Terry H. Schwadron
July 5, 2022
Naturally, the government’s decision last week to order Juul e-cigarette products off the shelves is not just a singular event.
It’s a broadside in the continuing tussle over where the lines are for governmental regulation, this time of tobacco product sales in the name of public health.
In recent weeks, we’ve seen the Federal Drug Administration move to cap nicotine in cigarettes, ban menthol cigarettes and flavored cigars sold disproportionately in minority areas, and have sued Juul for favoring teens in its advertising of vaping products. A federal court held up the order until a fuller hearing can be had, but stores are already acting.
As Axios and other news outlets have noted, the Biden administration has quietly been pursuing a broad tobacco agenda not seen in decades. Beyond Juul, the Biden administration wants to make the tobacco industry cut back the amount of nicotine in cigarettes sold in the U.S. to non-addictive levels.
Of course, Juul and the tobacco lobby are fighting back in court, seeking temporary and permanent turnarounds. Last April, Juul Labs agreed to pay $22.5 million to settle a lawsuit brought by Washington State over advertising campaigns that the state had argued were aimed to appeal to the young and to deceive consumers about the addictive qualities of vaping.
It’s a replay of what we once saw in decades past with Big Tobacco protecting its sale of cigarettes and cigars while heavily understating any ill health effects in advertising and promotion efforts.
Only now, it comes as a Supreme Court right-leaning majority seems committed to think anew about the regulatory powers of the federal government, and a perception of overregulation of silly things seems to be in the minds of angry voters.
Target: Teen Vaping
Let’s please start with the idea that no regulations would be needed if individuals and companies behaved well. They don’t. So, we need speed limits and traffic rules, and we apparently need public safety regs to keep vape makers from using bubble gum flavoring to attract young people. The same is true for overselling airplane flights, stopping unsound financial practices or eliminating bad emissions from carbon-emitting utilities.
To do so, we authorize legislation and give the enforcement job to federal and state agencies — until it all ends up in the courts.
For the tobacco lobby, e-cigarette makers and anyone inclined to fight the idea of government regulations overall, the strategy is to turn this into a long, drawn-out defense, including the arguments that eliminating Juul products would push users to traditional cigarettes and that the Juul fad has been passing in any case.
Medically, Juul and its allies persist in portraying e-cigarettes as an effective cessation tool to wean adult smokers off regular cigarettes. The FDA counters by saying Juul’s marketing application lacks sufficient evidence to show the sale of the company’s products would be appropriate for the protection of public health.
All parties agree that youth vaping is on the increase.
Public health groups like the American Lung Assn. see teen smoking increases as disastrous, just as the American Vapor Manufacturers Association sees he FDA as “hellbent on rigging the process to fulfill its prohibitionist agenda.”
Research in the journal Pediatrics concludes that Juul has led a new generation of teens to get hooked on smoking, driven by fruit and mint-flavored cartridges that fit in small vaping devices,
The FDA has banned most flavored cartridges products in a bid to cut off an alternative nicotine source, though it has authorized 23 e-cigarette products and has more applications that include bottled vaping liquids sold to adults in different flavors and nicotine strengths, The Washington Post has reported. The FDA has rejected applications for close to 1 million products, but last October granted tobacco giant R.J. Reynolds permission to sell three of its Vuse vaping products.
It is easy to conclude that the current decisions are not done, and that the FDA has not fully assessed the role of menthol and other flavoring in e-cigarettes.
As Always, Politics
All of this has the usual political fallout as well. There are many vocal Democrats who think the FDA is moving too slowly, and many Republicans who insist that the marketplace be left alone.
The Wall Street Journal has described the FDA’s approach towards the vaping industry as disjointed. The order to wipe Juul products took two years of review.
Even while its market share swelled, Juul has been in regulatory limbo for years. As of now, all e-cigarette products must go through pre-marketing reviews at the FDA, which missed a court-ordered deadline last fall to decide which products could be sold.
All of this is happening as the Supreme Court has an unrelated pending case about regulation of environmental emissions that well could affect the government’s ability to regulate any private industry, depending on how the decision is outlined.
Congress recently gave the FDA the authority to regulate synthetic nicotine products.
The FDA banned Juul flavored products as part of a bigger crackdown on flavored vapes, prompting many teens to use disposable e-cigarettes and menthol-flavored products that are still sold. From February 2020 to February 2022, disposable e-cigarette sales increased by 215.4%, data from the CDC Foundation show. The research suggests more than a million teens got hooked on nicotine, while flavored vape cartridges and pods were still available, since 2017.
Of the more general assault on tobacco, the FDA says tobacco is related to 480,000 deaths each year, prompting its concern and efforts to reduce nicotine levels. The FDA cannot ban cigarettes but can create “product standards” that make them less attractive, experts say. So on Tuesday, the agency proposed a rule to establish a maximum nicotine level in cigarettes and other certain finished tobacco products. It is unclear if they would do it at once or gradually.
As public policy that has been through a rocky period of covid rules, it is easy to see the FDA lost in a confusing message about lessening nicotine or banning particular e-cigarettes or perceived as overstepping in the marketplace.
Until told differently, the FDA wants regulation towards what it sees as better health.