Juul and the FDA: Smoke and Mirrors

 

Full disclosure:  I have never smoked tobacco, pot, or e-cigarettes, so I have no personal dog in the following fight.  But lots of people do, and the story's twists and turns say a lot about the way the U. S. Food and Drug Administration (FDA) throws its weight around like a 900-pound gorilla that's had too many fermented bananas.

 

The newsworthy tip of this iceberg caught my attention earlier this week when the FDA issued a ban on the sale of all Juul e-cigarette products.  The reason was that after a two-year review of data provided by the company to the FDA, that august entity decided that on balance, there were not more health benefits than harms caused by the sales of that particular brand of e-cigarette. 

 

By the time I settled down to write this column, a U. S. federal appeals court in Washington had temporarily blocked the ban at the request of Juul.  The ban was not a ruling on the merits of the case, but lasts only until July 12 in order for the court to have time to consider the matter more thoroughly.  In case the court ruling went the other way, Juul had allegedly also been preparing to declare bankruptcy, as e-cigarettes make up the bulk of its products. 

 

Other e-cigarette firms have undergone the FDA's scrutiny and gained its approval as long ago as October of last year.  It's not clear why some companies have been approved while Juul, once the most popular brand of e-cigarette but now suffering from declining market share, was denied approval. 

 

What is even more striking is why the FDA allows the sale of conventional cigarettes by the millions, which everybody knows cause lung cancer and other fatal and debilitating diseases, and then turns around and says to Juul no, you can't sell e-cigarettes.

 

A look into the history of the FDA and tobacco shows a pattern of arbitrary regulatory overreach unevenly distributed among the various tobacco and tobacco-like products on the market.  Back in August of 2016, in the waning days of the Obama administration, the FDA gave itself authority to regulate all tobacco products.  If one asks "whence comes this authority?" the only answer I can think of is Congress, which set up the FDA in the first place to interdict the interstate sales of "adulterated" food and drug products back in 1906.  The FDA's authority to do so waxed and waned over time and court cases, but each time the headlines carried news about deaths due to things like impure vaccines, public opinion pushed Congress to authorize more authority for the agency.

 

But since World War II, we have seen the explosion of what is called the administrative state, in which agencies such as the FDA acquire a quasi-independent status and basically make up their own rules, with the frequent collusion of the courts and the passive acceptance of Congress, which either has other things to do or simply lacks the nerve to interfere.  So when the FDA took upon itself the mantle of authority over all tobacco products, the e-cigarette makers decided to make an end run around them.

 

Tobacco products have to start from tobacco.  The essential ingredient in e-cigarettes is nicotine, which the e-cigarette makers had formerly been extracting from tobacco.  That made their wares tobacco products and subject to the FDA's rules.  Well, what if they get totally away from tobacco and turn to synthetic nicotine made from, say, petrochemicals?  No tobacco, no regulation by the FDA.

 

This worked for a while, but even government agencies can figure out when they're being bamboozled.  So last March, tucked in a spending bill passed by Congress and signed by President Biden, a provision changed the FDA's definition of "tobacco product" to include those made with synthetic nicotine. 

 

Amanda Wheeler, president of the American Vapor Manufacturers Association, was quick to criticize the decision to reclassify e-cigarettes with synthetic nicotine:  “This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”

 

Earlier, the FDA had decided that once it got authority to regulate e-cigarettes, the rule it would apply is this:  the supposed benefits of e-cigarettes, namely their tendency to keep people who would otherwise puff real cigarettes from doing so, had to outweigh the harms caused by the nicotine.  Now, how anyone would have the Solomonic wisdom and the utilitarian calculus ready to figure that out is beyond me.  But the FDA claims to have done it, favorably in the case of some e-cigarette companies examined last fall, and unfavorably in the case of Juul.

 

It really does begin to look like the FDA is a sock puppet whose manipulating hand leads straight to the big tobacco companies.  While those firms have moved into e-cigarettes to some degree, investing in or buying out vaping firms altogether, as a whole Big Tobacco would like e-cigarettes to go away and stop tempting people away from regular smoking. 

