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.

Social Media: For Adults Only?

 Writing in National Review, cultural critic Christine Rosen recently proposed a total ban on social media for everyone under the age of 16.  One can imagine all sorts of problems with this idea, ranging from enforcement issues to what it would be like living in a country where nearly all the teenagers start screaming at the same time.  But let's step back from the immediate issues and effects, and ask what the ethics of such a ban would be. 

Rosen cites a number of other things that we don't let teenagers and younger kids do:  driving, voting, drinking and smoking (at least in public), and enlisting in the military.  There are various specific reasons for each of these bans, but at bottom, they all amount to the same thing:  lack of judgmental maturity, specifically a virtue called prudence. 

This is not to say that there are no prudent 10-year-olds.  But the classical virtue of prudence involves a mature measure of reasoned self-discipline.  Our intuitive sense that younger people, especially teenagers, are on average less able to impose discipline on their powerful desires is confirmed by neurological studies of the brains of teenagers and adults that were observed in the lab while the subjects made decisions.  In teenagers, the part of the brain called the amygdala, which governs "fight-or-flight" impulsive behavior, tends to take precedence over the frontal cortex, which is where deliberation and conscious decision-making tend to occur.  If teenagers tend to be physically incapable of making certain decisions in a way that doesn't harm themselves or others, it is a good thing to remove the choice from them until they are older. 

Rosen cites an internal study by Instagram that showed fully one-third of teenage girls found using the platform made them feel worse, but they were unable to stop it.  She points out that the 18-year-old who killed 21 people, most of them children, in a Uvalde elementary school last month had the habit of bullying others on social media. These examples highlight the fact that a mixture of hormonally stimulated teenagers and electronic media expressly designed to promote "engagement" by pressing mental hot buttons exquisitely ferreted out and customized to the user, leads to behavior that exploits teenagers, displaces time that could be used for in-person interaction, working, or sleeping, and at the extremes, encourages callousness, bullying, cruelty, and abuse.  

And there doesn't seem to be any way to design out the bad features while leaving in the good features.  If only angels used social media, there would be no downsides to it, but as angels communicate by what amounts to telepathy, there would also be no point in it.  (Angels also don't have any money.)  As much as the social-media giants don't like to admit it, they are basically in the same business as gambling casinos are:  to encourage something that at best is an amusing pastime, but at worst can be an enslaving and life-destroying habit. 

Gambling is another thing that we generally don't let teenagers do, for the same reasons as for driving or drinking.  When Rosen points out that the average teen spends five hours a day on social media, that is a mind-boggling number of person-hours that has been commandeered by firms who take huge amounts of time from young people, make huge amounts of money from them, and deliver very little that benefits them—especially considering the other things that the teens could be doing.  

Similar debates took place back in the 1950s about the time people spent watching TV, which has been largely displaced among the young by social media.  TV was an almost completely passive medium, however, and it wasn't possible to insult your neighbor or bully your girlfriend through the tube.  Mass-market TV had its own problems, but they were demonstrably milder than the worst pathologies we are seeing today that social media contribute to.

How would a ban on use of social media by those under 16 be enforced?  I can daydream about some measures that might be impractical, but also might be worth trying. 

One would be to have a social-media license, comparable to a driver license.  I can't imagine what kind of test we could make up to qualify a person to be able to use social media responsibly.  Maybe a highly-monitored "test drive" in which the prospective licensee's every text and comment would be vetted for meanness or bullying?  Of course, even hypocrites can behave nicely if they have to, and we might just let everyone have a license once they reached their sixteenth birthday.   

 

But I kind of like the idea of making people work for it, and teaching them some ground rules about social-media behavior before turning them loose on the Internet.The license idea would also help to deal with the problem of enforcement.  The banks have worked out ways of knowing exactly who is at the keyboard in the vast majority of cases.  True, there are always identity thieves to be fought, but thieves go where the money is.  There's not much money in faking a social-media account identity, so I would think that enforcement policies as robust as those banks use would keep fake identity problems down to a minimum.

