Wednesday, December 13, 2023

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.



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