The U.S. Food and Drug Administration has ruled that Philip Morris International can sell its heated tobacco cigarette, iQOS, citing the product’s potential to help combustible cigarette smokers quit. The agency also set forth stipulations that it not be marketed to children.
The FDA approved the first of two Philip Morris applications, one to allow sales of the device and the other to market it as less harmful than cigarettes. PMI is waiting on a decision on the latter application.
“While the authorization of new tobacco products doesn’t mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole,” FDA’s Center for Tobacco Products Director Mitch Zeller said in a statement.
The new iQOS device product line consists of three items: Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks. Because Phillip Morris operates overseas, Richmond, Virginia-based Altria will sell the products in the U.S.
The FDA found the iQOS products “contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke.” Because cigarettes and iQOS deliver similar nicotine levels, IQOS may help smokers to transition away from combustible cigarettes.
In a statement on the decision, the FDA cited its belief that non-smokers and children won’t be attracted to iQOS. Its mission, said the FDA, is to protect the public health, especially young people, by driving all consumers away from smoking.
Unlike e-cigarettes, the FDA defines iQOS as a cigarette and must comply with FDA cigarette rules. That means the FDA must approve labeling, advertising, marketing plans and how PMI plans to restrict youth access, advertising and promotions.
PMI CEO Andre Calantzopoulos said in a statement that the company looks forward to working with the FDA to in assuring that iQOS is marketed only to current adult smokers.
Altria plans to start selling iQOS this summer by opening an iQOS store and mobile stores in Atlanta. Altria also said that it plans to distribute the Marlboro Heatsticks to about 500 retailers, including a number of c-stores chains.