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.

Vaping Turns Deadly

At this writing, three people have died and hundreds more have become ill from a mysterious lung ailment that is connected with certain types of e-cigarettes.  The victims typically have nausea or vomiting at first, then difficulty breathing.  Many end up in emergency rooms and hospitals because of lung damage.

Most of the sufferers are young people in their teens and twenties, and all were found to have been  using vaping products in the previous three months.  Many but not all were using e-cigarettes laced with THC, the active ingredient in marijuana.  Others were vaping only nicotine, but some early analysis indicates that a substance called vitamin-E acetate was found in many of the users' devices.  It's possible that this oily compound is at fault, but investigators at the U. S. Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) have not reached any conclusions yet. 

In fact, the two agencies have released different recommendations in response to the crisis.  The CDC is warning consumers to stay away from all e-cigarettes, but the FDA is limiting its cautions to those containing THC.  Regardless, it looks like the vaping party has received a damper that may change a lot of things.

So far, vaping and the e-cigarette industry is largely unregulated, unlike the tobacco industry.  It found its first mass market in China in the early 2000s.  The technology was made possible by the development of high-energy-density lithium batteries, among other things.  While vaporizers for medical use have been around since at least the 1920s, it wasn't possible to squeeze everything needed into a cigarette-size package until about fifteen years ago. 

Since then, vaping has taken off among young people.  A recent survey of  U. S. 12th-graders shows that about 20% of them have vaped in the last 30 days, and this is up from only about 11% in 2017, the sharpest two-year increase in the use of any drug that the National Institutes of Health has measured in its forty-some-odd year history of doing such surveys.

The ethical question of the hour is this:  has vaping become popular enough, mature enough, and dangerous enough, that some kind of regulation (either industrial self-policing or governmental oversight) is needed?  The answer doesn't hinge only on technical questions, but on one's political philosophy as well.

Take the extreme libertarian position, for example.  Libertarians start out by opposing all government activity of any kind, and then grudgingly allow certain unavoidable activities that are needed for a nation to be regarded as a nation:  national defense, for instance.  It's not reasonable to expect every household to defend itself against foreign aggression, so most libertarians admit the necessity of maintaining national defense in a collective way. 

           

But on an issue such as a consumer product, the libertarian view is "caveat emptor"—let the buyer beware.  If you choose to buy an off-brand e-cigarette because it promises to have more THC in it than the next guy's does, that's your business.  And if there's risk involved, well, people do all sorts of risky things that the government pays no attention to:  telling your wife "that dress makes you look fat" is one example that comes to mind. 

On the opposite extreme is the nanny-state model, favored generally by left-of-center partisans who see most private enterprises, especially large ones, as the enemy, and feel that government's responsibility is to even out the unfair advantage that huge companies have over the individual consumer.  These folks would regulate almost anything you buy, and have government-paid inspectors constantly checking for quality and value and so on. 

It's impractical to run your own bacteriological lab to inspect your own hamburgers and skim milk, so the government is supposed to do that for you.  Arguably, it's also impractical for vapers to take samples of their e-cigarette's goop and send it to a chemical lab for testing, and then decide on the basis of the results whether it's safe to use that particular product. 

My guess at this point is that sooner or later, probably sooner, the e-cigarette industry is going to find itself subject to government standards for something.  Exactly what isn't clear yet, because we do not yet know what exactly is causing the mysterious vaping illnesses and deaths.  But when we do, you can bet there will be lawsuits, at a minimum, and at least calls for regulation of the industry. 

Whether or not those calls are heeded will depend partly on the way the industry reacts.  Juul, currently the largest maker of vaping products, is one-third owned by the corporate entity formerly known as Philip Morris Companies.  In other words, the tobacco makers have seen the vaping handwriting on the wall, and are moving into the new business as their conventional tobacco product sales flatten or decline. 

The tobacco companies gained a prominent place in the Unethical Hall of Fame when they engaged in a decades-long campaign of disinformation to combat the idea that smoking could hurt or kill you, despite having inside information that it very well could.  In the face of an ongoing disaster such as the vaping illness, this ploy doesn't work so well.  But they could claim that only disreputable firms would sell vaping products that cause immediate harm, and pay for studies that show it's better than smoking and harmless for the vast majority of users.

Sometimes the hardest thing to do is be patient, and that's what we need to do right now, rather than rushing to conclusions that aren't supported by clinical evidence.  Investigators should eventually figure out what exactly is going on with the sick and dying vapers, and once we know that, we'll at least have something to act on.  Until then, if by chance anyone under 30 is reading this blog, take my advice:  leave those e-cigarettes alone. 

Sources: I referred to articles at CNBC.com (https://www.cnbc.com/2019/09/07/cdc-fda-clash-on-warning-consumers-during-lung-disease-outbreak.html) and vox.com (https://www.vox.com/science-and-health/2019/9/3/20847219/vaping-health-risks-2019-lung-damage-death) as well as the Wikipedia article on Juul.