High Stakes in Vaping Court Cases

Posted by Robert Taney on

Positive Trends

The CDC Youth Tobacco Survey has shown a huge reduction in teen vaping since 2018. This trend accelerated in 2021 and the survey would not even cover the shipping ban which only hit in at the beginning of November.

 

Negative Trends

For the first time in 20 years cigarette sales have increased. If science was dictating vaping regulations, it would be time for lawmakers to ease restrictions on the e-liquid flavors that most adult vapers prefer.

Unfortunately, too much money has been spent by lobbyists to bar what the FDA calls characterizing flavors. Every flavor but tobacco is classified as such by the FDA.

It is in the court room that important battles over the future viability of the independent vaping industry and adult access to their preferred vape flavors are taking shape.

Politicians will continue to meddle but hopefully the judiciary branch is persuaded by science rather than appeals to emotion and the pure monetary firepower of the anti-vaping lobby. 

 

New Administration 

The Biden administration promised to allow science to run its course without politics interfering. This was said to contrast with the previous administration.

Without getting too partisan or providing opinions on any other aspect of his term in office, while President Trump eventually succumbed to pressure and enacted vaping restrictions, the restrictions he imposed were more logical than the flavor bans on bottled e-liquids adopted by many states. 

Despite an effort by Bloomberg’s lobbyists to enact a full flavor ban, Trump only banned flavors in prefilled pods and carts. This was a more logical approach than banning bottled e-liquid flavors and open vaping hardware, which are used almost exclusively by adults.

As former FDA chief Scott Gottlieb told VOX in an interview, “The dramatic spike of youth [vaping] — that was driven in part at the very least if not largely by Juul. I hope they recognize the problem that’s been created has been created largely by their product.”

 

Outside Pressure

How well did Democrats fare at following President Biden's directive to let science dictate policy?

Only two weeks into 2021, Senate Democrats were pressuring the FDA to make favorable findings in the PMTA process.

Their letter included demands to bar all flavored vape juices, and whole classes of products. With polls not yet turning against their party, a follow-up email in March 2021 included demands that specific companies be shut down. 

Of course, these Senators operate independently on their leader in the White House, right? And there was bipartisan support. The usual cast of characters, establishment Blue State Democrats seconded by a solitary Utah Republican opposed to nicotine consumption in any form.

 

Liquid Nicotine Tax Proposed

President Biden’s ballyhooed Build Back Better Plan was proposed with the promise that taxes would not be increased on anyone outside of the top income brackets. Embedded in the bill was a tax on liquid nicotine. There was no corresponding tax increase on cigarettes.

The wealthiest Americans gave up smoking decades ago and do not vape nicotine in appreciable numbers. The same cannot be said for marginalized Americans and lower income brackets, who smoke and vape at disproportionately higher rates. LGBT community vapes at the highest rates of any census identified group according to the CDC.

 The wealthiest Americans do imbibe however. Underage drinking kills over 3000 minors annually and sends 130,000 to the emergency room. It will be interesting to see if they demand total alcohol abstinence and harsh restrictions on their vice of choice. Going to guess the answer is no to that 

 

Pillsbury v. FTC

The efforts by US Senators to meddle in the FDA’s PMTA process seems to cross a sharply delineated legal line.

In a 1966 Court case, Pillsbury Co v. FTC, the Fifth Circuit found that by pressuring the FTC members of a Senate subcommittee had committed an “improper intrusion into the adjudicatory process of the Commission.” This decision limits Congressional interference in executive branch commissions.

This monumental case determined that Pillsbury was denied due process. The pressure being placed on regulators to make a decision that reflected the will of politicians was chastised. “To subject an administrator to a searching examination as to how and why he reached his decision in a case still pending before him, and to criticize him for reaching the wrong’ decision, as the Senate subcommittee did in this case, sacrifices the appearance of impartiality—the sine qua non of American judicial justice.”

Will the vaping industry end up benefiting from this decision? If case law holds, a plaintiff suing the FDA would only need show that Congressional members cast doubt on the impartiality of the PMTA process. A decision that overturns Pillsbury would challenge the separation of powers.

 

 

Court Battles Over Marketing Denial Orders

Approximately 30 vape companies are challenging Marketing Denial Orders (MDOs) sent by the FDA in response to their PMTAs. Here are few of the highlights and lowlights of these crucial struggles.

