Philip Morris Allowed to Label IQOS as Reducing Harmful Exposure

Jul 7, 2020

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(Bloomberg) -- Philip Morris International Inc. can market its IQOS products as reducing consumers’ exposure to harmful chemicals found in cigarettes, the U.S. Food and Drug Administration said Tuesday.

IQOS heats tobacco rather than burning it, a process seen as less harmful than smoking conventional cigarettes. The FDA last year allowed IQOS, which is an electronic device that uses a tobacco plug, to be sold in the U.S. while it reviewed Philip Morris’ modified-risk product application.

The FDA on Tuesday said that available evidence shows the IQOS system produces less harmful and potentially harmful chemicals. The agency cited scientific studies showing that switching completely from conventional cigarettes to the IQOS system significantly reduces exposure to such chemicals.

“Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch,” Mitch Zelle, director of the FDA’s Center for Tobacco Products, said in a statement.

The agency stopped short of allowing IQOS to be marketed as reducing health risks associated with cigarette smoking, saying evidence did not support the claims Philip Morris proposed. Still, the decision gives IQOS an advantage in trying to lure customers away from cigarettes over other alternatives like e-cigarettes, which cannot make such claims without the FDA’s permission.

The FDA stressed the decision does not mean IQOS products are safe, rather they can be a less harmful alternative for people who completely switch from cigarettes.

Altria Group Inc., which sells Marlboro products in the U.S., is marketing IQOS in the country through an agreement with PMI, which sells Marlboro products in other countries. Sales of IQOS began in Atlanta last fall before being introduced into a handful of other markets.

Morgan Stanley analyst Pamela Kaufman said in a note to clients that the decision is a positive development -- but the relatively limited scope of the FDA’s designation could limit broader adoption of IQOS in the U.S.

Philip Morris International and Altria did not immediately respond to requests for comment.

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