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Who needs the FDA Center for Tobacco Products?
How the regulatory state fails consumers of nicotine and tobacco
Nearly ten years ago to the day, I published an article in the Atlantic detailing one entrepreneur’s struggle to bring a new cigarette to market. This is not a cause that one would expect to get sympathetic treatment in that publication, so it’s a testament to the Food and Drug Administration’s failures to effectively regulate tobacco that it got published there at all. At issue was the agency’s delay in ruling on an application for Hestia cigarettes, a nascent brand started by David Sley.
As I reported at the time, Hestia applied under the “substantial equivalence” pathway, which was supposed to be the easy path to FDA authorization. Basically, it means that new products that are substantially the same as pre-existing cigarettes, raising no new questions of health, should be allowed onto the market after a straightforward process of review. Sley submitted his application in June of 2012 comparing Hestia to American Spirits. As I wrote in my story:
Hestia Tobacco’s report details in minute specification the components of its cigarettes along with those of Natural American Spirit. One page lists the main ingredients, of which there are only two: flue-cured tobacco and water. Additional pages examine the filter and paper, everything down to the decorative ink. A final page looks at construction: Both cigarettes measure 84 millimeters in length and 24.5 millimeters in circumference. They are nearly identical in weight. They are, one might conclude, substantially equivalent.
This wasn’t enough to satisfy the FDA, which asked for much more information, including “a comparison of your new tobacco product and predicate tobacco product with respect to heating source” — in other words, asking how the cigarettes are lit. (With fire, duh.) The process of review was supposed to take a maximum of 90 or 180 days, depending on how one interprets the statute. When I wrote the article nearly a year later in March of 2013, Sley was still waiting along with 3,500 other applicants. The FDA hadn’t authorized a single one of them.
Eventually, in July 2014, the FDA informed Sley that his application was deficient and that Hestia cigarettes would not be allowed to be sold in the United States. I figured…