 

5th US Circuit of Appeals 

The 5th US Circuit of Appeals is weighing in on what vape juice companies argue is a de facto ban on flavored e-liquids. In August, some 55,000 flavored vapes received Market Denial Orders (MDOs). The FDA stated that long-term longitudinal studies that demonstrated the benefit of flavored vape juices would be required to receive PMTA approval.

The vape company plaintiffs argue the FDA has moved the goal posts and their requirements for PMTA applications are now substantially different than earlier FDA guidance. On October 26, 2021, the 5th Circuit issued a stay until a panel of judges could conduct a hearing. 

According to a report by Reuters, U.S. Circuit Judge Edith Jones seemed sympathetic to Triton. "It seems to me that's the height of arbitrariness and capriciousness, to say we are the FDA, trust us, which I might say some of us are becoming skeptical about in light of recent vaccine experiences."  

 

11th Circuit Court

The Eleventh Circuit Court of Appeals also allowed four nicotine vape manufacturers to continue selling their products. Bidi Vapor, Diamond Vapor, Johnny Cooper and Vapor Unlimited received judicial stays on their Marketing Denial Orders on February 1.

According to Filter, the manufacturers filing lawsuits in response to MDOs have similar complaints:. The FDA is acting in a capricious and arbitrary manner when denying their PMTAs.

Further, they assert that the FDA changed its PMTA process after the filing deadline and made no effort to communicate with applicants.

 

Fatal Flaw of PMTAs

Filter also reported that the FDA has applied a “Fatal Flaw” checklist to deny PMTAs for flavored e-liquids. If an application does not contain two specific types of long-term study, they are summarily rejected. These longitudinal studies require time and money only available to Big Tobacco, their subsidiaries, and partners. Big tobacco companies, their closed systems already barred from not selling tobacco flavors, avoid this same burden.

Bidi Vapor has spent $6.6 million to comply with the PMTA process and submitted 285,000 pages of information. Contained in this submission were, “Health risk and toxicological data, marketing restrictions, and scientific literature reviews,” and “demonstrated [the] products provide substantial benefits in terms of lower relative health risks [compared with smoking].”

The FDA did not bother reviewing any of this information. The also had previously communicated that Bidi would not need long-term studies.

“Significantly, in response to a February 2020 pre-PMTA meeting request by Bidi to discuss product comparison testing requirements, FDA sent a letter explicitly stating there are no requirements ‘for applicants to conduct clinical studies or trials to support a PMTA’ and there are no ‘specific requirements for evaluating comparator products.”

“Indeed, FDA never said Bidi must compare the cessation benefits of its non-tobacco flavored products to its tobacco flavored product and [that] the absence of such a study would, without any scientific review, automatically result in an MDO.”

 

 

Court Cases Cause for Hope and Concern

Judges are not always the most reliable judge of a subject matter as they have no expertise in the field of vaping. A similar case requested by Breeze Smoke in the Sixth Circuit failed to receive a stay.

Whether judges will be moved by the reality that the PMTA process and PACT Act threaten to turn the entire vape market over to the tobacco industry and their tobacco flavored vapes is unknown.

 

Lack of Expertise

There is still a huge gap in understanding when it comes to vaping. While Unicorn Milk and similar confectionary flavored high-VG juices are still cast as villains in 2022, the plain packaging and simple flavor of Juul Mint was by far the most popular flavor with minors. was the invention of nearly odorless and highly potent vapes that served as the catalyst for underage use.

High-VG juices were a non-factor in underage vaping due to the hardware such e-liquids require: loud, large, thirsty, and vapor billowing vape mods. High-VG juices are also sold in a significantly lower nicotine strength.

It has proven almost impossible to convince outsiders that nostalgic flavors evocative of the 80s and 90s indicate a product being marketed to adults who grew up during these decades, i.e., middle aged Millennial and Gen X vapers.

 

 

Uneven Playing Field

Every permutation of every e-liquid flavor from a given brand requires a PMTA. These bottled e-liquids are used in closed vaping devices.

The tobacco industry and their subsidiaries only sell closed vaping systems. A closed vaping system is one that cannot be refilled. Open vaping systems are the refillable vapes that require e-liquid to be purchased separately. Closed vaping systems are far more expensive to operate. It takes 43 Juul pods to equal one bottle of nic salts. It can cost hundreds of dollars a month to vape the equivalent of a single $20 vape juice bottle. This is a ten-fold difference in price. Combustible cigarettes seem like a better deal with the price advantage of vaping obliterated by profit margins.

