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.
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