 

E-cigarettes, which rely on technical advances such as lithium-ion batteries, show the falsity of the oft-repeated saying, "Technology is neutral—only the way people use it is good or bad."  There is not a lot you can do with an e-cigarette besides smoke it.  As to the morality of smoking—e-cigarettes, regular cigarettes, pipes, or big stinky cigars—that is a matter fraught with complicated implications there is no space to examine here. 

 

But I think we can all agree that any agency with authority should apply that authority in a way that is transparent, logical, and fair.  The arbitrary ban of Juul from a market in which regular tobacco is permitted seems to fly in the face of that principle.  It will be interesting to see what the court of appeals decides once the smoke has cleared and all the facts are examined.  But without a firmer hand on the rein by Congress, the FDA will keep misbehaving in a way that destabilizes markets and perturbs the public it was established to serve.

 

Sources:  I referred to the following articles:  from Reuters via NBC News at https://www.nbcnews.com/business/consumer/juul-e-cigarette-sales-ban-on-hold-pending-federal-appeal-rcna35308, from Bloomberg News at https://www.bloomberg.com/news/articles/2022-06-23/juul-vaping-products-are-ordered-off-the-market-in-the-us-by-fda, from the FDA's website at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products, from Time Magazine at https://time.com/6156327/fda-synthetic-nicotine-regulation/, and from the Wikipedia article on Juul.

Exploding E-Cigarettes and Ethical Theories

A recent article in the engineering magazine IEEE Spectrum describes how numerous users of e-cigarettes have received injuries ranging from minor to life-threatening when their devices caught fire or exploded.  E-cigarettes work by vaporizing a solution of nicotine and flavoring with a hot wire powered by a high-energy-density lithium-ion battery.  Lithium-ion batteries are in everything from mobile phones to airliners, but the particular design of e-cigarettes makes them especially hazardous in this application.  The high power required by the heater means that the battery is operating perilously near the maximum output current that it can maintain without overheating itself.  And if there are any manufacturing defects in the battery, as can often happen if substandard components are used by a fly-by-night manufacturer with inadequate quality control, the e-cigarette user ends up carrying around what amounts to a small pipe bomb.

The consequences can be dire.  The article tells the story of Otis Gooding, whose e-cigarette went off in his pants pocket, injuring both his thigh and the hand he used to try to get rid of it.  Other users have lost eyes, teeth, and parts of their cheeks to explosions and fires.

Anecdotes, however harrowing, do not constitute numerical evidence that the typical e-cigarette user is taking his or her life in their hands when they light up.  But various sources have estimated that the incidents of e-cigarette explosions or fires is in the dozens if not hundreds a year. 

The e-cigarette market had total sales exceeding $2 billion in 2016, and assuming the average user spends $150 a year on the habit, that means over 10 million people in the U. S. are likely regular users.  Say 100 of these have fireworks-type problems with their devices, and that amounts to an incidence of 1 per 100,000 per year, which is the type of ratio that public-health epidemiologists like to use.  Just to put that in perspective, deaths in the U. S. from lung cancer in the period 2011-2015 averaged about 43 per 100,000.  One of the advantages touted for e-cigarettes is that they don’t produce the tar and other nasty stuff that leads to lung cancer in regular cigarette smokers.  While e-cigarettes haven’t been around long enough for this assertion to be empirically verified—nobody  has been an e-cigarette user for forty years yet—there is probably something to this argument.

And such an argument would appeal to a certain type of ethical theorist called a utilitarian.  Utilitarians decide what the right thing is to do based on the greatest good for the greatest number.  A utilitarian might look at this situation and say, “Okay, we have Case A and Case B.  In Case A, 10 million people satisfy their craving for nicotine with plain old coffin-nails, and as a result a good many more than 43 of them die of lung cancer every year.  In Case B, we have the same 10 million people smoking e-cigarettes.  A lot fewer of them die of lung cancer, at the price of only one unlucky person whose e-cigarette explodes in his face.  Clearly, Case B is better.”

