Deeming Finalized

The FDA has finalized their rule for pulling e-cigarettes into their regulatory grasp. Litigation has already been filed in response. How will it all turn out?

Nobody knows. It’s that simple. The rule itself has a lot of things that make it look like the FDA is twisting the knob to 11, if they can. But how it will end up remains to be seen.

For example, they may be trying to close over the nicotine-free liquid market with the vague phrase intended or reasonably expected. A court may push back on that.

For example, they may be trying to force a de facto prohibition on open systems, through a burdensome regulatory process that would require open systems to mix-and-match matrix-style until every new product would require every other product to be tested with it.

But what will happen? A black market? A return to smoking? We will see.

How does this magic phrase, “intended or reasonably expected,” work? You have a nicotine-containing liquid. It’s, under the rule, a tobacco product. You put it in a tank. Now that tank is a tobacco product. You attach a drip-tip to the tank. Now the drip-tip is a tobacco product. You screw on a mod to the tank. Now the mod is a tobacco product. You put a battery in the mod. Now the battery is a tobacco product.

But under the rule, if you change one and only one thing, you can strike the word tobacco out from the paragraph above. That one thing: the fact that the liquid contains nicotine.

Now, assuming that the liquid is not bathtub-juice, that the nicotine is of high purity, the actual performance and harm of the same device is unchanged whether there’s nicotine or not. Whatever harmful constituents exist in the nicotine-free version will be identical to those in the nicotine version. But the regulatory difference is enough to bring an industry to its knees, call its lawyers, for black markets to open up.

Should these devices, which people use to inhale a flavored vapor, be regulated? Yes. It makes good sense that they be manufactured to a standard, that the public be protected against adulterated liquids (regardless of whether they contain nicotine), and so on. But the whole idea that it should all hinge upon something that constitutes, at most, six percent of the liquid (in the case of some cigalikes)? Dumb as all hell.

And the fact that the regulatory framework for these devices and products include so much testing that you’d think they were capable of far more than merely heating a liquid to point of vaporizing it so people could inhale it. I mean, your kitchen on an average night produces more harmful and potentially harmful constituents than a heavy e-cig user will in a week or a month. Your car produces more in a few minutes than an e-cig user will in a year. And so on.

The FDA probably couldn’t see any other way. Hopefully the courts and congress will.


The Teetotaler’s Mentality

Vapers that keep up see bans all the time. Not just regular public indoor bans, but apartment bans and outdoor bans. It offends the liberty-minded vapers, but it confounds even the average liberal. Why do they go after vaping? Lacking any good basis, the tendency is to resort to conspiracy theories. Big Pharma and taxes are popular bogeymen. Or a liberal agenda trying to turn the world into a combination of Disney and 1984.

As I’ve talked about before, some in the public health community have a gross fetish for stomping on smokers, and many in the public have joined that cause. The mass paranoia that we live with today, where a whiff of tobacco smoke may set off a Goldbergian reaction that ends with the offendee dead, their children’s dentures embedded in their spine, while the little creeps sing MMMBop and play pingpong with their eyeballs. Point is, people don’t just hate smokers, they’re scared of smoke, too.

Public opinion has had so much poison crammed into the notion of smoking that anything close might just rub off. The notion of vaping as smoking is popular (even among some ex-smokers). There’s still addiction to nicotine and the behavior. There’s still inhalation and exhalation of a nebulous, semi-opaque cloud of chemicals (in the pejorative sense of the word). And the fear, the paranoia is that in some years scientists will discover that vapers have just been putting cigarettes inside of metal and plastic enclosures and smoking them. That’s really what these people are on about. Full stop.

Some literally believe vaping is smoking. Others believe that we will one day find out that it has long-term hazards just as great. And still others may believe that sticking feathers up their butt would make them into chickens. But vaporizing a liquid is different than burning a solid. It ain’t water vapor, but it is a vapor (a vapor of mostly polyols and diols (glycerol and propylene glycol, respectively)).

