Ohio State University Gets $20 Million FDA Grant to Trash Nicotine Pouches

 

Ten Ohio State University faculty members, led by Brittney Keller-Hamilton, published a study in the journal Addiction concluding that two strengths of Zyn nicotine pouches (3 and 6 milligrams) did not relieve “craving symptoms at 5 minutes as strongly as a cigarette.”  They also reported that “using 6-mg pouches was associated with greater plasma nicotine delivery at 30 minutes than 3-mg [pouches] or cigarettes…”

The OSU authors emphasized only one time point for assessing craving relief: five minutes after using the products.  They likely knew that cigarettes would win this contest, as no one expects a nicotine pouch to produce a blood-nicotine spike as quickly as inhaled smoke.  However, they also acknowledged that “no other differences in craving relief were observed through the 90 minutes of follow-up.”

Those familiar with nicotine absorption know that at 30 minutes, users of pouches or other smokeless tobacco products can be equally or more satisfied than those inhaling cigarettes.  The study’s nicotine levels show that in the figure below. 

 

 

Further, satisfaction with smokeless products may last longer than with cigarettes, so smokers who normally light up every hour might be able to use fewer nicotine pouches or dips of moist snuff.  That is an observation we made 30 years ago in our pilot study switching smokers from cigarettes to Skoal Bandits.

The OSU results regarding appeal were reasonable.  “Overall, participants reported moderate appeal (e.g. pleasantness, wanting to use, extent of liking and enjoyment) of the study [pouches]…Participants consistently reported both [pouches] as less appealing than their usual brand cigarette.”

OSU handcuffed Zyn with respect to enjoyment.  While the researchers instructed participants to smoke their “usual brand cigarette,” they assigned them only one flavor of Zyn (Wintergreen), even though nine other flavors are marketed (Spearmint, Cool Mint, Menthol, Peppermint, Chill, Smooth, Citrus, Coffee and Cinnamon).  The authors explain this as a typical clinical trial control, but in that case, they should not have judged the product based on subjective participant impressions.

For these reasons, their “less appealing” finding was predestined.  No substitute can perfectly replicate a cigarette’s nicotine/tobacco satisfaction.  However, the results demonstrate that Zyn pouches, while not perfect, were moderately appealing and moderately satisfying.  It’s too bad that the OSU group didn’t include other FDA-approved substitutes, such as nicotine patches, gum and lozenges. 

OSU’s press release grossly misstated the results, with the headline, “pouch products do little to curb addictive nicotine cravings,” causing media outlets to amplify the fabrication (here and here). 

The OSU press release also touts the center’s “newly funded $20 million Tobacco Center for Regulatory Science grant from the Food and Drug Administration and National Institutes of Health. The grant will enable scientists to conduct further research to inform oral nicotine pouch regulations and promote public health.”

Readers of this blog know the sort of research that $20 million will generate (here here, here and here). There is little here for inveterate smokers or tobacco harm reduction proponents to celebrate.

 

 

Vaping Plays a Role in Young Adults’ Low Smoking Rate

The anti-tobacco Truth Initiative tweeted that the smoking rate among young adults (18-24 year old) in the U.S. is “just 10.4%,” based on the 2017 National Health Interview Survey (NHIS) (here). 

But the Initiative didn’t tell the whole tobacco “truth.”  Using the same NHIS data, I prepared the chart at left which confirms that smoking is way down among young adults, continuing a decline I reported previously (here).  Nearly 85% of young adults have never smoked, including 2.7% who currently vape, 13% who tried e-cigarettes and 69% who never used either product. 

Among the 5% who are former smokers in this age group, over half were current vapers or had tried vaping products.  Even more impressive, 7 out of 10 current smokers were either current vapers or had tried e-cigarettes, meaning they could eventually make the switch to smoke-free.

Advocates of greater tobacco control make a specious boast when they celebrate lower smoking rates while ignoring the positive impact of vaping. 

New Vaping Insights Based on FDA’s PATH Survey 2013-2014

Analyzing data from the baseline 2013-14 FDA-funded Population Assessment of Tobacco and Health (PATH) Study, my economist colleague Dr. Nantaporn Plurphanswat and I have produced a comprehensive study of e-cigarette use in the United States.  The research appears in the journal Nicotine & Tobacco Research (abstract here).

The standard vaping definition has two components: participants must have regularly vaped AND now vape every day or some days.  Using this definition, we estimate that there were 5.5 million current e-cigarette users (2.4% of the U.S. population), of which 2.3 million used them daily and 3.2 million used them some days.

However, there are 7.4 million participants who have NOT “regularly vaped” but report that they use e-cigs every day or some days.  It is important to count them too, and to distinguish them from current users, so we call them “e-cigarette triers,” the vast majority of whom (95%) use them some days.  The total of current users and triers is 12.9 million (or about 5.6% of the population).

(In a recent blog entry (here) I estimated that there were 8.9 million U.S. vapers in 2014, based on the National Health Interview Survey [NHIS].  The fact that the NHIS does not collect data on “regular” vaping likely accounts for the difference with our new PATH-based 12.9 million estimate.)

The figure above shows that the vast majority of every day current vapers were either current smokers (47%) or former smokers (46%).  In contrast, most some day vapers and all e-cigarette triers were current smokers, and the percentage of never smokers was higher in these groups (discussed below). 

PATH also collected more detailed cigarette smoking information than did NHIS.  In our new article we note that we use a similar “…classification strategy…for estimates of cigarette smoking. The number of current smokers in PATH was 41.5 million, and 80% were daily smokers, which is consistent with the 2014 NHIS.  However, there were also 7.1 million cigarette triers, who are distinguished by being every day or some day smokers who had not consumed 100 cigarettes in their lifetime.  Triers do not fit the traditional definition of current smokers, so we have included them as a subset of ‘never-smokers’ for comparison with NHIS surveys, where they would have been classified as never-smokers by answering ‘no’ to the 100-cigarette question and not being asked about every or some day smoking. This is an indication that a substantial number of American smokers may have been misclassified as never-smokers in previous national surveys.”

These details illuminate critical characteristics of both vapers and smokers.  For example, as shown the chart at left, the vast majority of vapers who “never smoked” according to the NHIS definition are actually current or former cigarette triers.  Only a small fraction (7-11%) have never tried cigarettes.  This finding refutes the common claim that vaping attracts never smokers.

Other vaping insights gleaned from the PATH survey will be discussed in a future post.