Altria & PMI Move Closer to Bringing Heat-Not-Burn to U.S.

RICHMOND, Va. — Three years after beginning a partnership around alternative tobacco products, Altria Group Inc. and Philip Morris International (PMI) are preparing to bring the heat-not-burn product iQOS to the United States.

During Altria's third-quarter earnings call on Oct. 27, Chairman, CEO and President Marty Barrington said the company continues to work with PMI on its iQOS application for the Food and Drug Administration (FDA). PMI recently announced that it remains on track to submit a modified risk tobacco product application to the agency by the end of this year, with a pre-market tobacco product application following early next year. 

PMI has already launched iQOS in other global markets.

"At Altria, we continue to make progress on our commercialization strategies for the U.S. market. We're excited about this opportunity and are working closely with PMI to incorporate insights from other iQOS markets," Barrington said. 

In other alternative tobacco product news, Altria's e-vapor arm Nu Mark LLC is continuing its rollout of MarkTen XL. According to Barrington, Nu Mark has been focused on preparing for the FDA's deeming rule and positioning itself to succeed in the new regulatory environment. 

"[Nu Mark] has a pipeline of promising e-vapor products and it continues to enhance its infrastructure and systems to move those products through the required regulatory approval processes," the chief excecutive said.

The FDA's deeming rule — which extends the agency's regulatory authority to now cover all tobacco products including electronic cigarettes, cigars, hookah tobacco and pipe tobacco — went into effect Aug. 8. The agency released the final deeming rule on May 5, as CSNews Online previously reported.

Barrington reported that all of Altria's tobacco products are now regulated by the FDA. 

"For us and others in the industry, this means greater regulatory complexity and more resource commitment. For the agency, this also means more work and the need to make progress on the existing backlog of substantial equivalents in new product applications, particularly as it prepares for a large volume of applications for newly deemed products," he explained. 

According to the executive, the agency now appears to be resourced and staffed, which is reflected in the increased pace of its work across all regulated segments. 

"Our strategy continues to be to focus on complying with the requirements of the act, while engaging constructively with the FDA to urge sensible interpretations consistent with the act," Barrington said. "We also are encouraging FDA to promote good public policy like harm reduction, and to create a regulatory environment that fosters innovation. Through this approach, we aim to maintain a constructive relationship with FDA while protecting the rights of adult tobacco consumers and other important stakeholders."

Richmond-based Altria Group is the parent company for Philip Morris USA, John Middleton, U.S. Smokeless Tobacco Co., Nu Mark and Ste. Michele Wine Estates. Altria also holds a continuing economic and voting interest in SABMiller. The brand portfolios of Altria's tobacco operating companies include Marlboro, Black & Mild, Copenhagen, Skoal, MarkTen and Green Smoke.