But fear is pernicious. It can cause the mind to lash out at things unrelated, at scapegoats. Vaping is a popular one today, because—facts check out—the anti-smoking movement has been a failure in many ways. It has been a failure of policy, of lawmaking, of compassion, of sense, from every village and hamlet, from every state and every city. Success is not merely an ends game, which the anti-smoking (really anti-tobacco and in some ways anti-nicotine) movement hasn’t succeeded in either, but as the saying goes, ‘it’s how you play.’

And the strategies and tactics have just been lousy. Not that the tobacco companies were cooperative, not that the politicians were humble, etc., but the movement as a whole hasn’t met the standards of a modern society. Its only saving grace has been science, what little science has been done compared to the money spent on pet projects and shoring up deficets due to lack of courage to raise the taxes.

The science of smoking and the public knowledge of it, fear of it, has had some success. But the science has always been overshadowed by the teetotaler’s mentality. This idea that abstinence is king, and we must all bow. We must all find it in our hearts to become masochists, to deny every vice that we have defined as vice (and yet to indulge the thousand others we have not yet defined as vice).

The teetotaler’s mentality is that holding a party with water and no beer is still a sin. Bingo is still gambling. Minced oaths are still curses. That veggie burgers are still murder. Contraception is abortion. And that vaping is still smoking.

They are zero tolerance, abstinence-only fiends. And they sometimes get the political ear to worry out a lame law. I still hold that in a decade a good many vaping bans will get reversed. But for now they keep coming. For now, the fearblind teetotalers have to change their diapers every time you vape.

But vaping is not smoking and no amount of agitprop will make vaping numbers drop off to levels where science won’t prove them much safer over the years. The teetotalers will find themselves prone on this issue, and many of these bans will get repealed as truth wears and tears at their jerking knees until they are stiff and arthritic.


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.


Brick by Brick: the Challenge of Regulating

Today I want to talk about the challenge of regulation, both in general and in the case of the FDA’s deeming proposal.

To start, where do regulations come from? The basic process:

  1. Congress passes a law, which is signed by the president. The law contains goals and general frameworks for regulation, but is something like a blueprint.
  2. The regulatory agency then takes that blueprint and tries to draft regulations based on it.
  3. The proposal bounces around inside the executive branch, to OMB and back to the agency, until a final proposal is ready.
  4. The proposal is announced (officially, via the Federal Register, and in media via press releases and press conferences).
  5. A period of comment is allowed for feedback on the various aspects of the proposal.
  6. The agency takes comments into consideration and refines the proposal into a final rule.
  7. The final rule bounces back and forth between OMB and the agency until ready.
  8. The final rule may be released, or another proposed version with another comment period may be used for further refinements.
  9. Once the agency begins enforcement actions, the affected parties may bring suits under a variety of causes, challenging the regulations.

The actual process is a little messier than the above, but that’s the basic framework. We are at step five in the process.

Now, the statute is law. Regulations have the force of law, but they are inferior to statute. So when people complain about an agency’s regulations, they may be off-base. Often, the statute, and by extension the congress, bears more blame for bad regulations than the agency.

Agencies can interpret statutes incorrectly (sometimes by mistake, other times due to vague or inconsistent statutory language). And they can overreach. But most agencies under most administrations try to follow the law, including the vague goals set in law by Congress.

Now to the proposal. The FSPTCA was designed for regular tobacco products, particularly cigarettes. Several years ago FDA took enforcement actions against ecigs as drug delivery devices. Why? Because under their interpretation of the law, they thought that action fit, and they enforce the law.

The judge in Sottera said that it did not fit, and suggested that FDA might regulate under the then-newly-passed FSPTCA. So FDA is going forward under the assumption that FSPTCA gives them authority, even if the law wasn’t written or intended to regulate ecigs. Keep in mind the FDA is still coming to terms with operating under the FSPTCA, as their regulatory history is of very different cloth.

