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FDA’s Juul crackdown is the latest blow in the irrational war on nicotine

Last week, the Food and Drug Administration handed down a consequential decision affecting millions of consumers: a marketing denial order for Juul Labs, maker of the popular pod-based Juul vaping device.

It’s best summarized as an immediate ban on Juul products.

This forces gas stations, convenience stores, vape shops, and other establishments that stock these devices and their flavored pods to immediately stop selling them to customers who want them.

Now, the FDA’s actions have been temporarily halted by the D.C. Appeals Court, giving the company additional time to argue its case in the judicial system.

While the judicial order is a fleeting sigh of relief for users of these products, it marks only the latest causality in the public health establishment’s irrational war on nicotine and nicotine products. And a sign that yet more denials will continue to reduce consumers’ access to nicotine alternatives, products known to be much less harmful than smoking.

The convoluted and byzantine process Juul failed is known as the Premarket Tobacco Product Application, an FDA-mandated permission test for any firm wanting to sell a new tobacco product (all pre-2007 are grandfathered in).  As one would guess, the standards for this test are opaque, unclear, and entirely arbitrary.

Only a handful of vaping products have been able to pass the FDA’s mandate of “improving public health” since 2015, and only one not made by a tobacco company. As of writing, there are tens of thousands of vaping devices, liquids, and component parts still awaiting their fate from the FDA.

That latter point is an important one because the FDA — and laws passed by Congress — now recognize vaping products, even those containing synthetic rather than tobacco-derived nicotine, as tobacco, which justified this strenuous process.

What the bureaucratic labyrinth forced on every mom-and-pop vaping firm and tobacco company alike shows us is that the FDA has a persistent bias against consumer use of nicotine vaping — and nicotine more broadly.

On its own website, the FDA lists the products it has approved for quitting smoking, mainly pharmaceutical drugs like Chantix and Zyban, or nicotine patches or gums from Nicorette, distributed in the U.S. by pharma giant GlaxoSmithKline.

The United Kingdom’s government, on the other hand, recognizes the benefits of vaping devices and actively recommends them, citing the figure of 1.2 million British vapers who have now quit smoking.

The UK cites internationally available scientific research and endorsements by health bodies as another reason why smokers should consider putting down their cigarettes for a vape. Does the FDA not have access to this data? Or is this part of a bigger trend?

In the same month the FDA handed down this decision, it is seeking public comments on its proposed bans on flavored cigars and menthol cigarettes and will soon introduce a rule limiting nicotine levels allowed in cigarettes. How these rules will impact the relationship between law enforcement and minority communities –  who use menthol products more often – has yet to be clarified, and neither has the risk of increased illicit markets, already the case in Massachusetts and Canada, which have their own menthol bans.

To think that when states are looking to legalize cannabis to end the drug war, it is baffling that we are beginning a new drug war on nicotine at the same time.

In all of this, the leading assumption, as the FDA website clearly states, is that people looking to quit already have the answers, and those answers are pharmaceutical products or nicotine abstinence programs that have received the government stamp of approval.

The millions of Americans who have quit smoking through vaping devices bought at gas stations or vape shops are taking a risk the FDA deems too dangerous, or as many health campaigners note are “more dangerous” than smoking.

Those claims stand against a litany of scientific studies and papers that prove that vaping is a less harmful alternative to tobacco use.

Why then, would noted anti-tobacco groups such as the Campaign for Tobacco-Free Kids, the Lung Association, and others be so focused on banning vaping products?

The nationwide anti-vaping efforts represent an organized effort by activist and tobacco control groups — often connected to the funding of billionaire former New York City Mayor Michael Bloomberg — to try to eliminate vaping as a safe and accessible nicotine alternative to combustible cigarettes.

We know this from several countries where these groups helped push vaping bans, such as Mexico and the Philippines, but also from Bloomberg’s $160 million grant to US organizations to campaign against youth vaping.

