that appear in this data (and emphasizing that several of these claims were about effects on bystanders rather than vapers). While it is difficult to respond to a long list of random claims from prohibitionists, vaping advocates can at least respond that the FDA does not actually endorse these claims.

For all practical purposes, this reporting system is about vapor products. For example, of the mere 14 reports about cigarettes, only two report issues with fires or burns even though cigarettes cause orders of magnitude more such events than e-cigarettes. Teenagers trying their first cigarette or other traditional tobacco product often experience the effects of mild nicotine overdose, as do some experienced consumers, and yet there are almost no reports of such events in this database.

It is difficult to not be suspicious about the FDA’s motives in making this information easily available. There is no possible way that these reports could lead to the discovery of some unknown side effect. It is theoretically possible that a systematic collection of reports about migraines and sinus problems (which appear multiple times in the reports) could reveal that vaping really does cause those problems for some people. But these random reports – unlike the more attentive and less political reporting of adverse events from pharmaceuticals – tell us nothing. The only apparent use for this information is for anti-vaping propaganda. But it can also be used to prepare to respond to that – forewarned is forearmed.

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Carl V. Phillips

Contributor

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