FDA advisory panel weighs alternative cigarette’s health claims

A Food and Drug Administration (FDA) advisory panel said Thursday that Philip Morris International had not proven that its new heat-not-burn cigarette can reduce the risk of tobacco-related diseases.

At an advisory hearing on the company’s application to market its new IQOS product as “less risky,” a majority of the FDA Tobacco Product Scientific Advisory Committee also said the company had not demonstrated that switching completely to the product presents less of a risk than continuing to smoke cigarettes.

{mosads}But the panel did rule 8-0 that switching completely from cigarettes to the IQOS system significantly reduces a person’s exposure to harmful or potentially harmful chemicals.

The rechargeable electronic device, which is already on the market in 25 countries, including Japan, heats a tobacco stick enough to release a nicotine vapor without burning the tobacco.

Because the tobacco is heated instead of burned, the company claims it cuts the harmful cancer-causing chemicals found in a combustible cigarette by 90 to 95 percent.

Philip Morris wanted to state on the product label and in advertising that “scientific studies have shown that switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases,” but the committee voted 8-0 that they had not demonstrated that’s actually true. 

The committee is charged with reviewing and evaluating tobacco products and will make a recommendation to FDA on whether to approve the company’s application to market the product as “lower-risk.”   

FDA has to first decide whether to grant or deny Philip Morris’s application to sell IQOS in the U.S.

If approved, the products will be marketed and sold by Altria Group, the parent company of Philip Morris USA, via a commercial agreement between the two companies.

In a statement, Philip Morris said it appreciates the “open, positive dialogue and the serious consideration” the committee showed in reviewing the complex science it presented with its modified-risk application.

“We are encouraged by the recognition of the risk reduction potential of IQOS that clearly emerged from the statements of the Committee members,” the company said.

“We are confident in our ability to address the valid questions raised by the Committee with the FDA as the review process for our application continues.”

Updated: 6:08 p.m.