The Food and Drug Administration (FDA) has approved a new tobacco-containing electronic device designed to help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals.

The IQOS Tobacco Heating System, made by Philip Morris Products S.A., generates a nicotine-containing aerosol by heating tobacco-filled sticks wrapped in paper, specifically Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks. While the IQOS system and heatsticks been on the market since April 2019, the FDA’s latest action specifically authorizes them as “modified risk tobacco products” or MRTPs.

The IQOS and heatsticks are the second set of products to be authorized as MRTPs and the first tobacco products to receive “exposure modification” orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance. The authorization requires Philip Morris to conduct surveillance and studies to determine whether the products are in fact helping smokers kick their habit and to ensure they aren’t easily accessible to or attracting youth.

“The FDA will closely monitor how IQOS is used by consumers to determine if these products meet this potential and do not cause increased use among youth. It is important to note that these products are not safe, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

The FDA granted the authorization for the IQOS system to be a MRTP based on evidence that the IQOS system heats tobacco but does not burn it, which significantly reduces the production of harmful and potentially harmful chemicals. Also, scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces the body’s exposure to harmful and potentially harmful chemicals.

By requiring companies to obtain MRTP authorization, the FDA is hoping to prevent companies from falsely marketing their products to help smokers transition off cigarettes, while actually working to attract new users, like JUUL and other vape companies who claimed their products were for smoking cessation. In particular, JUUL’s focus turned quickly to luring youth with flavored vape juices and using social media influencers to promote their products. The company also was not forthright with consumers about how much nicotine their vapes contained, leading to a vape epidemic among youth.

Beasley Allen lawyers Joseph VanZandt and Sydney Everett, together with Mass Torts Section Head Andy Birchfield, are currently representing several individuals who are suing the top U.S. vape maker JUUL for the negative impact its products have had on their lives. Recognizing the critical threat to young people ensnared by nicotine addiction, and its effect on our nation’s educational system, our firm has also joined other nationally recognized law firms to represent school districts and public entities across the country in the fight to stop the school vaping crisis.

The firms working together to represent school districts and public entities in this litigation together with Beasley Allen are Baron & Budd, P.C.; GozaHonnold Trial Lawyers; Panish Shea & Boyle LLP; Wagstaff & Cartmell; and Walkup, Melodia, Kelly & Schoenberger.

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