Tobacco Control Sues FDA

[Chukin'Vape]

Anti-Vaping Groups Sue the FDA to Reinstate the 2018 PMTA Deadline
Meet seven groups that want to wipe out the U.S. vapor market.

By
Jim McDonald
Anti-vaping groups are suing the FDA to push the agency to enforce its original deadline for all vaping products to go through premarket review. The original deadline was Aug. 8, 2018.

Seven organizations and five individual pediatricians filed a lawsuit in the Maryland U.S. District Court, claiming that the FDA’s four-year postponement of the due date for filing premarket tobacco applications (PMTA’s) exceeded its authority under the Family Smoking Prevention and Tobacco Control Act.

The FDA announced last July that it was postponing the deadline until Aug. 8, 2022. The delay allows products that were already available for sale on Aug. 8, 2016 to remain on the market without seeking authorization until the new deadline in 2022.

The plaintiffs are:

• American Academy of Pediatrics
• Maryland chapter — American Academy of Pediatrics
• American Cancer Society Cancer Action Network
• American Heart Association
• American Lung Association
• Campaign for Tobacco-Free Kids
• Truth Initiative

All other parts of the FDA Deeming Rule that went into effect in 2016 remained in place; it was just the deadline for submission of PMTA’s that changed. But to hear the lawsuit’s plaintiffs tell it, the PMTA deadline postponement unleashed an onslaught of kid-attractive products designed to lure “our kids” (as Matthew Myers says) into addiction. And the number-one culprit, of course, is JUUL.

Every day, vape shops and other small vaping businesses make decisions about signing leases, expanding, and hiring.
“The need for the FDA to review e-cigarettes now on the market has been underscored by the recent surge in popularity of JUUL, which has become the best-selling e-cigarette brand and is reported to be widely used by teens,” says the press release from the Campaign for Tobacco-Free Kids, on behalf of the plaintiffs.

“According to widespread news stories,” the press release adds, “reports from educators and documented social media posts, JUUL e-cigarettes have become very popular among high school and college students (see reports by The Boston Globe, Pittsburgh Post-Gazette, NPR and WJLA TV in Washington, DC). Despite these reports, the FDA has taken no action regarding JUUL.”

“The media reports of a teenage juuling ‘epidemic’ do not add up with population studies that show regular use of these products by never smokers to be very low,” University of Waterloo (Ontario) sociologist Amelia Howard said in Vaping360’s recent article on juuling. “The juuling stories have the classic hallmarks of a moral panic: widespread fear based on exaggerated risk.”


ECIGattorney®@ECIGattorney
https://twitter.com/ECIGattorney/status/978675309812830208

@TobaccoFreeKids and others have sued @FDATobacco and @SGottliebFDA to challenge the August 8, 2022 PMTA deadline extension for #vapor products. A victory would effectively ban the industry. We are looking to fight this. https://twitter.com/angelicalavito/status/978663814752296961 …

6:49 PM - Mar 27, 2018

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With the Cole-Bishop rider left out of the final omnibus budget bill by the Senate, and the outcome unclear for multiple lawsuits against the FDA by vaping organizations, a return to the Aug. 8, 2018 deadline for filing PMTA’s would essentially wipe out the American independent vapor industry.

If the FDA contests the lawsuit, it will take months or years to be resolved — so there’s probably no chance of a reinstatement of the 2018 deadline. But the uncertainty about what might happen will cause damage by itself. Every day, vape shops and other small vaping businesses make decisions about signing leases, expanding, and hiring. The FDA has already signalled its intention to crack down on non-compliant products.

And the multi-prong FDA plan to remake the nicotine marketplace offers no reassurance. The proposal to reduce nicotine in cigarettes comes along with a suggestion to eliminate liquid nicotine products. The agency’s e-liquid flavors notice is even worse. It’s clearly slanted toward eliminating most vaping products.

FDA Commissioner Scott Gottlieb defended his agency’s actions on Twitter Tuesday, but this is a distraction he’d probably like to avoid. The tobacco control lobby is powerful and persistent.

Who won’t be affected if this lawsuit succeeds? The cigarette industry. Their cornerstone product is grandfathered onto the market and profitable beyond belief. They have the lawyers and money to keep any reduced-nicotine scheme at bay for years. Anyway, the FDA and the whole tobacco control structure needs cigarettes.