And if you put it that way, it’s hard to argue the point.  But we don’t live idealized lives in which we’re always choosing between two clearly-defined cases.  And if I were an e-cigarette user (which I am not), I would still be concerned about the chances that my device could blow up or catch fire.  But the utilitiarian won’t help me.

So I go looking in the catalog of ethical theories and find something called virtue ethics.  Basically, virtue ethics encourages cultivation of the virtues, of which there are almost as many as there are virtue ethicists.  Of the virtues we could choose from, I’ll pick one that doesn’t have a particularly fancy name, but will work for our purposes:  thoughtfulness. 

If you open a cabinet door while making breakfast one morning, and then think to close it afterwards not because you want to (open cabinet doors don’t bother you at all) but because your wife has a thing about open cabinet doors, you’re being thoughtful.  What does thoughtfulness say about the situation of defective e-cigarettes leading to explosions and fires?

Well, it draws attention to the proximate causes of those explosions and fires, which in most cases prove to be defective lithium-ion batteries supplied by shady manufacturers who are almost exclusively in China, which is where most of the devices and their components are made.  Now there’s over a billion people in China, and probably most of them are doing the best they can in their lives, trying to improve their lot and fulfill their obligations.  China is a haven for entrepreneurs right now, especially in the exploding (so to speak) growth market of e-cigarettes.  And in a world economy where low prices speak louder than almost any other consideration, the organization that can underbid everybody else tends to get the business.  And so probably the management of a shady lithium-ion battery factory feels caught between the rock of maintaining quality and reliability on the one hand, and the hard place of not pricing their product above the minimum needed to get the business. 

The virtue ethicists would tell the makers of e-cigarettes to clean up their act.  “How would you like to be one of the customers whose lips are sent to Kingdom Come by one of your bad batteries?” they might ask.  Of course, if one company spends the money to improve the quality of their batteries, there may be another one around the corner willing to skip quality control and underbid the first company.  The e-cigarette makers who buy batteries also have reputations to uphold, and so they could also pay attention to the sermon of a virtue ethicist and take more responsibility for the quality of their products.  In any event, it’s easy to see that virtue ethics provides you with more reasons to do something about this situation than utilitarianism does.

This is not to say that utilitiarianism is useless.  In situations where there are lots of data to work with, utilitarian analyses can clarify choices between comparable courses of action.  But sooner or later, it always runs up against the questions of how to quantify good, and who to include in the greatest number.  And there are no universally agreed-upon answers to those questions.

Sources:  The print version of IEEE Spectrum carried the article “When E-Cigarettes Go Boom” on pp. 42-45 of the July 2018 issue.  A briefer version appeared on their website in February 2018 at https://spectrum.ieee.org/consumer-electronics/portable-devices/exploding-ecigarettes-are-a-growing-danger-to-public-health.  The statistic about lung cancer was obtained from https://seer.cancer.gov/statfacts/html/lungb.html, and the sales figures for e-cigarettes are from https://www.statista.com/statistics/285143/us-e-cigarettes-dollar-sales/.

To Vape or Not to Vape?

A year or two ago, the administration at Texas State University, where I teach, passed a regulation that abolished smoking everywhere on campus, inside and out.  I have mixed feelings about this.  Personally, I have never smoked.  Both my parents were moderate to heavy smokers, and my father died of lung cancer at the age of 57.  So I am familiar with the harm smoking can do.  On the other hand,  some see widespread bans on personal habits that have at least some redeeming features as abuse of governmental authority.  Overall, I was mildly pleased by the ban, and so when I walked by a student lounge area in our building the other day and saw what I thought was a puff of cigarette smoke, I was surprised.

But on closer inspection, the student turned out to be "vaping":  smoking (or whatever the appropriate verb is here) an electronic cigarette.  Was that violating the smoking ban or not?  So far, the university hasn't ruled on whether vaping counts as smoking.  Since electronic cigarettes are unquestionably an engineered product, their production, sale, and use fall within the purview of engineering ethics. 

