Senators Urge FDA to Reject iQOS Application

WASHINGTON, D.C. — Ten federal lawmakers have come together to ask the Food and Drug Administration to reject Philip Morris International's (PMI) bid to market its heat-not-burn product as a modified risk tobacco product.

The senators voiced their concern around the tobacco company's Modified Risk Tobacco Product application for iQOS in a letter to the FDA's commissioner, Scott Gottlieb, according to Reuters.

The lawmakers included Elizabeth Warren (D-Mass.), Dick Durbin (D-Ill.) and Jack Reed (D-R.I.) and Richard Blumenthal (D-Conn.). In the letter they cited remarks from the agency's Tobacco Products Scientific Advisory Committee (TPSAC), which rejected PMI's reduced-risk claims for iQOS in a meeting at the end of January.

TPSAC's recommendation to the FDA is nonbinding.

They also referred to a Reuters report in December that identified shortcomings in the training and professionalism of some of the lead investigators in the clinical trials submitted to the FDA by the tobacco giant. Former Philip Morris employees and contractors also described irregularities in those experiments, according to the news outlet.

In the letter dated Feb. 7, the senators asked Gottlieb to "avoid rushing through new products, such as IQOS, to fit within this evolving FDA policy, without requiring strong evidence that any such product will reduce the risk of disease, result in a large number of smokers quitting, and not increase youth tobacco use."

PMI has also submitted a Premarket Tobacco Product application to the FDA.