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Brick by Brick: The Regulatory Environment

One of the big problems with the FDA regulating e-cigarettes is the lag introduced by red tape.

The FDA approved 44 new cigarettes as substantially equivalent to existing cigarettes: FDA: 3 July 2014: Memorandum approving 44 SE applications

What’s interesting about this? The difference between the products comes down to what’s called FSC (Fire-safe cigarette) paper. This is paper that is formulated to burn slower and self-extinguish if left lit but unsmoked. The goal is to reduce fires resulting from people leaving cigarettes unattended. Despite numerous brands and laws requiring FSC paper, and despite the SE applications being filed several years ago, the FDA has only just approved them.

My main fear with the FDA regulating e-cigarettes isn’t the public use bans, it isn’t the very real chance that 99% of manufacturers could shut down, but it is the lack of ability for the FDA to move quickly on applications. I foresee public use bans being reversed in the coming decade as the science confirms the overwhelming lack of risk to the public from e-cigarettes. I foresee litigation and the FDA’s own restraint putting a check on the industry-crushing aspects of proposed rules.

What I do not foresee is the FDA transforming overnight from an agency that moves slowly on a variety of issues into one that can meet the needs of a fast-paced industry like vaping. I hope I’m wrong.

I wasn’t able to find the exact dates for the submissions of these applications, but it was earlier than August 2012 for at least some of them. That makes it likely that the turnaround time was over two years. Maybe we can chalk up some of that time to inadequate applications, but if any companies should be able to file robust applications it would be the traditional cigarette makers.

We’re left with two years where the cigarettes being sold under these brands were (apparently) less safe. What if the day after the e-cigarette regulations go final, it’s found that some minor tweak to a liquid would drastically reduce carbonyl formation? Wait two years for approval. What if some new atomizer technology removes all leaking, gurgling, dry hits, etc.? Wait two years.

The problem is that the regulations can end up becoming a cadence of progress. Instead of focusing on acute problems that can actually be addressed, the FDA can turn into a failed oracle, trying to predict the unpredictable.

Now to whether the FSC papered cigarettes are substantially safer. My guess is they are marginally safer. They aren’t absolutely safe. The order of gain is likely marginal. The popularity of the relevant brands plus the marginal gain in safety might amount to a few lives saved per year. Or per ten years. Who knows?

The good news is that once the first round of products run the FDA’s gauntlet, they will be available. If things pan out as expected, the market will be relatively safe once that happens. It will take further rulemaking or lawmaking to do major harm at that point. The bad news is that the rate of introduction of new (regulated) products will be reduced to the speed of the application process.

We do have to worry about lawmakers until the picture is clear enough to shut them up. See, for example, Congress: 113th Congress: H.R.5010: SMOKE Act (click on the “Text” tab if you want to read the bill). It would, among other things, codify the regulation of e-cigarette batteries. As far as I know, the FDA has no intention to regulate e-cigarette batteries, at least those sold separately and not part of integrated products.

It’s clear how unwise it would be for Congress to sick the FDA on batteries of all sorts just because they could be used to power e-cigarettes. But a plain-language reading suggests that’s what would happen if that bill became law. I have no doubt the Congress is ignorant (either basely so or simply through lack of consideration) of the fact that batteries can be used for many things. I can only be glad to have one small reason to be thankful for the dysfunctional and utterly obstructed Congress: H.R. 5010 isn’t going anywhere anytime soon.

Of course, it likely wouldn’t progress anyway. I’m all for ending the obstructionism in government, and there are plenty of idiotic bills proposed (e.g., Congress: 113th Congress: H.R.5034: Stop the EPA Act, which (no text yet) would require review of all existing regs, halt all proposed regs until then (with a moratorium on further proposals), and require all regs with economic impact over $50 million require Congress to approve). It’s not an major threat, but it is an ongoing threat.

Scare Tactics and Mortality

A brief look at the use of scare tactics to try to influence behaviors.

Graphic warnings on cigarette and tobacco products, mere warning labels, skull and crossbones on cleaning products, and transvaginal ultrasounds all have the common theme of being emotional appeals meant to shape behavior.

When you don’t buckle your seat belt in the car, it merely chimes and lights a “buckle-up” icon. Why not change that into screams or an icon of roadkill? Which reminds me of the cigarette lighters in India that chant Raam Naam Satya Hai (a funeral chant) (YouTube: Chanting Lighter).

And how long until the gun control advocates propose that gun buyers have to review graphic photographs of gunshot wounds before buying guns and ammunition?

The question is how far should we take these sorts of emotional appeals meant to remind people of inherent dangers? Should military enlistees be required to view statistics regarding casualties and mental illness risks associated with service? Should law school students be warned of the difficulties of finding jobs with their degrees?

Currently the use of scare tactics is rather arbitrary. People buying a home with a pool or having one built may pay higher insurance premiums, but they aren’t faced with the risks in graphic form. With Thanksgiving coming, we are reminded that every year people harm themselves in deep fryer accidents or undercooked stuffing causes food borne illnesses.

Parents of newborns often retrofit their homes in a religious ritual known as childproofing. This involves such feats as putting the kitchen knives behind electric fencing and turning all food into mush to prevent babies from wanting to eat it. They buy sophisticated surveillance equipment to spy on the babies at night, in case the babies are plotting anything. They even clothe the proto-humans in special garments to avoid granting them access to sensitive household equipment such as the toilet.

The question remains, how much does this all save in injuries and loss of life?

The fifth leading cause of death is accidents. But the top causes include heart disease, cancer, pulmonary diseases, and stroke. A decent amount (say 30%) of these others are estimated to be from tobacco use.

But that’s simplistic. Most of the deaths per year are of people over 64. The leading cause for people below 45 is accidents. 45-64 is cancer.

So smoking and other carcinogenic sources have long-term negative effects. Same with poor eating habits and lack of exercise. Does it make sense to use the same sort of scare tactic (skull-and-crossbones poison labeling) on something that kills you today and something that kills you in the distant future?

Same question for the ultrasound crowd. Will a scare tactic prevent abortions, when it is closer to the chronic condition (being a parent) category than the you will die if you eat a poison category?

Indeed, sans seatbelt seems more like a poison (a fixed risk of imminent death or injury) than tobacco or overeating do.

Ages 1-44 all have homicide in the top five leading causes of death. 10-44 has suicide in the top four. Where are the warnings there? Most homicides are in poor areas, and telling people they shouldn’t go home doesn’t help them unless they have an alternative. For suicide, mental health care would be required, so a scare tactic doesn’t really do.

But accidents (also known as unintentional injuries), they bear another look. Cars come in the top two for everyone at least one year of age. Unintentional poisoning is up there for ages 25-64. Gravity (the force, not the film)(AKA “unintentional fall”) leads among the over-64 group.

I’m just not sure how you would warn people about gravity. Parachute signs down from the sky? Plumb bobs?

But I do think that scare tactics need revisiting, because those old driver’s education videos didn’t make a big dent. There are still too many smokers. Diets need improving. More exercise is needed. And the overall quality of the environment needs work to protect our bodies from other (non-tobacco) man-made carcinogens.