The US FDA: MRTP

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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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