December 31, 2019

Stanton A. Glantz, PhD

Trump lets FDA take baby step toward dealing with e-cig flavors; local action remains the key

Updated January 1, 2020 to reflect more information.  "Baby step" is being too kind; this is a complete capitulation to industry that portends a lax regulatory environment for e-cigs as companies submit their premarket applications.

 

Press reports on New Year’s eve indicated that the White House will allow the FDA to stop allowing the sales of flavored e-cigarettes except menthol for closed systems (like Juul pods), but continue to all sales of flavored tank (open) systems.

This is a big win for the big tobacco companies (including Juul) because menthol is the most important flavor.    Juul, like the rest of the big tobacco companies, has been lobbying to keep menthol (and tobacco) flavors. 

Why?  When Juul stopped selling other flavors, sales of mint skyrocketed and made up the difference.  (Menthol is derived from mint.) 

As CNN reported when covering the announcement:

Studies published in the medical journal JAMA in November found that nearly 60% of high school students who vape use Juul, the market leader, and mint was the most popular flavor among US 10th and 12th graders. An estimated 2.4 million high school and middle school students use flavored e-cigarettes, one of the studies found. Fruit was the most commonly reported flavor category, at 66.1% for high school and 67.7% for middle school, followed by menthol or mint at 57.3% for high school and 31.1% for middle school.

My guess:  We will see big increases in menthol e-cig use once FDA starts enforcing the ban.  It will be important for health groups and agencies to monitor sales to see if this situation materializes. The chances that evidence will affect the FDA is small, but it will inform continuing local and state efforts to prohibit flavored e-cigarettes and other tobacco products to fill the vacuum the FDA created.

The exception for tank systems could end up being a big problem and a windfall for vape shops.  As the e-cig industry has been taken over by Big Tobacco, the vape shops have been getting squeezed out.  If kids shift to vape shops, that could further blunt the effect of the limited action the FDA is taking.

The open systems are also problematic because the user decides what to put in them, meaning that you have no idea what you are getting.  In addition, mixing flavors can lead to chemical reactions that can increase toxicity. 

It is also a win for Suorin, a popular brand with kids, which uses refillable pods.

This pullback in what the Trump Administration is doing is also a big payoff for the tobacco companies’ longstanding investment in conservative advocacy groups that was transferred over to opposing e-cigarette regulation after Big Tobacco got in the game.

The fact that the Administration announced this on New Year's Eve shows that they know this decision will not be popular with the public.  It's a well-establised PR principle to announce unpopular decisions late night or over the weekend in the hopes it will fall into the "news hole" when people are on vacation.

All of this reinforces the reality that in e-cigarette regulation, like everything else in tobacco control, will require continued effort at the local and state level, including comprehensive bans on the sales of flavored tobacco products, including menthol.

Comments

Comment: 

Here is the TFK statement, updated to include references to the President's NYE remarks and data showing the popularity of open systems among youth. 

FOR IMMEDIATE RELEASE: January 1, 2019

Contacts: Boot Bullwinkle, (650) 776-8486 OR Dave Lemmon (202) 738-7983

 Trump Administration Breaks Its Promise to Kids and Families to Eliminate Flavored E-Cigarettes, Prioritizes Industry Over the Health of Our Kids

 Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids

 WASHINGTON, DC – The e-cigarette policy announced today by the Trump Administration breaks the Administration’s promise to kids and families to eliminate the flavored e-cigarettes that are driving an epidemic of youth nicotine addiction. By leaving menthol flavored e-cigarettes widely available and completely exempting liquid flavored products, this policy will not stop the youth e-cigarette epidemic. It is a capitulation to both Juul and vape shops and gives a green light to the e-cigarette industry to continue to target and addict kids with flavored products.

There should be no question: The Administration has sided with Juul, Altria, the vape shops and other e-cigarette interests over our kids. Describing the policy to the media, President Trump said that while we have to protect families, “At the same time, it’s a big industry. We want to protect the industry.”

The evidence is clear that flavored e-cigarettes are driving the youth epidemic. Most youth e-cigarettes users use flavored products and cite flavors as a key reason for their use. Only the elimination of all flavored e-cigarettes can end the worsening youth e-cigarette epidemic and stop e-cigarette companies from luring and addicting kids with flavored products.

Rather than clear the market of all flavored e-cigarettes, as the Administration promised to do in September, the new policy allows menthol flavored e-cigarettes and flavored liquids in every imaginable flavor to remain widely available — and kids no doubt will be able to get their hands on them.

The Administration’s decision to exempt menthol e-cigarettes and all flavored e-liquids creates a giant loophole that benefits Juul — the company that created the youth epidemic — and irresponsible vape shops, leaving America’s kids at risk. Instead of keeping its promise to kids and parents to clear the market of all flavored e-cigarettes, the Administration has adopted the exact policy on e-cigarette flavors that Juul announced in November.

This policy falls woefully short of the bold action the Administration promised to address what it rightly called “the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities.”

The evidence indicates that if menthol e-cigarettes are left on the market, kids will shift to them. The National Youth Tobacco Survey shows that youth use of mint or menthol e-cigarettes soared in 2019 after Juul restricted the availability of other flavors such as mango. Under the Administration’s new policy, the likely result is that kids will now shift from mint to menthol. Decades of experience with menthol cigarettes demonstrate that menthol appeals to kids – in fact, over half of current youth smokers smoke menthol cigarettes.

Juul is well-prepared to exploit this menthol loophole by reclassifying its popular mint products as menthol. Juul has repeatedly described mint as a “menthol-based” flavor, and The Wall Street Journal has reported​ that Juul is considering renaming its mint pods as a “menthol variant.”

There is no public health justification for allowing continued sales of menthol e-cigarettes.

Additionally, the e-cigarette industry has already demonstrated the danger of allowing flavored e-liquids. Data from the 2019 National Youth Tobacco Survey, published in JAMA, found that after Juul, Suorin and Smok are the most popular e-cigarette devices among high school students. 7.8% of high school e-cigarette users reported using Suorin and 3.1% reported using Smok. These prevalence estimates are solely from write-in responses, since Suorin and Smok were not listed as options in the questionnaire, so actual use rates are likely higher. Both Suorin and Smok are open pod systems. Unlike Juul, which sells pre-filled, closed cartridges, Suorin and Smok devices come with empty, refillable pods that can be filled with e-liquids of varying nicotine strengths and flavors.

The Administration’s failure to protect our kids makes it even more critical that Congress, states and cities do so by quickly prohibiting the sale of all flavored e-cigarettes. There is no time to waste because this youth epidemic continues to get worse and more than 5.3 million kids now use e-cigarettes, including over 1 in 4 (27.5%) of high school students. Policymakers at all levels must act now to stop Juul and other companies from addicting a new generation of kids with flavored products.

Comment: 

My colleague Jerimiah Mock, who studies tobacco trash around schools, asked this important question: "I wonder how the FDA proposes to classify Puff Bars which we have found over the past few months in and near high school and middle schools, and students report are the latest preferred devices. Puff Bars, being totally 'disposable' have no cartridge and thus do not fit into the cartridge-based classification."  They also also not tank systems.