Five anti-smoking groups are criticizing the U.S. Food and Drug Administration (FDA) for authorizing Philip Morris’ marketing of a new “heated cigarette” as a “modified risk tobacco product” despite acknowledging that the company failed to show that the product has a lower risk of tobacco-related diseases.
The Campaign for Tobacco-Free Kids, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Truth Initiative also criticized the FDA for not requiring Philip Morris to provide evidence that the product’s marketing will not appeal to children.
The IQOS system heats tobacco within the IQOS device generating a nicotine-containing aerosol, the FDA said. Because the system heats the tobacco without burning it, evidence suggests the system significantly reduces the production of harmful chemicals in the smoke. The FDA noted that scientific studies have shown that switching from conventional cigarettes to the IQOS system reduces one’s exposure to harmful or potentially harmful chemicals.
In a statement to the FDA, the organizations said, in authorizing the product, the FDA has created a “real danger that kids and adults will falsely believe IQOS has been proven to present a lower health risk and that kids will be exposed to marketing that portrays IQOS, a highly addictive tobacco product, as an appealing, cool alternative to cigarettes, in much the same way as e-cigarettes.”
“In its decision, the FDA acknowledges that the impact on youth of allowing IQOS to be marketed as a modified risk product is ‘unclear,’” the letter from the groups said. “Such doubts should be resolved by protecting our kids, not by making them guinea pigs in a Philip Morris marketing experiment. The last thing we need is yet another tobacco product that addicts kids and misleads consumers about health risks.”
In its statement, the FDA said its goal is to ensure accurate information about reduced-risk or reduced exposure that is backed up by facts, is presented to consumers.
“Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch. 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.”
The FDA also said it would “closely monitor real-world data” to ensure the marketing is appropriate.
The organizations said in comments to the FDA during Philip Morris’ application process that the company failed to demonstrate that the modified risk claims would not increase tobacco use by non-users and youth, or that the marketing would only target adult smokers.
“The FDA should have denied Philip Morris’ application in its entirety because of the company’s failure to provide sufficient scientific evidence to support its claims and to demonstrate that the product will not be marketed in ways that appeal to kid,” the organizations said.