FDA Committee Rejects iQOS Modified-Risk Claim

Regulators will review recommendation, consider PMI’s reduced-risk arguments

WASHINGTON -- A committee advising the U.S. Food and Drug Administration (FDA) has denied a landmark effort by a major tobacco company to label a new product as less harmful or "modified risk."

Philip Morris International (PMI) wants to market its heat-not-burn smoking alternative called iQOS as a modified-risk or lower-risk alternative to combustible cigarettes. The committee's denial of the request creates a level of uncertainty as to how the tobacco company will move ahead with the device in the U.S. market.

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) met on Jan. 24 to hear and review arguments and research data from New York-based PMI and issued decisions on specific claims on PMI’s modified-risk tobacco product (MRTP) application on Jan. 25.

As of midday Jan. 25, the committee voted against the reduced-risk claim, 8-0, with one abstention. The panel also rejected a claim that iQOS is less risky than continuing to smoke cigarettes in a 5-4 vote, according to CNBC.

The committee voted 8-1 in favor of Philip Morris’ claim that iQOS reduces the body’s exposure to harmful or potentially harmful chemicals.

Philip Morris' stock price fell 1.4% on the news; shares of Richmond, Va.-based Altria, which would receive sole distribution for iQOS, if approved, were down 1.3%, CNBC reported.

The panel is scheduled to make a recommendation to the FDA on whether to approve PMI’s MRTP application for the iQOS system sometime soon. The decision is only a recommendation, so the FDA is not required to follow it.

The panel is scheduled to vote on several additional measures throughout Jan. 25.

These modified-risk decisions are separate from the larger, more general application PMI has with the FDA to market and sell iQOS in the United States, also known as its premarket tobacco product (PMTP) application. The timing on that PMTP decision is expected in February.

While the FDA still has to review the committee’s decision, industry observers have been predicting the agency will agree with the TPSAC’s verdict. Prior to the TPSAC rulings, PMI officials were optimistic about receiving TPSAC validation, which PMI requested in December 2016.

“PMI’s extensive regulatory filings for iQOS present a compelling case for the product’s harm-reduction potential,” said Sarah Knakmuhs, vice president of Philip Morris USA’s Heated Tobacco Products group, Richmond, Va., in public comments made last year. “For example, the research demonstrates that iQOS reduces levels of 18 harmful and potentially harmful constituents identified by the FDA by over 90% and reduces levels of 15 known carcinogens by more than 95% vs. conventional cigarettes.”

If the FDA ultimately rules in favor of allowing iQOS to be marketed as a lower-risk alternative to cigarettes, it would mark the first time the FDA has ever allowed a tobacco product to market itself as reduced harm and would set the standard for what’s required of MRTP applications moving forward.

“They’re going to be very active in this reduced-risk space in the next couple years,” Nik Modi, a tobacco analyst for RBC Capital Markets/Equity Research, New York, said of Altria.

Word on PMI’s general PMTA is expected next month. It was originally submitted to the FDA in March 2017 and accepted for scientific review in August. By the agency’s own guidelines, a decision should be made within 180 days of that acceptance.

In terms of the product itself, Philip Morris and Altria Group Inc. have provided plenty of information about its global performance. During an investor’s call in November 2017, Altria shared that iQOS sales have topped $1 billion in the 30 global markets where it has launched.

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