The US FDA: MRTP

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May 2024:

FDA announced that a Tobacco Products Scientific Advisory Committee (TPSAC) meeting is scheduled on June 26, 2024 to discuss the renewal of risk modification order submitted by Swedish Match USA (a fully-owned affiliate of Philip Morris International) for eight General loose snus and portioned snus products: 

– General Loose

– General Dry Mint Portion Original Mini

– General Portion Original Large

– General Classic Blend Portion White Large (12 ct)

– General Mint Portion White Large

– General Nordic Mint Portion White Large (12 ct)

– General Portion White Large

– General Wintergreen Portion White Large

At the TPSAC meeting, additional discussion about broader MRTP program developments, related to the conceptualization and measurement of consumer understanding, will also take place. 

PMI submitted the MRTP renewal application for General Snus in July 2023 and the MRTP renewal due date is October 2024. The most critical point to watch out will be the TPSAC’s recommendation on the 4 Mint / Wintergreen variants and whether (or not) the risk modification orders will eventually be renewed for these variants.

PMI also submitted the MRTP renewal application for IQOS3 in July 2023 (- MRTP renewal due date: July 2024).

November 2023:

US FDA announced the filling of MRTP renewal applications submitted by PMI/Swedish Match (for the 8 General Snus smokeless tobacco products, including 4 Mint/Wintergreen variants) for scientific review. US FDA granted these modified risk orders in 2019 and, to continue marketing the MRTPs after the authorized five-year term, PMI/SWMA submitted an MRTP renewal application.

Starting tomorrow, the public may submit comments on these applications. Once all materials for these MRTP applications, including amendments, have been made publicly available, FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials.

PMI submitted the MRTP renewal application for IQOS3 and General Snus in July 2023. MRTP renewal due date is July 2024 for IQOS3 and October 2024 for General Snus.

Background:

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 whole1.

16 MRTP orders are granted so far.

– 13 of these belong to PMI: 5 for IQOS (heat-not-burn tobacco) and 8 for General Snus (owned through the Swedish Match acquisition)

– 2 belong to the 22nd Century Group for regular/menthol very low nicotine cigarettes

– In March 2023, FDA authorized Altria (UST) to market Copenhagen Classic Snuff as a MRTP with the claim: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer”.

References:

  1. https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-tobacco-products ↩︎

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