The closed vape pod systems are only available in tobacco and not the characterizing fruit and beverage flavors that adult vapers find more appealing. Selling a more expensive product with fewer flavors is made easier when all the competition is removed from the market. Not only do most adult vapers prefer flavored e-liquids but this preference for “characterizing flavors” over tobacco increases the longer an adult vapes.

Because they have just a couple flavors and fewer nicotine strengths, Big Tobacco and their partners in the closed vape pod industry need to compile fewer PMTAs. They also have the economic firepower to conduct any study they choose and legal firepower to defend themselves.

 

Nicotine Strengths

The products most likely to survive the PMTA process, if it is not checked legally, are tobacco flavored, sold by tobacco companies or their partners, and are far more expensive.

Ignoring the flavor issue for a minute, the independent vaping industry is also punished because they carry LOWER nicotine options than the 25 and 50mg strengths found in Juul pods.

Nicotine strengths and vape juices is no small deal. A vaper who wants to reduce their nicotine intake certainly benefits from having lower nicotine strength options.  

On the Big Tobacco front, MyBlu does a much better job than Juul with freebase and nicotine salt juices. Vuse offers several devices but their most popular product the Vuse Alto. They now offer a third lower nicotine option, 1.8 percent, but nothing comparable to low nicotine vape juices available from e-juice manufacturers. The typical vape mod user purchases e-liquid between 0 and 6mg. The lowest strength Juul in the US is 25mg nicotine strength.

 

 

USPS Ban

The availability of private shipping companies has created something of a reprieve from the USPS ban. This delivery options will continue to expand and improve in efficiency.

The USPS vape mail ban can be traced to the PACT Act. This was another laser guided bomb that seemed to target the independent vaping industry while leaving well-healed tobacco allies unscathed.

Juul, NJOY, Blu, and Vuse control the shelf space at local brick and mortar stores. While most minors who vaped obtained their products through peers, hence the precipitous drop in teen vaping since the passage of Tobacco 21, this channel was far more common than online sales.

Age verification software and now adult signature on delivery by private carriers have choked off the small percent of elicit business that was slipping through the cracks.

 

Make Your Voice Heard

Court cases are unpredictable. It is just as important to organize and educate others on the appeal flavors to adult vapers. This is an area where gains are to be made. Until vapers are fully organized our voices will not be heard. Visit Casaa.org to stay informed on local and national vaping calls to action. 

We face a reality where tobacco companies, arch-villains in the eyes of most Americans, stand to profit from relentless attacks on the independent vaping industry. This should be a persuasive argument. Unfortunately, opponents of adult vaping have blurred the line between independent vape businesses like Kure and Big Tobacco owned e-cig companies and their allies. 

 

Tell Your Story

But your own story of how flavored vapes and open vaping devices helped your journey are also important. It is time to put a human face on the millions of vapers being denied access to their preferred products in an era when smoking rates are once again increasing.

 

Arguments Across the Political Spectrum

The attacks on the independent vaping industry should appall Americans on both the right and the left of the political spectrum.

For progressives, the model of UK and their single payer system that supports vaping is a great example. The UK will soon offer prescription vapes so that the marginalized and disadvantaged economically can save money when switching from combustible cigarettes to vaping. Extensive UK studies, and they are the foremost experts on this subject, have found vaping is at least 95 percent less harmful than smoking. Even ex-FDA commissioner Scott Gottlieb freely concedes that it is the chemicals from the combustion of tobacco that kill.

The relentless drumbeat of attacks on vaping, including the misreporting of EVALI,    have convinced a majority of Americans that electronic cigarettes are just as harmful or even more harmful than regular cigarettes. 

 

public opinion vaping  

 

The UK hosts the website Using E-Cigarettes to Stop Smoking. Progressive individuals should note that cities seeking to implement harm reduction policies to address IV drug use, specifically San Francisco and New York, have turned their backs on giving adult vapers access to the flavors they prefer.

For those with more conservative leanings, the power of a Michael Bloomberg lobbyists to create anti-vaping narratives in the media and spread misleading information on such disparate topics as EVALI and flavor preferences will surely look familiar.

The specter of onerous regulations destroying an entire independent vaping industry and allowing Big Tobacco to emerge victorious should be an anathema to any rock-ribbed Republican.


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