Brick by Brick: The Regulatory Environment

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.