The pivot away from tobacco to focus on vaping, especially the “youth vaping crisis,” is as much about the money as it is the numbers.

According to the CDC, the current U.S. smoking rate is just 12.5%, down from over 20% not more than a decade ago. Nicotine alternatives like vaping devices, snus, and pouches have played a large role in this, as have broader cultural taboos on smoking.

And while the justification for restricting vape devices is because of youth use, the CDC’s own data shows that less than 0.6% of high schoolers used a Juul device more than once a month, down considerably over just two years. That downtrend trend is consistent among all vape products.

The confusion comes with how the data is tabulated, showing the percentage breakdown of high schoolers who vape and the products they use, often leading politicians and campaigners with the impression that far greater young people try vaping than they do. And this does not include those who vape cannabis products, which in former surveys showed higher numbers than nicotine vaping.

Regardless of those facts, vaping is in the crosshairs.

Despite the millions spent, there is no admission that responsible adults use these products in far greater numbers, and have positive health outcomes as a result.

This latter point has, thankfully, been taken up by a select group of tobacco researchers who understand the continuum of risk and laud vaping’s potential for getting smokers to quit, including Cliff Douglas, director of the University of Michigan Tobacco Research Network and the former vice president for tobacco control at the American Cancer Society.

Were this a rational and science-based conversation and regulatory process, those positive health outcomes would be a no-brainer. Unfortunately, as we have seen with the global war against vaping products, this is more an ideological battle than a mission of pure health.

The FDA has been all too willing to play this game in the court of politics, and they should be condemned for doing so.

Yaël Ossowski is a Canadian-American writer and deputy director at the Consumer Choice Center.

The FDA is betraying millions of consumers by killing one of the most popular anti-smoking devices

Washington, D.C. – The Food & Drug Administration is reportedly set to deny Juul’s pre-market authorization applications, which would effectively ban all Juul nicotine vaping products in the United States.

The Consumer Choice Center calls the FDA’s actions a “betrayal” for consumers and former smokers who have used Juul and other vaping products to quit smoking.

“The FDA is ratcheting up its all-out Nicotine Prohibition Campaign, this time by leaking that it will soon rip popular Juul products from the shelves of gas stations, convenience stores, and vape shops,” said Yaël Ossowski, deputy director of the Consumer Choice Center.

“This is an act of betrayal to the millions of former smokers who have switched to less harmful products like Juul to get them away from cigarettes. When you add this specific FDA marketing denial to the tens of thousands of others from smaller vapor companies, the FDA has explicitly chosen the anti-scientific stance of denying that harm reduction is a significant tool in getting smokers to switch. 

“The fact that we are in a time of economic uncertainty, high gas prices, and rising inflation, and the Biden Administration and its agencies are more focused on removing legal products from consumers’ hands tells you all you need to know. This administration does not care about consumers, and it cares even less about your health,” said Ossowski.

RELATED: The CCC recently hosted the Menthol Melee to explore the impact of the FDA’s looming bans on menthol and flavored tobacco products, again underscoring the agency’s troubling rulemaking.

Congress wants to sneak in an effective ban on synthetic nicotine vaping that would harm consumers

WASHINGTON, D.C. – This week, it was revealed that several congressmen and US senators have added a provision in the upcoming emergency government funding bill that would relegate tobacco-free synthetic nicotine to the regulatory authority of the Food and Drug Administration and its premarket tobacco application process.

This would give vaping firms less than two months to file a lengthy and convoluted Premarket Tobacco Application (PMTA), which will ultimately lead to most small vaping firms and shops going out of business.

Yaël Ossowski, deputy director of the Consumer Choice Center, said this will actively harm adults who want to quit smoking.

“The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski.

“Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.

“Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit,” added Ossowski.

“The method of fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits, is shameful in our modern American Republic.

