FDA Begins Review of PMI's Heat-Not-Burn Product

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FDA Begins Review of PMI's Heat-Not-Burn Product


SILVER SPRING, Md. — The Food and Drug Administration (FDA) has begun its scientific review of Philip Morris International's (PMI) bid to bring its heat-not-burn product to the United States. 

On May 24, the agency published the executive summary and research summaries supporting PMI's Modified Risk Tobacco Product (MRTP). In connection, the FDA announced it will publish a notice in the Federal Register establishing a formal docket for public comments on the application at a later date.

PMI filed the MRTP application in December, as CSNews Online previously reported.

"We welcome FDA and public review of the comprehensive scientific evidence package that we submitted to the agency through its MRTP application process," said Moira Gilchrist, PMI's vice president Corporate Affairs of Reduced-Risk Products. 

"PMI's application demonstrates our commitment to develop innovative, smoke-free technologies that can ultimately replace combustible cigarettes to the benefit of smokers, public health and society at large," Gilchrist said. 

PMI followed the MRTP application with a Premarket Tobacco Product application (PMTA) in March. 

Upon regulatory approval of the PMTA by the FDA, Altria Group Inc.'s operating company Philip Morris USA (PM USA) has an exclusive license to sell the heat-not-burn product — known internationally as iQOS — in the United States.

In late 2013, PMI and Altria teamed up to establish a framework to commercialize reduced-risk products and electronic cigarettes.

Subsidiaries of the two tobacco companies entered into a series of agreements to address intellectual property licensing, regulatory engagement and contract manufacturing. Specifically:

  • Altria is providing PMI with an exclusive license to commercialize Altria's e-vapor products internationally.
  • PMI is providing Altria, on an exclusive basis, two of PMI's heated tobacco products for commercialization in the United States.
  • The companies are cooperating on scientific assessment, regulatory engagement and sharing improvements regarding those products.

In July 2015, the two tobacco leaders expanded that pact to include a joint research, development and technology-sharing agreement.

"PM USA is actively working on commercialization plans and we look forward to bringing this electronically heated product to the U.S. market. We are excited about the opportunity to add this product to our portfolio for adult tobacco consumers who are looking for an alternative to conventional cigarettes," said Sarah Knakmuhs, vice president of Heated Tobacco Products, PM USA.

To view PMI's application summaries, click here.

PMI is the world's leading international tobacco company, with six of the world's top 15 international brands and products sold in more than 180 markets. 

Richmond, Va.-based Altria's wholly owned subsidiaries include PM USA, U.S. Smokeless Tobacco Co. LLC, John Middleton Co., Sherman Group Holdings LLC, Nu Mark LLC, Ste. Michelle Wine Estates Ltd. and Philip Morris Capital Corp.