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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.

Brick by Brick: Questions for the Lay Comment

Some questions that lay comments can answer in writing to FDA about their deeming proposal.

This post focuses on the questions the FDA asks in its deeming proposal that best fit for layperson comment. Some questions may be best answered by experts or by vendors and manufacturers, but a variety of questions are suitable for comment by vapers themselves.

Foremost, in submitting this type of comment, you should lightly pepper it with phrases like, “further study is needed.” The FDA wants existing studies, existing science. But in many important areas there have been no studies, and the FDA will be undertaking studies based on areas of comment that show scientific ignorance.

By submitting particular comments about these areas, saying you believe there is a relationship between aspects of vaping, but do not have a study to show them, it will establish the need to undertake that type of study. In many ways, this comment period is as much about influencing the regulation as it is about influencing the direction of FDA dollars to study the real issues that can help vaping.

Flavors

The flavor issue is not directly regulated in the proposal, which has been described as foundational. The FDA could include flavor regulations in its final proposal, but it is more likely to address flavors in subsequent proposals.

That said, product users can and should address the flavor issue head-on in their comments to FDA. Particular areas of interest to FDA will be:

  • What flavors do you, as an adult, use? Not just in ecigs, but do you really like some particular Halloween candy (that you steal from your children who worked so hard trick-or-treating to get it)? Do you really like a certain flavor of ice cream? Of soda?
  • What flavors have you tried that may be “adult-oriented” that you found unsatisfying in vaping? Did you start on a tobacco flavor that did nothing for you?
  • What other adult-oriented products have a variety of flavors that might be seen as appealing to children?
  • What effect did flavors have on your potential to dual-use ecigs with cigarettes? Did you find cigarettes disgusting after trying to smoke a cigarette following prolonged use of vapor products?

In general, the FDA would prefer some magical study that showed definitively how flavors affect human behavior, but we do not have that magic study yet. So they should be interested to know the reality of the flavor situation, if only to inform them of future areas of research they should pursue.

Product Variability

The FDA wants comments on how to regulate ecigs. While you may not want them to, or you might want to limit regulation to a few key areas, you can still give them information that will help strike the right regulatory balance.

Did you “progress” in the types of vapor products you use? How did that progression go for you:

  • Was it easy to move to more advanced products?
  • Did you find the less advanced products less satisfying (both at the time they were your primary products and once you had moved on)?
  • If you started as a dual-user, how did the advanced products help you switch exclusively to ecigs?
  • If you lowered your nicotine levels over time, what about the products made that possible? What could have made it easier?
  • How many flavors did you try that you did not like? How many did you try before you found an “all-day vape” or a favorite?

You should distinguish what the advance was for you. Was it longer battery life? Better vapor production? Better flavor production? Easier to use? More consistent?

Studies on cigarettes show that the first cigarette of the day is the hardest to give up for a subset of smokers. The FDA should hear if you struggled with that, or if you found that once you used ecigs it was not a problem. Particularly, did you find it easier once you began using more advanced products?

Other types of variability will interest them.

  • What is the most frustrating part about using vapor products? They are often more complicated to use than cigarettes. Was there any point during your use (especially early use) when something frustrated you enough to have or almost have a cigarette?
  • Does the fact that some flavors of liquids need to “steep” cause frustration? Do you have trouble waiting, or do you forget to order liquids soon enough so that they have time to “steep?”
  • How consistent are products? A new coil versus old coil? A new bottle of liquid versus an old bottle?

Online Sales

Finally, you could discuss the amount of products you have bought online versus in person. While the FDA has not made any express moves against online sale of vapor products, they may do so in the future. You may also point to some of the benefits that online commerce presents over traditional commerce including (especially if you have participated in or used them):

  • Co-op buys
  • Auctions/used equipment sales
  • Comparison shopping (including price, quality, reviews, etc.)
  • Increased competition driving improved product quality

The FDA does not want to ban online sales, but may be sympathetic to the issue of youth access. You can tell them if you believe that technological systems to prevent youth access are a viable option (comparing viability to other access controls, such as for online banking).

We should let the FDA know that consumers support a more robust and comprehensive system for handling nuances in online commerce (including, e.g., prescription verification, which is right in their wheelhouse). It will benefit not only ecig commerce, but the growth of online commerce in general.

Wrapping Up

The FDA would love if they could do valid scientific studies on everything. They can’t, and in many cases they either don’t know what to study or science lacks the ability to measure what they want to study.

I believe average vapers that include feedback on these issues will at least give them direction on what they should study to inform future regulations. It may also help them to improve potential product manufacturing standards in ways that result in better equipment, especially for newer vapers that have not progressed to advanced products.

The flavoring issue is particularly important. The FDA has no science to back claims that they should ban particular flavors. But they need to understand that flavors are also one of the biggest draws switching to ecigs. By sending them comments that raise your particular experiences with flavors, you will help convince FDA to undertake flavor-specific studies that will show that flavors are an important component of the success ecigs offer to help smokers switch. They will find that flavors also help vapers drop their nicotine levels. And so on.

Brick by Brick: the Challenge of Regulating

Overview of the regulatory process and the balance the FDA needs to strike.

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.