Monday, May 11, 2020

First Study of ZYN, A Novel Consumer Nicotine Product

The American Journal on Addictions has just published (here) an analysis by my colleagues and me of the consumer appeal of a new nicotine product, ZYN.

Swedish Match test-marketed ZYN six years ago in Colorado; distribution expanded to 11 states in the western U.S. in 2016, and nationwide in April 2019.  While ZYN marketing was limited to a website and point-of-sale promotions, press reports (here, here and here) indicated remarkable sales success. 

In 2018, the company commissioned from a private contractor two marketing surveys on ZYN perceptions and use.  Last year a research group consisting of Drs. Karl Fagerström from Sweden and John Hughes from the University of Vermont, as well as Nantaporn Plurphanswat and me from the University of Louisville, was granted full access by Swedish Match to that survey data so that we could produce an independent analysis.  Our group previously published a research article describing how proposed changes in Swedish snus warning labels would affect tobacco users’ perceptions and use of the products (here).  Other than providing us with the data, the company had no role in our analysis or reporting of the results.       

In the current study, we assess adult appeal and interest in buying ZYN, and we describe the characteristics of ZYN users and patterns of ZYN use after purchase.

We found that while nearly 90% of never and former tobacco users did not find ZYN to be appealing, one-third of current smokers, more than half of current smokeless tobacco (ST) users, and two-thirds of dual cigarette-ST users did.  More importantly, only 3% of never, and 2% of former users were interested in buying the product.

In addition, we found that the likelihood of buying ZYN compared with other tobacco products was highest among exclusive ST users.  That cohort may be more inclined to buy ZYN because its manner of use is similar to that of other ST products, i.e., placing the product between the lip and gum; additionally, Swedish Match was offering the product on stores’ ST shelves.

The vast majority of ZYN users were white men, which is consistent with ST use. About 90% used the pouches every day, and most chose the 6 mg nicotine pouch, rather than the 3 mg version.  More than one-third had used ZYN about 3-6 months.

When offered a variety of reasons for using ZYN, participants frequently chose options such as “less harmful…”, “no one can tell when using”, and “to avoid spitting”.  Among current smokers, the top answers were, “less harmful for my health than cigarettes” and “do not cause me to smell like smoke/tobacco.”

There was no information about tobacco cessation due to ZYN, and time since quitting tobacco, so we cannot know if participants used ZYN to quit other products.  We also had no information about how frequently and how many pouches were used.

ZYN’s striking entry was quickly followed by similar products DRYFT ( and On! ( ).  None of these brands contain tobacco, only pharmaceutical-grade nicotine at different levels: ZYN pouches contain either 3 or 6 mg; On! is available in 2, 4 and 8 mg strengths; and DRYFT pouches have 2 or 7 mg. The highest nicotine dose approved by the FDA for medicinal nicotine gum and lozenges is 4 mg. Higher nicotine doses in the new pouch products may explain their popularity, since medicinal nicotine offerings have proven unsatisfying to consumers who can’t or don’t want to achieve nicotine abstinence.

Our study was the first to assess interest in and actual usage of a new tobacco product, ZYN nicotine pouches.  Non-users of tobacco had little interest, and ST users constituted the majority of ZYN regular users.




Monday, April 20, 2020

CDC’s Misuse of EVALI Misleads Americans That Smoking Safer Than Vaping

In a campaign of disinformation, culminating in the prolonged mischaracterization of the EVALI (e-cigarette, or vaping, associated lung injuries) crisis, the Centers for Disease Control and Prevention has caused more Americans to believe the untruth that vaping is more dangerous than cigarette smoking.

Bentley University economist Dhaval Dave and colleagues at the City University of New York and Cornell have authored an article titled “News That Takes Your Breath Away: Risk Perceptions During an Outbreak of Vaping-Related Lung Injuries,” published by the National Bureau of Economic Research.  It analyzes the effect of actions taken by the CDC.

Dave et al. describe the federal response to EVALI: “Statements issued by the CDC during the early ‘crisis’ period were direct and clear suggesting that individuals should stop using all vaping products in the late summer of 2019.” (emphasis added). 

The CDC was silent on marijuana until December 10, 2019, when it acknowledged in a tweet that “products that contain THC, particularly from informal sources…play a major role in the current lung injury outbreak.”  The agency had delayed focusing public attention on cannabis products for over three months, as it was clear by early September to many observers, including me (here) and Boston University’s Dr. Michael Siegel (here), that the lung injuries were unrelated to nicotine-based e-cigarettes and vaping products which had been used by tens of millions of consumers for some 10 years with no serious lung problems.    

