FDA should not grant PMI's Premarket Tobacco Product Application for IQOS

On January 18, 2018, Goldman Sachs reported that the FDA is expected to approve Philip Morris International's "Premarket Tobacco Product Application" (PMTA) for IQOS as early as February. This application is different from the "Modified Risk Tobacco Product" (MRTP) that has been open for public comment and that is scheduled to be discussed at the TPSAC meeting on January 24-25 (assuming that the government is open then). The difference between a PMTA and an MRTP is that the PMTA is an application to sell IQOS in the United States whereas the MRTP application is a request to make health claims about the IQOS.

In both cases the law requires the FDA to determine that approving the application is “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole, considering both users and nonusers. Lacking this essential finding, FDA is required to deny the PMTA under section 910(c)(2)(A) of the Family Smoking Prevention and Tobacco Control Act.

Unlike the MRTP application, however, FDA is not required to solicit and consider public comments on the PMTA or even solicit TPSAC's advice on whether such an approval would be "appropriate for the protection of the public health."

We have submitted extensive public comments explaining why FDA should not approve PMI's MRTP application. All the same evidence applies to the PMTA.

While there is not a formal docket to express this concern (because FDA has not sought public comment on the IQOS PMTA), we have written to Center for Tobacco Products director Mitch Zeller urging FDA not to approve the application. The text of the letter appears below and a PDF of the letter, including all the attachments, is available here.

20 January 2018

Mr. Mitchell Zeller

Director, Center for Tobacco Products

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Re: Premarket Tobacco Product Application for IQOS System with Heatsticks

Dear Mr. Zeller:

The attached report from Goldman-Sachs suggests that FDA may make a decision on the Premarket Tobacco Product Application (PMTA) for Philip Morris’s IQOS System with Heatsticks as soon as February.

Although FDA has not set a formal procedure for the public to comment on the PMTA, we are submitting for FDA’s consideration the ten public comments that we submitted previously to the docket for the MRTP application for IQOS (attached). These comments are as relevant to the PMTA for IQOS as they are to the MRTPA.

As you know, a central requirement for issuing a PMTA order under section 910(c)(4) is a finding by the FDA that issuing a PMTA is “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole, considering both users and nonusers. This is the same standard required to issue a Modified Risk Tobacco Product (MRTP) order under section 911(g).

Taken together, these comments based on scientific evidence and analysis reach the conclusion that permitting IQOS to be marketed would not be “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole, considering both users and nonusers. Lacking this essential finding, FDA is required to deny the PMTA under section 910(c)(2)(A).

We urge you to carefully review these comments before taking any final action. Additionally, we urge FDA to refer the PMTA to the Tobacco Products Scientific Advisory Committee (TPSAC) (per section 910(b)(2)) and review TPSAC’s recommendations on the PMTA before taking final action.

Best wishes,

Stanton A. Glantz, PhD

Professor of Medicine

Truth Initiative Distinguished Professor of Tobacco Control

Director, Center for Tobacco Control Research and Education

Lauren Kass Lempert, JD, MPH

Law and Policy Specialist

Center for Tobacco Control Research and Education

Attachments:

Public comments submitted by UCSF concerning Philip Morris’s MRTP applications for IQOS
Goldman-Sachs report on IQOS