Court Challenges to Vape Restrictions
Any informed wholesale vape seller, vape shop owner, or vaper should be alarmed by the laundry list of restrictions and obstacles being placed between adult vapers and the flavored vape juices they prefer.
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.
Despite this positive trend and the indisputable evidence that most adult vapers preferred flavored e-liquids, the runaway train of vaping restrictions seems impossible to stop.
It is up to adult vapers and members of the independent vaping industry to make our voices heard. Vape wholesalers and vape shop owners are in the unusual position of facing the public and helping vaping initiates.
The science is on our side and the stakes are very high. Combustible tobacco products sales increased for the first time in 20 years in 2021. The long-term future of vaping will rely on vapers being heard. In the short term, the battles are in the courts. Hopefully, the judicial system proves more capable of parsing fact from lobbying spin.
The Case for Vaping
A plurality of Americans falls into one or two ideological camps, with a vast center hopefully most amenable to persuasion.
Pointing out the efforts in the UK is always a good starting point. The NHS will soon offer prescription vapes to marginalized traditional nicotine users who might not otherwise make the switch. They also host the website Using E-Cigarettes to Stop traditional nicotine users. This is a single payer system and a compassionate policy.
If defending vaping to someone with more conservative values, do not hesitate to point out that this overregulation threatens to drive small businesses bankrupt and put thousands out of work. Court cases are revealing an FDA that is not acting in a transparent manner. Questionable narratives are being spread by well-funded lobbyists through the legacy media.
Between an example of how a single payer health care system in Western Europe has embraced vapes for humane harm reduction and the case against overregulating an industry in the face of science, there are arguments that appeal to both sides of the political spectrum.
The most important story is your own and of your own acquaintances and customers. These powerful stories make up the rich tapestry which is the American vaper. The wretched failuresof prohibition, societal control on consenting adults and the war on drugs have reemerged. This impulse to control will eventually be turned back. But a victory today, rather than in 2026, will save thousands of jobs. And potentially even more lives.
Outside Interference
The vaping industry is quite active now and the crucial battles are happening in court. But the meddling of anti-vaping politicians continues.
Despite the Biden administration promising to allow science to run its course without politics, Senate Democrats were pressuring the FDA to make favorable findings in the PMTA process just two weeks into 2021. Favorable for them is adult vapers denied access to flavored vapes, thousands put out of work, and the tobacco industry being given control of the combustible tobacco alternatives market.
The Senator’s letter made blanket demands of the FDA to bar whole classes of vaping products. Specifically flavored vape juices. A later letter in March 2021 called out specific manufacturers they wanted banned.
Partisan double dealing continued with the Build Back Better plan. The funding of this bill would supposedly not impact anyone outside the top income brackets. Yet a tax on liquid nicotine, with no corresponding increase on cigarettes, was included in the bill. Marginalized Americans and lower income brackets for traditional nicotine users and vapers at disproportionately higher rates. The LGBT community at the highest rates of any census identified group according to the CDC. The wealthy stopped traditional nicotine use a quarter century ago. So much for that promise.
Whether it is in the House or Senate, the characters involved in vape legislation is almost always the same: a group of blue state, establishment Democrats flanked by a lone Utah Republican opposed to nicotine in all forms.
Pillsbury v. FTC
Senatorial efforts at meddling in the PMTA process may cross a legal line. In the 1966 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.” The Pillsbury Company, of giggling doughboy fame, fought to limit Congressional interference in executive branch commissions.
This monumental Supreme Court 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 hereached 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.
Marketing Denial Orders
Independent of future Pillsbury based challenges, approximately 30 vape companies are challenging FDA marketing denial orders that followed the rejection of 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 whether the FDA unfairly barred flavored vaping products. 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.
This requirement was 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 stay in the 5th Circuit is still being litigated but provides a glimmer of hope. On February 1, 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.
According to Filter, the manufacturers filing lawsuits in response to MDOs are raising nearly identical arguments. Their complaint centers around the FDA acting in a capricious and arbitrary manner denying their PMTAs.