A visit to the website HowStuffWorks.com informed me that a Chinese pharmacist invented e-cigarettes a decade ago.  They depend on small lithium batteries for their energy source, and rechargeable lithium batteries themselves haven't been around for much longer than that.  The power goes through a voltage regulator to a small heating element, where a solution of nicotine in propylene glycol is vaporized and inhaled by the user.  The stuff becomes a finely dispersed mist upon exhaling and looks different than true cigarette smoke, probably because the particles are larger and evaporate rather than dispersing.  The current form of the device was originally marketed as an aid to help people quit smoking, but as with many such aids for addiction, the cure may not be much of an improvement over the disease.

Who is affected by vaping?  Well, there are the manufacturers of the product and its auxiliary apparatus and supplies:  chargers, the nicotine solution, the e-cigarettes themselves.  There are users, many but not all of whom are former smokers of real cigarettes.  There are the makers of conventional tobacco products, who may either feel threatened by the new development or may co-opt it once the market gets large enough, and start selling similar products themselves.  There are various organizational entities ranging from private companies up to things like the European Union, which are now tasked with deciding what if anything to do about vaping.  And last, but hopefully not least, there is the general non-smoking public for whom second-hand-smoke bans were enacted.  But partly because e-cigarettes are so new, nobody has a lot of solid data on their health hazards and whether second-hand nicotine-tinged propylene glycol is something to worry about. 

Hong Kong and Singapore, among other countries, have imposed flat-out bans on e-cigarettes, but most nations either have no laws about them or impose only mild regulation.  Their status in the U. S. has been the subject of numerous court cases, and attempts to get them classified as drug delivery devices have been unsuccessful.  The latest court ruling, which is more definite than logical, says they can be regulated only as tobacco products, which is a little like classifying tires as agricultural products because rubber comes from trees.  But the effect is that governments can't do anything to e-cigarettes that they can't do to regular cigarettes.  Consequently, some state governments have banned sales to minors, but that is about the extent of U. S. regulation so far.

It seems to me that e-cigarettes are all about the nicotine, which has been proved time and again to be addictive.  But so has alcohol, and we all know what a flop Prohibition was.  I confess that I don't relish the idea of attending a party at which I discover several of my friends or students sucking on phony cigarettes, but then again, I don't go to a lot of parties anyway.  In the last couple of decades, the latent puritanical streak in American culture has fastened onto cigarettes, with the result that most people who smoke, as well as most non-smokers, regard the cigarette habit as a disreputable vice.  And this attitude itself will probably keep e-cigarettes from becoming as common as cellphones, for example.

The medical and health evidence on vaping is still largely lacking, so the precautionary principle says to leave it alone until it's been proven to be safe, whatever "safe" means in this context.  The main ingredients of the vapor—nicotine and propylene glycol—are well-understood compounds.  Nicotine use in any form is psychologically addictive, but doesn't itself cause cancer.  Propylene glycol, if pure, is approved for use in foods.  So it's unlikely that their combination in e-cigarettes poses a sinister unknown risk, although one can't be sure without the appropriate long-term studies.

The thing I dislike the most about e-cigarettes is that they present one more opportunity for people, especially young people, to become dependent on a costly habit that otherwise doesn't make the world a better place.  I say that in full knowledge that some of the historical figures I most admire, including G. K. Chesterton and C. S. Lewis, were smokers, not of e-cigarettes but of the original old smelly tobacco products themselves.  E-cigarettes are an addition to a spectrum of products that are potentially habit-forming, products that lie on a spectrum whose mildest end includes coffee and tea, and whose opposite malignant end winds up with heroin and crystal meth.  Some people can choose to stay in one place on the harmless end of that spectrum, while others find that they are drawn through the milder products to take dangerous and illegal risks at the other end.  This is not to say that everyone who tries e-cigarettes will end up hooked on them, or will start smoking real ones.  But some will.  And is the pleasure, or whatever satisfaction that people get from them, worth the risk to those who may find that they are being controlled by their habit, rather than the other way around?  We don't know, but it is a risk both governments and individuals should consider seriously. 

Sources:  HowStuffWorks.com has a good description of e-cigarettes I referred to at http://science.howstuffworks.com/innovation/everyday-innovations/electronic-cigarette1.htm, and I also referred to Wikipedia's articles on electronic cigarettes, nicotine, and propylene glycol.