 

Whatever the enforcement mechanism would be, it would have to come with severe penalties to the social-media companies for violations as well.  Shutting down half their servers, for example, might be a much more meaningful penalty than a fine, which is usually chump change to these giants.

 

I will close with an anecdote about a car salesman, about twenty-five years old, who I fell into conversation with one day as we were taking a new car for a test drive.  He was obviously aiming to please, but the remark he made as my wife and I reminisced about cars we had twenty and thirty years ago wasn't calculated to please me.

 

Apropos of nothing, he said, "Well, there's some things you folks enjoyed back then that I wish I could have experienced.  It's life without those," he said, pointing to my wife's mobile phone. Of all the changes from our generation to his that he could have mentioned, he saw the personal phone as something he wished he could have lived without.

 

The obstacles are many, but I hope Rosen's idea to ban social media for those under 16 gets serious consideration.  Evidence has been accumulating for decades that it is probably a net harm to young people, and what we lack now is only the will to make the change.

 

Sources: Christine Rosen's article "Ban Kids from Social Media" was published on June 9, 2022 at https://www.nationalreview.com/magazine/2022/06/27/ban-kids-from-social-media/.  I also referred to the American Academy of Child and Adolescent Psychology's website at https://www.aacap.org/AACAP/Families_and_Youth/Facts_for_Families/FFF-Guide/The-Teen-Brain-Behavior-Problem-Solving-and-Decision-Making-095.aspx.

Cooking with Gas No More: Natural Gas Bans

 

When I was growing up in Texas in the 1960s, natural gas was cheap, abundant, and generally regarded as one of the boons of modern life.  For a time, my father even worked for Lone Star Gas, the local franchisee in Fort Worth.  We had a gas stove, gas floor heaters and space heaters, a gas water heater, and many people we knew even had decorative gas lanterns that looked like miniature street lamps standing on their front lawns, emitting a greenish-white glow from a gas mantle while consuming gas 24 hours a day, which was why the gas company promoted them so much. 

 

So when I read recently that New York City, Los Angeles, and even some entire states are moving to ban the installation of natural gas in new construction, I understood their reasoning, which is that fossil fuels need to be phased out in favor of renewable-energy-produced electricity.  But at the same time, I couldn't help but wonder what they're going to be missing.

 

Switching from gas to electric heating and cooking is climate-change-friendly only if that electricity is produced from renewable sources.  As of February of this year, about 60% of electricity in the U. S. comes from fossil fuels, 20% from nuclear energy, and only 20% from renewables (primarily wind, hydropower, and solar).  So even if we shut off every gas valve in the country (except those at power plants) and used electricity instead, we'd end up producing more greenhouse gases under present circumstances.

 

Why?  Because if you start with a given amount of heat energy from natural gas, it's more efficient to burn it right where you use it—in a stove or a heating furnace—than it is to burn it in a power plant, make steam with the heat, turn a generator with the steam, and transmit the electricity to the place you're going to use it.  So-called Carnot-cycle heat engines, of which a fossil-fuel-fired power plant is an example, inevitably have efficiencies less than 100%, so it will take more gas to make electricity that is then turned into heat, than it would simply to burn the gas where you need the heat in the first place.

 

Of course, as the electric grid moves away from fossil fuels, this argument will gradually lose force, but right now it's still valid to the degree that places banning new natural gas installations still derive some of their electric power from fossil fuels. 

 

A recent article in National Review pointed out that certain types of restaurants depend on gas stoves for cooking particular kinds of food.  Asian food cooked in woks and certain types of Latin-American food really need gas, according to some Los Angeles chefs who are facing costly conversions if the city cuts off their gas supplies.  I have cooked Chinese dishes in a wok on an electric stove, and it can be done, but it takes longer than it would with a gas stove, and I can see why Chinese restaurants favor gas flames for cooking everything except rice. 

 

Representatives of the American Gas Association oppose such bans, saying that it drives up costs for new construction while not yielding a clear benefit with regard to greenhouse-gas emissions. 

