Federal Judge Orders FDA to Speed Up Review of E-Cigs

Science and Law Don't Mix

The inability of the legal system to keep garbage science out of the court rooms is well documented. This issue was best summarized by the American Bar Association: “Lawyers and judges often do not have the background to correctly assess data, scientific research or technology.” Paid expert witnesses can have a disproportionate impact on proceedings.

This issue was brought into stark focus by District Judge Paul W. Grimm of the US District Court. The persuasiveness of an erroneous narrative painted by anti-vaping advocates, that fruit and dessert flavored ejuices were designed to hook kids, played a role in his ruling to void FDA’s decision to delay premarket tobacco applications until 2021.  

A Grimm Take on the E-Cig Market

The first line of his opinion demonstrates just how far down the anti-vaping rabbit hole Judge Grimm decided to burrow. “Even addiction has become electronic. And not only among adults, but particularly for teenagers (and younger kids). Especially, as manufacturers of e-cigarettes have learned, if they are fruit or dessert flavored, and marketed as cool or alluring.”

Cool or alluring?The plaintiff’s lawyers, representing American Academy of Pediatrics and four other organizations, obviously did an excellent job of presenting their case. Paid expert witnesses have a way of doing that, but this common misconception does little to address teen vaping or the use of combustible cigarettes.

The honorable Judge might be surprised to learn that Juul Mint, a menthol derivative, is the most popular flavor with minors. I recommend that he check out our feature article, The Truth and Technology Behind Juul and Nic Salts Revealed, because any informed opinion on the teen vaping epidemic should consider the role played by high nicotine levels and discrete pod systems.

As a general rule of thumb, any critique that hammers vaping and does not mention nic salts should raise eyebrows. The UK actively promotes e-cigs as a smoking cessation tool, but has a lower rate of teen vaping. They also have a cap on nicotine levels. If you have any questions on nicotine salt ejuices, our deep-dive “What is Salt Nic?” will answer them.

And what about those fancy dessert themed ejuices in retro boxes that make vaping "cool and alluring"? Those are consumed using mods, a delivery system that makes up a small fraction of the market and are used almost exclusively by adult vapers.

As a Vietnam veteran, he should remember the Reagan era well. E-Juices that taste like the sugar coated cereals and candies from the 1980s are targeting individuals who were children during that era. In other words, middle aged adults. Or to put it more succinctly, retro ejuice packaging appeals to adults and not minors.

Premarket Tobacco Applications

The FDA deadline for premarket tobacco applications (PMTA) was originally August of 2018, but this date was pushed back. Little guidance has been provided to vape product manufacturers. With no actionable guidelines, even deep-pocketed Big Tobacco companies and Juul have been unable to seek approval.

The expense of completing a PMTA, which would cost millions and could conceivably be required for every variant of an ejuice flavor or device, could have the perverse impact of leaving only Juul and their big tobacco rivals left standing.

By delaying the deadline, the judge determined that the FDA had abdicated their legal duty to regulate e-cigarettes. This lack of oversight is now being blamed for the uptick in vaping among teens. The FDA argues that the complexity and number of products on the markets requires appropriate preparation.

What Next?

The FDA is expected to appeal the decision, after the plaintiffs recommend what action should be taken. FDA spokesman Michael Felberbaum said the agency will review court decision and “will continue to tackle the troubling epidemic of e-cigarette use among kids.” The agency will have the option of appealing the decision.

As reported by CNN, American Vaping Association President Gregory Conley strongly disagreed with the ruling.

"We believe that the FDA's deadline extension was a proper and legal exercise of agency power. Despite promises by the FDA, the agency has still yet to finalize critical documents that the industry needs to file pre‐market applications."  

"In order to protect adult access to less harmful alternatives to cigarettes and stop over one hundred thousand Americans from becoming unemployed, FDA and [the Department of Justice] must appeal this ruling."

The teen vaping epidemic remains an existential threat to the vaping industry. Although strict e-cig laws harm marginalized groups, this court case is another example of actors associated with the center left Democratic party effectively to denying cigarette alternatives to former smokers. Grimm was an Obama nominee. This is an unfortunate turn of events, as vaping and smoking are issues that should not be politicized.

The worst example is San Francisco, a bastion of humane harm reduction policies and LGBTQ plus activism. On one hand, they provide needle exchanges and safe injection sites for intravenous drug users. On the other hand, San Francisco's e-cig ban disproportionately harms a group that vapes and smokes than a higher rate than any other demographic group.

The reason it is so easy for politicians to target vapers is that the vast majority are former smokers, and not teenagers. The wealthy largely gave up smoking a couple decades ago, and as Judge Grimm's comments demonstrated, vaping is quite simply practice they are unfamiliar with.

Contrast vaping with alcohol, a scourge that kills 5,000 teens annually. Currently, 3.5 percent of high school students currently binge drink, and only 2.5 percent of high school students vape on a daily basis. Why is one largely ignored and the other is being legislated out of existence?

The failure of prohibition in the 1920s plays a role, but that was nearly a century ago. A bigger role is played by demographics and access to power. Drinking rates are highest among educated, high income adults.