IQOS USA: FDA Review

Share on facebook
Share on twitter
Share on email
Share on whatsapp
Share on linkedin

October 2023

Projecting a faster path to the break-even in the USA with IQOS ILUMA, Philip Morris International (PMI) will refrain from investing heavily on the initial US launch that will take place with (the old generation) IQOS3 device (internal heating with a blade). IQOS ILUMA (without a blade) uses induction to heat tobacco within.

Earning the IQOS ILUMA marketing order from US FDA is the prerequisite for the major geographic expansion and commercial investment uplift for the IQOS franchise in the US. In October 2023, PMI submitted PMTAs (seeking right to market) and MRTP Applications (seeking reduced exposure claim) to the US FDA for three IQOS ILUMA devices and five TEREA heated tobacco stick variants. PMI has 8 granted marketing orders (PMTA approvals) so far and is applying for 8 new ones (- see the summary below).

It took 718 days on average (from submission to decision) for the US FDA to complete the IQOS PMTA reviews. The only exception is IQOS 3 PMTA, whose review took only 252 days on the basis that changes in the device architecture (vis-à-vis the 2.4 version) was mostly relating to the physical appearance. However, this is not the case for the current submissions as IQOS ILUMA products rely on a fundamentally different heating system and contain numerous technological improvements. Thereby, US FDA review of the current IQOS PMTAs is likely to take 18-24 months (decision in July 2025 – Jan 2026). This explains PMI’s revised guidance on IQOS ILUMA launch timeline: in the second half of the 2024-26 forecast period (i.e. H2 2025 or later).

July 2023

Although the US FDA’s marketing order (PMTA approval) doesn’t have an expiration date in terms of placing a product to the market, its authorization for modified risk tobacco product (MRTP) claim has a set expiration date – which is July 2024 for the “reduced exposure” claim of IQOS. In anticipation of the expiry, PMI submitted a renewal request to the US FDA. This is the first-ever renewal request for a MRTP claim and contains the additional evidence (new data) collected on IQOS globally since the FDA’s original authorization in July 2020.

January 2023

US FDA grants marketing order (PMTA approval) to Marlboro Sienna, Marlboro Bronze and Marlboro Amber heatsticks. PMI submitted the PMTA for these products in December 2020.

March 2022

US FDA grants modified risk order to IQOS3 system (IQOS3 Holder & Charger). PMI submitted the IQOS3 MRTP Application in March 2021.

December 2020

US FDA grants marketing order to IQOS3 system (IQOS3 Holder & Charger). In both IQOS3 and IQOS2.4 system, the tobacco substrate (“heatstick”) is heated internally through a ceramic sensor blade – which simultaneously heats tobacco and monitors the tobacco temperature to ensure a consistent taste delivery and avoid burning the tobacco. PMI submitted the IQOS3 PMTA in March 2020.

July 2020

US FDA grants modified risk order to IQOS2.4 system (IQOS2.4 Holder & Charger), Marlboro Fresh Menthol, Marlboro Smooth Menthol and Marlboro (Red) heatsticks. PMI submitted the MRTP Applications for these products in November 2016.

According to the US FDA’s decision summary, scientific review has demonstrated that:

– the IQOS system heats tobacco but does not burn it

– this significantly reduces the production of harmful and potentially harmful chemicals (HPHCs)

– switching completely from conventional cigarettes to the IQOS system significantly reduces body’s exposure to HPHCs.

Thereby, US FDA grants IQOS “Exposure Modification” order. At the same time, US FDA rejects PMI’s “Risk Modification” order request noting that

“Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system can reduce the risks of tobacco‐related diseases” and “Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes” are not substantiated claims.

April 2019

US FDA grants marketing order to IQOS2.4 system (IQOS2.4 Holder & Charger), Marlboro Fresh Menthol, Marlboro Smooth Menthol and Marlboro (Red) heatsticks. PMI submitted the PMTA for these products in May 2017.

According to the US FDA’s decision summary, scientific review has demonstrated that:

– There are adequate process controls and quality assurance procedures in place to help ensure that these products are manufactured consistently to meet product specifications

– Although some of the chemicals found in the product aerosols are genotoxic or cytotoxic, these chemicals are present in very low levels and potential effects are outweighed by the substantial decrease in the number & levels of HPHCs found in cigarettes

– Toxicological profiles of the stick variants are essentially identical except for the quantity of menthol. The available toxicological data indicates the potential for a relative benefit for smokers who switch completely to IQOS

– Smooth Menthol contains 6.98 mg menthol/stick. Fresh Menthol contains 13.23 mg menthol/stick (versus 2.9-19.5 mg menthol/stick in a set of 23 menthol cigarette brands in the US)

– Pharmacokinetics (PK) studies indicate that these products have nicotine delivery, addiction potential, and abuse liability similar to cigarettes: potentially beneficial for smokers to switch to IQOS (i.e “satisfying”) while posing an addiction risk (for non-tobacco users) not higher than currently available tobacco products (i.e. initiation is expected to be low)

– The 5-day studies demonstrate improved biomarkers of exposure (BOE) and, thereby, reduced HPHC exposures; improvement trends persist in the 90-day and six-month studies

– Although the studies do not demonstrate reduction in long-term disease risks, the currently available evidence indicates smokers who switch completely to IQOS will have reduced toxic exposures and, likely, have less risk of tobacco-related diseases (data less conclusive for dual users of IQOS and cigarettes)

– No specific, immediate health-related issues or product quality issues. Uncommon & unlikely misuse.

Background Information

A Pre-market Tobacco Product Application (PMTA) is submitted to obtain FDA Marketing Order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.

A Modified Risk Tobacco Product (MRTP) application is submitted to obtain FDA Modified Risk Order. The application must demonstrate that the product will benefit the health of the population as a whole.

Call Request:
Reports

We will reach out to you within 24 hours to discuss your request. Please note that we only respond to requests with a valid business e-mail address
Disclaimer: The content in our Market Pulse section is/shall not be construed as investment advice. It is for informative purposes only and does not take into account the individual needs, investment objectives and specific financial circumstances. Any action taken upon the information in our Market Pulse section is strictly at the reader’s own risk. We assume no responsibility or liability for the actions taken. Moreover, we also assume no responsibility or liability for any errors or omissions in our content – which is provided on an “as is” basis with no guarantees of completeness, accuracy, usefulness or timeliness even if we only depend on the infromation sources that are believed to be accurate.

Consultation
Session Request

We will reach out to you within 24 hours to discuss your request. Please note that we only respond to requests with a valid business e-mail address