“We hope our elected representatives reject this particular provision on synthetic nicotine and go back to the drawing board to offer a more permanent, sane, and smart policy on the next generation of vaping products,” said Ossowski.

How liability lawsuits drive up drug prices, stifle innovation, and harm patients

A single drug can cost up to 2 million dollars per treatment. In the light of COVID-19, patient groups and activists have been using the crisis of the moment to call for capping drug and vaccine prices and cracking down on barriers to access for patients. In developing countries, large parts of drug prices are caused by tariffs, taxes, and other regulatory barriers. The United States, on the other hand, has the highest per-capita drug expenditure and drug prices in the world.

Bringing a drug to the US market is usually critical for a company to recoup the roughly 2 billion dollars of development costs per successfully launched medicine. At the same time, the country’s unique legal liability and injury system (called tort law) leads to higher drug prices without necessarily creating benefits for patients. Once a drug has passed the rigorous approval process demonstrating safety and efficacy to the US Food and Drug Administration (FDA), it is still subject to various liability laws at the state level.

In the last two decades, Pfizer set aside a whopping 21 billion dollars for settlements following tort lawsuits against the diet drug Fen-Phen. Those who were harmed by the drug were able to seek legal recourse. That said, thousands and thousands of people who were not harmed by the drug were also able to seek compensation. So much so that it is assumed that at least 70% of the payouts went to claimants who weren’t harmed at all by the drug.

Johnson & Johnson was ordered to pay 8 billion dollars to one patient for side effects caused by the antipsychotic drug Risperdal. These are just a few examples of a plethora of multi-billion-dollar payments drug companies have been compelled to make after being dragged to court, despite them being deemed safe by the FDA.

Patient advocates who are passionate about lowering drug prices in the USA should take a serious look at liability laws and how their misuse inflates prices. Abolishing liability beyond FDA requirements could reduce drug prices in the United States by 12 to 120 billion dollars a year and therefore give many more patients access to medicines. 

In 2019, US patients spent a total of $360 billion on prescription drugs. Between 3 and 30% of this amount could be freed up for other treatments or price cuts if liability rules for FDA-approved drugs would be reformed. This change might seem radical, but it is what Congress has approved for FDA-approved medical devices. A similar preemption was extended to vaccines in the late 1980s via the Vaccine Injury Compensation Program.

Another impact of lawsuits following product withdrawals of FDA-approved drugs is that they negatively affect new investments in development. Pfizer’s settlement for Fen-Phen alone could have been used to bring 10-15 new innovative and life-saving drugs to patients.

Rather than using these financial resources for more research and development, or to lower drug prices, pharmaceutical manufacturers have to fight law firms who enrich themselves by abusing the US tort system. Tort law on top of FDA regulation is not just stifling innovation, but also an expensive way to compensate for the harm caused to patients. Paul H. Rubin suggests that the costs of settlement for the legal process account for half of the total settlement fees. Reducing this burden could increase the speed of new drugs being developed and reduce their price. Critics of tort reform will say that changing liability rules will endanger patients, but that’s far from the truth. A 2007 study shows that tort law reform in some states led to a total of 24,000 fewer deaths due to price reductions and the arrival of new innovative drugs. That’s something to keep in mind.

As long as we keep existing tort law on top of the FDA approval framework, consumers are being de facto forced to pay a massive markup on drugs in order to get insured against potential side effects. This is a very expensive and inefficient way of insuring patients against harm. 

A smarter way of designing such a compensation scheme is to either expand the vaccine compensation scheme to pharmaceuticals or to allow consumers to personally purchase insurance against such damages. This could, for instance, be supplementary insurance on top of the patient’s existing health insurance plans. Such a system would allow patients who opt-in much lower fees than the existing mandatory tort law system.

Exempting drugs from state tort law would be an easy step to reduce drug prices without putting patients under more risk. American patients would save billions a year and be able to access more treatments than they can currently. This will lead to a net benefit for patients and the health of the nation. Why not give it a try?

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