FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 1) | Anti-THR Lies and related topics

Before getting to the substance it is worth noting that this is really the first bit of genuine regulation proposed by the FDA Center for Tobacco Products (CTP) in its eight years. Despite CTP reportedly approaching $4 billion in cumulative expenditures, it has only implemented a few inconsequential rules that were specifically required by the enabling legislation, and has never actually created a standard or specific requirement like a real regulator. Instead, everything it has done has been what I have dubbed weaponized kafkaism. The variation on the word “kafkaesque” refers, of course, to Kafka’s horror stories of bureaucratic (in the pejorative sense) rules that create injustice via impossible procedural burdens. “Weaponized” refers to turning something that is harmful but not malign into a tool for intentionally inflicting harm. CTP has turned filing and paperwork hurdles into a weapon.

It is bad enough when sloppiness, laziness, and incompetence create cost, inefficiency, opaque or even impossible requirements, and uncertainty. But in this case, those results — throwing sand in the gears of the regulated industry, making whatever they and their customers want to do difficult and uncertain — are the goals of the agency. Sloppiness, laziness, and incompetence tend to cause kafkaesque burdens to pile up if no effort is made to push back. They also perfectly camouflage the malevolence of intentionally created burdens.

The march toward a near-ban of e-cigarettes is an example of this. Products will not be banned because they violate some standard or other substantive requirement. CTP is simply taking advantage of the administrative rules that any products that were not on the market in 2007 (i.e., all e-cigarettes) must receive approval as a new product. Requiring new product approvals is not itself particularly unusual or problematic regulation until you observe that CTP has no rules about what makes a new product approvable. It is not even clear what an application should contain. Any application can, and probably will, be arbitrarily disapproved. This is even worse than the oft-noted fact that the new product application process is prohibitively expensive for anything other than a very promising mass-production product, which >99% of e-cigarette products are not, though that also is a kafkaesque burden.