FDA Friday, May 16th

Welcome to the newest installment of FDA Friday. As you should probably know by now, the FDA has proposed new legislation that would classify e-cigarettes and e-cig accessories as “tobacco products.” This change in the legal classification of e-cigarettes threatens the entire industry in the US. Around the internet, there has been a lot of talk about this proposal, largely centering on how it will affect not only vapers’ consumption habits and practices, but also public health. Recently, CASAA has published an action plan to help us fight these short-sighted proposals, and we recommend that anybody interested in preserving the industry follow CASAA’s guidelines and keep track of new developments on either their website or the ECF Forums.

I was going to write something similar to last week’s post, but considering the news of the day, I have decided against it. You see, on May 12th, Margaret A. Hamburg, Commissioner of the FDA, wrote an opinion letter that was published by the New York Times, in “clarification” of some statements made in another article about possible carcinogens that could be ingested by vapers who are on the more radical end of the DIY spectrum.

What follows is my assessment of Hamburg’s letter to the New York Times:

Margaret Hamburg could not have chosen a less effective way to defend the proposed guidelines if she tried. In her May 12th letter to the New York Times, Hamburg preaches to those already predisposed to ban the products, and exacerbates vaping advocates’ concerns that the FDA is not interested in their opinions, their health, or their safety.

Hamburg’s letter opens by referring to electronic cigarettes as an “emerging technology,” about which “much remains to be learned.” Electronic cigarettes are not, in fact, an emerging technology. A decade ago, they were, but the fundamental mechanisms behind it were patented and developed in 1963, by Herbert A. Gilbert. The first modern electronic cigarettes were developed in 2003, by the Chinese company Golden Dragon Holdings, who have been exporting these devices since 2005. Electronic cigarette technology is over 50 years old, and in its present state nobody should doubt the maturity of a technology that is now being developed and sold by no fewer than five major international tobacco companies.

By Hamburg’s measure of emergence, iPhones (first released in 2007) are also an “emerging technology” about which “much remains to be learned.” And yet very little remains to be learned about e-cigarettes at all, as the technology which drives them is the same as that of the water-soluble (propylene glycol and vegetable glycerin based) fluids used in fog or haze machines, which have been in use internationally in a variety of contexts since 1979. The reason people use electronic cigarettes is largely to sustain their addiction to nicotine, the active ingredient in tobacco smoke. Other nicotine delivery methods, such as the transdermal nicotine patch, have been available since 1985. Are fog machines and nicotine patches also “emerging technologies”?

Continuing on through the first paragraph of the letter, Hamburg lists her concerns as: “the risks of e-cigarettes to health, as well as their possible benefits”; and “any use of e-cigarettes by children and adolescents.” Hamburg, and by implication the rest of the FDA, seems to have made up her mind that e-cigarettes are risks to health, but only possibly beneficial. How can a federal organization be so prejudiced as to assume the existence of imminent, restriction-worthy, danger after admitting that “much remains to be learned” about them.

In the final paragraph of the letter, Hamburg attempts to mollify her critics with the following tortured sentence:

Where the science does not exist, we are able to finance the research to answer key questions related to e-cigarette safety and consumer behavior, including four studies that will focus on the contents of e-cigarette vapor.

On first reading, it may seem as though Hamburg has suggested that the FDA intends to fund further scientific research on electronic cigarettes. However, by paying close attention to her choice of language, it is evident that such a conclusion would be false. The FDA does not intend to fund research at all.

Instead, by using the phrase “we are able to,” Hamburg merely asserts that the FDA is authorized to do so. By reducing the “four studies that will focus on the contents of e-cigarette vapor” to a dependent, passive, clause, Hamburg adds meaningless details. If the FDA was in fact actually funding studies, surely it would tout the prestige and expertise of the researchers it has hired. By withholding such details, Hamburg gestures towards the existence of research without confirming that it will be timely, accurate, or meaningful, and without confirming that the research will actually take place. Hamburg provides neither evidence nor assurances that it will.

When Hamburg does provide the reader with concrete details, it soon becomes clear that she and the FDA are concerned about “risks”; that they are positioning themselves “to extend the agency’s authority”; that they desire to “bring an end to the…e-cigarette marketplace,” because e-cigarettes contain “harmful…chemical compounds.”

The FDA’s ears are closed to reason and to sense. It will require significant community effort to resist their proposal, but we vapers must do so in order to safeguard our own health and our tobacco-free lives. Margaret Hamburg and the FDA are not, evidently, interested in listening to the existing science supporting this practice, and their proposed policies will work to the benefit of only the largest tobacco companies.  We must instead convince both Hamburg and the FDA to do their job by considering seriously the self-evident and scientifically proven harm-reduction effect of electronic cigarettes, and in doing so putting the needs of the common American first.

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