Late last week, a scientific advisory committee dealt a blow to tobacco giant Philip Morris International’s (PMI) bid to claim its heat-not-burn tobacco product IQOS is safer than cigarettes, by recommending that the U.S. Food and Drug Administration reject the company’s application for “reduced risk” status.

Despite assurances from PMI officials that IQOS would only be marketed to active smokers, several members of the Tobacco Products Scientific Advisory Committee (TPSAC) expressed concerns that the device would prove attractive to non-smokers, especially non-smoking teens.

Now data from a small study examining IQOS use and product awareness in Italy appears to confirm those fears.

Three years after IQOS was launched in the country, about one-fifth of the 3,086 Italians taking part in a nationally-representative survey had heard of it. Just 1.4% saying they had tried it and 2.3% saying they intended to try it.

But those who had tried it or intended to try it were almost as likely to be nonsmokers and former smokers as active smokers.

The study was published in the journal Tobacco Control.

IQOS is currently under review by the FDA for sale in the U.S. It is sold in 30 other countries, including 19 European nations.

“Our data indicate that 739,000 Italians have already tried IQOS, including 329.000 never smokers,” wrote researcher Xiaoqui Liu, of the Institute for Pharmacological Research ‘Mario Negri’ in Milan, and colleagues. “Moreover, another 1,205,000 Italian adults, including 619,000 non-smokers expressed their intention to try IQOS in the future.”

IQOS is the only heat-not-burn tobacco product sold in Italy.

The research suggests that the absolute number of never smokers who have already tried IQOS in Italy is comparable to that of current smokers.

“Among Italian adults with an intention to try IQOS, the number of non-smokers even exceeds that of current smokers. Therefore, these findings suggest that IQOS may create new nicotine addicted generations,” the researchers wrote.

In response to request for comment, a PMI spokesperson pointed to study limitations acknowledged by the researchers, including the relatively small survey sample size and the fact that the information on use and awareness of the device was self reported.

“Based on extensive U.S.-based perception and behavior models submitted as part of our applications, we believe the likelihood of unintended use of IQOS is low,” an emailed statement said. “In addition, real-world data from countries where IQOS is currently available show little to no interest in the product by never and former tobacco users.”

Tobacco researcher John W. Ayers, PhD, of San Diego State University, told MedPage Today that the jury is still out on how heat-not-burn products like IQOS will be used by consumers, since they have only been on the market for a few years.

“It’s not clear if heat-not-burn tobacco will appeal to a new generation of never smokers or if it will cause more of the public to start using traditional cigarettes,” he said. “But this study suggests we should be prepared to mitigate these potential effects.”