Figure 5 in Dave’s article, seen above, shows the effect of the anti-vaping misinformation campaign that has been supported since 2012 by the transfer of hundreds of millions of dollars from the FDA to the National Institutes of Health to cooperating university researchers.  This scheme has generated hundreds of laboratory and epidemiologic studies reporting exaggerated or downright false vaping harm. 

The chart shows the success of the misinformation campaign from 2012 to 2019.  The percentage of Americans viewing e-cigarettes as more harmful than cigarettes grew at a consistent rate of about two percentage points per year. 

The 2019 EVALI debacle took the public’s fear of nicotine e-cigarettes and vaping products to new heights.  As Dave et al. write, “the immediate impact…was to increase the fraction of respondents who perceived e-cigarettes as more harmful than smoking by about 16 percentage points.”  After the CDC issued its December 10 tweet emphasizing “the role of THC e-cigarette products, e-cigarette risk perceptions were partially revised downwards.”

That downward movement was minimal, as Figure 6 from the analysis illustrates:

Dave et al. generously refer to the CDC’s delayed identification of marijuana as the cause of EVALI as “precautionary” but they suggest that it may have had “unintended consequences. More targeted advice about the risks of THC e-cigarettes might have more effectively reduced the use of those products, potentially preventing EVALI cases. Moreover, the increase in e-cigarette risk perceptions might discourage adult smokers from using e-cigarettes…the increase in e-cigarette risk perceptions might slow the downward trend in youth smoking.”

By not announcing early on that contaminated marijuana products cause EVALI, the CDC increased the number of injuries and deaths.  The agency inaction also discouraged smokers from switching and might have even encouraged teens to smoke.

Wednesday, April 1, 2020

FDA and CDC’s Irresponsible Covid-19 Actions and Inactions

Long after today’s Covid-19 crisis, Americans will remember the catastrophic failures of the Centers for Disease Control and Prevention, and the Food and Drug Administration, the two federal agencies tasked with protecting public health.

Covid-19 infections were first reported in Washington State in late January, virtually at the same time as in South Korea.  According to a detailed timeline, that country immediately “pursued a trace, test, and treat strategy that identifies and isolates those infected with the coronavirus while allowing healthy people to go about their normal lives…the U.S. lost six crucial weeks because regulators stuck to rigid regulations…” which “proved disastrous in a pandemic.”  A Reuters headline put it succinctly: “…Korea trounced U.S. in [a] race to test people for coronavirus.”

John P.A. Ioannidis, professor of medicine, epidemiology and population health at Stanford University, opined: “Covid-19 has been called a once-in-a-century pandemic. But it may also be a once-in-a-century evidence fiasco.”  He noted that as a consequence of the testing disaster, officials have been required to institute draconian countermeasures, including extreme social distancing and lockdowns.  “But,” he observes, “with lockdowns of months, if not years, life largely stops, short-term and long-term consequences are entirely unknown, and billions, not just millions, of lives may be eventually at stake.  If we decide to jump off the cliff, we need some data to inform us about the rationale of such an action and the chances of landing somewhere safe.”

Bureaucrats at the CDC and the FDA delayed the rapid development of Covid-19 testing by failing to adapt to emergent conditions and stuck to rigid regulations that take months and years.  These failures have been documented in publications from across the political spectrum, including conservative and libertarian outlets, and the liberal New York Times (here and here).

The FDA’s primary error was its failure to quickly approve Covid-19 tests from university and commercial laboratories.  This sort of “regulatory purgatory” has plagued the sale of vastly safer cigarette substitutes (examples here, here, here and here) -- inaction that contributes to the premature deaths of 480,000 inveterate smokers annually.  Delayed Covid-19 testing has already resulted in tens of millions of Americans having lost their livelihoods, and for far too many, their lives.

The FDA is continuing its unscientific anti-vape campaign with a Covid-19 twist.  Spokesperson Michael Felberbaum provided this warning to Bloomberg News: “People with underlying health issues, such as heart or lung problems, may have increased risk for serious complications from Covid-19.  This includes people who smoke and/or vape tobacco or nicotine-containing products.  E-cigarettes can damage lung cells.”

There is absolutely no evidence that individuals who vape have increased Covid-19 risks.  It is irresponsible for the FDA to make unscientific and unsubstantiated allegations about e-cigarettes without a shred of evidence.