Specifically, the FDA changed its PMTA process after the filing deadline and made no effort to communicate with applicants. If the FDA is not acting in good faith or moving goal posts, we can hope that the judicial branch is willing to put a stop to the farce.
Fatal Flaw of PMTAs
Filter also reports that the FDA has applied a “Fatal Flaw” checklist to deny PMTAs. 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 legacy nicotine companies, their subsidiaries, and partners.
According to court filings, Bidi Vapor 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 and had previously communicated 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
It is unfortunate that the future of independent vaping seems to hinge on judges. A similar case requested by Breeze Smoke in the Sixth Circuit failed to receive a stay. Ideally, politicians would operate independent of outside influence and adopt a more humane approach to vaping that does not threaten to turn the entire market over to tobacco companies selling tobacco flavored vapes in gas stations.
As these cases are similar, a visit to the Supreme Court is not out of the question. 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. High-VG juices being a complete non-factor in underage vaping as they require loud, large, thirsty, and vapor billowing vape mods. They also use vape juice with 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.
While the wisdom of vape juice companies adopting the trade dress of consumable food products seems questionable now, and long since removed from the market, it was the invention of nearly odorless and highly potent vapes that served as the catalyst for underage use.
How PMTAs Hurt Adult Vapers
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.
The tobacco e-liquids of closed systems are designed for a specific low-wattage devices. They do not have the range of VG/PG ratios and nicotine strengths found in the e-liquids sold for open systems.
This means the larger companies need to compile fewer PMTAs. They also have the economic firepower to conduct any study they choose and legal firepower to defend themselves.
The federal ban on flavored vape pods limited the vaping products of the tobacco giants to tobacco flavored nicotine vape juices. They materially benefit when flavored vapes, which are preferred by adult vapers, are chased 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.
It also must be noted that legacy nicotines prefilled vaping products are significantly more expensive and directly tied to the teen vaping epidemic. Altria bought a large stake in Juul, and it takes some 43 Juul pods to equal the e-liquid volume of single salt nic vape juice bottle. Yet a 4-pack of Juul pods costs more than a single bottle of nic salt landed at your doorstep. This is a ten-fold difference in price. Combustible tobacco products seem like a better deal with the price advantage of vaping obliterated by profit margins.
Regulatory Hurdles
Every permutation of every e-liquid for an open device needs a PMTA. Juul only has a few flavors, and one device. It was this single device which in many ways kicked off the crackdown on adult vaping, and the widespread flavor bans.
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.”
The PMTA process does not only threaten to deny adult vapers their preferred flavors, making combustible tobacco products perhaps a more appealing option. It is a process threatens hardware and the variety of vape juices used to fuel these devices.
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 legacy nicotine 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 and expect greater efficiency in the future as they ramp up their infrastructure. This USPS 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.
Misreporting of EVALI
The independent vaping industry always realized that underage vaping posed an existential threat. Other crises have also been falsely attributed to nicotine vapes and the independent vaping industry.
There is no better example of this than EVALI. EVALI is an inaccurate acronym, that stands for E-Cigarette or Vaping Use Associated Lung Injury.
Emergency nicotine vape bans, flavor bans and other restrictions passed during the fall of 2019 and spring of 2020 due to the several thousand who were sickened, and dozens killed by vitamin E acetate in black market THC carts. As Winston Churchill said, “Never let a good crisis go to waste.”
Not a single drop of this vitamin E acetate was found in a commercially available nicotine vape juice during the CDC investigation. Their study revealed vitamin E as an adulterant was incompatible with vegetable glycerin and propylene glycol blends used in nicotine vapes while it closely resembled cannabis oils in viscosity.
Unintended Consequences
The constant drumbeat of anti-vaping commercials, press conferences and restrictions has had a real impact on the lives of adult smokers. A survey by the National Cancer Institute found 34.9 percent of adults polled thought vaping was just as harmful as smoking. Only 8.3 percent felt it was much less harmful.
Message to Share
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.
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 is the most persuasive argument of all.