Tag: FDA

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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.

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Brick by Brick: The Final Stretch

We’re closing in on comments-due on 8 August 2014. If you haven’t commented, I urge you to do so by then. I will be submitting my own comment as well.

The process from 9 August 2014 is for the FDA to read all the comments they have not yet read, process them, and then formulate their new view of the matters at stake. Then they will amend the proposed regulation and it goes through the OMB loop again, letting them push back a bit. And then it eventually gets finalized.

Once finalized, the fun really starts. Lawyers of various stakeholders will begin helping them formulate their compliance behaviors for the new rules (larger and more established companies probably already have regulatory compliance work ongoing, but it will have to be modified and extended to fit the new rules). Lawyers will also begin considering how challenges to various provisions of the rules on various grounds might play out.

The provisions will all have effective dates, compliance periods, and so on. The companies will have to decide whether they want to force the issue on certain provisions by failing to comply entirely or let the FDA come after them for partial compliance, etc. Posturing will go on. The media will do whatever it is that they do. Throw darts at the proposal and print the words they land on?

But right now we still have time to finish our comments. For a little under a week, anyway. And then we get to wait for the final rule. Or maybe another comment period. If the FDA believes enough has changed once they reformulate, they could offer us another chance to comment, on an updated proposal. I actually think this may be the case.

We asked the FDA to extend the comment period, which they did. But they didn’t extend it very much. A very strange move, that. My guess is that either they don’t think the comments matter very much, or they feel that enough will change that spending too much time on first-round comments will be somewhat wasted. Given the comments do tend to matter, I lean toward the latter.

Keeping it short today, as I want to spend more time on my comment. Good luck!

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Brick by Brick: Why E-cigarettes?

The FDA’s deeming regulations target electronic cigarettes. Much of the how of the regulations is by statute, originally meant to mainly cover tobacco cigarettes. The FDA gives an option in their proposal to largely exempt cigars that retail at over $10, on the premise that they are not likely to be smoked heavily by most of the population and especially by youth.

But why go after ecigs? That’s one choice the FDA does have, and is making, in their proposal. Aside from smokeless tobacco and cigarettes (and NRTs like the patch, which are exempt from the TCA as drug delivery devices), the FDA has discretion in which tobacco products to regulate. The question should be examined.

Foremost, vaping caught the FDA off guard back around 2007. At the time, some companies were making what the FDA (and likely the law) views as medical claims. The notion that you can quit smoking with some product makes it a medical matter, as smoking addiction is viewed as a medical problem (the disease model of addiction) that requires a medical solution. Never mind the fact you can write a book about ecigs, How to Quit Smoking with Electronic Cigarettes and the FDA can’t touch it. Or you can open the Church of the Electronic Cigarette and have people pray away their addiction while puffing on vaporizers and the FDA can’t do anything.

The FDA tried to take these companies to task, playing house detective for the pharmaceutical industry’s NRT and psychotropics meant to combat smoking addiction. The pharmaceutical industry does a lot of business with the FDA. The FDA believes all firms in similar businesses should therefore be subject to similar approval processes. This is both a feeling of fairness to the FDA and a way to guard their reputation; they need to believe their work matters: both that it both protects public health and that their labor is worthwhile.

Vaping won in court. The FDA could have shrugged it off, continued policing for medical claims, but leaving the vaping industry alone otherwise. Here’s where the inertia of bureaucracy kicks in. Having made overtures to regulate as NRTs, the FDA felt like they had to keep coming in whatever capacity remained. The perception of vaping as the latest stunt by the tobacco industry to skirt the 40-foot border fence put up to try to finally rid us of tobacco-related disease meant the FDA felt compelled to act. Out of internal pressures from the failed first attempt, out of media pressures, out of public health pressures, and out of political pressures, the FDA has to show they are up to the challenge.

It would be like if someone invented electronic food that gave the sensation of eating without gaining weight, and the health community came out, along with the legislators and executive agencies, demanding that we keep electronic food under a tight leash. They might do so on the premise that it would actually encourage more eating. They might say it will entice children to become over-eaters in the future. And, of course, they might say the risks of virtual food are unknown, unstudied. They would definitely say that we’ve been played by the food industry before (remember the TwinkieⓇ diet), and we can’t afford a repeat of that.

The problem is, even if there were problems with the current form of vaping (and there are no real indications of any major problems at present), the general goal and the technologies that exist can and should moot them. That is, the promise of vaping, even if it weren’t the reality, is entirely real. And even still there are members of Congress, employees of the FDA, and representatives of the public health community, that oppose vaping at its root on a variety of false premises (even Senator Tom Harkin of Iowa, political beneficiary and protector of the herbal supplements industry, showed confusion and lamentation that the FDA couldn’t regulate ecigs as drug delivery devices, something he would lose his seat for if he said it about herbal supplements).

Their main reason for opposition is the history of the tobacco industry. History they contributed to, mind you. The Tobacco Control Act largely protects the basic tobacco cigarette which is the main cause of tobacco-related disease and is the biggest seller of the tobacco industry. The TCA says that the tobacco cigarettes on sale as of 15 February 2007 may remain on the market despite any and all advances in technology (i.e., even if by some miracle biology invented a carcinogen-free combustion cigarette, the FDA would not be able to mandate the switch without a new law from Congress).

If anything, the TCA is built to impede progress. It requires an onerous process to garner approval for better, safer products. It requires an even harder road to make legitimate claims that a product is safer. Yet the world of perception that the media and the Congress live in says, ‘We have a law to protect us from tobacco, and e-cigarettes must be thereby regulated.’

The design isn’t necessarily meant to protect tobacco, but could just as easily have arisen from a desire to prevent what public health sees as tobacco’s ulterior motive of making deadlier, or at least more addictive, products. Yet it equally blocks safer, less addictive, or otherwise improved products all the same.

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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.

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Brick by Brick: Questions for the Lay Comment

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.