FDA Tobacco Products Scientific Advisory Committee should recommend against FDA allowing Philip Morris Products continuing to make misleading reduced risk claims about IQOS

FDA has scheduled a virtual meeting of its Tobacco Products Scientific Advisory Committee (TPSAC) meeting for October 7, 2025, to discuss the modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products that is happening despite the government shutdown. (Participants can attend via a live webcast.) This meeting is required by law if FDA is to move forward on allowing Philip Morris to continue to make reduced exposure claims about IQOS.

FDA has posted draft questions the it has asked TPSAC which themselves raise questions that TPSAC and the public should be asking the FDA.

First, the FDA should be asked why it is focusing the health risk assessment of IQOS on its badly outdated more than decade old (2012) list of harmful and potentially harmful compounds (HPHC list) which is heavily based on combustion products that cigarettes produce and does not include important toxicants that IQOS and other heated tobacco products produce.

The fact that FDA is using the outdated list is even more concerning because in 2019 FDA proposed adding 19 compounds to the list that includes important toxins in new heated tobacco products including IQOS, notably polypropylene glycol, but never finalized the updated list. This is very important because using the old list severely biases the risk assessments to underestimate risks for noncombusted products including IQOS.

Fortunately, there is nothing that limits FDA to using the old list, so they they should be pressed on the implications of the new list and that they update the risk assessment and assessment of Philip Morris Products’ statements for IQOS.

Second, the FDA needs to be questioned about still-relevant earlier comments (from 2021) from health groups, including UCSF. on IQOS MRTP (with links): .  The earlier comments on IQOS, particularly consumer misunderstanding of interpreting reduced exposure claims as reduced risk claims, are particularly relevant now.

The FDA has posted all the public comments it has received so far. Not surprisingly, most are from industry allies supporting Philip Morris, but two are from health advocates.

Tobacco Free Kids makes several important points (from page 20 through page 148, including all the supporting materials, of the PDF that includes all the public comments) and recommends against approving Philip Morris’ application:

As detailed below, PMI has failed to meet the statutory standard for renewal of its MRGOs [modified risk granted orders] for the following reasons:

1. Independent research since issuance of the original MRGO shows that the reduced
   exposure message is misinterpreted by consumers.
2. PMI’s repeated misleading and deceptive statements regarding the orders fuel public
   misunderstanding about IQOS.
3. Independent studies published since the MRGOs contradict PMI’s claims about IQOS use patterns, do not show that heated tobacco products (“HTPs”) like IQOS provide a
   population-wide public health benefit, and raise doubts about potential individual benefits.
4. PMI’s marketing and promotion of IQOS appeals to young people rather than its purported target population, existing adult smokers.
5. FDA’s conclusions supporting a prohibition on menthol cigarettes contradict any
   justification for renewal of the MRGOs for the menthol-flavored IQOS products.

The New York City Department of Health and Mental Hygiene also recommends against renewing authorization to make reduced exposure statements (pages 149-153 of PDF).

(The fact that the Trump Administration is moving forward with this meeting now suggests that they want to give PM what it wants, since the Administration is shutting down things it doesn’t like.)

Hopefully, TPSAC will move beyond just “answering FDA’s questions” and use the strong evidentiary record to recommend against Philip Morris being authorized to continue making misleading statements about IQOS.

All the meeting materials, including a draft agenda, backgrounders from Philip Morris Products S.A. and FDA, and draft questions to the committee—are available on the 2025 TPSAC Meeting Materials and Information page.