 

This is a more complicated problem than it looks like at first glance.  For one thing, some bans are set to phase in over a schedule that extends several years in the future.  And a ban only on new construction using gas means that the total mix of housing using gas will gradually decline rather than falling off a cliff.  At the same time, the fraction of electric energy made from renewables will probably rise.  So the benefits in terms of greenhouse-gas emissions are hard to calculate and lie mostly in the future.

 

On the other hand, people living in places that have enacted bans or propose retroactive laws that don't exempt existing gas users are going to be put at a severe disadvantage pretty soon.  Fortunately, exemptions are being considered for such cases, and there don't seem to be any Carry Nations of the anti-gas lobby going around shutting off gas lines without permission. 

 

This is an example of how difficult it is to factor what economists call an externality (such as air pollution or greenhouse gas emissions) into local regulations that affect the lives of individual people differently. 

 

Something similar happened when automakers began adding anti-pollution equipment such as catalytic converters to cars.  Only in that case, most of the rules applied nationwide, although California tended to take the lead, using its large car market to impose regulations on the rest of the country almost by default. 

 

However it happened, everybody who buys a car now pays a certain extra amount for the anti-pollution gear in order that everybody in a region (or the country as a whole) can enjoy clean air.  After a good amount of tussling, we worked that problem out, and are well down the road toward the ultimate goal of zero-emission vehicles, which electric cars achieve if you don't pay attention to where the electricity comes from (see the above discussion about sources of electric energy).

 

It's not possible to make gas stoves or furnaces that burn a lot less gas for the same amount of heat, or burn it in a way that doesn't contribute to global warming.  In other words, there's no such thing as a catalytic converter for a wok.  So in order to reduce the greenhouse-gas contributions of residential and commercial gas users, they just have to be eliminated, or at least banned from new construction.  And that is intrinsically a geographically-bound issue.

 

Not surprisingly, some states such as Utah have put a ban on gas bans—the state is acting to prohibit localities from banning gas appliances.  Here in Texas, I haven't heard anybody promoting bans on natural gas, not even in the bluest part of Austin.  It's just too much a part of our regional DNA to turn our backs on something that was foundational to the prosperity of the state, and to a large degree still is. 

 

But that's the beauty of federalism—we don't all have to do things the same way.  Berkeley and New York City can make do with electric-range kung-pao chicken (it is possible), and Texans can still say good-by to their evening guests by the light of a gas-mantle yard lamp.  Only in America.

 

Sources:  The article "Gas Stove Bans Are Starting to Look Racist" appeared on the National Review website at https://www.nationalreview.com/the-weekend-jolt/gas-stove-bans-are-starting-to-look-racist/.  I also referred to an article in the Stateline blog section of the Pew Trust website at https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2022/01/06/natural-gas-bans-are-new-front-in-effort-to-curb-emissions.  The percentages of electric energy sources are from https://www.eia.gov/tools/faqs/faq.php?id=427&t=3. 

Cyberattack Forestalled—For a Change

 

This blog focuses on engineering ethics situations that make headlines.  And by the nature of what makes headlines, most of the time it's bad news.  But every so often, some disaster is narrowly averted instead of going ahead and killing people or causing damage, so today I'd like to look at a small but significant success story, as reported in a recent Associated Press item.

 

Back in 2014, a hacker and activist named Martin Gottesfeld got upset about a teenager under treatment at Boston Children's Hospital who was involved in a highly publicized custody battle.  Gottesfeld decided to use his hacking skills to jam up the hospital's computer networks with junk data that took two weeks to unsnarl and cost the hospital an estimated $600,000.  The FBI got involved in tracking him down and convicting him, and he was sentenced to ten years in prison.

 

This incident familiarized the Children's Hospital IT people with the FBI.  When the FBI learned last summer that agents apparently hired by Iran were planning a cyberattack on the hospital, the FBI supplied their IT people with enough defensive help to forestall the attempted attack.  This bit of good news was unveiled recently at a cybersecurity conference at Boston College by FBI Director Christopher Wray.

