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.