FDA permits sale of Philip Morris IQOS tobacco-heating alternative to cigarettes

(Reuters) – The U.S. Food and Drug Administration on Tuesday said it would allow Philip Morris to sell a heated tobacco product called IQOS in the United States, a major victory for the international tobacco giant as it looks to sell more alternatives to traditional cigarettes.

Following a review of about two years, the FDA determined that authorizing the device for sale in the U.S. market was “appropriate for the protection of public health” because the products produce “fewer or lower levels of some toxins than combustible cigarettes.”

Unlike combustible cigarettes, the IQOS devices heat tobacco-filled sticks wrapped in paper, which generates an aerosol that contains nicotine. They are different from e-cigarettes such as the popular Juul device, which vaporizes a nicotine-filled liquid.

Altria Group Inc, which sells Marlboro cigarettes in the United States, will market IQOS devices as part of a licensing agreement with Philip Morris International.

Altria Chairman and CEO Howard Willard said the IQOS will first be introduced in the Atlanta area. The move gives Altria yet another stake in a product designed as an alternative to traditional cigarettes, following its $12.8 billion deal in December to take a 35 percent stake in Juul Labs Inc.

André Calantzopoulos, CEO of Philip Morris International, called the FDA announcement a milestone. “All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation,” he said.

While Tuesday’s FDA decision allows Philip Morris to sell IQOS products, they must carry the same warning labels as traditional cigarettes. The FDA is still reviewing the company’s request to make claims that the products pose less of a health risk than cigarettes.

IQOS is currently available in Japan, South Korea, the United Kingdom and throughout much of Europe. Tuesday’s announcement by the FDA opens a huge market for the devices and the decision is likely to be cited by health regulators in other countries as Philip Morris expands distribution.

Philip Morris International has made the IQOS a centerpiece of what it is calling its “smoke-free future” initiative, which the company has promoted heavily in full-page newspaper advertisements in the United States and across the world.

Company executives have promoted the idea that non-combustible products such as IQOS will replace cigarettes and that the company is well positioned to help smokers switch to less harmful products.

Anti-smoking and public health advocates have criticized the campaign, asking why the company does not stop selling cigarettes altogether.

Last year Philip Morris International derived about 14 percent of its annual revenue from “reduced-risk products” such as IQOS.