The Food and Drug Administration will allow Philip Morris International to sell a new tobacco device that’s designed as an alternative to traditional cigarettes.
The iQOS is a small pen-like electronic device that heats a stick of tobacco, rather than burning it, making the vapor less harmful than smoke from traditional cigarettes.
{mosads}The tobacco stick also sets the device apart from electronic cigarettes, which utilize a nicotine-laced liquid that allows users to inhale much stronger levels of nicotine and tobacco than a traditional cigarette.
FDA said allowing the device to be sold is “appropriate for the protection of the public health because … the products produce fewer or lower levels of some toxins than combustible cigarettes.”
The FDA review took nearly two years to complete, highlighting the public health debate over the device.
Harold Wimmer, president and CEO of the American Lung Association said the group is “deeply concerned” about the health impacts of the new product, and urged FDA to “carefully monitor how this product is actually being used — and by whom.”
The agency noted that even though the device is now legally allowed to be sold, “it does not mean these products are safe. All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue not to.”
Data suggest nonsmokers and kids won’t be attracted to iQOS, FDA said, but the agency placed stringent marketing restrictions on the products in an effort to prevent minors from using the device.
“We’ll be keeping a close watch on … how the company is marketing these products, and will take action as necessary to ensure the continued sale of these products in the U.S. remains appropriate,” said Mitch Zeller, director of FDA’s Center for Tobacco Products.
The device was cleared as a cigarette, which means no television or radio ads. In addition, online and social media advertising must also be aimed at adults.
Altria, which will sell the device in the U.S., also has to notify FDA about its labeling, advertising, marketing plans and how it plans to restrict youth access, advertising and promotions.
E-cigarettes like Juul do not currently have to meet those requirements, although FDA has proposed certain restrictions as the industry has come under fire for selling flavors that appeal to kids.
The Campaign for Tobacco Free Kids warned FDA not to let children become addicted to iQOS, noting that Philip Morris International has marketed the product abroad in ways that appeal to children.
“If the FDA fails to prevent such tactics in the U.S., there is a serious risk that IQOS will become the next Juul and worsen the current youth epidemic,” the group said.
PMI’s Chief Executive Officer André Calantzopoulos praised the agency’s decision, despite the restrictions.
“Today’s decision by FDA makes this opportunity available to American adult smokers. All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation. FDA’s announcement is a historic milestone,” Calantzopoulos said.
Altria will begin selling the devices in Atlanta beginning this summer. It will also open an iQOS retail store, as well as mobile stores. The tobacco sticks will be available in about 500 convenience stores.