When regulating drugs, FDA has a clear partner and adversary in the pharmaceutical industry. They have a clear mandate and a long history of how drugs get approved, and their employment and measures reflect a particular understanding of their duty. The culture for tobacco products at FDA is still nascent.

As they attempt to regulate ecigs, or even traditional tobacco, there are sure signs of the opposing forces of their drug regulation culture and the statutory requirements for tobacco products. They aren’t used to dealing with an industry without doctors, for example. Drugs mostly go through doctors and pharmacists.

They aren’t used to consumer products, as drugs and medical devices don’t tweet every time you use them (okay, so no ecig does that yet). And medical products tend to be expensive, so FDA isn’t used to products that need to retain reasonable prices.

The regulatory schema for food under FDA is very different. It’s mostly a matter of safety. Keep out cancer-causing substances, for example. And some of the authority over food sits with the USDA, which means FDA only partially controls the landscape.

FDA wants to strike the right balance, while upholding the law. That’s their job. But as consumers our chance to tell the FDA what that balance should be is the comment period. By submitting good comments, we can help the FDA understand the proper model for regulation here, and in doing so help them develop the right culture for all tobacco regulation going forward.


Against the Ban of Online Sales

There is a call among some of the opponents of vaping, now including the New York Times‘ editorial board, to ban the online sale of (at least) nicotine-containing liquids. Their position falls, apparently, below the rubric of halting underaged purchases. The position is not unique, as it comes up from opponents of just about any good or service.

In our age, to suggest the need to ban any common commerce from the Internet simply fails, at least before the attempt is made to find technical solutions. Online buying and selling already, or will soon, amount to at least a billion dollars per day in the United States alone. And that’s just business-to-customer, so business-to-business is likely at least as large.

Online banking is another major online commercial activity. The fact that banks trust the current security regime enough to move forward is a clear sign that restricted items such as nicotine products, alcohol, and others should be allowed via the Internet.

Indeed, pornography is regularly purchased on the Internet. But a more important analog to nicotine would be e-pharmacies. While there are some illegitimate pharmacies online, many reputable, accredited pharmacies do sell via the Internet. The FDA even has pages devoted to helping consumers “Find a safe online pharmacy.”

Given the general direction of society toward e-commerce, and that we are obviously capable of meeting the challenges it poses (which in the case of drugs include temperature control, access control, etc.), it seems that any knee-jerk argument that some goods must only be sold in person falls on its face. We already have need to have authentication and chain-of-custody in purchases. While online sales ought to be regulated appropriately, they simply must be permitted and the regulations will merely serve to strengthen the e-commerce landscape for all goods.

Okay, so what about guns? Once again, as for any other restricted good, verification should suffice. A legitimate purchase is fine. Given the broad availability of illegal guns (not to mention drugs), there is absolutely no reason to believe that Internet sales will make the problem worse.

The call for banning of online sales is akin to incorporation of so-called digital rights management into digital content. It only punishes the legitimate consumers and users of the goods and services. It does not seriously hinder anyone that wishes to skirt the law. Worst of all, it weakens the market considerably, removing opportunities for new efficiencies and growth.

So what good is a call for banning online sales? It sure sounds good. Just like DRM. To quote H.L. Mencken, “there is always a well-known solution to every human problem — neat, plausible, and wrong.” Banning of commerce, even merely through one trade route, is the use of a cleaver to remove a splinter from your finger. It is a drastic overreach, beyond the pale except in the most extreme circumstances (e.g., plutonium and uranium in the case of outright prohibition, or maybe vending machines that sold cigarettes).

Sales via the Internet simply aren’t the issue, and we have a host of products that need proper age verification and/or buyer authentication. These, at volumes large enough to justify the cost of implementing the proper controls on purchasers, require the government to step in and regulate, but in no way justify a ban.