  

For every really bad engineering-related tragedy that hits the headlines, there are usually several other less harmful or even harmless incidents that go unreported, either because the results were not bad enough to make the news, or because someone fixed the problem before it got really out of hand.  The FBI's success in preventing Boston Children's Hospital from falling victim to Iranian-sponsored cyberterrorists is in this category. 

 

In today's hyperspeed news cycle, the traditional slant toward bad news that has existed ever since print media was invented has only gotten worse.  This means that most of what we learn about institutions of all kinds—government agencies, the legal profession, the medical profession, and even religious organizations—tends to be critical or derogatory in some way.

 

Now to some extent, that is as it should be.  One important function of a free press is to search out wrongdoing and incompetence and expose it to the light of publicity, where one hopes that the democratic process, or embarrassment, or something, will cause an improvement in the situation.  So it's only natural that editors choose stories about something going wrong over happy-clappy items that say how wonderfully some new product is working, or how some federal agency successfully rescued people from a disaster.  But some good news does get out anyway.

 

Specifically with regard to the FBI, its popularity among the public has shifted in recent years.  According to a 2019 Pew research poll, the percentage of Americans with a favorable opinion of the FBI remained remarkably constant among both Democrats and Republicans from 2010 to 2016, within a few percentage points of 70%.  But after that, partisanship began to show, with the percentage of Republicans favoring it dipping to about half, and the percentage of Democrats rising above 70%.  Still, on average, as of three years ago, the FBI was still favorably viewed by a majority of U. S. citizens, according to Pew.

           

We depend so much in complex industrial societies for the proper functioning of institutions that it's hard to imagine what we'd do if they broke down.  But there are a number of ways public institutions fail, and one of them is to lose the public's trust. 

 

Even if an institution's actual performance is just as good as it ever was, if somebody convinces a lot of people that the institution is untrustworthy, it's going to be harder for the institution to carry out its job.  On the other hand, prior good experience with an institution tends to carry forward favorably.

 

The Boston Children's Hospital is a case in point.  From the 2014 experience, it had a positive view of the FBI and probably some personal relationships that made it easy for the FBI to convince them of the seriousness of the recent Iranian threat.  Consequently, they took action that successfully prevented the attack. 

 

But they didn't have to take the FBI seriously, and if this had happened to an organization that either had no prior history with the FBI, or a negative one, the protective advice might well have been ignored, to the detriment of everyone involved.

 

Some of the largest technically-intensive institutions these days which have taken big hits in their public perceptions are the social-media firms:  Facebook, Google, Twitter, and company.  Elon Musk represents no one other than himself, presumably, but his recent move to buy Twitter and take it private is being applauded by those who feel that Twitter has been too high-handed in censoring and banning certain views and people from their system.

 

At the same time, social media, along with the way the Internet treats news in general, bear a lot of responsibility for driving a wedge between the public and all kinds of institutions, social media giants included.  Now that real-time feedback has been finely tuned to maximize "engagement," millions (billions, if you count global numbers) are constantly whipped into outrage about something, and that something usually involves some kind of public institution—if you broaden the definition of "institution" to include things like the Kardashians.

 

It looks like Aristotle's advice of finding a happy medium needs to be followed here.  All-good-news-only media are confined to totalitarian countries such as Russia, and that extreme is to be avoided.  But it looks like we may have something closer to the opposite extreme, an institution-corroding situation in which the only things you hear about the government, educators, legislators, media personalities, and churches is bad news. 

 

I think the real answer lies not so much in yet more government regulation, or eccentric billionaires taking media companies private, but in a more mature citizenry who will not let themselves be coerced into a kind of universal cynicism, but instead use the ancient virtues of justice and prudence to find out the truth amid the smog of disinformation and hype.  And achieving that maturity has to happen one person at a time. 

 

Sources:  The AP website carried the item about Boston Children's Hospital at

https://apnews.com/article/russia-ukraine-technology-health-middle-east-e4f8e7145e4b4447a331d4b0cc5a5bd3.  I also referred to the Pew poll report summarized at https://www.pewresearch.org/politics/2019/10/01/public-expresses-favorable-views-of-a-number-of-federal-agencies/.