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Court Battles Rage Over the Future of Vaping

by Robert Taney on February 16, 2022

Follow the Science?

President Biden administration promised voters that science would be directing policy if he won the presidency. This vow was intended to contrast with the Trump administration. 

Bloomberg’s lobbyists pushed hard to enact a full vape flavor ban in the fall and winter of 2018. In the end, flavors were only banned in prefilled or vape products. While punitive to Juul and the Big Tobacco subsidiaries, it was a more scientific approach than banning the bottled e-liquid flavors and open systems 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

Only two weeks into 2021, a committee headed by Senate Democrats was pressuring the FDA to find in their favor during the PMTA process. That they have a vested interest in the outcome is a damning indictment of the influence of money in politics. It was this sort of outside influence that led to scandal and veto-proof bills abolishing flavor bans in the Philippines. Read more about the scandal here.

Back in a country in the US, where there are fewer concerns about a single wealthy man having too much influence on a country’s health policies and vaping regulations, the Senator’s  letter included demands to bar all flavored vape juices, and whole classes of products.

With the Democrat’s honeymoon period not yet over, a follow-up email in March 2021 included demands that specific companies be shut down.

 

Build Back Better Funded by Marginalized 

The cornerstone of Joe Biden’s first year in office was Build Back Better Plan. It was sold to voters with the express claim that taxes would not be increased on anyone outside of the top income brackets.

Yet a tax on liquid nicotine, with no corresponding tax increase on cigarettes, would partially fund the infrastructure bill.

Marginalized Americans and lower income brackets smoke and vape at disproportionately higher rates. The wealthiest Americans ceased smoking a quarter century ago and do not vape in large numbers. The CDC has found that the LGBT community vapes at the highest rates of any census identified group.

 

 

Pillsbury v. FTC

The efforts by US Senators in the FDA’s PMTA process may cross a legal line. Pillsbury Co v. FTC found that by pressuring the FTC members of a Senate subcommittee committed “improper intrusion into the adjudicatory process of the Commission.” In an example of separation of powers, Congressional interference in executive branch commissions is expressly barred.

Pillsbury was denied due process by pressure placed on regulators to make a decision that reflected the will of politicians.

“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.”

Plaintiffs only need show that Congressional members cast doubt on the impartiality of the PMTA process.

 

Battles Over Marketing Denial Orders

Approximately 30 vape companies are challenging Marketing Denial Orders (MDOs) sent by the FDA in response to their PMTAs.

 

5th US Circuit of Appeals

 

The 5th US Circuit of Appeals is weighing in on what appears to be a de facto ban on flavored e-liquids by the FDA. 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 permitted 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 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 rejected before being reviewed. The longitudinal studies required to meet this undisclosed threshold are expensive. Big Tobacco, their subsidiaries, and partners can afford them. They also do not need them. Trump’s ban on flavored vape pods and carts limits their closed systems to tobacco flavors.

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 previously communicated that Bidi would not need long-term studies. Moving the goal posts so that it would be impossible for Bidi to successfully navigate the PMTA process.

“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.”

 

 

Deeper Pockets Fewer Products

The tobacco industry, their partners and 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.

 

 

Nicotine Strengths

Not only do the gas station pod systems have fewer flavors to submit PMTAs for but they also have fewer nicotine strengths By offering more lower nicotine options, the independent vape industry greatly complicated their administrative burden.

The independent vaping industry is being punished because they carry LOWER nicotine options than the 25 and 50mg strengths found in Juul pods.

In the interest of fairness, 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.

At Mad Vapes, we have found that over time our customers reduce their nicotine intake. We would like nothing more than for every vaper to eventually adopt a nicotine and vape free life style. 

 

PACT Act 

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. 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. Mad Vapes has no interest in selling our products to minors or anyone who does not already use nicotine.

 

 

Make Your Voice Heard

Share your own story of how flavored vapes and open vaping devices helped you on your journey. Check CASAA.org for calls to action in your area. No matter you affiliations, there are strong ideological reasons to oppose the destruction of the independent vaping industry. In 2021, Cigarette sales increased for the first time in 20 years. The stakes are high.

 

Liberal Argument for Easing Vaping Restrictions

For progressives, the model of UK and their single payer system that supports vaping is a great example. The UK is beginning a program that offers prescription vapes. The goal is to help marginalized and economically disadvantaged citizens and subsidize making the switch. They also host the website Using E-Cigarettes to Stop Smoking. Few wealthy smoke or vape. The highest rates of vaping smoking occur among marginalized. Vaping instead of smoking also reduces house fires in multifamily and tenement housing, a cause which the London Fire Brigade has taken up.

This humane Western European approach stands in harsh contrast to cities like San Francisco and New York. This supposed pillars of progressivism pay lip service to embracing humane harm reduction policies when it involves illegal drugs. Talks of needle exchanges, and NARCAN interventions have been going on for years.

When it comes to vaping, adults are denied access to a legal substance because they do not approve of the more palatable flavor profiles adults prefer. They have no qualms leaving the fox in charge of the henhouse, in this case on tobacco flavored products made with tobacco derived nicotine and manufactured by tobacco companies in most cases.

It is noteworthy that the gold standard of abstinence, which would get you laughed out of the room in any liberal circle if discussing another consensual and legal activity, is only applied to vaping. The same logic is not applied to alcohol, a true scourge that kills 3000 minors annually and send 130,000 to the ER according to the CDC. Probably because the wealthiest imbibe at a higher rate than poorer Americans. 

 

Conservative Argument for Easing Vaping Restrictions

For those with more conservative leanings, onerous regulations destroying an entire independent vaping industry and putting thousands out of work is objectionable. Federal agencies creating a set of rules that allow the tobacco industry to emerge victorious and with a monopoly on all nicotine products should concern any citizen. The result resembles regulatory capture. This is a form of corruption where lobbyists and major stakeholders control the policies of a regulatory body assigned to protect public health and safety. 

Of course, legacy media misreporting vaping and providing misinformation that casts vaping in the worst possible light should also resonate. The Michael Bloomberg has dumped 150 million into his vaping vanity project is not a great look. 

Total nicotine abstinence or the use of pharmaceutical interventions such as nicotine replacement therapy, the official stand of Orwellian-named groups like the Truth Initiative, run contrary to all libertarian impulses. Especially since vaping handily defeated nicotine replacement as a smoking cessation tool in a New Journal of Medicine study.

The shameful coverage of EVALI lung disease in the fall of 2019 and suspect emergency orders passed in blue states are sure to raise red flags as well.

Governor Whitmer Scandal

Governor Whitmer of Michigan was at the center of a particularly egregious scandal. Her career was funded by cannabis interests, which she has worked to further. When it was determined early in the EVALI outbreak that black market THC cartridges were entirely responsible, vitamin E acetate not being found in a single sample of nicotine vape juice, she responded with emergency efforts to ban NICOTINE vaping flavors.

Meanwhile, the Michigan Department of Health failed to warn citizens of the real cause of EVALI until late October. A decision which threatened the lives of anyone inclined to purchase THC carts. The Detroit Metro News covered this sordid affair with some excellent reporting. 

 

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