The FDA just took a significant step toward killing the vaping industry. While ostensibly acting to "protect public health," the agency has effectively banned millions of products and made it harder for smokers to give up their deadly habit.
Did you quit smoking with the help of an electronic cigarette like I did? The FDA is unimpressed with your progress toward a healthier lifestyle. On September 9, the agency refused to grant marketing approval for millions of vaping products, effectively outlawing them. The agency's actions are nonsensical, unscientific, and politically motivated, as we'll see below. But the truly tragic aspect of this development is that it will incentivize many smokers to continue in their deadly habit when a far safer alternative is available.
The regulatory details are complicated, but here are the basics. Manufacturers of tobacco products had to submit a Pre-Market Tobacco Application (PMTA) for every product they began selling after February 15, 2007. Every vaping product now on the market had to undergo this review process, since none of them had been introduced before that grandfather date. PMTAs must demonstrate that the products are “appropriate for the protection of public health.”
Vaping companies rushed to submit more than 6.5 million applications by the September 9 deadline. The agency rejected the majority of these, and none have so far been approved. The FDA summarized the situation in an update published the same day:
As of Sept. 8, we have completed filing review for about 90 percent of applications submitted via the PMTA pathway by the Sept. 9, 2020 deadline. Many of the accepted applications ultimately received a Refuse-To-File (RTF) letter at the filing stage of the review process because the application did not include required information.
For example, companies received RTF letters for not including required content such as ingredient listings, labels for each product to be marketed, or adequate environmental assessments. One such RTF letter was issued on Aug. 9 to a single company for PMTAs associated with approximately 4.5 million products because their PMTAs lacked an adequate Environmental Assessment.
Strictly speaking, this isn't a ban on vaping products, but it's a clear indication that the FDA is throwing the bureaucratic book at the industry without considering what the evidence says about its products.
The FDA requires manufacturers to show that their products “have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.” That's a fine standard, but the agency has, even recently, approved non-vaping tobacco products without requiring specific evidence that they won't be used by children.
“The abuse potential of the proposed products is understood to be within the range of similar marketed products,” the agency wrote in its review of snus (a type of smokeless tobacco) produced by Swedish Match North America. Why does the abuse potential of vaping products matter more than the risk posed by snus?
There isn't a particularly good answer; double standards are never easy to justify. This is where politics comes into play. Well-funded activist groups like the Truth Initiative have consistently pressured the FDA to ban most flavored nicotine liquid. They even sued the agency for trying to extend the PMTA deadline to August 2022. And they're not the only critics who have pressured the FDA to clamp down on vaping; a cadre of influential senators joined the effort earlier this year. As Forbes reported last month:
On January 14, 2021, a group of Senators led by Majority Whip Durbin sent a pointed letter to FDA Commissioner Stephen Hahn. The Senators alleged that the agency’s slow-walk of the PMTA process contributed to underage use of e-cigarettes and urged FDA to focus intently on youth use when reviewing applications. In addition to these general complaints, the letter provided FDA with a very specific “non-exhaustive list of principles that should guide FDA’s review of PMTAs.”
This lobbying has been justified on the grounds that e-cigarettes "attract youth and harm public health," to use the Truth Initiative's phrasing. While teenage nicotine use is never acceptable, the evidence is clear that most junior-high and high-school students have no interest in vaping; those who do are already smokers trying to quit. Studies going back to at least 2016 back up this conclusion, and the evidence continues to accumulate, according to the authors of a 2021 study:
Not only does the current study demonstrate that actual data are much more consistent with a diversion effect than a catalyst effect, but the magnitude of this effect is somewhat large, even using conservative assumptions. This is consistent with other recent research showing that declines in cigarette use have accelerated after the introduction of [electronic cigarettes].
When we factor in the evidence that vaping helps adult smokers give up cigarettes in significant numbers, we have a sound scientific case that the smoking alternative meets the FDA's standard for protecting public health.
You'll get fewer choices—and you'll like it
So, now what happens? I don't make predictions, but two sources familiar with the regulatory situation told ACSH off the record that the FDA's actions could wipe out a major portion of the vaping industry. The bigger companies and trade groups will sue the FDA to stall the process. Other manufacturers may switch to products containing synthetic nicotine, which end-runs agency regulation; the 2009 Family Smoking Prevention and Tobacco Control Act (TCA) only applies to products derived from tobacco. But this is a short-term solution. Congress can revise the TCA to cover synthetic nicotine.
If any of these products survive the regulatory hurdles, a pending tax hike proposed by the Democrats could double or even triple the prices consumers pay for nicotine-containing e-liquid. Research has shown that such tax increases will encourage millions of people to continue smoking combustible cigarettes, which are undeniably far more dangerous than their electronic counterparts.
In short, consumers will probably have access to an artificially small selection of vaping devices and e-liquid flavors, all sold by giant companies which are owned by even bigger tobacco firms that helped author the tobacco control act. Economists call that rent-seeking, by the way. A black market for the banned products will sprout up to fill the void, but many people will go back to cigarettes out of convenience. A lot of them will end up very sick or dead as a result. Public health triumphs once again.