NATO Summarizes TPSAC Decisions

Panel finalizes recommendations on PMI’s iQOS and HeatStick

MINNEAPOLIS -- In a public hearing conducted Jan. 24-25, the U.S. Food and Drug Administration’s (FDA's) Tobacco Product Scientific Advisory Committee (TPSAC) voted on several scientific recommendations for the FDA to consider in the agency’s ongoing review of New York-based Philip Morris International’s application for modified-risk tobacco product (MRTP) status of the company’s iQOS heat-not-burn product and Marlboro HeatSticks.

A modified-risk product is a tobacco product that reduces harm or the risk of tobacco-related disease. To obtain MRTP status, a manufacturer needs to file a MRTP application with the FDA for review and action. As a part of the MRTP process, TPSAC reviews and makes nonbinding recommendations to the FDA on the product.

After reviewing PMI's application for the iQOS product and Marlboro Heatsticks, the nine-member TSPAC panel voted during the public hearing as follows:

  • On a vote of 8 in favor and 1 against, TPSAC supported the claim that the iQOS product “significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
  • On a vote of 5 against and 3 in favor, with one member abstaining, the TPSAC panel stated that PMI had not proved that reducing harmful exposure would “translate to a measurable and substantial reduction in morbidity and mortality.”
  • On a vote of 8 against and 0 in favor, with one member abstaining, TPSAC did not support the claim that the iQOS product would reduce the risk for tobacco-related diseases.
  • On a close vote of 5 against and 4 in favor, a simple majority of TPSAC panel members did not support the claim that “switching completely to iQOS presents less risk of harm than continuing to smoke cigarettes.”

During the two-day hearing, company representatives described the iQOS product as a device into which compressed sticks of tobacco are inserted; then, upon depressing a button, the tobacco is heated to a temperature that produces an aerosol that contains nicotine. The tobacco does not heat to the point of combustion. While the representatives acknowledged that “iQOS emits toxicants and is not risk-free,” they said that “iQOS emits significantly lower levels of toxicants than regular cigarettes” and that “switching to iQOS can significantly reduce the risk of disease compared to regular smoking.”

During the second day of the hearing, 30 members of the public provided comments on the application. While a few people testified in opposition to the MRTP application, a significant majority of them, including several representatives from health organizations and a professor of public health sciences at a major university, urged TPSAC to recommend approval of the application so that current smokers would have a potentially safer alternative to cigarettes.

Because TPSAC is an advisory panel, the FDA may or may not accept its recommendations on an MRTP application. The FDA will now finalize its review of the application and issue a final decision on the iQOS product and Marlboro Heatsticks. While the MRTP application focuses only on whether PMI will be allowed to make a claim of reduced health risk, the company has also filed a premarket tobacco application with the FDA requesting an order to allow the sale of the iQOS product and Marlboro HeatSticks in the United States. A premarket tobacco application is separate from a MRTP application and seeks permission from the FDA to sell a new tobacco product that was not on the market as of Aug. 8, 2016, the date the FDA’s deeming regulations went into effect.

If the FDA does issue an order allowing the sale of the iQOS system and Marlboro HeatSticks, Philip Morris USA would then be the exclusive marketer and seller of the products in the United States.

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