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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.

The Myth of the Vaping Crisis is Sparking a New War on Flavored Nicotine Products – And That Harms Consumers

In the backdrop of a very busy Congress, members of the U.S. House are pushing a bill that would eradicate entire categories of flavored nicotine products.

This sweeping ban would directly harm consumers who use menthol tobacco, flavored cigars, snus, and vaping products by outlawing the products they use and pushing them to the black market.

The proposed law comes in the wake of the much-hyped “vaping crisis” that transpired over the summer, in which thousands of individuals suffered lung damage from inhaling vapor products, also called e-cigarette, or vaping, product use-associated lung injury (EVALI).

In the end, the culprit was revealed to be illegal cannabis vaping cartridges loaded with Vitamin E acetate and not nicotine vaping products, according to the Centers for Disease Control.

Read the Consumer Choice Center Policy Primer: Myths and Facts on Vaping: What Policymakers Should Know

Though scientific experts correctly identified the cause of the injuries – black market THC cannabis vape cartridges – that hasn’t stopped legislators from using that pretext to introduce new prohibitions on flavored tobacco products used responsibly by adult consumers.

H.R. 2339, named the Reversing the Youth Tobacco Epidemic Act of 2019, proposes several sweeping changes to flavored consumer products and is expected to soon hit the House floor for a vote.

The bill would outlaw the following:

  • Menthol products
  • Flavored cigars and cigarillos
  • Flavored smokeless tobacco, known as snus or dip.
  • Some flavored vaping products

The goal is to significantly reduce or eliminate youth use of these products, which is a noble pursuit.

But youth smoking is at an all-time low

Fewer young people than ever are using traditional tobacco products – less than 2.3%. That’s a significant decline since the year 2000, where nearly 15% of minors smoked cigarettes, according to the CDC.

  • This represents a public health victory, and one that has been achieved with sensible education, regulation, and innovation. The same is true for adult smokers. Just 13.7% of adults currently smoke, the lowest number ever recorded.
  • The latest CDC figures show that 20.8 percent of high schoolers have vaped at least once in the last 30 days. But 7 to 8% of those were vaping cannabis rather than nicotine.
  • A total flavor ban on all tobacco products and vaping products for adults would do little to curb use among youth.
  • It may even exacerbate the problem and only punish lawful adult consumers and deprive them of their choice, not to mention devastate the communities that rely on tobacco taxes to fund important social programs.

What’s more, by categorizing non-tobacco vapor products as tobacco products, House members are attacking the very innovation that has led to the lowest-ever figure of recorded tobacco use.

Prohibition Hasn’t Worked

The 100-year anniversary of the passage of Prohibition of alcohol took place last month.

  • All these years later, we know that outlawing certain consumer products does not eradicate their existence. Rather, it moves them from the legal, regulated market to the illicit and unregulated black market.
  • This makes the products themselves less safe, and the trade around those products even more dangerous.

After an entire nation had awoken to the disaster of Prohibition, it was successfully repealed in 1933.

Minorities are more likely to use menthol products

According to the CDC, African-Americans who use tobacco are 90% more likely to favor menthol products and represent the vast majority of consumers in the flavored tobacco market.

  • A ban would create an illicit market without regulations or ID checks
  • Such bans would then force police officers to crack down on illicit menthol cigarette trade, further straining relations between the African-American community
  • As seen in the case of Eric Garner, who was choked out by a police officer and later died in New York City for selling loose cigarettes on the street, bans and restrictions that create illegal markets can lead to devastating consequences.
  • If a law bans menthol and flavored tobacco products, the demand wouldn’t disappear.

Rather, it would be pushed into the unregulated market, siphoning away tobacco taxes and incenting police officers to use their power to enforce laws in minority communities.

Age-restriction by law is a powerful means of dissuading youth use

By penalizing convenience retailers that sell to minors, regulators have already created a significant barrier to youth access.

  • This allows law enforcement to prosecute bad actors and focus their efforts on illicit markets where dealers don’t ask for ID.
  • Recently, Congress’ raising of the age to purchase tobacco and vaping products to 21 years old also dissuades youth use, ensuring no high schooler will be able to legally purchase these products.
  • Nearly half of tobacco and vape shops don’t ID young customers.

Enforcing existing laws on youth access, including prosecuting shops that don’t check ID, are a powerful means of keeping youth away from tobacco products.

Bans Deny the Science on Harm Reduction by Vaping and Smokeless Products

For many adult smokers looking to quit, vaping products have been proven key to harm reduction.

  • About 4.4% of adults, nearly 11 million, are now using vaping devices
  • National health bodies around the world, including Public Health England, the New Zealand Ministry of Health, and Health Canada have endorsed vaping as a smoking cessation method.
  • The U.K.’s top health body has repeatedly said that vaping and e-cigarettes are 95 percent less harmful than smoking.
  • Bans that include flavored vaping products would deprive adult smokers of a less harmful method of consuming nicotine

We all have an interest in eliminating the number of young people who take up smoking. But counterintuitive bans would make that goal harder, not easier to achieve.

And depriving adult consumers of harm reducing technologies like flavored vaping products will reserve the decades of public health successes.

Let’s hope our members of Congress consider these facts before they vote on H.R. 2339.

Download the full policy note here.

FDA’s menthol ban and vaping restrictions will have consequences

CONTACT: Jeff Stier Senior Fellow Consumer Choice Center jstier@consumerchoicecenter.org FDA’s menthol ban and vaping restrictions will have consequences WASHINGTON, D.C. – Last week, FDA Commissioner Scott Gottlieb announced severe sales and flavor restrictions on vaping products and introduced a new ban on menthol flavors in combustible tobacco products. Reacting to the news, Consumer Choice Center […]

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