After all, who funds the FDA Center for Tobacco Products? That’s right — 100 percent of the center’s operations are paid for by tobacco company user fees. Philip Morris already has PMTA and modified risk applications in for its IQOS heat-not-burn device, and British American Tobacco/RJ Reynolds will follow soon with Glo.

The vape company probably most likely to have the money, knowledge, and ability to succeed through the PMTA route — JUUL Labs — is the subject of a massive attack campaign run by the same groups filing this lawsuit. Tobacco-Free Kids’ Matt Myers and his cronies don’t want open system vaping and bottled e-liquid to remain available, and a closed-system product like JUUL that is clearly aimed at providing adults a smoking alternative is also unacceptable. What else is there?

“You’re guaranteeing you’re going to kill off all the novel products and we’re going to once again be favoring the cigarette which is by far the most deadly of all tobacco products,” University of Michigan emeritus professor of public health Kenneth Warner told BuzzFeed News.

The message to the vape industry is clear: please die quickly and rot in hell.



Jim McDonald
Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

 

[RichJB]

From another (non-vaping) forum I frequent, I know a lawyer in the US who is very, very knowledgeable and up to speed on cases involving the federal govt being sued. He can cite you chapter and verse on almost any such case in history. I messaged him and asked him about this case, in the hope that I could relay his expertise to the podcast viewers. Unfortunately, he's been in court and didn't have the time to respond to me yet. If he does, I'll pass along his views on this case and his assessment of whether the plaintiffs actually have a valid case and a chance of winning.

My sense is that they don't. In most cases where the federal govt was sued for over-reach, the plaintiffs either were a state govt or had the backing of a state govt. These plaintiffs don't appear to have that backing. They also seem to be among the more militant and less informed activist organisations. The American Lung Association, in particular, do not inspire confidence. This was their article on the Harvard diacetyl study. I wouldn't expect a .com mainstream news outlet to know that there is more diacetyl in tobacco smoke than vapour. But I would expect a .org health body to know it. Particularly when that body claim to be experts in lung health. That they seem blissfully unaware of the diacetyl in tobacco smoke doesn't say much about their level of professional expertise. I would expect any lung health association to be intimately familiar with every single carcinogen or otherwise harmful chemical in tobacco smoke. Yes, it's a long list with more than a thousand chemicals on it. But when it's your job to know them...

 

[RichJB]

OK, he just got back to me with his views. The US is extremely sensitive to federal agencies going beyond the scope of what they are allowed to do under the Acts that govern them, hence the many cases of states suing the federal govt. He says it is a legitimate concern and cited the case of the Deferred Action for Childhood Arrivals (DACA) programme enacted by Obama, which was considered (by some) to be a case of federal over-reach in hindering/delaying enforcement of illegal immigration laws and deporting illegals. In the DACA case, ten conservative state attorneys had threatened to challenge DACA and get the courts to rescind it. Trump's AG Sessions was not confident that the Dept of Justice could defend the programme in court.

The bottom line is that the US illegal immigration laws are there to protect the citizens. Obama's DACA - as empathetic and humane as it is - went over the heads of the immigration agencies and hindered them from enforcing the laws as they stand. Additionally, children protected under DACA were not promised citizenship. They were merely temporarily (two years) protected from being deported. So the programme was seen as a delaying tactic to defer deportation rather than a viable solution to the problem of illegal immigration.

Likewise, in this case, the bottom line is that the Tobacco Control Act is there to protect the citizens, especially the youth, from tobacco harms. Setting back the PMTA process for four years can justifiably be seen as a delaying tactic that subjects the nation to risk. The key difference is that, in this case, Trump's office didn't use executive authority to enact a separate programme that goes over the heads of the FDA and hinders them from doing their job. Instead, it was the FDA themselves who acknowledged that the timeline was unrealistic. That doesn't mean there is no case, it can still be argued that the FDA is not fulfilling its responsibilities under the terms of the Act.

Nevertheless, he thinks the plaintiffs will lose. He notes that even though the judiciary is independent, they have shown an historical tendency to grant latitude because they are aware that the realities of governance sometimes dictate inevitable delays in regulation. His take is that as long as the FDA can provide even nominally plausible reasons for the delay, the courts will find in their favour.

As Gottlieb has argued, the delay also does not prevent the FDA from cracking down in the meantime on marketing to children and selling vaping products to minors. He also has his proposed flavour ban as evidence that he is anything but soft on vaping, and that he is thus not acting in conflict with his public protection mandate under the Act.